Skip to content
Triangle logo TriangleGet started
← Back to this collection

LABELS · 228e1e3f-d207-481f-8e14-9fdcbd0470e9

KEYTRUDA

Open original source → · Download preserved record

Preserved label snapshot, not confirmation of a current approved indication. Approval/withdrawal status must be checked for the exact disease, setting and regimen.

Label effective date
2026-07-10
Captured
2026-09-09T23:37:42.544548+00:00
Current indication reconciliation
Not reconciled

Indications and usage: exact source text

  1. 1 INDICATIONS AND USAGE KEYTRUDA is a programmed death receptor-1 (PD-1)-blocking antibody indicated: Melanoma for the treatment of patients with unresectable or metastatic melanoma. ( 1.1 ) for the adjuvant treatment of adult and pediatric (12 years and older) patients with Stage IIB, IIC, or III melanoma following complete resection. ( 1.1 ) Non-Small Cell Lung Cancer (NSCLC) in combination with pemetrexed and platinum chemotherapy, as first-line treatment of patients with metastatic nonsquamous NSCLC, with no EGFR or ALK genomic tumor aberrations. ( 1.2 ) in combination with carboplatin and either paclitaxel or paclitaxel protein-bound, as first-line treatment of patients with metastatic squamous NSCLC. ( 1.2 ) as a single agent for the first-line treatment of patients with NSCLC expressing PD-L1 [Tumor Proportion Score (TPS) ≥1%] as determined by an FDA-authorized test, with no EGFR or ALK genomic tumor aberrations, and is: Stage III where patients are not candidates for surgical resection or definitive chemoradiation, or metastatic. ( 1.2 , 2.1 ) as a single agent for the treatment of patients with metastatic NSCLC whose tumors express PD-L1 (TPS ≥1%) as determined by an FDA-authorized test, with disease progression on or after platinum-containing chemotherapy. Patients with EGFR or ALK genomic tumor aberrations should have disease progression on FDA-approved therapy for these aberrations prior to receiving KEYTRUDA. ( 1.2 , 2.1 ) for the treatment of patients with resectable (tumors ≥4 cm or node positive) NSCLC in combination with platinum-containing chemotherapy as neoadjuvant treatment, and then continued as a single agent as adjuvant treatment after surgery. ( 1.2 ) as a single agent, for adjuvant treatment following resection and platinum-based chemotherapy for adult patients with Stage IB (T2a ≥4 cm), II, or IIIA NSCLC. ( 1.2 ) Malignant Pleural Mesothelioma (MPM) in combination with pemetrexed and platinum chemotherapy, as first-line treatment of adult patients with unresectable advanced or metastatic MPM. ( 1.3 ) Head and Neck Squamous Cell Cancer (HNSCC) for the treatment of adult patients with resectable locally advanced HNSCC whose tumors express PD-L1 [Combined Positive Score (CPS) ≥1] as determined by an FDA-authorized test, as a single agent as neoadjuvant treatment, continued as adjuvant treatment in combination with radiotherapy (RT) with or without cisplatin and then as a single agent. ( 1.4 ) in combination with platinum and FU for the first-line treatment of patients with metastatic or with unresectable, recurrent HNSCC. ( 1.4 ) as a single agent for the first-line treatment of patients with metastatic or with unresectable, recurrent HNSCC whose tumors express PD-L1 [Combined Positive Score (CPS) ≥1] as determined by an FDA-authorized test. ( 1.4 , 2.1 ) as a single agent for the treatment of patients with recurrent or metastatic HNSCC with disease progression on or after platinum-containing chemotherapy. ( 1.4 ) Classical Hodgkin Lymphoma (cHL) for the treatment of adult patients with relapsed or refractory cHL. ( 1.5 ) for the treatment of pediatric patients with refractory cHL, or cHL that has relapsed after 2 or more lines of therapy. ( 1.5 ) Primary Mediastinal Large B-Cell Lymphoma (PMBCL) for the treatment of adult and pediatric patients with refractory PMBCL, or who have relapsed after 2 or more prior lines of therapy. ( 1.6 ) Limitations of Use : KEYTRUDA is not recommended for treatment of patients with PMBCL who require urgent cytoreductive therapy. Urothelial Cancer in combination with enfortumab vedotin-ejfv, for the treatment of adult patients with locally advanced or metastatic urothelial cancer. ( 1.7 ) as a single agent for the treatment of patients with locally advanced or metastatic urothelial carcinoma who: are not eligible for any platinum-containing chemotherapy, or who have disease progression during or following platinum-containing chemotherapy or within 12 months of neoadjuvant or adjuvant treatment with platinum-containing chemotherapy. ( 1.7 ) in combination with enfortumab vedotin-ejfv, as neoadjuvant treatment and then continued after cystectomy as adjuvant treatment of adult patients with muscle invasive bladder cancer (MIBC). ( 1.7 ) as a single agent for the treatment of patients with Bacillus Calmette-Guerin (BCG)-unresponsive, high-risk, non-muscle invasive bladder cancer (NMIBC) with carcinoma in situ (CIS) with or without papillary tumors who are ineligible for or have elected not to undergo cystectomy. ( 1.7 ) Microsatellite Instability-High or Mismatch Repair Deficient Cancer for the treatment of adult and pediatric patients with unresectable or metastatic microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) solid tumors, as determined by an FDA-authorized test, that have progressed following prior treatment and who have no satisfactory alternative treatment options. ( 1.8 , 2.1 ) Microsatellite Instability-High or Mismatch Repair Deficient Colorectal Cancer (CRC) for the treatment of patients with unresectable or metastatic MSI-H or dMMR colorectal cancer (CRC) as determined by an FDA-authorized test. ( 1.9 , 2.1 ) Gastric Cancer in combination with trastuzumab, fluoropyrimidine- and platinum-containing chemotherapy, for the first-line treatment of adults with locally advanced unresectable or metastatic HER2-positive gastric or gastroesophageal junction (GEJ) adenocarcinoma whose tumors express PD-L1 (CPS ≥1) as determined by an FDA-authorized test. ( 1.10 ) in combination with fluoropyrimidine- and platinum-containing chemotherapy, for the first-line treatment of adults with locally advanced unresectable or metastatic HER2-negative gastric or gastroesophageal junction (GEJ) adenocarcinoma whose tumors express PD-L1 (CPS ≥1) as determined by an FDA-authorized test. ( 1.10 ) Esophageal Cancer for the treatment of patients with locally advanced or metastatic esophageal or gastroesophageal junction (GEJ) (tumors with epicenter 1 to 5 centimeters above the GEJ) carcinoma that is not amenable to surgical resection or definitive chemoradiation either: in combination with platinum- and fluoropyrimidine-based chemotherapy for patients whose tumors express PD-L1 (CPS ≥1) as determined by an FDA-authorized test, or as a single agent after one or more prior lines of systemic therapy for patients with tumors of squamous cell histology that express PD-L1 (CPS ≥10) as determined by an FDA-authorized test. ( 1.11 , 2.1 ) Cervical Cancer in combination with chemoradiotherapy, for the treatment of patients with locally advanced cervical cancer involving the lower third of the vagina, with or without extension to pelvic sidewall, or hydronephrosis/non-functioning kidney, or spread to adjacent pelvic organs (FIGO 2014 Stage III-IVA). ( 1.12 ) in combination with chemotherapy, with or without bevacizumab, for the treatment of patients with persistent, recurrent, or metastatic cervical cancer whose tumors express PD-L1 (CPS ≥1) as determined by an FDA-authorized test. ( 1.12 , 2.1 ) as a single agent for the treatment of patients with recurrent or metastatic cervical cancer with disease progression on or after chemotherapy whose tumors express PD-L1 (CPS ≥1) as determined by an FDA-authorized test. ( 1.12 , 2.1 ) Hepatocellular Carcinoma (HCC) for the treatment of patients with HCC secondary to hepatitis B who have received prior systemic therapy other than a PD-1/PD-L1-containing regimen. ( 1.13 ) Biliary Tract Cancer (BTC) in combination with gemcitabine and cisplatin, for the treatment of patients with locally advanced unresectable or metastatic biliary tract cancer. ( 1.14 ) Merkel Cell Carcinoma (MCC) for the treatment of adult and pediatric patients with recurrent locally advanced or metastatic Merkel cell carcinoma. ( 1.15 ) Renal Cell Carcinoma (RCC) in combination with axitinib, for the first-line treatment of adult patients with advanced RCC. ( 1.16 ) in combination with lenvatinib, for the first-line treatment of adult patients with advanced RCC. ( 1.16 ) for the adjuvant treatment of patients with RCC at intermediate-high or high risk of recurrence following nephrectomy, or following nephrectomy and resection of metastatic lesions. ( 1.16 ) in combination with belzutifan, for the adjuvant treatment of adult patients with RCC with a clear cell component (ccRCC) at intermediate-high or high risk of recurrence following nephrectomy, or following nephrectomy and resection of metastatic lesions. ( 1.16 ) Endometrial Carcinoma in combination with carboplatin and paclitaxel, followed by KEYTRUDA as a single agent, for the treatment of adult patients with primary advanced or recurrent endometrial carcinoma. ( 1.17 ) in combination with lenvatinib, for the treatment of adult patients with advanced endometrial carcinoma that is mismatch repair proficient (pMMR) or not MSI-H as determined by an FDA-authorized test, who have disease progression following prior systemic therapy in any setting and are not candidates for curative surgery or radiation. ( 1.17 , 2.1 ) as a single agent, for the treatment of adult patients with advanced endometrial carcinoma that is MSI-H or dMMR, as determined by an FDA-authorized test, who have disease progression following prior systemic therapy in any setting and are not candidates for curative surgery or radiation. ( 1.17 , 2.1 ) Tumor Mutational Burden-High (TMB-H) Cancer for the treatment of adult and pediatric patients with unresectable or metastatic tumor mutational burden-high (TMB-H) [≥10 mutations/megabase (mut/Mb)] solid tumors, as determined by an FDA-authorized test, that have progressed following prior treatment and who have no satisfactory alternative treatment options. 1 ( 1.18 , 2.1 ) Limitations of Use : The safety and effectiveness of KEYTRUDA in pediatric patients with TMB-H central nervous system cancers have not been established. Cutaneous Squamous Cell Carcinoma (cSCC) for the treatment of patients with recurrent or metastatic cSCC or locally advanced cSCC that is not curable by surgery or radiation. ( 1.19 ) Triple-Negative Breast Cancer (TNBC) for the treatment of patients with high-risk early-stage TNBC in combination with chemotherapy as neoadjuvant treatment, and then continued as a single agent as adjuvant treatment after surgery. ( 1.20 ) in combination with sacituzumab govitecan-hziy, for the first-line treatment of adult patients with unresectable locally advanced or metastatic TNBC whose tumors express PD-L1 (CPS ≥10) as determined by an FDA-authorized test. ( 1.20 , 2.1 ) in combination with chemotherapy, for the treatment of patients with locally recurrent unresectable or metastatic TNBC whose tumors express PD-L1 (CPS ≥10) as determined by an FDA-authorized test. ( 1.20 , 2.1 ) Ovarian Cancer in combination with paclitaxel, with or without bevacizumab, for the treatment of adult patients with platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal carcinoma whose tumors express PD-L1 (CPS ≥1) as determined by an FDA-authorized test, and who have received one or two prior systemic treatment regimens. ( 1.21 , 2.1 ) 1 This indication is approved under accelerated approval based on tumor response rate and durability of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trials. 1.1 Melanoma KEYTRUDA ® is indicated for the treatment of patients with unresectable or metastatic melanoma. KEYTRUDA is indicated for the adjuvant treatment of adult and pediatric (12 years and older) patients with Stage IIB, IIC, or III melanoma following complete resection. 1.2 Non-Small Cell Lung Cancer KEYTRUDA, in combination with pemetrexed and platinum chemotherapy, is indicated for the first-line treatment of patients with metastatic nonsquamous non-small cell lung cancer (NSCLC), with no EGFR or ALK genomic tumor aberrations. KEYTRUDA, in combination with carboplatin and either paclitaxel or paclitaxel protein-bound, is indicated for the first-line treatment of patients with metastatic squamous NSCLC. KEYTRUDA, as a single agent, is indicated for the first-line treatment of patients with NSCLC expressing PD-L1 [Tumor Proportion Score (TPS) ≥1%] as determined by an FDA-authorized test [see Dosage and Administration (2.1) ] , with no EGFR or ALK genomic tumor aberrations, and is: Stage III where patients are not candidates for surgical resection or definitive chemoradiation, or metastatic. KEYTRUDA, as a single agent, is indicated for the treatment of patients with metastatic NSCLC whose tumors express PD-L1 (TPS ≥1%) as determined by an FDA-authorized test [see Dosage and Administration (2.1) ] , with disease progression on or after platinum-containing chemotherapy. Patients with EGFR or ALK genomic tumor aberrations should have disease progression on FDA-approved therapy for these aberrations prior to receiving KEYTRUDA. KEYTRUDA is indicated for the treatment of patients with resectable (tumors ≥4 cm or node positive) NSCLC in combination with platinum-containing chemotherapy as neoadjuvant treatment, and then continued as a single agent as adjuvant treatment after surgery. KEYTRUDA, as a single agent, is indicated as adjuvant treatment following resection and platinum-based chemotherapy for adult patients with Stage IB (T2a ≥4 cm), II, or IIIA NSCLC. 1.3 Malignant Pleural Mesothelioma KEYTRUDA, in combination with pemetrexed and platinum chemotherapy, is indicated for the first-line treatment of adult patients with unresectable advanced or metastatic malignant pleural mesothelioma (MPM). 1.4 Head and Neck Squamous Cell Cancer KEYTRUDA is indicated for the treatment of adult patients with resectable locally advanced HNSCC whose tumors express PD-L1 [Combined Positive Score (CPS) ≥1] as determined by an FDA-authorized test [see Dosage and Administration (2.1) ] , as a single agent as neoadjuvant treatment, continued as adjuvant treatment in combination with radiotherapy (RT) with or without cisplatin and then as a single agent. KEYTRUDA, in combination with platinum and fluorouracil (FU), is indicated for the first-line treatment of patients with metastatic or with unresectable, recurrent head and neck squamous cell carcinoma (HNSCC). KEYTRUDA, as a single agent, is indicated for the first-line treatment of patients with metastatic or with unresectable, recurrent HNSCC whose tumors express PD-L1 [Combined Positive Score (CPS) ≥1] as determined by an FDA-authorized test [see Dosage and Administration (2.1) ] . KEYTRUDA, as a single agent, is indicated for the treatment of patients with recurrent or metastatic HNSCC with disease progression on or after platinum-containing chemotherapy. 1.5 Classical Hodgkin Lymphoma KEYTRUDA is indicated for the treatment of adult patients with relapsed or refractory classical Hodgkin lymphoma (cHL). KEYTRUDA is indicated for the treatment of pediatric patients with refractory cHL, or cHL that has relapsed after 2 or more lines of therapy. 1.6 Primary Mediastinal Large B-Cell Lymphoma KEYTRUDA is indicated for the treatment of adult and pediatric patients with refractory primary mediastinal large B-cell lymphoma (PMBCL), or who have relapsed after 2 or more prior lines of therapy. Limitations of Use : KEYTRUDA is not recommended for treatment of patients with PMBCL who require urgent cytoreductive therapy. 1.7 Urothelial Cancer KEYTRUDA, in combination with enfortumab vedotin-ejfv, is indicated for the treatment of adult patients with locally advanced or metastatic urothelial cancer. KEYTRUDA, as a single agent, is indicated for the treatment of patients with locally advanced or metastatic urothelial carcinoma: who are not eligible for any platinum-containing chemotherapy, or who have disease progression during or following platinum-containing chemotherapy or within 12 months of neoadjuvant or adjuvant treatment with platinum-containing chemotherapy. KEYTRUDA, in combination with enfortumab vedotin-ejfv, as neoadjuvant treatment and then continued after cystectomy as adjuvant treatment, is indicated for the treatment of adult patients with muscle invasive bladder cancer (MIBC). KEYTRUDA, as a single agent, is indicated for the treatment of patients with Bacillus Calmette-Guerin (BCG)-unresponsive, high-risk, non-muscle invasive bladder cancer (NMIBC) with carcinoma in situ (CIS) with or without papillary tumors who are ineligible for or have elected not to undergo cystectomy. 1.8 Microsatellite Instability-High or Mismatch Repair Deficient Cancer KEYTRUDA is indicated for the treatment of adult and pediatric patients with unresectable or metastatic microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) solid tumors, as determined by an FDA-authorized test, that have progressed following prior treatment and who have no satisfactory alternative treatment options [see Dosage and Administration (2.1) ] . 1.9 Microsatellite Instability-High or Mismatch Repair Deficient Colorectal Cancer KEYTRUDA is indicated for the treatment of patients with unresectable or metastatic MSI-H or dMMR colorectal cancer (CRC) as determined by an FDA-authorized test [see Dosage and Administration (2.1) ] . 1.10 Gastric Cancer KEYTRUDA, in combination with trastuzumab, fluoropyrimidine- and platinum-containing chemotherapy, is indicated for the first-line treatment of adults with locally advanced unresectable or metastatic HER2-positive gastric or gastroesophageal junction (GEJ) adenocarcinoma whose tumors express PD-L1 (CPS ≥1) as determined by an FDA-authorized test [see Dosage and Administration (2.1) ] . KEYTRUDA, in combination with fluoropyrimidine- and platinum-containing chemotherapy, is indicated for the first-line treatment of adults with locally advanced unresectable or metastatic HER2-negative gastric or gastroesophageal junction (GEJ) adenocarcinoma whose tumors express PD-L1 (CPS ≥ 1) as determined by an FDA-authorized test [see Dosage and Administration (2.1) ] . 1.11 Esophageal Cancer KEYTRUDA is indicated for the treatment of patients with locally advanced or metastatic esophageal or gastroesophageal junction (GEJ) (tumors with epicenter 1 to 5 centimeters above the GEJ) carcinoma that is not amenable to surgical resection or definitive chemoradiation either: in combination with platinum- and fluoropyrimidine-based chemotherapy for patients with tumors that express PD-L1 (CPS ≥ 1) as determined by an FDA-authorized test [see Dosage and Administration (2.1) ] , or as a single agent after one or more prior lines of systemic therapy for patients with tumors of squamous cell histology that express PD-L1 (CPS ≥10) as determined by an FDA-authorized test [see Dosage and Administration (2.1) ] . 1.12 Cervical Cancer KEYTRUDA, in combination with chemoradiotherapy (CRT), is indicated for the treatment of patients with locally advanced cervical cancer involving the lower third of the vagina, with or without extension to pelvic sidewall, or hydronephrosis/non-functioning kidney, or spread to adjacent pelvic organs (FIGO 2014 Stage III-IVA). KEYTRUDA, in combination with chemotherapy, with or without bevacizumab, is indicated for the treatment of patients with persistent, recurrent, or metastatic cervical cancer whose tumors express PD-L1 (CPS ≥1) as determined by an FDA-authorized test [see Dosage and Administration (2.1) ]. KEYTRUDA, as a single agent, is indicated for the treatment of patients with recurrent or metastatic cervical cancer with disease progression on or after chemotherapy whose tumors express PD-L1 (CPS ≥1) as determined by an FDA-authorized test [see Dosage and Administration (2.1) ] . 1.13 Hepatocellular Carcinoma KEYTRUDA is indicated for the treatment of patients with hepatocellular carcinoma (HCC) secondary to hepatitis B who have received prior systemic therapy other than a PD-1/PD-L1-containing regimen. 1.14 Biliary Tract Cancer KEYTRUDA, in combination with gemcitabine and cisplatin, is indicated for the treatment of patients with locally advanced unresectable or metastatic biliary tract cancer (BTC). 1.15 Merkel Cell Carcinoma KEYTRUDA is indicated for the treatment of adult and pediatric patients with recurrent locally advanced or metastatic Merkel cell carcinoma (MCC). 1.16 Renal Cell Carcinoma KEYTRUDA, in combination with axitinib, is indicated for the first-line treatment of adult patients with advanced renal cell carcinoma (RCC). KEYTRUDA, in combination with lenvatinib, is indicated for the first-line treatment of adult patients with advanced RCC. KEYTRUDA is indicated for the adjuvant treatment of patients with RCC at intermediate-high or high risk of recurrence following nephrectomy, or following nephrectomy and resection of metastatic lesions [see Clinical Studies (14.16) ] . KEYTRUDA, in combination with belzutifan, is indicated for the adjuvant treatment of adult patients with RCC with a clear cell component (ccRCC) at intermediate-high or high risk of recurrence following nephrectomy, or following nephrectomy and resection of metastatic lesions. 1.17 Endometrial Carcinoma KEYTRUDA, in combination with carboplatin and paclitaxel, followed by KEYTRUDA as a single agent, is indicated for the treatment of adult patients with primary advanced or recurrent endometrial carcinoma. KEYTRUDA, in combination with lenvatinib, is indicated for the treatment of adult patients with advanced endometrial carcinoma that is mismatch repair proficient (pMMR) or not MSI-H as determined by an FDA-authorized test, who have disease progression following prior systemic therapy in any setting and are not candidates for curative surgery or radiation [see Dosage and Administration (2.1) ] . KEYTRUDA, as a single agent, is indicated for the treatment of adult patients with advanced endometrial carcinoma that is MSI-H or dMMR, as determined by an FDA-authorized test, who have disease progression following prior systemic therapy in any setting and are not candidates for curative surgery or radiation [see Dosage and Administration (2.1) ] . 1.18 Tumor Mutational Burden-High Cancer KEYTRUDA is indicated for the treatment of adult and pediatric patients with unresectable or metastatic tumor mutational burden-high (TMB-H) [≥10 mutations/megabase (mut/Mb)] solid tumors, as determined by an FDA-authorized test [see Dosage and Administration (2.1) ] , that have progressed following prior treatment and who have no satisfactory alternative treatment options. This indication is approved under accelerated approval based on tumor response rate and durability of response [see Clinical Studies (14.18) ] . Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trials. Limitations of Use : The safety and effectiveness of KEYTRUDA in pediatric patients with TMB-H central nervous system cancers have not been established. 1.19 Cutaneous Squamous Cell Carcinoma KEYTRUDA is indicated for the treatment of patients with recurrent or metastatic cutaneous squamous cell carcinoma (cSCC) or locally advanced cSCC that is not curable by surgery or radiation. 1.20 Triple-Negative Breast Cancer KEYTRUDA is indicated for the treatment of patients with high-risk early-stage triple-negative breast cancer (TNBC) in combination with chemotherapy as neoadjuvant treatment, and then continued as a single agent as adjuvant treatment after surgery. KEYTRUDA, in combination with sacituzumab govitecan-hziy, is indicated for the first-line treatment of adult patients with unresectable locally advanced or metastatic TNBC whose tumors express PD-L1 (CPS ≥10) as determined by an FDA-authorized test [see Dosage and Administration (2.1) ] . KEYTRUDA, in combination with chemotherapy, is indicated for the treatment of patients with locally recurrent unresectable or metastatic TNBC whose tumors express PD-L1 (CPS ≥10) as determined by an FDA-authorized test [see Dosage and Administration (2.1) ] . 1.21 Ovarian Cancer KEYTRUDA, in combination with paclitaxel, with or without bevacizumab, is indicated for the treatment of adult patients with platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal carcinoma whose tumors express PD-L1 (CPS ≥1) as determined by an FDA-authorized test [see Dosage and Administration (2.1) ] , and who have received one or two prior systemic treatment regimens.
Full extracted label fields
application numbers
  1. BLA125514
boxed warning exact
    brand names
    1. KEYTRUDA
    current indication status
    not_reconciled
    dailymed set url
    https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=9333c79b-d487-4538-a9f0-71b91a02b287
    generic names
    1. PEMBROLIZUMAB
    id
    228e1e3f-d207-481f-8e14-9fdcbd0470e9
    indications and usage exact
    1. 1 INDICATIONS AND USAGE KEYTRUDA is a programmed death receptor-1 (PD-1)-blocking antibody indicated: Melanoma for the treatment of patients with unresectable or metastatic melanoma. ( 1.1 ) for the adjuvant treatment of adult and pediatric (12 years and older) patients with Stage IIB, IIC, or III melanoma following complete resection. ( 1.1 ) Non-Small Cell Lung Cancer (NSCLC) in combination with pemetrexed and platinum chemotherapy, as first-line treatment of patients with metastatic nonsquamous NSCLC, with no EGFR or ALK genomic tumor aberrations. ( 1.2 ) in combination with carboplatin and either paclitaxel or paclitaxel protein-bound, as first-line treatment of patients with metastatic squamous NSCLC. ( 1.2 ) as a single agent for the first-line treatment of patients with NSCLC expressing PD-L1 [Tumor Proportion Score (TPS) ≥1%] as determined by an FDA-authorized test, with no EGFR or ALK genomic tumor aberrations, and is: Stage III where patients are not candidates for surgical resection or definitive chemoradiation, or metastatic. ( 1.2 , 2.1 ) as a single agent for the treatment of patients with metastatic NSCLC whose tumors express PD-L1 (TPS ≥1%) as determined by an FDA-authorized test, with disease progression on or after platinum-containing chemotherapy. Patients with EGFR or ALK genomic tumor aberrations should have disease progression on FDA-approved therapy for these aberrations prior to receiving KEYTRUDA. ( 1.2 , 2.1 ) for the treatment of patients with resectable (tumors ≥4 cm or node positive) NSCLC in combination with platinum-containing chemotherapy as neoadjuvant treatment, and then continued as a single agent as adjuvant treatment after surgery. ( 1.2 ) as a single agent, for adjuvant treatment following resection and platinum-based chemotherapy for adult patients with Stage IB (T2a ≥4 cm), II, or IIIA NSCLC. ( 1.2 ) Malignant Pleural Mesothelioma (MPM) in combination with pemetrexed and platinum chemotherapy, as first-line treatment of adult patients with unresectable advanced or metastatic MPM. ( 1.3 ) Head and Neck Squamous Cell Cancer (HNSCC) for the treatment of adult patients with resectable locally advanced HNSCC whose tumors express PD-L1 [Combined Positive Score (CPS) ≥1] as determined by an FDA-authorized test, as a single agent as neoadjuvant treatment, continued as adjuvant treatment in combination with radiotherapy (RT) with or without cisplatin and then as a single agent. ( 1.4 ) in combination with platinum and FU for the first-line treatment of patients with metastatic or with unresectable, recurrent HNSCC. ( 1.4 ) as a single agent for the first-line treatment of patients with metastatic or with unresectable, recurrent HNSCC whose tumors express PD-L1 [Combined Positive Score (CPS) ≥1] as determined by an FDA-authorized test. ( 1.4 , 2.1 ) as a single agent for the treatment of patients with recurrent or metastatic HNSCC with disease progression on or after platinum-containing chemotherapy. ( 1.4 ) Classical Hodgkin Lymphoma (cHL) for the treatment of adult patients with relapsed or refractory cHL. ( 1.5 ) for the treatment of pediatric patients with refractory cHL, or cHL that has relapsed after 2 or more lines of therapy. ( 1.5 ) Primary Mediastinal Large B-Cell Lymphoma (PMBCL) for the treatment of adult and pediatric patients with refractory PMBCL, or who have relapsed after 2 or more prior lines of therapy. ( 1.6 ) Limitations of Use : KEYTRUDA is not recommended for treatment of patients with PMBCL who require urgent cytoreductive therapy. Urothelial Cancer in combination with enfortumab vedotin-ejfv, for the treatment of adult patients with locally advanced or metastatic urothelial cancer. ( 1.7 ) as a single agent for the treatment of patients with locally advanced or metastatic urothelial carcinoma who: are not eligible for any platinum-containing chemotherapy, or who have disease progression during or following platinum-containing chemotherapy or within 12 months of neoadjuvant or adjuvant treatment with platinum-containing chemotherapy. ( 1.7 ) in combination with enfortumab vedotin-ejfv, as neoadjuvant treatment and then continued after cystectomy as adjuvant treatment of adult patients with muscle invasive bladder cancer (MIBC). ( 1.7 ) as a single agent for the treatment of patients with Bacillus Calmette-Guerin (BCG)-unresponsive, high-risk, non-muscle invasive bladder cancer (NMIBC) with carcinoma in situ (CIS) with or without papillary tumors who are ineligible for or have elected not to undergo cystectomy. ( 1.7 ) Microsatellite Instability-High or Mismatch Repair Deficient Cancer for the treatment of adult and pediatric patients with unresectable or metastatic microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) solid tumors, as determined by an FDA-authorized test, that have progressed following prior treatment and who have no satisfactory alternative treatment options. ( 1.8 , 2.1 ) Microsatellite Instability-High or Mismatch Repair Deficient Colorectal Cancer (CRC) for the treatment of patients with unresectable or metastatic MSI-H or dMMR colorectal cancer (CRC) as determined by an FDA-authorized test. ( 1.9 , 2.1 ) Gastric Cancer in combination with trastuzumab, fluoropyrimidine- and platinum-containing chemotherapy, for the first-line treatment of adults with locally advanced unresectable or metastatic HER2-positive gastric or gastroesophageal junction (GEJ) adenocarcinoma whose tumors express PD-L1 (CPS ≥1) as determined by an FDA-authorized test. ( 1.10 ) in combination with fluoropyrimidine- and platinum-containing chemotherapy, for the first-line treatment of adults with locally advanced unresectable or metastatic HER2-negative gastric or gastroesophageal junction (GEJ) adenocarcinoma whose tumors express PD-L1 (CPS ≥1) as determined by an FDA-authorized test. ( 1.10 ) Esophageal Cancer for the treatment of patients with locally advanced or metastatic esophageal or gastroesophageal junction (GEJ) (tumors with epicenter 1 to 5 centimeters above the GEJ) carcinoma that is not amenable to surgical resection or definitive chemoradiation either: in combination with platinum- and fluoropyrimidine-based chemotherapy for patients whose tumors express PD-L1 (CPS ≥1) as determined by an FDA-authorized test, or as a single agent after one or more prior lines of systemic therapy for patients with tumors of squamous cell histology that express PD-L1 (CPS ≥10) as determined by an FDA-authorized test. ( 1.11 , 2.1 ) Cervical Cancer in combination with chemoradiotherapy, for the treatment of patients with locally advanced cervical cancer involving the lower third of the vagina, with or without extension to pelvic sidewall, or hydronephrosis/non-functioning kidney, or spread to adjacent pelvic organs (FIGO 2014 Stage III-IVA). ( 1.12 ) in combination with chemotherapy, with or without bevacizumab, for the treatment of patients with persistent, recurrent, or metastatic cervical cancer whose tumors express PD-L1 (CPS ≥1) as determined by an FDA-authorized test. ( 1.12 , 2.1 ) as a single agent for the treatment of patients with recurrent or metastatic cervical cancer with disease progression on or after chemotherapy whose tumors express PD-L1 (CPS ≥1) as determined by an FDA-authorized test. ( 1.12 , 2.1 ) Hepatocellular Carcinoma (HCC) for the treatment of patients with HCC secondary to hepatitis B who have received prior systemic therapy other than a PD-1/PD-L1-containing regimen. ( 1.13 ) Biliary Tract Cancer (BTC) in combination with gemcitabine and cisplatin, for the treatment of patients with locally advanced unresectable or metastatic biliary tract cancer. ( 1.14 ) Merkel Cell Carcinoma (MCC) for the treatment of adult and pediatric patients with recurrent locally advanced or metastatic Merkel cell carcinoma. ( 1.15 ) Renal Cell Carcinoma (RCC) in combination with axitinib, for the first-line treatment of adult patients with advanced RCC. ( 1.16 ) in combination with lenvatinib, for the first-line treatment of adult patients with advanced RCC. ( 1.16 ) for the adjuvant treatment of patients with RCC at intermediate-high or high risk of recurrence following nephrectomy, or following nephrectomy and resection of metastatic lesions. ( 1.16 ) in combination with belzutifan, for the adjuvant treatment of adult patients with RCC with a clear cell component (ccRCC) at intermediate-high or high risk of recurrence following nephrectomy, or following nephrectomy and resection of metastatic lesions. ( 1.16 ) Endometrial Carcinoma in combination with carboplatin and paclitaxel, followed by KEYTRUDA as a single agent, for the treatment of adult patients with primary advanced or recurrent endometrial carcinoma. ( 1.17 ) in combination with lenvatinib, for the treatment of adult patients with advanced endometrial carcinoma that is mismatch repair proficient (pMMR) or not MSI-H as determined by an FDA-authorized test, who have disease progression following prior systemic therapy in any setting and are not candidates for curative surgery or radiation. ( 1.17 , 2.1 ) as a single agent, for the treatment of adult patients with advanced endometrial carcinoma that is MSI-H or dMMR, as determined by an FDA-authorized test, who have disease progression following prior systemic therapy in any setting and are not candidates for curative surgery or radiation. ( 1.17 , 2.1 ) Tumor Mutational Burden-High (TMB-H) Cancer for the treatment of adult and pediatric patients with unresectable or metastatic tumor mutational burden-high (TMB-H) [≥10 mutations/megabase (mut/Mb)] solid tumors, as determined by an FDA-authorized test, that have progressed following prior treatment and who have no satisfactory alternative treatment options. 1 ( 1.18 , 2.1 ) Limitations of Use : The safety and effectiveness of KEYTRUDA in pediatric patients with TMB-H central nervous system cancers have not been established. Cutaneous Squamous Cell Carcinoma (cSCC) for the treatment of patients with recurrent or metastatic cSCC or locally advanced cSCC that is not curable by surgery or radiation. ( 1.19 ) Triple-Negative Breast Cancer (TNBC) for the treatment of patients with high-risk early-stage TNBC in combination with chemotherapy as neoadjuvant treatment, and then continued as a single agent as adjuvant treatment after surgery. ( 1.20 ) in combination with sacituzumab govitecan-hziy, for the first-line treatment of adult patients with unresectable locally advanced or metastatic TNBC whose tumors express PD-L1 (CPS ≥10) as determined by an FDA-authorized test. ( 1.20 , 2.1 ) in combination with chemotherapy, for the treatment of patients with locally recurrent unresectable or metastatic TNBC whose tumors express PD-L1 (CPS ≥10) as determined by an FDA-authorized test. ( 1.20 , 2.1 ) Ovarian Cancer in combination with paclitaxel, with or without bevacizumab, for the treatment of adult patients with platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal carcinoma whose tumors express PD-L1 (CPS ≥1) as determined by an FDA-authorized test, and who have received one or two prior systemic treatment regimens. ( 1.21 , 2.1 ) 1 This indication is approved under accelerated approval based on tumor response rate and durability of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trials. 1.1 Melanoma KEYTRUDA ® is indicated for the treatment of patients with unresectable or metastatic melanoma. KEYTRUDA is indicated for the adjuvant treatment of adult and pediatric (12 years and older) patients with Stage IIB, IIC, or III melanoma following complete resection. 1.2 Non-Small Cell Lung Cancer KEYTRUDA, in combination with pemetrexed and platinum chemotherapy, is indicated for the first-line treatment of patients with metastatic nonsquamous non-small cell lung cancer (NSCLC), with no EGFR or ALK genomic tumor aberrations. KEYTRUDA, in combination with carboplatin and either paclitaxel or paclitaxel protein-bound, is indicated for the first-line treatment of patients with metastatic squamous NSCLC. KEYTRUDA, as a single agent, is indicated for the first-line treatment of patients with NSCLC expressing PD-L1 [Tumor Proportion Score (TPS) ≥1%] as determined by an FDA-authorized test [see Dosage and Administration (2.1) ] , with no EGFR or ALK genomic tumor aberrations, and is: Stage III where patients are not candidates for surgical resection or definitive chemoradiation, or metastatic. KEYTRUDA, as a single agent, is indicated for the treatment of patients with metastatic NSCLC whose tumors express PD-L1 (TPS ≥1%) as determined by an FDA-authorized test [see Dosage and Administration (2.1) ] , with disease progression on or after platinum-containing chemotherapy. Patients with EGFR or ALK genomic tumor aberrations should have disease progression on FDA-approved therapy for these aberrations prior to receiving KEYTRUDA. KEYTRUDA is indicated for the treatment of patients with resectable (tumors ≥4 cm or node positive) NSCLC in combination with platinum-containing chemotherapy as neoadjuvant treatment, and then continued as a single agent as adjuvant treatment after surgery. KEYTRUDA, as a single agent, is indicated as adjuvant treatment following resection and platinum-based chemotherapy for adult patients with Stage IB (T2a ≥4 cm), II, or IIIA NSCLC. 1.3 Malignant Pleural Mesothelioma KEYTRUDA, in combination with pemetrexed and platinum chemotherapy, is indicated for the first-line treatment of adult patients with unresectable advanced or metastatic malignant pleural mesothelioma (MPM). 1.4 Head and Neck Squamous Cell Cancer KEYTRUDA is indicated for the treatment of adult patients with resectable locally advanced HNSCC whose tumors express PD-L1 [Combined Positive Score (CPS) ≥1] as determined by an FDA-authorized test [see Dosage and Administration (2.1) ] , as a single agent as neoadjuvant treatment, continued as adjuvant treatment in combination with radiotherapy (RT) with or without cisplatin and then as a single agent. KEYTRUDA, in combination with platinum and fluorouracil (FU), is indicated for the first-line treatment of patients with metastatic or with unresectable, recurrent head and neck squamous cell carcinoma (HNSCC). KEYTRUDA, as a single agent, is indicated for the first-line treatment of patients with metastatic or with unresectable, recurrent HNSCC whose tumors express PD-L1 [Combined Positive Score (CPS) ≥1] as determined by an FDA-authorized test [see Dosage and Administration (2.1) ] . KEYTRUDA, as a single agent, is indicated for the treatment of patients with recurrent or metastatic HNSCC with disease progression on or after platinum-containing chemotherapy. 1.5 Classical Hodgkin Lymphoma KEYTRUDA is indicated for the treatment of adult patients with relapsed or refractory classical Hodgkin lymphoma (cHL). KEYTRUDA is indicated for the treatment of pediatric patients with refractory cHL, or cHL that has relapsed after 2 or more lines of therapy. 1.6 Primary Mediastinal Large B-Cell Lymphoma KEYTRUDA is indicated for the treatment of adult and pediatric patients with refractory primary mediastinal large B-cell lymphoma (PMBCL), or who have relapsed after 2 or more prior lines of therapy. Limitations of Use : KEYTRUDA is not recommended for treatment of patients with PMBCL who require urgent cytoreductive therapy. 1.7 Urothelial Cancer KEYTRUDA, in combination with enfortumab vedotin-ejfv, is indicated for the treatment of adult patients with locally advanced or metastatic urothelial cancer. KEYTRUDA, as a single agent, is indicated for the treatment of patients with locally advanced or metastatic urothelial carcinoma: who are not eligible for any platinum-containing chemotherapy, or who have disease progression during or following platinum-containing chemotherapy or within 12 months of neoadjuvant or adjuvant treatment with platinum-containing chemotherapy. KEYTRUDA, in combination with enfortumab vedotin-ejfv, as neoadjuvant treatment and then continued after cystectomy as adjuvant treatment, is indicated for the treatment of adult patients with muscle invasive bladder cancer (MIBC). KEYTRUDA, as a single agent, is indicated for the treatment of patients with Bacillus Calmette-Guerin (BCG)-unresponsive, high-risk, non-muscle invasive bladder cancer (NMIBC) with carcinoma in situ (CIS) with or without papillary tumors who are ineligible for or have elected not to undergo cystectomy. 1.8 Microsatellite Instability-High or Mismatch Repair Deficient Cancer KEYTRUDA is indicated for the treatment of adult and pediatric patients with unresectable or metastatic microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) solid tumors, as determined by an FDA-authorized test, that have progressed following prior treatment and who have no satisfactory alternative treatment options [see Dosage and Administration (2.1) ] . 1.9 Microsatellite Instability-High or Mismatch Repair Deficient Colorectal Cancer KEYTRUDA is indicated for the treatment of patients with unresectable or metastatic MSI-H or dMMR colorectal cancer (CRC) as determined by an FDA-authorized test [see Dosage and Administration (2.1) ] . 1.10 Gastric Cancer KEYTRUDA, in combination with trastuzumab, fluoropyrimidine- and platinum-containing chemotherapy, is indicated for the first-line treatment of adults with locally advanced unresectable or metastatic HER2-positive gastric or gastroesophageal junction (GEJ) adenocarcinoma whose tumors express PD-L1 (CPS ≥1) as determined by an FDA-authorized test [see Dosage and Administration (2.1) ] . KEYTRUDA, in combination with fluoropyrimidine- and platinum-containing chemotherapy, is indicated for the first-line treatment of adults with locally advanced unresectable or metastatic HER2-negative gastric or gastroesophageal junction (GEJ) adenocarcinoma whose tumors express PD-L1 (CPS ≥ 1) as determined by an FDA-authorized test [see Dosage and Administration (2.1) ] . 1.11 Esophageal Cancer KEYTRUDA is indicated for the treatment of patients with locally advanced or metastatic esophageal or gastroesophageal junction (GEJ) (tumors with epicenter 1 to 5 centimeters above the GEJ) carcinoma that is not amenable to surgical resection or definitive chemoradiation either: in combination with platinum- and fluoropyrimidine-based chemotherapy for patients with tumors that express PD-L1 (CPS ≥ 1) as determined by an FDA-authorized test [see Dosage and Administration (2.1) ] , or as a single agent after one or more prior lines of systemic therapy for patients with tumors of squamous cell histology that express PD-L1 (CPS ≥10) as determined by an FDA-authorized test [see Dosage and Administration (2.1) ] . 1.12 Cervical Cancer KEYTRUDA, in combination with chemoradiotherapy (CRT), is indicated for the treatment of patients with locally advanced cervical cancer involving the lower third of the vagina, with or without extension to pelvic sidewall, or hydronephrosis/non-functioning kidney, or spread to adjacent pelvic organs (FIGO 2014 Stage III-IVA). KEYTRUDA, in combination with chemotherapy, with or without bevacizumab, is indicated for the treatment of patients with persistent, recurrent, or metastatic cervical cancer whose tumors express PD-L1 (CPS ≥1) as determined by an FDA-authorized test [see Dosage and Administration (2.1) ]. KEYTRUDA, as a single agent, is indicated for the treatment of patients with recurrent or metastatic cervical cancer with disease progression on or after chemotherapy whose tumors express PD-L1 (CPS ≥1) as determined by an FDA-authorized test [see Dosage and Administration (2.1) ] . 1.13 Hepatocellular Carcinoma KEYTRUDA is indicated for the treatment of patients with hepatocellular carcinoma (HCC) secondary to hepatitis B who have received prior systemic therapy other than a PD-1/PD-L1-containing regimen. 1.14 Biliary Tract Cancer KEYTRUDA, in combination with gemcitabine and cisplatin, is indicated for the treatment of patients with locally advanced unresectable or metastatic biliary tract cancer (BTC). 1.15 Merkel Cell Carcinoma KEYTRUDA is indicated for the treatment of adult and pediatric patients with recurrent locally advanced or metastatic Merkel cell carcinoma (MCC). 1.16 Renal Cell Carcinoma KEYTRUDA, in combination with axitinib, is indicated for the first-line treatment of adult patients with advanced renal cell carcinoma (RCC). KEYTRUDA, in combination with lenvatinib, is indicated for the first-line treatment of adult patients with advanced RCC. KEYTRUDA is indicated for the adjuvant treatment of patients with RCC at intermediate-high or high risk of recurrence following nephrectomy, or following nephrectomy and resection of metastatic lesions [see Clinical Studies (14.16) ] . KEYTRUDA, in combination with belzutifan, is indicated for the adjuvant treatment of adult patients with RCC with a clear cell component (ccRCC) at intermediate-high or high risk of recurrence following nephrectomy, or following nephrectomy and resection of metastatic lesions. 1.17 Endometrial Carcinoma KEYTRUDA, in combination with carboplatin and paclitaxel, followed by KEYTRUDA as a single agent, is indicated for the treatment of adult patients with primary advanced or recurrent endometrial carcinoma. KEYTRUDA, in combination with lenvatinib, is indicated for the treatment of adult patients with advanced endometrial carcinoma that is mismatch repair proficient (pMMR) or not MSI-H as determined by an FDA-authorized test, who have disease progression following prior systemic therapy in any setting and are not candidates for curative surgery or radiation [see Dosage and Administration (2.1) ] . KEYTRUDA, as a single agent, is indicated for the treatment of adult patients with advanced endometrial carcinoma that is MSI-H or dMMR, as determined by an FDA-authorized test, who have disease progression following prior systemic therapy in any setting and are not candidates for curative surgery or radiation [see Dosage and Administration (2.1) ] . 1.18 Tumor Mutational Burden-High Cancer KEYTRUDA is indicated for the treatment of adult and pediatric patients with unresectable or metastatic tumor mutational burden-high (TMB-H) [≥10 mutations/megabase (mut/Mb)] solid tumors, as determined by an FDA-authorized test [see Dosage and Administration (2.1) ] , that have progressed following prior treatment and who have no satisfactory alternative treatment options. This indication is approved under accelerated approval based on tumor response rate and durability of response [see Clinical Studies (14.18) ] . Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trials. Limitations of Use : The safety and effectiveness of KEYTRUDA in pediatric patients with TMB-H central nervous system cancers have not been established. 1.19 Cutaneous Squamous Cell Carcinoma KEYTRUDA is indicated for the treatment of patients with recurrent or metastatic cutaneous squamous cell carcinoma (cSCC) or locally advanced cSCC that is not curable by surgery or radiation. 1.20 Triple-Negative Breast Cancer KEYTRUDA is indicated for the treatment of patients with high-risk early-stage triple-negative breast cancer (TNBC) in combination with chemotherapy as neoadjuvant treatment, and then continued as a single agent as adjuvant treatment after surgery. KEYTRUDA, in combination with sacituzumab govitecan-hziy, is indicated for the first-line treatment of adult patients with unresectable locally advanced or metastatic TNBC whose tumors express PD-L1 (CPS ≥10) as determined by an FDA-authorized test [see Dosage and Administration (2.1) ] . KEYTRUDA, in combination with chemotherapy, is indicated for the treatment of patients with locally recurrent unresectable or metastatic TNBC whose tumors express PD-L1 (CPS ≥10) as determined by an FDA-authorized test [see Dosage and Administration (2.1) ] . 1.21 Ovarian Cancer KEYTRUDA, in combination with paclitaxel, with or without bevacizumab, is indicated for the treatment of adult patients with platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal carcinoma whose tumors express PD-L1 (CPS ≥1) as determined by an FDA-authorized test [see Dosage and Administration (2.1) ] , and who have received one or two prior systemic treatment regimens.
    indications and usage tables exact
      is original packager
      1. true
      manufacturer names
      1. Merck Sharp & Dohme LLC
      matched search terms
      1. cancer
      2. carcinoma
      3. lymphoma
      4. melanoma
      5. tumor
      6. tumors
      7. malignant
      package ndcs
      1. 0006-3029-01
      2. 0006-3029-02
      3. 0006-3026-01
      4. 0006-3026-02
      5. 0006-3026-04
      product ndcs
      1. 0006-3026
      2. 0006-3029
      product types
      1. HUMAN PRESCRIPTION DRUG
      recent major changes exact
      1. Indications and Usage ( 1 ) 07/2026 Dosage and Administration ( 2 ) 07/2026 Warnings and Precautions ( 5 ) 05/2026
      record type
      complete_spl_indications_section_candidate
      routes
      1. INTRAVENOUS
      rxcuis
      1. 1657746
      2. 1657749
      3. 1657750
      4. 1657751
      source batch
      file
      /private/tmp/cancer-full-research/indications/raw/labels-00100.json
      meta
      disclaimer
      Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. We may limit or otherwise restrict your access to the API in line with our Terms of Service.
      last updated
      2026-09-09
      results
      limit
      100
      skip
      100
      total
      830
      sha256
      fc39a8c5cf96bf95ca20b85578140167b66b2741f7d9217f500d9ba0847ac058
      url
      https://api.fda.gov/drug/label.json?search=%28indications_and_usage%3Acancer+OR+indications_and_usage%3Acarcinoma+OR+indications_and_usage%3Acarcinomas+OR+indications_and_usage%3Alymphoma+OR+indications_and_usage%3Alymphomas+OR+indications_and_usage%3Aleukemia+OR+indications_and_usage%3Aleukaemia+OR+indications_and_usage%3Asarcoma+OR+indications_and_usage%3Asarcomas+OR+indications_and_usage%3Amelanoma+OR+indications_and_usage%3Amyeloma+OR+indications_and_usage%3Atumor+OR+indications_and_usage%3Atumors+OR+indications_and_usage%3Atumour+OR+indications_and_usage%3Atumours+OR+indications_and_usage%3Aneoplasm+OR+indications_and_usage%3Aneoplasms+OR+indications_and_usage%3Amalignant+OR+indications_and_usage%3Amalignancy+OR+indications_and_usage%3Amyelodysplastic+OR+indications_and_usage%3Amyelofibrosis+OR+indications_and_usage%3Amastocytosis+OR+indications_and_usage%3Aglioma+OR+indications_and_usage%3Aglioblastoma+OR+indications_and_usage%3Aneuroblastoma+OR+indications_and_usage%3Aretinoblastoma+OR+indications_and_usage%3Apheochromocytoma+OR+indications_and_usage%3Aparaganglioma+OR+indications_and_usage%3Amyeloproliferative+OR+indications_and_usage%3Awaldenstrom+OR+indications_and_usage%3Apolycythemia+OR+indications_and_usage%3Athrombocythemia+OR+indications_and_usage%3Adesmoid+OR+indications_and_usage%3Aneurofibromatosis+OR+indications_and_usage%3Ahistiocytosis%29+AND+%28openfda.application_number%3ANDA%2A+OR+openfda.application_number%3ABLA%2A%29&limit=100&skip=100&sort=id%3Aasc
      source url
      https://api.fda.gov/drug/label.json?search=id%3A%22228e1e3f-d207-481f-8e14-9fdcbd0470e9%22
      spl effective date
      2026-07-10
      spl effective time
      20260710
      spl set id
      9333c79b-d487-4538-a9f0-71b91a02b287
      spl version
      228
      substance names
      1. PEMBROLIZUMAB
      uniis
      1. DPT0O3T46P
      verification flags
      1. oncology_keyword_candidate_not_clinically_classified
      2. spl_text_not_verified_identical_to_latest_approved_label
      3. individual_indications_not_split_or_reconciled
      4. fda_label_posted_after_spl_effective_date_requires_version_review
      Drugs@FDA application source records
      1. application number
        BLA125514
        payload
        all indexed label documents
        1. Appl No
          125514
          Application Docs Date
          2019-06-05 00:00:00
          Application Docs ID
          18929
          Application Docs Title
          0
          Application Docs Type ID
          2
          Submission No
          3
          Submission Type
          SUPPL
        2. Appl No
          125514
          Application Docs Date
          2015-12-18 00:00:00
          Application Docs ID
          18930
          Application Docs Title
          0
          Application Docs Type ID
          2
          Submission No
          4
          Submission Type
          SUPPL
        3. Appl No
          125514
          Application Docs Date
          2015-10-02 00:00:00
          Application Docs ID
          18931
          Application Docs Title
          0
          Application Docs Type ID
          2
          Submission No
          5
          Submission Type
          SUPPL
        4. Appl No
          125514
          Application Docs Date
          2014-09-04 00:00:00
          Application Docs ID
          39983
          Application Docs Title
          0
          Application Docs Type ID
          2
          Submission No
          1
          Submission Type
          ORIG
        5. Appl No
          125514
          Application Docs Date
          2015-12-18 00:00:00
          Application Docs ID
          39984
          Application Docs Title
          0
          Application Docs Type ID
          2
          Submission No
          6
          Submission Type
          SUPPL
        6. Appl No
          125514
          Application Docs Date
          2016-08-05 00:00:00
          Application Docs ID
          44996
          Application Docs Title
          0
          Application Docs Type ID
          2
          Submission No
          9
          Submission Type
          SUPPL
        7. Appl No
          125514
          Application Docs Date
          2016-10-25 00:00:00
          Application Docs ID
          45592
          Application Docs Title
          0
          Application Docs Type ID
          2
          Submission No
          12
          Submission Type
          SUPPL
        8. Appl No
          125514
          Application Docs Date
          2016-10-31 00:00:00
          Application Docs ID
          45722
          Application Docs Title
          0
          Application Docs Type ID
          2
          Submission No
          8
          Submission Type
          SUPPL
        9. Appl No
          125514
          Application Docs Date
          2017-03-14 00:00:00
          Application Docs ID
          47558
          Application Docs Title
          0
          Application Docs Type ID
          2
          Submission No
          15
          Submission Type
          SUPPL
        10. Appl No
          125514
          Application Docs Date
          2017-05-11 00:00:00
          Application Docs ID
          48350
          Application Docs Title
          0
          Application Docs Type ID
          2
          Submission No
          16
          Submission Type
          SUPPL
        11. Appl No
          125514
          Application Docs Date
          2017-05-18 00:00:00
          Application Docs ID
          48438
          Application Docs Title
          0
          Application Docs Type ID
          2
          Submission No
          17
          Submission Type
          SUPPL
        12. Appl No
          125514
          Application Docs Date
          2017-05-18 00:00:00
          Application Docs ID
          48439
          Application Docs Title
          0
          Application Docs Type ID
          2
          Submission No
          18
          Submission Type
          SUPPL
        all submission records
        1. Appl No
          125514
          Review Priority
          STANDARD
          Submission Class Code ID
          2
          Submission No
          138
          Submission Status
          AP
          Submission Status Date
          2023-10-12 00:00:00
          Submission Type
          SUPPL
          Submissions Public Notes
        2. Appl No
          125514
          Review Priority
          PRIORITY
          Submission Class Code ID
          2
          Submission No
          136
          Submission Status
          AP
          Submission Status Date
          2023-04-03 00:00:00
          Submission Type
          SUPPL
          Submissions Public Notes
        3. Appl No
          125514
          Review Priority
          STANDARD
          Submission Class Code ID
          2
          Submission No
          135
          Submission Status
          AP
          Submission Status Date
          2023-08-14 00:00:00
          Submission Type
          SUPPL
          Submissions Public Notes
        4. Appl No
          125514
          Review Priority
          STANDARD
          Submission Class Code ID
          2
          Submission No
          134
          Submission Status
          AP
          Submission Status Date
          2023-08-14 00:00:00
          Submission Type
          SUPPL
          Submissions Public Notes
        5. Appl No
          125514
          Review Priority
          STANDARD
          Submission Class Code ID
          3
          Submission No
          133
          Submission Status
          AP
          Submission Status Date
          2022-08-05 00:00:00
          Submission Type
          SUPPL
          Submissions Public Notes
        6. Appl No
          125514
          Review Priority
          STANDARD
          Submission Class Code ID
          2
          Submission No
          132
          Submission Status
          AP
          Submission Status Date
          2023-03-28 00:00:00
          Submission Type
          SUPPL
          Submissions Public Notes
        7. Appl No
          125514
          Review Priority
          STANDARD
          Submission Class Code ID
          3
          Submission No
          131
          Submission Status
          AP
          Submission Status Date
          2022-06-21 00:00:00
          Submission Type
          SUPPL
          Submissions Public Notes
        8. Appl No
          125514
          Review Priority
          STANDARD
          Submission Class Code ID
          2
          Submission No
          128
          Submission Status
          AP
          Submission Status Date
          2023-01-26 00:00:00
          Submission Type
          SUPPL
          Submissions Public Notes
        9. Appl No
          125514
          Review Priority
          STANDARD
          Submission Class Code ID
          2
          Submission No
          127
          Submission Status
          AP
          Submission Status Date
          2022-12-16 00:00:00
          Submission Type
          SUPPL
          Submissions Public Notes
        10. Appl No
          125514
          Review Priority
          STANDARD
          Submission Class Code ID
          3
          Submission No
          125
          Submission Status
          AP
          Submission Status Date
          2022-02-04 00:00:00
          Submission Type
          SUPPL
          Submissions Public Notes
        11. Appl No
          125514
          Review Priority
          STANDARD
          Submission Class Code ID
          2
          Submission No
          124
          Submission Status
          AP
          Submission Status Date
          2024-01-25 00:00:00
          Submission Type
          SUPPL
          Submissions Public Notes
        12. Appl No
          125514
          Review Priority
          STANDARD
          Submission Class Code ID
          2
          Submission No
          123
          Submission Status
          AP
          Submission Status Date
          2022-05-20 00:00:00
          Submission Type
          SUPPL
          Submissions Public Notes
        application number
        BLA125514
        approval interpretation
        Application linkage and approved submission are not indication-level current approval verification
        current indication status
        not_reconciled
        has approved submission record
        true
        latest approved submission date
        2026-07-10
        latest label selection rule
        max FDA ApplicationDocsDate, including all ties; posting date is not approval date and latest indexed document may be incomplete
        latest posted label documents
        1. Appl No
          125514
          Application Docs Date
          2026-07-15 00:00:00
          Application Docs ID
          86556
          Application Docs Title
          0
          Application Docs Type ID
          2
          Submission No
          194
          Submission Type
          SUPPL
        official application record
        Appl No
        125514
        Appl Public Notes
        Appl Type
        BLA
        Sponsor Name
        MERCK SHARP DOHME
        openfda application present
        true
        products
        1. Active Ingredient
          PEMBROLIZUMAB
          Appl No
          125514
          Drug Name
          KEYTRUDA
          Form
          SOLUTION;INTRAVENOUS
          Product No
          001
          Reference Drug
          0
          Reference Standard
          Strength
          100MG/4ML (25MG/ML)
          marketing status
          1. Prescription

      Source passages and status connections

      Passage classifications are automated and are not treatment recommendations. Connections apply only to their recorded indication scope.

      Passage 1 · positive indication candidate
      application numbers
      1. BLA125514
      brand names
      1. KEYTRUDA
      classification reasons
      1. explicit_positive_indication_predicate
      2. tumor_or_malignant_hematology_words_in_positive_statement
      clinical review status
      pending
      content role
      positive_indication_candidate
      context span
      end
      382
      end exclusive
      true
      exact text
      1 INDICATIONS AND USAGE KEYTRUDA is a programmed death receptor-1 (PD-1)-blocking antibody indicated: Melanoma for the treatment of patients with unresectable or metastatic melanoma. ( 1.1 ) for the adjuvant treatment of adult and pediatric (12 years and older) patients with Stage IIB, IIC, or III melanoma following complete resection. ( 1.1 ) Non-Small Cell Lung Cancer (NSCLC) i
      label id
      228e1e3f-d207-481f-8e14-9fdcbd0470e9
      offset unit
      unicode_code_points
      source array index
      0
      source field
      indications_and_usage_exact
      source text sha256
      e526ba14c91f10737e6d3331fe23a6219f58c0eca6380bfce9bd78b573fea912
      start
      0
      current approval status
      not_reconciled
      duplicate text group
      dup-7b15aa806bd9061ed2c1
      extraction review status
      automated_candidate_pending_source_review
      generic names
      1. PEMBROLIZUMAB
      id
      ind-span-6a27a2e082e794ef2b92
      label id
      228e1e3f-d207-481f-8e14-9fdcbd0470e9
      positive predicate support span
      end
      100
      end exclusive
      true
      exact text
      is a programmed death receptor-1 (PD-1)-blocking antibody indicated
      label id
      228e1e3f-d207-481f-8e14-9fdcbd0470e9
      offset unit
      unicode_code_points
      source array index
      0
      source field
      indications_and_usage_exact
      source text sha256
      e526ba14c91f10737e6d3331fe23a6219f58c0eca6380bfce9bd78b573fea912
      start
      33
      qualifier mentions
      1. context exact
        Melanoma for the treatment of patients with unresectable or metastatic melanoma.
        kind
        biomarker
        polarity
        not_inferred
        span
        end
        181
        end exclusive
        true
        exact text
        metastatic melanoma
        label id
        228e1e3f-d207-481f-8e14-9fdcbd0470e9
        offset unit
        unicode_code_points
        source array index
        0
        source field
        indications_and_usage_exact
        source text sha256
        e526ba14c91f10737e6d3331fe23a6219f58c0eca6380bfce9bd78b573fea912
        start
        162
      2. context exact
        body indicated: Melanoma for the treatment of patients with unresectable or metastatic melanoma.
        kind
        stage_or_setting
        polarity
        not_inferred
        span
        end
        181
        end exclusive
        true
        exact text
        unresectable or metastatic melanoma
        label id
        228e1e3f-d207-481f-8e14-9fdcbd0470e9
        offset unit
        unicode_code_points
        source array index
        0
        source field
        indications_and_usage_exact
        source text sha256
        e526ba14c91f10737e6d3331fe23a6219f58c0eca6380bfce9bd78b573fea912
        start
        146
      regulatory links
        schema version
        0.1.0
        source batch sha256
        fc39a8c5cf96bf95ca20b85578140167b66b2741f7d9217f500d9ba0847ac058
        source defined aliases
        1. abbreviation
          NSCLC
          definition exact
          Non-Small Cell Lung Cancer
          definition span
          end
          380
          end exclusive
          true
          exact text
          Non-Small Cell Lung Cancer (NSCLC)
          label id
          228e1e3f-d207-481f-8e14-9fdcbd0470e9
          offset unit
          unicode_code_points
          source array index
          0
          source field
          indications_and_usage_exact
          source text sha256
          e526ba14c91f10737e6d3331fe23a6219f58c0eca6380bfce9bd78b573fea912
          start
          346
        2. abbreviation
          CRC
          definition exact
          Colorectal Cancer
          definition span
          end
          5042
          end exclusive
          true
          exact text
          Colorectal Cancer (CRC)
          label id
          228e1e3f-d207-481f-8e14-9fdcbd0470e9
          offset unit
          unicode_code_points
          source array index
          0
          source field
          indications_and_usage_exact
          source text sha256
          e526ba14c91f10737e6d3331fe23a6219f58c0eca6380bfce9bd78b573fea912
          start
          5019
        source span
        end
        182
        end exclusive
        true
        exact text
        1 INDICATIONS AND USAGE KEYTRUDA is a programmed death receptor-1 (PD-1)-blocking antibody indicated: Melanoma for the treatment of patients with unresectable or metastatic melanoma.
        label id
        228e1e3f-d207-481f-8e14-9fdcbd0470e9
        offset unit
        unicode_code_points
        source array index
        0
        source field
        indications_and_usage_exact
        source text sha256
        e526ba14c91f10737e6d3331fe23a6219f58c0eca6380bfce9bd78b573fea912
        start
        0
        source url
        https://api.fda.gov/drug/label.json?search=id%3A%22228e1e3f-d207-481f-8e14-9fdcbd0470e9%22
        spl effective date
        2026-07-10
        spl set id
        9333c79b-d487-4538-a9f0-71b91a02b287
        spl version
        228
        structured fields status
        not_extracted_no_values_inferred_from_mentions
        structured indication
        age
        Source null
        approval pathway
        Source null
        biomarker and test
        Source null
        disease stage
        Source null
        limitations
        Source null
        line
        Source null
        prior therapy
        Source null
        regimen
        Source null
        tumor histology
        Source null
        use intent
        tumor_directed_candidate
        Passage 2 · unclassified context
        application numbers
        1. BLA125514
        brand names
        1. KEYTRUDA
        classification reasons
        1. no_unambiguous_positive_indication_predicate
        clinical review status
        pending
        content role
        unclassified_context
        context span
        end
        390
        end exclusive
        true
        exact text
        1 INDICATIONS AND USAGE KEYTRUDA is a programmed death receptor-1 (PD-1)-blocking antibody indicated: Melanoma for the treatment of patients with unresectable or metastatic melanoma. ( 1.1 ) for the adjuvant treatment of adult and pediatric (12 years and older) patients with Stage IIB, IIC, or III melanoma following complete resection. ( 1.1 ) Non-Small Cell Lung Cancer (NSCLC) in combin
        label id
        228e1e3f-d207-481f-8e14-9fdcbd0470e9
        offset unit
        unicode_code_points
        source array index
        0
        source field
        indications_and_usage_exact
        source text sha256
        e526ba14c91f10737e6d3331fe23a6219f58c0eca6380bfce9bd78b573fea912
        start
        0
        current approval status
        not_reconciled
        duplicate text group
        dup-7d96d06ad0b13d3985cc
        extraction review status
        automated_candidate_pending_source_review
        generic names
        1. PEMBROLIZUMAB
        id
        ind-span-4097a1c282096baaa34f
        label id
        228e1e3f-d207-481f-8e14-9fdcbd0470e9
        positive predicate support span
        Source null
        qualifier mentions
          regulatory links
            schema version
            0.1.0
            source batch sha256
            fc39a8c5cf96bf95ca20b85578140167b66b2741f7d9217f500d9ba0847ac058
            source defined aliases
            1. abbreviation
              NSCLC
              definition exact
              Non-Small Cell Lung Cancer
              definition span
              end
              380
              end exclusive
              true
              exact text
              Non-Small Cell Lung Cancer (NSCLC)
              label id
              228e1e3f-d207-481f-8e14-9fdcbd0470e9
              offset unit
              unicode_code_points
              source array index
              0
              source field
              indications_and_usage_exact
              source text sha256
              e526ba14c91f10737e6d3331fe23a6219f58c0eca6380bfce9bd78b573fea912
              start
              346
            2. abbreviation
              CRC
              definition exact
              Colorectal Cancer
              definition span
              end
              5042
              end exclusive
              true
              exact text
              Colorectal Cancer (CRC)
              label id
              228e1e3f-d207-481f-8e14-9fdcbd0470e9
              offset unit
              unicode_code_points
              source array index
              0
              source field
              indications_and_usage_exact
              source text sha256
              e526ba14c91f10737e6d3331fe23a6219f58c0eca6380bfce9bd78b573fea912
              start
              5019
            source span
            end
            190
            end exclusive
            true
            exact text
            ( 1.1 )
            label id
            228e1e3f-d207-481f-8e14-9fdcbd0470e9
            offset unit
            unicode_code_points
            source array index
            0
            source field
            indications_and_usage_exact
            source text sha256
            e526ba14c91f10737e6d3331fe23a6219f58c0eca6380bfce9bd78b573fea912
            start
            183
            source url
            https://api.fda.gov/drug/label.json?search=id%3A%22228e1e3f-d207-481f-8e14-9fdcbd0470e9%22
            spl effective date
            2026-07-10
            spl set id
            9333c79b-d487-4538-a9f0-71b91a02b287
            spl version
            228
            structured fields status
            not_extracted_no_values_inferred_from_mentions
            structured indication
            age
            Source null
            approval pathway
            Source null
            biomarker and test
            Source null
            disease stage
            Source null
            limitations
            Source null
            line
            Source null
            prior therapy
            Source null
            regimen
            Source null
            tumor histology
            Source null
            use intent
            unclear
            Passage 3 · positive indication candidate
            application numbers
            1. BLA125514
            brand names
            1. KEYTRUDA
            classification reasons
            1. inherited_predicate_from_same_label_section_requires_review
            2. tumor_or_malignant_hematology_words_in_positive_statement
            clinical review status
            pending
            content role
            positive_indication_candidate
            context span
            end
            537
            end exclusive
            true
            exact text
            1 INDICATIONS AND USAGE KEYTRUDA is a programmed death receptor-1 (PD-1)-blocking antibody indicated: Melanoma for the treatment of patients with unresectable or metastatic melanoma. ( 1.1 ) for the adjuvant treatment of adult and pediatric (12 years and older) patients with Stage IIB, IIC, or III melanoma following complete resection. ( 1.1 ) Non-Small Cell Lung Cancer (NSCLC) in combination with pemetrexed and platinum chemotherapy, as first-line treatment of patients with metastatic nonsquamous NSCLC, with no EGFR or ALK genomic
            label id
            228e1e3f-d207-481f-8e14-9fdcbd0470e9
            offset unit
            unicode_code_points
            source array index
            0
            source field
            indications_and_usage_exact
            source text sha256
            e526ba14c91f10737e6d3331fe23a6219f58c0eca6380bfce9bd78b573fea912
            start
            0
            current approval status
            not_reconciled
            duplicate text group
            dup-e620b75868053fe02ae4
            extraction review status
            automated_candidate_pending_source_review
            generic names
            1. PEMBROLIZUMAB
            id
            ind-span-23ea9409c3e169317afc
            label id
            228e1e3f-d207-481f-8e14-9fdcbd0470e9
            positive predicate support span
            end
            100
            end exclusive
            true
            exact text
            is a programmed death receptor-1 (PD-1)-blocking antibody indicated
            label id
            228e1e3f-d207-481f-8e14-9fdcbd0470e9
            offset unit
            unicode_code_points
            source array index
            0
            source field
            indications_and_usage_exact
            source text sha256
            e526ba14c91f10737e6d3331fe23a6219f58c0eca6380bfce9bd78b573fea912
            start
            33
            qualifier mentions
            1. context exact
              for the adjuvant treatment of adult and pediatric (12 years and older) patients with Stage IIB,
              kind
              age
              polarity
              not_inferred
              span
              end
              226
              end exclusive
              true
              exact text
              adult
              label id
              228e1e3f-d207-481f-8e14-9fdcbd0470e9
              offset unit
              unicode_code_points
              source array index
              0
              source field
              indications_and_usage_exact
              source text sha256
              e526ba14c91f10737e6d3331fe23a6219f58c0eca6380bfce9bd78b573fea912
              start
              221
            2. context exact
              for the adjuvant treatment of adult and pediatric (12 years and older) patients with Stage IIB, IIC, or III m
              kind
              age
              polarity
              not_inferred
              span
              end
              240
              end exclusive
              true
              exact text
              pediatric
              label id
              228e1e3f-d207-481f-8e14-9fdcbd0470e9
              offset unit
              unicode_code_points
              source array index
              0
              source field
              indications_and_usage_exact
              source text sha256
              e526ba14c91f10737e6d3331fe23a6219f58c0eca6380bfce9bd78b573fea912
              start
              231
            3. context exact
              for the adjuvant treatment of adult and pediatric (12 years and older) patients with Stage IIB, IIC, or III melanoma following co
              kind
              age
              polarity
              not_inferred
              span
              end
              260
              end exclusive
              true
              exact text
              12 years and older
              label id
              228e1e3f-d207-481f-8e14-9fdcbd0470e9
              offset unit
              unicode_code_points
              source array index
              0
              source field
              indications_and_usage_exact
              source text sha256
              e526ba14c91f10737e6d3331fe23a6219f58c0eca6380bfce9bd78b573fea912
              start
              242
            4. context exact
              for the adjuvant treatment of adult and pediatric (12 years and older) patients with Stage IIB, IIC, or III mel
              kind
              stage_or_setting
              polarity
              not_inferred
              span
              end
              242
              end exclusive
              true
              exact text
              adjuvant treatment of adult and pediatric (
              label id
              228e1e3f-d207-481f-8e14-9fdcbd0470e9
              offset unit
              unicode_code_points
              source array index
              0
              source field
              indications_and_usage_exact
              source text sha256
              e526ba14c91f10737e6d3331fe23a6219f58c0eca6380bfce9bd78b573fea912
              start
              199
            regulatory links
              schema version
              0.1.0
              source batch sha256
              fc39a8c5cf96bf95ca20b85578140167b66b2741f7d9217f500d9ba0847ac058
              source defined aliases
              1. abbreviation
                NSCLC
                definition exact
                Non-Small Cell Lung Cancer
                definition span
                end
                380
                end exclusive
                true
                exact text
                Non-Small Cell Lung Cancer (NSCLC)
                label id
                228e1e3f-d207-481f-8e14-9fdcbd0470e9
                offset unit
                unicode_code_points
                source array index
                0
                source field
                indications_and_usage_exact
                source text sha256
                e526ba14c91f10737e6d3331fe23a6219f58c0eca6380bfce9bd78b573fea912
                start
                346
              2. abbreviation
                CRC
                definition exact
                Colorectal Cancer
                definition span
                end
                5042
                end exclusive
                true
                exact text
                Colorectal Cancer (CRC)
                label id
                228e1e3f-d207-481f-8e14-9fdcbd0470e9
                offset unit
                unicode_code_points
                source array index
                0
                source field
                indications_and_usage_exact
                source text sha256
                e526ba14c91f10737e6d3331fe23a6219f58c0eca6380bfce9bd78b573fea912
                start
                5019
              source span
              end
              337
              end exclusive
              true
              exact text
              for the adjuvant treatment of adult and pediatric (12 years and older) patients with Stage IIB, IIC, or III melanoma following complete resection.
              label id
              228e1e3f-d207-481f-8e14-9fdcbd0470e9
              offset unit
              unicode_code_points
              source array index
              0
              source field
              indications_and_usage_exact
              source text sha256
              e526ba14c91f10737e6d3331fe23a6219f58c0eca6380bfce9bd78b573fea912
              start
              191
              source url
              https://api.fda.gov/drug/label.json?search=id%3A%22228e1e3f-d207-481f-8e14-9fdcbd0470e9%22
              spl effective date
              2026-07-10
              spl set id
              9333c79b-d487-4538-a9f0-71b91a02b287
              spl version
              228
              structured fields status
              not_extracted_no_values_inferred_from_mentions
              structured indication
              age
              Source null
              approval pathway
              Source null
              biomarker and test
              Source null
              disease stage
              Source null
              limitations
              Source null
              line
              Source null
              prior therapy
              Source null
              regimen
              Source null
              tumor histology
              Source null
              use intent
              tumor_directed_candidate
              Passage 4 · positive indication candidate
              application numbers
              1. BLA125514
              brand names
              1. KEYTRUDA
              classification reasons
              1. inherited_predicate_from_same_label_section_requires_review
              2. tumor_or_malignant_hematology_words_in_positive_statement
              clinical review status
              pending
              content role
              positive_indication_candidate
              context span
              end
              756
              end exclusive
              true
              exact text
              ts with unresectable or metastatic melanoma. ( 1.1 ) for the adjuvant treatment of adult and pediatric (12 years and older) patients with Stage IIB, IIC, or III melanoma following complete resection. ( 1.1 ) Non-Small Cell Lung Cancer (NSCLC) in combination with pemetrexed and platinum chemotherapy, as first-line treatment of patients with metastatic nonsquamous NSCLC, with no EGFR or ALK genomic tumor aberrations. ( 1.2 ) in combination with carboplatin and either paclitaxel or paclitaxel protein-bound, as first-line treatment of patients with metastatic squamous NSCLC. ( 1.2 ) as a single agent for the first-
              label id
              228e1e3f-d207-481f-8e14-9fdcbd0470e9
              offset unit
              unicode_code_points
              source array index
              0
              source field
              indications_and_usage_exact
              source text sha256
              e526ba14c91f10737e6d3331fe23a6219f58c0eca6380bfce9bd78b573fea912
              start
              138
              current approval status
              not_reconciled
              duplicate text group
              dup-2db7555f10691876b74d
              extraction review status
              automated_candidate_pending_source_review
              generic names
              1. PEMBROLIZUMAB
              id
              ind-span-1e7dde1ebb614e27532d
              label id
              228e1e3f-d207-481f-8e14-9fdcbd0470e9
              positive predicate support span
              end
              100
              end exclusive
              true
              exact text
              is a programmed death receptor-1 (PD-1)-blocking antibody indicated
              label id
              228e1e3f-d207-481f-8e14-9fdcbd0470e9
              offset unit
              unicode_code_points
              source array index
              0
              source field
              indications_and_usage_exact
              source text sha256
              e526ba14c91f10737e6d3331fe23a6219f58c0eca6380bfce9bd78b573fea912
              start
              33
              qualifier mentions
              1. context exact
                inum chemotherapy, as first-line treatment of patients with metastatic nonsquamous NSCLC, with no EGFR or ALK genomic tumor aberrations.
                kind
                biomarker
                polarity
                not_inferred
                span
                end
                508
                end exclusive
                true
                exact text
                metastatic nonsquamous NSCLC
                label id
                228e1e3f-d207-481f-8e14-9fdcbd0470e9
                offset unit
                unicode_code_points
                source array index
                0
                source field
                indications_and_usage_exact
                source text sha256
                e526ba14c91f10737e6d3331fe23a6219f58c0eca6380bfce9bd78b573fea912
                start
                480
              2. context exact
                ment of patients with metastatic nonsquamous NSCLC, with no EGFR or ALK genomic tumor aberrations.
                kind
                biomarker
                polarity
                not_inferred
                span
                end
                555
                end exclusive
                true
                exact text
                EGFR or ALK genomic tumor aberrations
                label id
                228e1e3f-d207-481f-8e14-9fdcbd0470e9
                offset unit
                unicode_code_points
                source array index
                0
                source field
                indications_and_usage_exact
                source text sha256
                e526ba14c91f10737e6d3331fe23a6219f58c0eca6380bfce9bd78b573fea912
                start
                518
              3. context exact
                inum chemotherapy, as first-line treatment of patients with metastatic nonsquamous NSCLC, with no EGFR or ALK genomic tumor aberrations.
                kind
                stage_or_setting
                polarity
                not_inferred
                span
                end
                508
                end exclusive
                true
                exact text
                metastatic nonsquamous NSCLC
                label id
                228e1e3f-d207-481f-8e14-9fdcbd0470e9
                offset unit
                unicode_code_points
                source array index
                0
                source field
                indications_and_usage_exact
                source text sha256
                e526ba14c91f10737e6d3331fe23a6219f58c0eca6380bfce9bd78b573fea912
                start
                480
              4. context exact
                n combination with pemetrexed and platinum chemotherapy, as first-line treatment of patients with metastatic nonsquamous NSCLC, with no EGFR or ALK genomic tumor aberrations.
                kind
                prior_therapy_or_line
                polarity
                not_inferred
                span
                end
                555
                end exclusive
                true
                exact text
                first-line treatment of patients with metastatic nonsquamous NSCLC, with no EGFR or ALK genomic tumor aberrations
                label id
                228e1e3f-d207-481f-8e14-9fdcbd0470e9
                offset unit
                unicode_code_points
                source array index
                0
                source field
                indications_and_usage_exact
                source text sha256
                e526ba14c91f10737e6d3331fe23a6219f58c0eca6380bfce9bd78b573fea912
                start
                442
              5. context exact
                ( 1.1 ) Non-Small Cell Lung Cancer (NSCLC) in combination with pemetrexed and platinum chemotherapy, as first-line treatment of patients with metastatic nonsquamous NSCLC, with no EGFR or ALK genomic tumor aberrations.
                kind
                regimen
                polarity
                not_inferred
                span
                end
                555
                end exclusive
                true
                exact text
                in combination with pemetrexed and platinum chemotherapy, as first-line treatment of patients with metastatic nonsquamous NSCLC, with no EGFR or ALK genomic tumor aberrations
                label id
                228e1e3f-d207-481f-8e14-9fdcbd0470e9
                offset unit
                unicode_code_points
                source array index
                0
                source field
                indications_and_usage_exact
                source text sha256
                e526ba14c91f10737e6d3331fe23a6219f58c0eca6380bfce9bd78b573fea912
                start
                381
              regulatory links
                schema version
                0.1.0
                source batch sha256
                fc39a8c5cf96bf95ca20b85578140167b66b2741f7d9217f500d9ba0847ac058
                source defined aliases
                1. abbreviation
                  NSCLC
                  definition exact
                  Non-Small Cell Lung Cancer
                  definition span
                  end
                  380
                  end exclusive
                  true
                  exact text
                  Non-Small Cell Lung Cancer (NSCLC)
                  label id
                  228e1e3f-d207-481f-8e14-9fdcbd0470e9
                  offset unit
                  unicode_code_points
                  source array index
                  0
                  source field
                  indications_and_usage_exact
                  source text sha256
                  e526ba14c91f10737e6d3331fe23a6219f58c0eca6380bfce9bd78b573fea912
                  start
                  346
                2. abbreviation
                  CRC
                  definition exact
                  Colorectal Cancer
                  definition span
                  end
                  5042
                  end exclusive
                  true
                  exact text
                  Colorectal Cancer (CRC)
                  label id
                  228e1e3f-d207-481f-8e14-9fdcbd0470e9
                  offset unit
                  unicode_code_points
                  source array index
                  0
                  source field
                  indications_and_usage_exact
                  source text sha256
                  e526ba14c91f10737e6d3331fe23a6219f58c0eca6380bfce9bd78b573fea912
                  start
                  5019
                source span
                end
                556
                end exclusive
                true
                exact text
                ( 1.1 ) Non-Small Cell Lung Cancer (NSCLC) in combination with pemetrexed and platinum chemotherapy, as first-line treatment of patients with metastatic nonsquamous NSCLC, with no EGFR or ALK genomic tumor aberrations.
                label id
                228e1e3f-d207-481f-8e14-9fdcbd0470e9
                offset unit
                unicode_code_points
                source array index
                0
                source field
                indications_and_usage_exact
                source text sha256
                e526ba14c91f10737e6d3331fe23a6219f58c0eca6380bfce9bd78b573fea912
                start
                338
                source url
                https://api.fda.gov/drug/label.json?search=id%3A%22228e1e3f-d207-481f-8e14-9fdcbd0470e9%22
                spl effective date
                2026-07-10
                spl set id
                9333c79b-d487-4538-a9f0-71b91a02b287
                spl version
                228
                structured fields status
                not_extracted_no_values_inferred_from_mentions
                structured indication
                age
                Source null
                approval pathway
                Source null
                biomarker and test
                Source null
                disease stage
                Source null
                limitations
                Source null
                line
                Source null
                prior therapy
                Source null
                regimen
                Source null
                tumor histology
                Source null
                use intent
                tumor_directed_candidate
                Passage 5 · unclassified context
                application numbers
                1. BLA125514
                brand names
                1. KEYTRUDA
                classification reasons
                1. no_unambiguous_positive_indication_predicate
                clinical review status
                pending
                content role
                unclassified_context
                context span
                end
                764
                end exclusive
                true
                exact text
                ell Lung Cancer (NSCLC) in combination with pemetrexed and platinum chemotherapy, as first-line treatment of patients with metastatic nonsquamous NSCLC, with no EGFR or ALK genomic tumor aberrations. ( 1.2 ) in combination with carboplatin and either paclitaxel or paclitaxel protein-bound, as first-line treatment of patients with metastatic squamous NSCLC. ( 1.2 ) as a single agent for the first-line tre
                label id
                228e1e3f-d207-481f-8e14-9fdcbd0470e9
                offset unit
                unicode_code_points
                source array index
                0
                source field
                indications_and_usage_exact
                source text sha256
                e526ba14c91f10737e6d3331fe23a6219f58c0eca6380bfce9bd78b573fea912
                start
                357
                current approval status
                not_reconciled
                duplicate text group
                dup-cae292898e7240dcc6f1
                extraction review status
                automated_candidate_pending_source_review
                generic names
                1. PEMBROLIZUMAB
                id
                ind-span-6c413db61d24a2e5395c
                label id
                228e1e3f-d207-481f-8e14-9fdcbd0470e9
                positive predicate support span
                Source null
                qualifier mentions
                  regulatory links
                    schema version
                    0.1.0
                    source batch sha256
                    fc39a8c5cf96bf95ca20b85578140167b66b2741f7d9217f500d9ba0847ac058
                    source defined aliases
                    1. abbreviation
                      NSCLC
                      definition exact
                      Non-Small Cell Lung Cancer
                      definition span
                      end
                      380
                      end exclusive
                      true
                      exact text
                      Non-Small Cell Lung Cancer (NSCLC)
                      label id
                      228e1e3f-d207-481f-8e14-9fdcbd0470e9
                      offset unit
                      unicode_code_points
                      source array index
                      0
                      source field
                      indications_and_usage_exact
                      source text sha256
                      e526ba14c91f10737e6d3331fe23a6219f58c0eca6380bfce9bd78b573fea912
                      start
                      346
                    2. abbreviation
                      CRC
                      definition exact
                      Colorectal Cancer
                      definition span
                      end
                      5042
                      end exclusive
                      true
                      exact text
                      Colorectal Cancer (CRC)
                      label id
                      228e1e3f-d207-481f-8e14-9fdcbd0470e9
                      offset unit
                      unicode_code_points
                      source array index
                      0
                      source field
                      indications_and_usage_exact
                      source text sha256
                      e526ba14c91f10737e6d3331fe23a6219f58c0eca6380bfce9bd78b573fea912
                      start
                      5019
                    source span
                    end
                    564
                    end exclusive
                    true
                    exact text
                    ( 1.2 )
                    label id
                    228e1e3f-d207-481f-8e14-9fdcbd0470e9
                    offset unit
                    unicode_code_points
                    source array index
                    0
                    source field
                    indications_and_usage_exact
                    source text sha256
                    e526ba14c91f10737e6d3331fe23a6219f58c0eca6380bfce9bd78b573fea912
                    start
                    557
                    source url
                    https://api.fda.gov/drug/label.json?search=id%3A%22228e1e3f-d207-481f-8e14-9fdcbd0470e9%22
                    spl effective date
                    2026-07-10
                    spl set id
                    9333c79b-d487-4538-a9f0-71b91a02b287
                    spl version
                    228
                    structured fields status
                    not_extracted_no_values_inferred_from_mentions
                    structured indication
                    age
                    Source null
                    approval pathway
                    Source null
                    biomarker and test
                    Source null
                    disease stage
                    Source null
                    limitations
                    Source null
                    line
                    Source null
                    prior therapy
                    Source null
                    regimen
                    Source null
                    tumor histology
                    Source null
                    use intent
                    unclear
                    Passage 6 · positive indication candidate
                    application numbers
                    1. BLA125514
                    brand names
                    1. KEYTRUDA
                    classification reasons
                    1. inherited_predicate_from_same_label_section_requires_review
                    2. tumor_or_malignant_hematology_words_in_positive_statement
                    clinical review status
                    pending
                    content role
                    positive_indication_candidate
                    context span
                    end
                    915
                    end exclusive
                    true
                    exact text
                    Cancer (NSCLC) in combination with pemetrexed and platinum chemotherapy, as first-line treatment of patients with metastatic nonsquamous NSCLC, with no EGFR or ALK genomic tumor aberrations. ( 1.2 ) in combination with carboplatin and either paclitaxel or paclitaxel protein-bound, as first-line treatment of patients with metastatic squamous NSCLC. ( 1.2 ) as a single agent for the first-line treatment of patients with NSCLC expressing PD-L1 [Tumor Proportion Score (TPS) ≥1%] as determined by an FDA-authorized test, with no EGFR or ALK genomic
                    label id
                    228e1e3f-d207-481f-8e14-9fdcbd0470e9
                    offset unit
                    unicode_code_points
                    source array index
                    0
                    source field
                    indications_and_usage_exact
                    source text sha256
                    e526ba14c91f10737e6d3331fe23a6219f58c0eca6380bfce9bd78b573fea912
                    start
                    365
                    current approval status
                    not_reconciled
                    duplicate text group
                    dup-18c575534e5a16bf3a0a
                    extraction review status
                    automated_candidate_pending_source_review
                    generic names
                    1. PEMBROLIZUMAB
                    id
                    ind-span-c45f10094f4c9a92258a
                    label id
                    228e1e3f-d207-481f-8e14-9fdcbd0470e9
                    positive predicate support span
                    end
                    100
                    end exclusive
                    true
                    exact text
                    is a programmed death receptor-1 (PD-1)-blocking antibody indicated
                    label id
                    228e1e3f-d207-481f-8e14-9fdcbd0470e9
                    offset unit
                    unicode_code_points
                    source array index
                    0
                    source field
                    indications_and_usage_exact
                    source text sha256
                    e526ba14c91f10737e6d3331fe23a6219f58c0eca6380bfce9bd78b573fea912
                    start
                    33
                    qualifier mentions
                    1. context exact
                      xel protein-bound, as first-line treatment of patients with metastatic squamous NSCLC.
                      kind
                      biomarker
                      polarity
                      not_inferred
                      span
                      end
                      714
                      end exclusive
                      true
                      exact text
                      metastatic squamous NSCLC
                      label id
                      228e1e3f-d207-481f-8e14-9fdcbd0470e9
                      offset unit
                      unicode_code_points
                      source array index
                      0
                      source field
                      indications_and_usage_exact
                      source text sha256
                      e526ba14c91f10737e6d3331fe23a6219f58c0eca6380bfce9bd78b573fea912
                      start
                      689
                    2. context exact
                      xel protein-bound, as first-line treatment of patients with metastatic squamous NSCLC.
                      kind
                      stage_or_setting
                      polarity
                      not_inferred
                      span
                      end
                      714
                      end exclusive
                      true
                      exact text
                      metastatic squamous NSCLC
                      label id
                      228e1e3f-d207-481f-8e14-9fdcbd0470e9
                      offset unit
                      unicode_code_points
                      source array index
                      0
                      source field
                      indications_and_usage_exact
                      source text sha256
                      e526ba14c91f10737e6d3331fe23a6219f58c0eca6380bfce9bd78b573fea912
                      start
                      689
                    3. context exact
                      latin and either paclitaxel or paclitaxel protein-bound, as first-line treatment of patients with metastatic squamous NSCLC.
                      kind
                      prior_therapy_or_line
                      polarity
                      not_inferred
                      span
                      end
                      714
                      end exclusive
                      true
                      exact text
                      first-line treatment of patients with metastatic squamous NSCLC
                      label id
                      228e1e3f-d207-481f-8e14-9fdcbd0470e9
                      offset unit
                      unicode_code_points
                      source array index
                      0
                      source field
                      indications_and_usage_exact
                      source text sha256
                      e526ba14c91f10737e6d3331fe23a6219f58c0eca6380bfce9bd78b573fea912
                      start
                      651
                    4. context exact
                      in combination with carboplatin and either paclitaxel or paclitaxel protein-bound, as first-line treatment of patients with metastatic squamous NSCLC.
                      kind
                      regimen
                      polarity
                      not_inferred
                      span
                      end
                      714
                      end exclusive
                      true
                      exact text
                      in combination with carboplatin and either paclitaxel or paclitaxel protein-bound, as first-line treatment of patients with metastatic squamous NSCLC
                      label id
                      228e1e3f-d207-481f-8e14-9fdcbd0470e9
                      offset unit
                      unicode_code_points
                      source array index
                      0
                      source field
                      indications_and_usage_exact
                      source text sha256
                      e526ba14c91f10737e6d3331fe23a6219f58c0eca6380bfce9bd78b573fea912
                      start
                      565
                    regulatory links
                      schema version
                      0.1.0
                      source batch sha256
                      fc39a8c5cf96bf95ca20b85578140167b66b2741f7d9217f500d9ba0847ac058
                      source defined aliases
                      1. abbreviation
                        NSCLC
                        definition exact
                        Non-Small Cell Lung Cancer
                        definition span
                        end
                        380
                        end exclusive
                        true
                        exact text
                        Non-Small Cell Lung Cancer (NSCLC)
                        label id
                        228e1e3f-d207-481f-8e14-9fdcbd0470e9
                        offset unit
                        unicode_code_points
                        source array index
                        0
                        source field
                        indications_and_usage_exact
                        source text sha256
                        e526ba14c91f10737e6d3331fe23a6219f58c0eca6380bfce9bd78b573fea912
                        start
                        346
                      2. abbreviation
                        CRC
                        definition exact
                        Colorectal Cancer
                        definition span
                        end
                        5042
                        end exclusive
                        true
                        exact text
                        Colorectal Cancer (CRC)
                        label id
                        228e1e3f-d207-481f-8e14-9fdcbd0470e9
                        offset unit
                        unicode_code_points
                        source array index
                        0
                        source field
                        indications_and_usage_exact
                        source text sha256
                        e526ba14c91f10737e6d3331fe23a6219f58c0eca6380bfce9bd78b573fea912
                        start
                        5019
                      source span
                      end
                      715
                      end exclusive
                      true
                      exact text
                      in combination with carboplatin and either paclitaxel or paclitaxel protein-bound, as first-line treatment of patients with metastatic squamous NSCLC.
                      label id
                      228e1e3f-d207-481f-8e14-9fdcbd0470e9
                      offset unit
                      unicode_code_points
                      source array index
                      0
                      source field
                      indications_and_usage_exact
                      source text sha256
                      e526ba14c91f10737e6d3331fe23a6219f58c0eca6380bfce9bd78b573fea912
                      start
                      565
                      source url
                      https://api.fda.gov/drug/label.json?search=id%3A%22228e1e3f-d207-481f-8e14-9fdcbd0470e9%22
                      spl effective date
                      2026-07-10
                      spl set id
                      9333c79b-d487-4538-a9f0-71b91a02b287
                      spl version
                      228
                      structured fields status
                      not_extracted_no_values_inferred_from_mentions
                      structured indication
                      age
                      Source null
                      approval pathway
                      Source null
                      biomarker and test
                      Source null
                      disease stage
                      Source null
                      limitations
                      Source null
                      line
                      Source null
                      prior therapy
                      Source null
                      regimen
                      Source null
                      tumor histology
                      Source null
                      use intent
                      tumor_directed_candidate
                      Passage 7 · unclassified context
                      application numbers
                      1. BLA125514
                      brand names
                      1. KEYTRUDA
                      classification reasons
                      1. no_unambiguous_positive_indication_predicate
                      clinical review status
                      pending
                      content role
                      unclassified_context
                      context span
                      end
                      923
                      end exclusive
                      true
                      exact text
                      o EGFR or ALK genomic tumor aberrations. ( 1.2 ) in combination with carboplatin and either paclitaxel or paclitaxel protein-bound, as first-line treatment of patients with metastatic squamous NSCLC. ( 1.2 ) as a single agent for the first-line treatment of patients with NSCLC expressing PD-L1 [Tumor Proportion Score (TPS) ≥1%] as determined by an FDA-authorized test, with no EGFR or ALK genomic tumor ab
                      label id
                      228e1e3f-d207-481f-8e14-9fdcbd0470e9
                      offset unit
                      unicode_code_points
                      source array index
                      0
                      source field
                      indications_and_usage_exact
                      source text sha256
                      e526ba14c91f10737e6d3331fe23a6219f58c0eca6380bfce9bd78b573fea912
                      start
                      516
                      current approval status
                      not_reconciled
                      duplicate text group
                      dup-cae292898e7240dcc6f1
                      extraction review status
                      automated_candidate_pending_source_review
                      generic names
                      1. PEMBROLIZUMAB
                      id
                      ind-span-755e3787a9d9c0a611a6
                      label id
                      228e1e3f-d207-481f-8e14-9fdcbd0470e9
                      positive predicate support span
                      Source null
                      qualifier mentions
                        regulatory links
                          schema version
                          0.1.0
                          source batch sha256
                          fc39a8c5cf96bf95ca20b85578140167b66b2741f7d9217f500d9ba0847ac058
                          source defined aliases
                          1. abbreviation
                            NSCLC
                            definition exact
                            Non-Small Cell Lung Cancer
                            definition span
                            end
                            380
                            end exclusive
                            true
                            exact text
                            Non-Small Cell Lung Cancer (NSCLC)
                            label id
                            228e1e3f-d207-481f-8e14-9fdcbd0470e9
                            offset unit
                            unicode_code_points
                            source array index
                            0
                            source field
                            indications_and_usage_exact
                            source text sha256
                            e526ba14c91f10737e6d3331fe23a6219f58c0eca6380bfce9bd78b573fea912
                            start
                            346
                          2. abbreviation
                            CRC
                            definition exact
                            Colorectal Cancer
                            definition span
                            end
                            5042
                            end exclusive
                            true
                            exact text
                            Colorectal Cancer (CRC)
                            label id
                            228e1e3f-d207-481f-8e14-9fdcbd0470e9
                            offset unit
                            unicode_code_points
                            source array index
                            0
                            source field
                            indications_and_usage_exact
                            source text sha256
                            e526ba14c91f10737e6d3331fe23a6219f58c0eca6380bfce9bd78b573fea912
                            start
                            5019
                          source span
                          end
                          723
                          end exclusive
                          true
                          exact text
                          ( 1.2 )
                          label id
                          228e1e3f-d207-481f-8e14-9fdcbd0470e9
                          offset unit
                          unicode_code_points
                          source array index
                          0
                          source field
                          indications_and_usage_exact
                          source text sha256
                          e526ba14c91f10737e6d3331fe23a6219f58c0eca6380bfce9bd78b573fea912
                          start
                          716
                          source url
                          https://api.fda.gov/drug/label.json?search=id%3A%22228e1e3f-d207-481f-8e14-9fdcbd0470e9%22
                          spl effective date
                          2026-07-10
                          spl set id
                          9333c79b-d487-4538-a9f0-71b91a02b287
                          spl version
                          228
                          structured fields status
                          not_extracted_no_values_inferred_from_mentions
                          structured indication
                          age
                          Source null
                          approval pathway
                          Source null
                          biomarker and test
                          Source null
                          disease stage
                          Source null
                          limitations
                          Source null
                          line
                          Source null
                          prior therapy
                          Source null
                          regimen
                          Source null
                          tumor histology
                          Source null
                          use intent
                          unclear
                          Passage 8 · positive indication candidate
                          application numbers
                          1. BLA125514
                          brand names
                          1. KEYTRUDA
                          classification reasons
                          1. inherited_predicate_from_same_label_section_requires_review
                          2. tumor_or_malignant_hematology_words_in_positive_statement
                          clinical review status
                          pending
                          content role
                          positive_indication_candidate
                          context span
                          end
                          1253
                          end exclusive
                          true
                          exact text
                          r ALK genomic tumor aberrations. ( 1.2 ) in combination with carboplatin and either paclitaxel or paclitaxel protein-bound, as first-line treatment of patients with metastatic squamous NSCLC. ( 1.2 ) as a single agent for the first-line treatment of patients with NSCLC expressing PD-L1 [Tumor Proportion Score (TPS) ≥1%] as determined by an FDA-authorized test, with no EGFR or ALK genomic tumor aberrations, and is: Stage III where patients are not candidates for surgical resection or definitive chemoradiation, or metastatic. ( 1.2 , 2.1 ) as a single agent for the treatment of patients with metastatic NSCLC whose tumors express PD-L1 (TPS ≥1%) as determined by an FDA-authorized test, with disease progression on or after
                          label id
                          228e1e3f-d207-481f-8e14-9fdcbd0470e9
                          offset unit
                          unicode_code_points
                          source array index
                          0
                          source field
                          indications_and_usage_exact
                          source text sha256
                          e526ba14c91f10737e6d3331fe23a6219f58c0eca6380bfce9bd78b573fea912
                          start
                          524
                          current approval status
                          not_reconciled
                          duplicate text group
                          dup-c230663d5e2fdcee8f52
                          extraction review status
                          automated_candidate_pending_source_review
                          generic names
                          1. PEMBROLIZUMAB
                          id
                          ind-span-4539e078388a3cac24af
                          label id
                          228e1e3f-d207-481f-8e14-9fdcbd0470e9
                          positive predicate support span
                          end
                          100
                          end exclusive
                          true
                          exact text
                          is a programmed death receptor-1 (PD-1)-blocking antibody indicated
                          label id
                          228e1e3f-d207-481f-8e14-9fdcbd0470e9
                          offset unit
                          unicode_code_points
                          source array index
                          0
                          source field
                          indications_and_usage_exact
                          source text sha256
                          e526ba14c91f10737e6d3331fe23a6219f58c0eca6380bfce9bd78b573fea912
                          start
                          33
                          qualifier mentions
                          1. context exact
                            the first-line treatment of patients with NSCLC expressing PD-L1 [Tumor Proportion Score (TPS) ≥1%] as determined by an FDA-authorized test, with no EGFR or ALK gen
                            kind
                            biomarker
                            polarity
                            not_inferred
                            span
                            end
                            850
                            end exclusive
                            true
                            exact text
                            PD-L1 [Tumor Proportion Score (TPS) ≥1%] as d
                            label id
                            228e1e3f-d207-481f-8e14-9fdcbd0470e9
                            offset unit
                            unicode_code_points
                            source array index
                            0
                            source field
                            indications_and_usage_exact
                            source text sha256
                            e526ba14c91f10737e6d3331fe23a6219f58c0eca6380bfce9bd78b573fea912
                            start
                            805
                          2. context exact
                            (TPS) ≥1%] as determined by an FDA-authorized test, with no EGFR or ALK genomic tumor aberrations, and is: Stage III where patients are not candidates for su
                            kind
                            biomarker
                            polarity
                            not_inferred
                            span
                            end
                            932
                            end exclusive
                            true
                            exact text
                            EGFR or ALK genomic tumor aberrations
                            label id
                            228e1e3f-d207-481f-8e14-9fdcbd0470e9
                            offset unit
                            unicode_code_points
                            source array index
                            0
                            source field
                            indications_and_usage_exact
                            source text sha256
                            e526ba14c91f10737e6d3331fe23a6219f58c0eca6380bfce9bd78b573fea912
                            start
                            895
                          3. context exact
                            tes for surgical resection or definitive chemoradiation, or metastatic.
                            kind
                            biomarker
                            polarity
                            not_inferred
                            span
                            end
                            1052
                            end exclusive
                            true
                            exact text
                            metastatic
                            label id
                            228e1e3f-d207-481f-8e14-9fdcbd0470e9
                            offset unit
                            unicode_code_points
                            source array index
                            0
                            source field
                            indications_and_usage_exact
                            source text sha256
                            e526ba14c91f10737e6d3331fe23a6219f58c0eca6380bfce9bd78b573fea912
                            start
                            1042
                          4. context exact
                            tes for surgical resection or definitive chemoradiation, or metastatic.
                            kind
                            stage_or_setting
                            polarity
                            not_inferred
                            span
                            end
                            1052
                            end exclusive
                            true
                            exact text
                            metastatic
                            label id
                            228e1e3f-d207-481f-8e14-9fdcbd0470e9
                            offset unit
                            unicode_code_points
                            source array index
                            0
                            source field
                            indications_and_usage_exact
                            source text sha256
                            e526ba14c91f10737e6d3331fe23a6219f58c0eca6380bfce9bd78b573fea912
                            start
                            1042
                          5. context exact
                            as a single agent for the first-line treatment of patients with NSCLC expressing PD-L1 [Tumor Proportion Score (TPS) ≥1%] as determined by an FDA-authorized test, with no EGFR or ALK genomic tumor aberrations, and is: Stage III where patients are not candi
                            kind
                            prior_therapy_or_line
                            polarity
                            not_inferred
                            span
                            end
                            920
                            end exclusive
                            true
                            exact text
                            first-line treatment of patients with NSCLC expressing PD-L1 [Tumor Proportion Score (TPS) ≥1%] as determined by an FDA-authorized test, with no EGFR or ALK genomic tumor
                            label id
                            228e1e3f-d207-481f-8e14-9fdcbd0470e9
                            offset unit
                            unicode_code_points
                            source array index
                            0
                            source field
                            indications_and_usage_exact
                            source text sha256
                            e526ba14c91f10737e6d3331fe23a6219f58c0eca6380bfce9bd78b573fea912
                            start
                            750
                          6. context exact
                            as a single agent for the first-line treatment of patients with NSCLC expressing PD-L1 [Tumor Proportion Score (TPS) ≥1%] as determined by an FDA-authorized test, with no EGFR or ALK genomic tumor aberrations, and is: Stage III where pat
                            kind
                            regimen
                            polarity
                            not_inferred
                            span
                            end
                            901
                            end exclusive
                            true
                            exact text
                            as a single agent for the first-line treatment of patients with NSCLC expressing PD-L1 [Tumor Proportion Score (TPS) ≥1%] as determined by an FDA-authorized test, with no EGFR o
                            label id
                            228e1e3f-d207-481f-8e14-9fdcbd0470e9
                            offset unit
                            unicode_code_points
                            source array index
                            0
                            source field
                            indications_and_usage_exact
                            source text sha256
                            e526ba14c91f10737e6d3331fe23a6219f58c0eca6380bfce9bd78b573fea912
                            start
                            724
                          regulatory links
                            schema version
                            0.1.0
                            source batch sha256
                            fc39a8c5cf96bf95ca20b85578140167b66b2741f7d9217f500d9ba0847ac058
                            source defined aliases
                            1. abbreviation
                              NSCLC
                              definition exact
                              Non-Small Cell Lung Cancer
                              definition span
                              end
                              380
                              end exclusive
                              true
                              exact text
                              Non-Small Cell Lung Cancer (NSCLC)
                              label id
                              228e1e3f-d207-481f-8e14-9fdcbd0470e9
                              offset unit
                              unicode_code_points
                              source array index
                              0
                              source field
                              indications_and_usage_exact
                              source text sha256
                              e526ba14c91f10737e6d3331fe23a6219f58c0eca6380bfce9bd78b573fea912
                              start
                              346
                            2. abbreviation
                              CRC
                              definition exact
                              Colorectal Cancer
                              definition span
                              end
                              5042
                              end exclusive
                              true
                              exact text
                              Colorectal Cancer (CRC)
                              label id
                              228e1e3f-d207-481f-8e14-9fdcbd0470e9
                              offset unit
                              unicode_code_points
                              source array index
                              0
                              source field
                              indications_and_usage_exact
                              source text sha256
                              e526ba14c91f10737e6d3331fe23a6219f58c0eca6380bfce9bd78b573fea912
                              start
                              5019
                            source span
                            end
                            1053
                            end exclusive
                            true
                            exact text
                            as a single agent for the first-line treatment of patients with NSCLC expressing PD-L1 [Tumor Proportion Score (TPS) ≥1%] as determined by an FDA-authorized test, with no EGFR or ALK genomic tumor aberrations, and is: Stage III where patients are not candidates for surgical resection or definitive chemoradiation, or metastatic.
                            label id
                            228e1e3f-d207-481f-8e14-9fdcbd0470e9
                            offset unit
                            unicode_code_points
                            source array index
                            0
                            source field
                            indications_and_usage_exact
                            source text sha256
                            e526ba14c91f10737e6d3331fe23a6219f58c0eca6380bfce9bd78b573fea912
                            start
                            724
                            source url
                            https://api.fda.gov/drug/label.json?search=id%3A%22228e1e3f-d207-481f-8e14-9fdcbd0470e9%22
                            spl effective date
                            2026-07-10
                            spl set id
                            9333c79b-d487-4538-a9f0-71b91a02b287
                            spl version
                            228
                            structured fields status
                            not_extracted_no_values_inferred_from_mentions
                            structured indication
                            age
                            Source null
                            approval pathway
                            Source null
                            biomarker and test
                            Source null
                            disease stage
                            Source null
                            limitations
                            Source null
                            line
                            Source null
                            prior therapy
                            Source null
                            regimen
                            Source null
                            tumor histology
                            Source null
                            use intent
                            tumor_directed_candidate
                            Passage 9 · unclassified context
                            application numbers
                            1. BLA125514
                            brand names
                            1. KEYTRUDA
                            classification reasons
                            1. no_unambiguous_positive_indication_predicate
                            clinical review status
                            pending
                            content role
                            unclassified_context
                            context span
                            end
                            1486
                            end exclusive
                            true
                            exact text
                            mined by an FDA-authorized test, with no EGFR or ALK genomic tumor aberrations, and is: Stage III where patients are not candidates for surgical resection or definitive chemoradiation, or metastatic. ( 1.2 , 2.1 ) as a single agent for the treatment of patients with metastatic NSCLC whose tumors express PD-L1 (TPS ≥1%) as determined by an FDA-authorized test, with disease progression on or after platinum-containing chemotherapy. Patients with EGFR or ALK genomic tumor aberrations should have disease progression on FDA-approved therapy for these aberrations prior to receiving KEYTRUDA. ( 1.2 , 2.1 ) for the treatment of patie
                            label id
                            228e1e3f-d207-481f-8e14-9fdcbd0470e9
                            offset unit
                            unicode_code_points
                            source array index
                            0
                            source field
                            indications_and_usage_exact
                            source text sha256
                            e526ba14c91f10737e6d3331fe23a6219f58c0eca6380bfce9bd78b573fea912
                            start
                            854
                            current approval status
                            not_reconciled
                            duplicate text group
                            dup-641d194608f28a75e22c
                            extraction review status
                            automated_candidate_pending_source_review
                            generic names
                            1. PEMBROLIZUMAB
                            id
                            ind-span-6dba420e66b7df41d13b
                            label id
                            228e1e3f-d207-481f-8e14-9fdcbd0470e9
                            positive predicate support span
                            Source null
                            qualifier mentions
                            1. context exact
                              2.1 ) as a single agent for the treatment of patients with metastatic NSCLC whose tumors express PD-L1 (TPS ≥1%) as determined by an FDA-authorized test, with dis
                              kind
                              biomarker
                              polarity
                              not_inferred
                              span
                              end
                              1164
                              end exclusive
                              true
                              exact text
                              metastatic NSCLC whose tumors express PD-L1
                              label id
                              228e1e3f-d207-481f-8e14-9fdcbd0470e9
                              offset unit
                              unicode_code_points
                              source array index
                              0
                              source field
                              indications_and_usage_exact
                              source text sha256
                              e526ba14c91f10737e6d3331fe23a6219f58c0eca6380bfce9bd78b573fea912
                              start
                              1121
                            2. context exact
                              2.1 ) as a single agent for the treatment of patients with metastatic NSCLC whose tumors express PD-L1 (TPS ≥1%) as determined by an FDA-authorized test, with disea
                              kind
                              stage_or_setting
                              polarity
                              not_inferred
                              span
                              end
                              1166
                              end exclusive
                              true
                              exact text
                              metastatic NSCLC whose tumors express PD-L1 (
                              label id
                              228e1e3f-d207-481f-8e14-9fdcbd0470e9
                              offset unit
                              unicode_code_points
                              source array index
                              0
                              source field
                              indications_and_usage_exact
                              source text sha256
                              e526ba14c91f10737e6d3331fe23a6219f58c0eca6380bfce9bd78b573fea912
                              start
                              1121
                            3. context exact
                              ( 1.2 , 2.1 ) as a single agent for the treatment of patients with metastatic NSCLC whose tumors express PD-L1 (TPS ≥1%) as determined by an FDA-authorized test, with disease progression on or after platinum-containing chemotherapy.
                              kind
                              regimen
                              polarity
                              not_inferred
                              span
                              end
                              1245
                              end exclusive
                              true
                              exact text
                              as a single agent for the treatment of patients with metastatic NSCLC whose tumors express PD-L1 (TPS ≥1%) as determined by an FDA-authorized test, with disease progression on o
                              label id
                              228e1e3f-d207-481f-8e14-9fdcbd0470e9
                              offset unit
                              unicode_code_points
                              source array index
                              0
                              source field
                              indications_and_usage_exact
                              source text sha256
                              e526ba14c91f10737e6d3331fe23a6219f58c0eca6380bfce9bd78b573fea912
                              start
                              1068
                            regulatory links
                              schema version
                              0.1.0
                              source batch sha256
                              fc39a8c5cf96bf95ca20b85578140167b66b2741f7d9217f500d9ba0847ac058
                              source defined aliases
                              1. abbreviation
                                NSCLC
                                definition exact
                                Non-Small Cell Lung Cancer
                                definition span
                                end
                                380
                                end exclusive
                                true
                                exact text
                                Non-Small Cell Lung Cancer (NSCLC)
                                label id
                                228e1e3f-d207-481f-8e14-9fdcbd0470e9
                                offset unit
                                unicode_code_points
                                source array index
                                0
                                source field
                                indications_and_usage_exact
                                source text sha256
                                e526ba14c91f10737e6d3331fe23a6219f58c0eca6380bfce9bd78b573fea912
                                start
                                346
                              2. abbreviation
                                CRC
                                definition exact
                                Colorectal Cancer
                                definition span
                                end
                                5042
                                end exclusive
                                true
                                exact text
                                Colorectal Cancer (CRC)
                                label id
                                228e1e3f-d207-481f-8e14-9fdcbd0470e9
                                offset unit
                                unicode_code_points
                                source array index
                                0
                                source field
                                indications_and_usage_exact
                                source text sha256
                                e526ba14c91f10737e6d3331fe23a6219f58c0eca6380bfce9bd78b573fea912
                                start
                                5019
                              source span
                              end
                              1286
                              end exclusive
                              true
                              exact text
                              ( 1.2 , 2.1 ) as a single agent for the treatment of patients with metastatic NSCLC whose tumors express PD-L1 (TPS ≥1%) as determined by an FDA-authorized test, with disease progression on or after platinum-containing chemotherapy.
                              label id
                              228e1e3f-d207-481f-8e14-9fdcbd0470e9
                              offset unit
                              unicode_code_points
                              source array index
                              0
                              source field
                              indications_and_usage_exact
                              source text sha256
                              e526ba14c91f10737e6d3331fe23a6219f58c0eca6380bfce9bd78b573fea912
                              start
                              1054
                              source url
                              https://api.fda.gov/drug/label.json?search=id%3A%22228e1e3f-d207-481f-8e14-9fdcbd0470e9%22
                              spl effective date
                              2026-07-10
                              spl set id
                              9333c79b-d487-4538-a9f0-71b91a02b287
                              spl version
                              228
                              structured fields status
                              not_extracted_no_values_inferred_from_mentions
                              structured indication
                              age
                              Source null
                              approval pathway
                              Source null
                              biomarker and test
                              Source null
                              disease stage
                              Source null
                              limitations
                              Source null
                              line
                              Source null
                              prior therapy
                              Source null
                              regimen
                              Source null
                              tumor histology
                              Source null
                              use intent
                              unclear
                              Passage 10 · unclassified context
                              application numbers
                              1. BLA125514
                              brand names
                              1. KEYTRUDA
                              classification reasons
                              1. no_unambiguous_positive_indication_predicate
                              clinical review status
                              pending
                              content role
                              unclassified_context
                              context span
                              end
                              1645
                              end exclusive
                              true
                              exact text
                              or the treatment of patients with metastatic NSCLC whose tumors express PD-L1 (TPS ≥1%) as determined by an FDA-authorized test, with disease progression on or after platinum-containing chemotherapy. Patients with EGFR or ALK genomic tumor aberrations should have disease progression on FDA-approved therapy for these aberrations prior to receiving KEYTRUDA. ( 1.2 , 2.1 ) for the treatment of patients with resectable (tumors ≥4 cm or node positive) NSCLC in combination with platinum-containing chemotherapy as neoadjuvant treatment, and then continued as
                              label id
                              228e1e3f-d207-481f-8e14-9fdcbd0470e9
                              offset unit
                              unicode_code_points
                              source array index
                              0
                              source field
                              indications_and_usage_exact
                              source text sha256
                              e526ba14c91f10737e6d3331fe23a6219f58c0eca6380bfce9bd78b573fea912
                              start
                              1087
                              current approval status
                              not_reconciled
                              duplicate text group
                              dup-06445d0b116646587e17
                              extraction review status
                              automated_candidate_pending_source_review
                              generic names
                              1. PEMBROLIZUMAB
                              id
                              ind-span-9493ebeab90b98aa5902
                              label id
                              228e1e3f-d207-481f-8e14-9fdcbd0470e9
                              positive predicate support span
                              Source null
                              qualifier mentions
                              1. context exact
                                Patients with EGFR or ALK genomic tumor aberrations should have disease progression on FDA-approved therapy for these
                                kind
                                biomarker
                                polarity
                                not_inferred
                                span
                                end
                                1345
                                end exclusive
                                true
                                exact text
                                EGFR or ALK genomic tumor aberrations should
                                label id
                                228e1e3f-d207-481f-8e14-9fdcbd0470e9
                                offset unit
                                unicode_code_points
                                source array index
                                0
                                source field
                                indications_and_usage_exact
                                source text sha256
                                e526ba14c91f10737e6d3331fe23a6219f58c0eca6380bfce9bd78b573fea912
                                start
                                1301
                              regulatory links
                                schema version
                                0.1.0
                                source batch sha256
                                fc39a8c5cf96bf95ca20b85578140167b66b2741f7d9217f500d9ba0847ac058
                                source defined aliases
                                1. abbreviation
                                  NSCLC
                                  definition exact
                                  Non-Small Cell Lung Cancer
                                  definition span
                                  end
                                  380
                                  end exclusive
                                  true
                                  exact text
                                  Non-Small Cell Lung Cancer (NSCLC)
                                  label id
                                  228e1e3f-d207-481f-8e14-9fdcbd0470e9
                                  offset unit
                                  unicode_code_points
                                  source array index
                                  0
                                  source field
                                  indications_and_usage_exact
                                  source text sha256
                                  e526ba14c91f10737e6d3331fe23a6219f58c0eca6380bfce9bd78b573fea912
                                  start
                                  346
                                2. abbreviation
                                  CRC
                                  definition exact
                                  Colorectal Cancer
                                  definition span
                                  end
                                  5042
                                  end exclusive
                                  true
                                  exact text
                                  Colorectal Cancer (CRC)
                                  label id
                                  228e1e3f-d207-481f-8e14-9fdcbd0470e9
                                  offset unit
                                  unicode_code_points
                                  source array index
                                  0
                                  source field
                                  indications_and_usage_exact
                                  source text sha256
                                  e526ba14c91f10737e6d3331fe23a6219f58c0eca6380bfce9bd78b573fea912
                                  start
                                  5019
                                source span
                                end
                                1445
                                end exclusive
                                true
                                exact text
                                Patients with EGFR or ALK genomic tumor aberrations should have disease progression on FDA-approved therapy for these aberrations prior to receiving KEYTRUDA.
                                label id
                                228e1e3f-d207-481f-8e14-9fdcbd0470e9
                                offset unit
                                unicode_code_points
                                source array index
                                0
                                source field
                                indications_and_usage_exact
                                source text sha256
                                e526ba14c91f10737e6d3331fe23a6219f58c0eca6380bfce9bd78b573fea912
                                start
                                1287
                                source url
                                https://api.fda.gov/drug/label.json?search=id%3A%22228e1e3f-d207-481f-8e14-9fdcbd0470e9%22
                                spl effective date
                                2026-07-10
                                spl set id
                                9333c79b-d487-4538-a9f0-71b91a02b287
                                spl version
                                228
                                structured fields status
                                not_extracted_no_values_inferred_from_mentions
                                structured indication
                                age
                                Source null
                                approval pathway
                                Source null
                                biomarker and test
                                Source null
                                disease stage
                                Source null
                                limitations
                                Source null
                                line
                                Source null
                                prior therapy
                                Source null
                                regimen
                                Source null
                                tumor histology
                                Source null
                                use intent
                                unclear
                                Passage 11 · unclassified context
                                application numbers
                                1. BLA125514
                                brand names
                                1. KEYTRUDA
                                classification reasons
                                1. no_unambiguous_positive_indication_predicate
                                clinical review status
                                pending
                                content role
                                unclassified_context
                                context span
                                end
                                1896
                                end exclusive
                                true
                                exact text
                                after platinum-containing chemotherapy. Patients with EGFR or ALK genomic tumor aberrations should have disease progression on FDA-approved therapy for these aberrations prior to receiving KEYTRUDA. ( 1.2 , 2.1 ) for the treatment of patients with resectable (tumors ≥4 cm or node positive) NSCLC in combination with platinum-containing chemotherapy as neoadjuvant treatment, and then continued as a single agent as adjuvant treatment after surgery. ( 1.2 ) as a single agent, for adjuvant treatment following resection and platinum-based chemotherapy for adult patients with Stage IB (T2a ≥4 cm), II, or IIIA NSCLC. ( 1.2 ) Malignant Pleural Mesoth
                                label id
                                228e1e3f-d207-481f-8e14-9fdcbd0470e9
                                offset unit
                                unicode_code_points
                                source array index
                                0
                                source field
                                indications_and_usage_exact
                                source text sha256
                                e526ba14c91f10737e6d3331fe23a6219f58c0eca6380bfce9bd78b573fea912
                                start
                                1246
                                current approval status
                                not_reconciled
                                duplicate text group
                                dup-e46fb2a9efac371ad334
                                extraction review status
                                automated_candidate_pending_source_review
                                generic names
                                1. PEMBROLIZUMAB
                                id
                                ind-span-4a166529de3c45aab007
                                label id
                                228e1e3f-d207-481f-8e14-9fdcbd0470e9
                                positive predicate support span
                                Source null
                                qualifier mentions
                                1. context exact
                                  ( 1.2 , 2.1 ) for the treatment of patients with resectable (tumors ≥4 cm or node positive) NSCLC in combination with platinum-containing chemotherapy as
                                  kind
                                  stage_or_setting
                                  polarity
                                  not_inferred
                                  span
                                  end
                                  1540
                                  end exclusive
                                  true
                                  exact text
                                  resectable (tumors ≥4 cm or node positive) NS
                                  label id
                                  228e1e3f-d207-481f-8e14-9fdcbd0470e9
                                  offset unit
                                  unicode_code_points
                                  source array index
                                  0
                                  source field
                                  indications_and_usage_exact
                                  source text sha256
                                  e526ba14c91f10737e6d3331fe23a6219f58c0eca6380bfce9bd78b573fea912
                                  start
                                  1495
                                2. context exact
                                  CLC in combination with platinum-containing chemotherapy as neoadjuvant treatment, and then continued as a single agent as adjuvant treatment
                                  kind
                                  stage_or_setting
                                  polarity
                                  not_inferred
                                  span
                                  end
                                  1621
                                  end exclusive
                                  true
                                  exact text
                                  neoadjuvant treatment
                                  label id
                                  228e1e3f-d207-481f-8e14-9fdcbd0470e9
                                  offset unit
                                  unicode_code_points
                                  source array index
                                  0
                                  source field
                                  indications_and_usage_exact
                                  source text sha256
                                  e526ba14c91f10737e6d3331fe23a6219f58c0eca6380bfce9bd78b573fea912
                                  start
                                  1600
                                3. context exact
                                  adjuvant treatment, and then continued as a single agent as adjuvant treatment after surgery.
                                  kind
                                  stage_or_setting
                                  polarity
                                  not_inferred
                                  span
                                  end
                                  1695
                                  end exclusive
                                  true
                                  exact text
                                  adjuvant treatment after surgery
                                  label id
                                  228e1e3f-d207-481f-8e14-9fdcbd0470e9
                                  offset unit
                                  unicode_code_points
                                  source array index
                                  0
                                  source field
                                  indications_and_usage_exact
                                  source text sha256
                                  e526ba14c91f10737e6d3331fe23a6219f58c0eca6380bfce9bd78b573fea912
                                  start
                                  1663
                                4. context exact
                                  ients with resectable (tumors ≥4 cm or node positive) NSCLC in combination with platinum-containing chemotherapy as neoadjuvant treatment, and then continued as a single agent as adjuvant treatment after surgery.
                                  kind
                                  regimen
                                  polarity
                                  not_inferred
                                  span
                                  end
                                  1695
                                  end exclusive
                                  true
                                  exact text
                                  in combination with platinum-containing chemotherapy as neoadjuvant treatment, and then continued as a single agent as adjuvant treatment after surgery
                                  label id
                                  228e1e3f-d207-481f-8e14-9fdcbd0470e9
                                  offset unit
                                  unicode_code_points
                                  source array index
                                  0
                                  source field
                                  indications_and_usage_exact
                                  source text sha256
                                  e526ba14c91f10737e6d3331fe23a6219f58c0eca6380bfce9bd78b573fea912
                                  start
                                  1544
                                regulatory links
                                  schema version
                                  0.1.0
                                  source batch sha256
                                  fc39a8c5cf96bf95ca20b85578140167b66b2741f7d9217f500d9ba0847ac058
                                  source defined aliases
                                  1. abbreviation
                                    NSCLC
                                    definition exact
                                    Non-Small Cell Lung Cancer
                                    definition span
                                    end
                                    380
                                    end exclusive
                                    true
                                    exact text
                                    Non-Small Cell Lung Cancer (NSCLC)
                                    label id
                                    228e1e3f-d207-481f-8e14-9fdcbd0470e9
                                    offset unit
                                    unicode_code_points
                                    source array index
                                    0
                                    source field
                                    indications_and_usage_exact
                                    source text sha256
                                    e526ba14c91f10737e6d3331fe23a6219f58c0eca6380bfce9bd78b573fea912
                                    start
                                    346
                                  2. abbreviation
                                    CRC
                                    definition exact
                                    Colorectal Cancer
                                    definition span
                                    end
                                    5042
                                    end exclusive
                                    true
                                    exact text
                                    Colorectal Cancer (CRC)
                                    label id
                                    228e1e3f-d207-481f-8e14-9fdcbd0470e9
                                    offset unit
                                    unicode_code_points
                                    source array index
                                    0
                                    source field
                                    indications_and_usage_exact
                                    source text sha256
                                    e526ba14c91f10737e6d3331fe23a6219f58c0eca6380bfce9bd78b573fea912
                                    start
                                    5019
                                  source span
                                  end
                                  1696
                                  end exclusive
                                  true
                                  exact text
                                  ( 1.2 , 2.1 ) for the treatment of patients with resectable (tumors ≥4 cm or node positive) NSCLC in combination with platinum-containing chemotherapy as neoadjuvant treatment, and then continued as a single agent as adjuvant treatment after surgery.
                                  label id
                                  228e1e3f-d207-481f-8e14-9fdcbd0470e9
                                  offset unit
                                  unicode_code_points
                                  source array index
                                  0
                                  source field
                                  indications_and_usage_exact
                                  source text sha256
                                  e526ba14c91f10737e6d3331fe23a6219f58c0eca6380bfce9bd78b573fea912
                                  start
                                  1446
                                  source url
                                  https://api.fda.gov/drug/label.json?search=id%3A%22228e1e3f-d207-481f-8e14-9fdcbd0470e9%22
                                  spl effective date
                                  2026-07-10
                                  spl set id
                                  9333c79b-d487-4538-a9f0-71b91a02b287
                                  spl version
                                  228
                                  structured fields status
                                  not_extracted_no_values_inferred_from_mentions
                                  structured indication
                                  age
                                  Source null
                                  approval pathway
                                  Source null
                                  biomarker and test
                                  Source null
                                  disease stage
                                  Source null
                                  limitations
                                  Source null
                                  line
                                  Source null
                                  prior therapy
                                  Source null
                                  regimen
                                  Source null
                                  tumor histology
                                  Source null
                                  use intent
                                  unclear
                                  Passage 12 · unclassified context
                                  application numbers
                                  1. BLA125514
                                  brand names
                                  1. KEYTRUDA
                                  classification reasons
                                  1. no_unambiguous_positive_indication_predicate
                                  clinical review status
                                  pending
                                  content role
                                  unclassified_context
                                  context span
                                  end
                                  1904
                                  end exclusive
                                  true
                                  exact text
                                  sectable (tumors ≥4 cm or node positive) NSCLC in combination with platinum-containing chemotherapy as neoadjuvant treatment, and then continued as a single agent as adjuvant treatment after surgery. ( 1.2 ) as a single agent, for adjuvant treatment following resection and platinum-based chemotherapy for adult patients with Stage IB (T2a ≥4 cm), II, or IIIA NSCLC. ( 1.2 ) Malignant Pleural Mesothelioma (
                                  label id
                                  228e1e3f-d207-481f-8e14-9fdcbd0470e9
                                  offset unit
                                  unicode_code_points
                                  source array index
                                  0
                                  source field
                                  indications_and_usage_exact
                                  source text sha256
                                  e526ba14c91f10737e6d3331fe23a6219f58c0eca6380bfce9bd78b573fea912
                                  start
                                  1497
                                  current approval status
                                  not_reconciled
                                  duplicate text group
                                  dup-cae292898e7240dcc6f1
                                  extraction review status
                                  automated_candidate_pending_source_review
                                  generic names
                                  1. PEMBROLIZUMAB
                                  id
                                  ind-span-33233721bc8285e82a4d
                                  label id
                                  228e1e3f-d207-481f-8e14-9fdcbd0470e9
                                  positive predicate support span
                                  Source null
                                  qualifier mentions
                                    regulatory links
                                      schema version
                                      0.1.0
                                      source batch sha256
                                      fc39a8c5cf96bf95ca20b85578140167b66b2741f7d9217f500d9ba0847ac058
                                      source defined aliases
                                      1. abbreviation
                                        NSCLC
                                        definition exact
                                        Non-Small Cell Lung Cancer
                                        definition span
                                        end
                                        380
                                        end exclusive
                                        true
                                        exact text
                                        Non-Small Cell Lung Cancer (NSCLC)
                                        label id
                                        228e1e3f-d207-481f-8e14-9fdcbd0470e9
                                        offset unit
                                        unicode_code_points
                                        source array index
                                        0
                                        source field
                                        indications_and_usage_exact
                                        source text sha256
                                        e526ba14c91f10737e6d3331fe23a6219f58c0eca6380bfce9bd78b573fea912
                                        start
                                        346
                                      2. abbreviation
                                        CRC
                                        definition exact
                                        Colorectal Cancer
                                        definition span
                                        end
                                        5042
                                        end exclusive
                                        true
                                        exact text
                                        Colorectal Cancer (CRC)
                                        label id
                                        228e1e3f-d207-481f-8e14-9fdcbd0470e9
                                        offset unit
                                        unicode_code_points
                                        source array index
                                        0
                                        source field
                                        indications_and_usage_exact
                                        source text sha256
                                        e526ba14c91f10737e6d3331fe23a6219f58c0eca6380bfce9bd78b573fea912
                                        start
                                        5019
                                      source span
                                      end
                                      1704
                                      end exclusive
                                      true
                                      exact text
                                      ( 1.2 )
                                      label id
                                      228e1e3f-d207-481f-8e14-9fdcbd0470e9
                                      offset unit
                                      unicode_code_points
                                      source array index
                                      0
                                      source field
                                      indications_and_usage_exact
                                      source text sha256
                                      e526ba14c91f10737e6d3331fe23a6219f58c0eca6380bfce9bd78b573fea912
                                      start
                                      1697
                                      source url
                                      https://api.fda.gov/drug/label.json?search=id%3A%22228e1e3f-d207-481f-8e14-9fdcbd0470e9%22
                                      spl effective date
                                      2026-07-10
                                      spl set id
                                      9333c79b-d487-4538-a9f0-71b91a02b287
                                      spl version
                                      228
                                      structured fields status
                                      not_extracted_no_values_inferred_from_mentions
                                      structured indication
                                      age
                                      Source null
                                      approval pathway
                                      Source null
                                      biomarker and test
                                      Source null
                                      disease stage
                                      Source null
                                      limitations
                                      Source null
                                      line
                                      Source null
                                      prior therapy
                                      Source null
                                      regimen
                                      Source null
                                      tumor histology
                                      Source null
                                      use intent
                                      unclear
                                      Passage 13 · unclassified context
                                      application numbers
                                      1. BLA125514
                                      brand names
                                      1. KEYTRUDA
                                      classification reasons
                                      1. no_unambiguous_positive_indication_predicate
                                      clinical review status
                                      pending
                                      content role
                                      unclassified_context
                                      context span
                                      end
                                      2063
                                      end exclusive
                                      true
                                      exact text
                                      (tumors ≥4 cm or node positive) NSCLC in combination with platinum-containing chemotherapy as neoadjuvant treatment, and then continued as a single agent as adjuvant treatment after surgery. ( 1.2 ) as a single agent, for adjuvant treatment following resection and platinum-based chemotherapy for adult patients with Stage IB (T2a ≥4 cm), II, or IIIA NSCLC. ( 1.2 ) Malignant Pleural Mesothelioma (MPM) in combination with pemetrexed and platinum chemotherapy, as first-line treatment of adult patients with unresectable advanced or metastatic MPM. ( 1.3 )
                                      label id
                                      228e1e3f-d207-481f-8e14-9fdcbd0470e9
                                      offset unit
                                      unicode_code_points
                                      source array index
                                      0
                                      source field
                                      indications_and_usage_exact
                                      source text sha256
                                      e526ba14c91f10737e6d3331fe23a6219f58c0eca6380bfce9bd78b573fea912
                                      start
                                      1505
                                      current approval status
                                      not_reconciled
                                      duplicate text group
                                      dup-407a9c4e8b400b785a2f
                                      extraction review status
                                      automated_candidate_pending_source_review
                                      generic names
                                      1. PEMBROLIZUMAB
                                      id
                                      ind-span-a4d24a6766f4ae469a79
                                      label id
                                      228e1e3f-d207-481f-8e14-9fdcbd0470e9
                                      positive predicate support span
                                      Source null
                                      qualifier mentions
                                      1. context exact
                                        ent following resection and platinum-based chemotherapy for adult patients with Stage IB (T2a ≥4 cm), II, or IIIA NSCLC.
                                        kind
                                        age
                                        polarity
                                        not_inferred
                                        span
                                        end
                                        1817
                                        end exclusive
                                        true
                                        exact text
                                        adult patients
                                        label id
                                        228e1e3f-d207-481f-8e14-9fdcbd0470e9
                                        offset unit
                                        unicode_code_points
                                        source array index
                                        0
                                        source field
                                        indications_and_usage_exact
                                        source text sha256
                                        e526ba14c91f10737e6d3331fe23a6219f58c0eca6380bfce9bd78b573fea912
                                        start
                                        1803
                                      2. context exact
                                        as a single agent, for adjuvant treatment following resection and platinum-based chemotherapy for adult patients with Stage IB
                                        kind
                                        stage_or_setting
                                        polarity
                                        not_inferred
                                        span
                                        end
                                        1771
                                        end exclusive
                                        true
                                        exact text
                                        adjuvant treatment following resection and
                                        label id
                                        228e1e3f-d207-481f-8e14-9fdcbd0470e9
                                        offset unit
                                        unicode_code_points
                                        source array index
                                        0
                                        source field
                                        indications_and_usage_exact
                                        source text sha256
                                        e526ba14c91f10737e6d3331fe23a6219f58c0eca6380bfce9bd78b573fea912
                                        start
                                        1728
                                      3. context exact
                                        as a single agent, for adjuvant treatment following resection and platinum-based chemotherapy for adult patients with Stage IB (T2a ≥4 cm), II, or IIIA NSCLC.
                                        kind
                                        regimen
                                        polarity
                                        not_inferred
                                        span
                                        end
                                        1862
                                        end exclusive
                                        true
                                        exact text
                                        as a single agent, for adjuvant treatment following resection and platinum-based chemotherapy for adult patients with Stage IB (T2a ≥4 cm), II, or IIIA NSCLC
                                        label id
                                        228e1e3f-d207-481f-8e14-9fdcbd0470e9
                                        offset unit
                                        unicode_code_points
                                        source array index
                                        0
                                        source field
                                        indications_and_usage_exact
                                        source text sha256
                                        e526ba14c91f10737e6d3331fe23a6219f58c0eca6380bfce9bd78b573fea912
                                        start
                                        1705
                                      regulatory links
                                        schema version
                                        0.1.0
                                        source batch sha256
                                        fc39a8c5cf96bf95ca20b85578140167b66b2741f7d9217f500d9ba0847ac058
                                        source defined aliases
                                        1. abbreviation
                                          NSCLC
                                          definition exact
                                          Non-Small Cell Lung Cancer
                                          definition span
                                          end
                                          380
                                          end exclusive
                                          true
                                          exact text
                                          Non-Small Cell Lung Cancer (NSCLC)
                                          label id
                                          228e1e3f-d207-481f-8e14-9fdcbd0470e9
                                          offset unit
                                          unicode_code_points
                                          source array index
                                          0
                                          source field
                                          indications_and_usage_exact
                                          source text sha256
                                          e526ba14c91f10737e6d3331fe23a6219f58c0eca6380bfce9bd78b573fea912
                                          start
                                          346
                                        2. abbreviation
                                          CRC
                                          definition exact
                                          Colorectal Cancer
                                          definition span
                                          end
                                          5042
                                          end exclusive
                                          true
                                          exact text
                                          Colorectal Cancer (CRC)
                                          label id
                                          228e1e3f-d207-481f-8e14-9fdcbd0470e9
                                          offset unit
                                          unicode_code_points
                                          source array index
                                          0
                                          source field
                                          indications_and_usage_exact
                                          source text sha256
                                          e526ba14c91f10737e6d3331fe23a6219f58c0eca6380bfce9bd78b573fea912
                                          start
                                          5019
                                        source span
                                        end
                                        1863
                                        end exclusive
                                        true
                                        exact text
                                        as a single agent, for adjuvant treatment following resection and platinum-based chemotherapy for adult patients with Stage IB (T2a ≥4 cm), II, or IIIA NSCLC.
                                        label id
                                        228e1e3f-d207-481f-8e14-9fdcbd0470e9
                                        offset unit
                                        unicode_code_points
                                        source array index
                                        0
                                        source field
                                        indications_and_usage_exact
                                        source text sha256
                                        e526ba14c91f10737e6d3331fe23a6219f58c0eca6380bfce9bd78b573fea912
                                        start
                                        1705
                                        source url
                                        https://api.fda.gov/drug/label.json?search=id%3A%22228e1e3f-d207-481f-8e14-9fdcbd0470e9%22
                                        spl effective date
                                        2026-07-10
                                        spl set id
                                        9333c79b-d487-4538-a9f0-71b91a02b287
                                        spl version
                                        228
                                        structured fields status
                                        not_extracted_no_values_inferred_from_mentions
                                        structured indication
                                        age
                                        Source null
                                        approval pathway
                                        Source null
                                        biomarker and test
                                        Source null
                                        disease stage
                                        Source null
                                        limitations
                                        Source null
                                        line
                                        Source null
                                        prior therapy
                                        Source null
                                        regimen
                                        Source null
                                        tumor histology
                                        Source null
                                        use intent
                                        unclear
                                        Passage 14 · unclassified context
                                        application numbers
                                        1. BLA125514
                                        brand names
                                        1. KEYTRUDA
                                        classification reasons
                                        1. no_unambiguous_positive_indication_predicate
                                        clinical review status
                                        pending
                                        content role
                                        unclassified_context
                                        context span
                                        end
                                        2254
                                        end exclusive
                                        true
                                        exact text
                                        djuvant treatment after surgery. ( 1.2 ) as a single agent, for adjuvant treatment following resection and platinum-based chemotherapy for adult patients with Stage IB (T2a ≥4 cm), II, or IIIA NSCLC. ( 1.2 ) Malignant Pleural Mesothelioma (MPM) in combination with pemetrexed and platinum chemotherapy, as first-line treatment of adult patients with unresectable advanced or metastatic MPM. ( 1.3 ) Head and Neck Squamous Cell Cancer (HNSCC) for the treatment of adult patients with resectable locally advanced HNSCC whose tumors express PD-L1 [Combined Positive Score (CPS) ≥1] as determin
                                        label id
                                        228e1e3f-d207-481f-8e14-9fdcbd0470e9
                                        offset unit
                                        unicode_code_points
                                        source array index
                                        0
                                        source field
                                        indications_and_usage_exact
                                        source text sha256
                                        e526ba14c91f10737e6d3331fe23a6219f58c0eca6380bfce9bd78b573fea912
                                        start
                                        1664
                                        current approval status
                                        not_reconciled
                                        duplicate text group
                                        dup-eb4f8ba5f9df02769a94
                                        extraction review status
                                        automated_candidate_pending_source_review
                                        generic names
                                        1. PEMBROLIZUMAB
                                        id
                                        ind-span-51f6e87ba8aa23cd49b8
                                        label id
                                        228e1e3f-d207-481f-8e14-9fdcbd0470e9
                                        positive predicate support span
                                        Source null
                                        qualifier mentions
                                        1. context exact
                                          rexed and platinum chemotherapy, as first-line treatment of adult patients with unresectable advanced or metastatic MPM.
                                          kind
                                          age
                                          polarity
                                          not_inferred
                                          span
                                          end
                                          2008
                                          end exclusive
                                          true
                                          exact text
                                          adult patients
                                          label id
                                          228e1e3f-d207-481f-8e14-9fdcbd0470e9
                                          offset unit
                                          unicode_code_points
                                          source array index
                                          0
                                          source field
                                          indications_and_usage_exact
                                          source text sha256
                                          e526ba14c91f10737e6d3331fe23a6219f58c0eca6380bfce9bd78b573fea912
                                          start
                                          1994
                                        2. context exact
                                          e treatment of adult patients with unresectable advanced or metastatic MPM.
                                          kind
                                          biomarker
                                          polarity
                                          not_inferred
                                          span
                                          end
                                          2053
                                          end exclusive
                                          true
                                          exact text
                                          metastatic MPM
                                          label id
                                          228e1e3f-d207-481f-8e14-9fdcbd0470e9
                                          offset unit
                                          unicode_code_points
                                          source array index
                                          0
                                          source field
                                          indications_and_usage_exact
                                          source text sha256
                                          e526ba14c91f10737e6d3331fe23a6219f58c0eca6380bfce9bd78b573fea912
                                          start
                                          2039
                                        3. context exact
                                          hemotherapy, as first-line treatment of adult patients with unresectable advanced or metastatic MPM.
                                          kind
                                          stage_or_setting
                                          polarity
                                          not_inferred
                                          span
                                          end
                                          2053
                                          end exclusive
                                          true
                                          exact text
                                          unresectable advanced or metastatic MPM
                                          label id
                                          228e1e3f-d207-481f-8e14-9fdcbd0470e9
                                          offset unit
                                          unicode_code_points
                                          source array index
                                          0
                                          source field
                                          indications_and_usage_exact
                                          source text sha256
                                          e526ba14c91f10737e6d3331fe23a6219f58c0eca6380bfce9bd78b573fea912
                                          start
                                          2014
                                        4. context exact
                                          n combination with pemetrexed and platinum chemotherapy, as first-line treatment of adult patients with unresectable advanced or metastatic MPM.
                                          kind
                                          prior_therapy_or_line
                                          polarity
                                          not_inferred
                                          span
                                          end
                                          2053
                                          end exclusive
                                          true
                                          exact text
                                          first-line treatment of adult patients with unresectable advanced or metastatic MPM
                                          label id
                                          228e1e3f-d207-481f-8e14-9fdcbd0470e9
                                          offset unit
                                          unicode_code_points
                                          source array index
                                          0
                                          source field
                                          indications_and_usage_exact
                                          source text sha256
                                          e526ba14c91f10737e6d3331fe23a6219f58c0eca6380bfce9bd78b573fea912
                                          start
                                          1970
                                        5. context exact
                                          ( 1.2 ) Malignant Pleural Mesothelioma (MPM) in combination with pemetrexed and platinum chemotherapy, as first-line treatment of adult patients with unresectable advanced or metastatic MPM.
                                          kind
                                          regimen
                                          polarity
                                          not_inferred
                                          span
                                          end
                                          2053
                                          end exclusive
                                          true
                                          exact text
                                          in combination with pemetrexed and platinum chemotherapy, as first-line treatment of adult patients with unresectable advanced or metastatic MPM
                                          label id
                                          228e1e3f-d207-481f-8e14-9fdcbd0470e9
                                          offset unit
                                          unicode_code_points
                                          source array index
                                          0
                                          source field
                                          indications_and_usage_exact
                                          source text sha256
                                          e526ba14c91f10737e6d3331fe23a6219f58c0eca6380bfce9bd78b573fea912
                                          start
                                          1909
                                        regulatory links
                                          schema version
                                          0.1.0
                                          source batch sha256
                                          fc39a8c5cf96bf95ca20b85578140167b66b2741f7d9217f500d9ba0847ac058
                                          source defined aliases
                                          1. abbreviation
                                            NSCLC
                                            definition exact
                                            Non-Small Cell Lung Cancer
                                            definition span
                                            end
                                            380
                                            end exclusive
                                            true
                                            exact text
                                            Non-Small Cell Lung Cancer (NSCLC)
                                            label id
                                            228e1e3f-d207-481f-8e14-9fdcbd0470e9
                                            offset unit
                                            unicode_code_points
                                            source array index
                                            0
                                            source field
                                            indications_and_usage_exact
                                            source text sha256
                                            e526ba14c91f10737e6d3331fe23a6219f58c0eca6380bfce9bd78b573fea912
                                            start
                                            346
                                          2. abbreviation
                                            CRC
                                            definition exact
                                            Colorectal Cancer
                                            definition span
                                            end
                                            5042
                                            end exclusive
                                            true
                                            exact text
                                            Colorectal Cancer (CRC)
                                            label id
                                            228e1e3f-d207-481f-8e14-9fdcbd0470e9
                                            offset unit
                                            unicode_code_points
                                            source array index
                                            0
                                            source field
                                            indications_and_usage_exact
                                            source text sha256
                                            e526ba14c91f10737e6d3331fe23a6219f58c0eca6380bfce9bd78b573fea912
                                            start
                                            5019
                                          source span
                                          end
                                          2054
                                          end exclusive
                                          true
                                          exact text
                                          ( 1.2 ) Malignant Pleural Mesothelioma (MPM) in combination with pemetrexed and platinum chemotherapy, as first-line treatment of adult patients with unresectable advanced or metastatic MPM.
                                          label id
                                          228e1e3f-d207-481f-8e14-9fdcbd0470e9
                                          offset unit
                                          unicode_code_points
                                          source array index
                                          0
                                          source field
                                          indications_and_usage_exact
                                          source text sha256
                                          e526ba14c91f10737e6d3331fe23a6219f58c0eca6380bfce9bd78b573fea912
                                          start
                                          1864
                                          source url
                                          https://api.fda.gov/drug/label.json?search=id%3A%22228e1e3f-d207-481f-8e14-9fdcbd0470e9%22
                                          spl effective date
                                          2026-07-10
                                          spl set id
                                          9333c79b-d487-4538-a9f0-71b91a02b287
                                          spl version
                                          228
                                          structured fields status
                                          not_extracted_no_values_inferred_from_mentions
                                          structured indication
                                          age
                                          Source null
                                          approval pathway
                                          Source null
                                          biomarker and test
                                          Source null
                                          disease stage
                                          Source null
                                          limitations
                                          Source null
                                          line
                                          Source null
                                          prior therapy
                                          Source null
                                          regimen
                                          Source null
                                          tumor histology
                                          Source null
                                          use intent
                                          unclear
                                          Passage 15 · unclassified context
                                          application numbers
                                          1. BLA125514
                                          brand names
                                          1. KEYTRUDA
                                          classification reasons
                                          1. no_unambiguous_positive_indication_predicate
                                          clinical review status
                                          pending
                                          content role
                                          unclassified_context
                                          context span
                                          end
                                          2651
                                          end exclusive
                                          true
                                          exact text
                                          A NSCLC. ( 1.2 ) Malignant Pleural Mesothelioma (MPM) in combination with pemetrexed and platinum chemotherapy, as first-line treatment of adult patients with unresectable advanced or metastatic MPM. ( 1.3 ) Head and Neck Squamous Cell Cancer (HNSCC) for the treatment of adult patients with resectable locally advanced HNSCC whose tumors express PD-L1 [Combined Positive Score (CPS) ≥1] as determined by an FDA-authorized test, as a single agent as neoadjuvant treatment, continued as adjuvant treatment in combination with radiotherapy (RT) with or without cisplatin and then as a single agent. ( 1.4 ) in combination with platinum and FU for the first-line treatment of patients with metastatic or with unresectable, recurrent HNSCC. ( 1.4 ) as a single agent for the first-line treatment of p
                                          label id
                                          228e1e3f-d207-481f-8e14-9fdcbd0470e9
                                          offset unit
                                          unicode_code_points
                                          source array index
                                          0
                                          source field
                                          indications_and_usage_exact
                                          source text sha256
                                          e526ba14c91f10737e6d3331fe23a6219f58c0eca6380bfce9bd78b573fea912
                                          start
                                          1855
                                          current approval status
                                          not_reconciled
                                          duplicate text group
                                          dup-635ac889b81974eb973b
                                          extraction review status
                                          automated_candidate_pending_source_review
                                          generic names
                                          1. PEMBROLIZUMAB
                                          id
                                          ind-span-dcb5a87d6e01d76468dc
                                          label id
                                          228e1e3f-d207-481f-8e14-9fdcbd0470e9
                                          positive predicate support span
                                          Source null
                                          qualifier mentions
                                          1. context exact
                                            and Neck Squamous Cell Cancer (HNSCC) for the treatment of adult patients with resectable locally advanced HNSCC whose tumors express
                                            kind
                                            age
                                            polarity
                                            not_inferred
                                            span
                                            end
                                            2141
                                            end exclusive
                                            true
                                            exact text
                                            adult patients
                                            label id
                                            228e1e3f-d207-481f-8e14-9fdcbd0470e9
                                            offset unit
                                            unicode_code_points
                                            source array index
                                            0
                                            source field
                                            indications_and_usage_exact
                                            source text sha256
                                            e526ba14c91f10737e6d3331fe23a6219f58c0eca6380bfce9bd78b573fea912
                                            start
                                            2127
                                          2. context exact
                                            with resectable locally advanced HNSCC whose tumors express PD-L1 [Combined Positive Score (CPS) ≥1] as determined by an FDA-authorized test, as a single agent as ne
                                            kind
                                            biomarker
                                            polarity
                                            not_inferred
                                            span
                                            end
                                            2247
                                            end exclusive
                                            true
                                            exact text
                                            PD-L1 [Combined Positive Score (CPS) ≥1] as d
                                            label id
                                            228e1e3f-d207-481f-8e14-9fdcbd0470e9
                                            offset unit
                                            unicode_code_points
                                            source array index
                                            0
                                            source field
                                            indications_and_usage_exact
                                            source text sha256
                                            e526ba14c91f10737e6d3331fe23a6219f58c0eca6380bfce9bd78b573fea912
                                            start
                                            2202
                                          3. context exact
                                            ell Cancer (HNSCC) for the treatment of adult patients with resectable locally advanced HNSCC whose tumors express PD-L1 [Combined Positive Score (CPS) ≥1] as determ
                                            kind
                                            stage_or_setting
                                            polarity
                                            not_inferred
                                            span
                                            end
                                            2192
                                            end exclusive
                                            true
                                            exact text
                                            resectable locally advanced HNSCC whose tumor
                                            label id
                                            228e1e3f-d207-481f-8e14-9fdcbd0470e9
                                            offset unit
                                            unicode_code_points
                                            source array index
                                            0
                                            source field
                                            indications_and_usage_exact
                                            source text sha256
                                            e526ba14c91f10737e6d3331fe23a6219f58c0eca6380bfce9bd78b573fea912
                                            start
                                            2147
                                          4. context exact
                                            determined by an FDA-authorized test, as a single agent as neoadjuvant treatment, continued as adjuvant treatment in combination with radiot
                                            kind
                                            stage_or_setting
                                            polarity
                                            not_inferred
                                            span
                                            end
                                            2326
                                            end exclusive
                                            true
                                            exact text
                                            neoadjuvant treatment
                                            label id
                                            228e1e3f-d207-481f-8e14-9fdcbd0470e9
                                            offset unit
                                            unicode_code_points
                                            source array index
                                            0
                                            source field
                                            indications_and_usage_exact
                                            source text sha256
                                            e526ba14c91f10737e6d3331fe23a6219f58c0eca6380bfce9bd78b573fea912
                                            start
                                            2305
                                          5. context exact
                                            t, as a single agent as neoadjuvant treatment, continued as adjuvant treatment in combination with radiotherapy (RT) with or without cisplatin and then as a single
                                            kind
                                            stage_or_setting
                                            polarity
                                            not_inferred
                                            span
                                            end
                                            2384
                                            end exclusive
                                            true
                                            exact text
                                            adjuvant treatment in combination with radi
                                            label id
                                            228e1e3f-d207-481f-8e14-9fdcbd0470e9
                                            offset unit
                                            unicode_code_points
                                            source array index
                                            0
                                            source field
                                            indications_and_usage_exact
                                            source text sha256
                                            e526ba14c91f10737e6d3331fe23a6219f58c0eca6380bfce9bd78b573fea912
                                            start
                                            2341
                                          6. context exact
                                            ve Score (CPS) ≥1] as determined by an FDA-authorized test, as a single agent as neoadjuvant treatment, continued as adjuvant treatment in combination with radiotherapy (RT) with or without cisplatin and then as a single agent.
                                            kind
                                            regimen
                                            polarity
                                            not_inferred
                                            span
                                            end
                                            2450
                                            end exclusive
                                            true
                                            exact text
                                            as a single agent as neoadjuvant treatment, continued as adjuvant treatment in combination with radiotherapy (RT) with or without cisplatin and then as a single agent
                                            label id
                                            228e1e3f-d207-481f-8e14-9fdcbd0470e9
                                            offset unit
                                            unicode_code_points
                                            source array index
                                            0
                                            source field
                                            indications_and_usage_exact
                                            source text sha256
                                            e526ba14c91f10737e6d3331fe23a6219f58c0eca6380bfce9bd78b573fea912
                                            start
                                            2284
                                          regulatory links
                                            schema version
                                            0.1.0
                                            source batch sha256
                                            fc39a8c5cf96bf95ca20b85578140167b66b2741f7d9217f500d9ba0847ac058
                                            source defined aliases
                                            1. abbreviation
                                              NSCLC
                                              definition exact
                                              Non-Small Cell Lung Cancer
                                              definition span
                                              end
                                              380
                                              end exclusive
                                              true
                                              exact text
                                              Non-Small Cell Lung Cancer (NSCLC)
                                              label id
                                              228e1e3f-d207-481f-8e14-9fdcbd0470e9
                                              offset unit
                                              unicode_code_points
                                              source array index
                                              0
                                              source field
                                              indications_and_usage_exact
                                              source text sha256
                                              e526ba14c91f10737e6d3331fe23a6219f58c0eca6380bfce9bd78b573fea912
                                              start
                                              346
                                            2. abbreviation
                                              CRC
                                              definition exact
                                              Colorectal Cancer
                                              definition span
                                              end
                                              5042
                                              end exclusive
                                              true
                                              exact text
                                              Colorectal Cancer (CRC)
                                              label id
                                              228e1e3f-d207-481f-8e14-9fdcbd0470e9
                                              offset unit
                                              unicode_code_points
                                              source array index
                                              0
                                              source field
                                              indications_and_usage_exact
                                              source text sha256
                                              e526ba14c91f10737e6d3331fe23a6219f58c0eca6380bfce9bd78b573fea912
                                              start
                                              5019
                                            source span
                                            end
                                            2451
                                            end exclusive
                                            true
                                            exact text
                                            ( 1.3 ) Head and Neck Squamous Cell Cancer (HNSCC) for the treatment of adult patients with resectable locally advanced HNSCC whose tumors express PD-L1 [Combined Positive Score (CPS) ≥1] as determined by an FDA-authorized test, as a single agent as neoadjuvant treatment, continued as adjuvant treatment in combination with radiotherapy (RT) with or without cisplatin and then as a single agent.
                                            label id
                                            228e1e3f-d207-481f-8e14-9fdcbd0470e9
                                            offset unit
                                            unicode_code_points
                                            source array index
                                            0
                                            source field
                                            indications_and_usage_exact
                                            source text sha256
                                            e526ba14c91f10737e6d3331fe23a6219f58c0eca6380bfce9bd78b573fea912
                                            start
                                            2055
                                            source url
                                            https://api.fda.gov/drug/label.json?search=id%3A%22228e1e3f-d207-481f-8e14-9fdcbd0470e9%22
                                            spl effective date
                                            2026-07-10
                                            spl set id
                                            9333c79b-d487-4538-a9f0-71b91a02b287
                                            spl version
                                            228
                                            structured fields status
                                            not_extracted_no_values_inferred_from_mentions
                                            structured indication
                                            age
                                            Source null
                                            approval pathway
                                            Source null
                                            biomarker and test
                                            Source null
                                            disease stage
                                            Source null
                                            limitations
                                            Source null
                                            line
                                            Source null
                                            prior therapy
                                            Source null
                                            regimen
                                            Source null
                                            tumor histology
                                            Source null
                                            use intent
                                            unclear
                                            Passage 16 · unclassified context
                                            application numbers
                                            1. BLA125514
                                            brand names
                                            1. KEYTRUDA
                                            classification reasons
                                            1. no_unambiguous_positive_indication_predicate
                                            clinical review status
                                            pending
                                            content role
                                            unclassified_context
                                            context span
                                            end
                                            2659
                                            end exclusive
                                            true
                                            exact text
                                            ined by an FDA-authorized test, as a single agent as neoadjuvant treatment, continued as adjuvant treatment in combination with radiotherapy (RT) with or without cisplatin and then as a single agent. ( 1.4 ) in combination with platinum and FU for the first-line treatment of patients with metastatic or with unresectable, recurrent HNSCC. ( 1.4 ) as a single agent for the first-line treatment of patients
                                            label id
                                            228e1e3f-d207-481f-8e14-9fdcbd0470e9
                                            offset unit
                                            unicode_code_points
                                            source array index
                                            0
                                            source field
                                            indications_and_usage_exact
                                            source text sha256
                                            e526ba14c91f10737e6d3331fe23a6219f58c0eca6380bfce9bd78b573fea912
                                            start
                                            2252
                                            current approval status
                                            not_reconciled
                                            duplicate text group
                                            dup-643d7acb74987b5a60b2
                                            extraction review status
                                            automated_candidate_pending_source_review
                                            generic names
                                            1. PEMBROLIZUMAB
                                            id
                                            ind-span-abc297db9982e93e8db4
                                            label id
                                            228e1e3f-d207-481f-8e14-9fdcbd0470e9
                                            positive predicate support span
                                            Source null
                                            qualifier mentions
                                              regulatory links
                                                schema version
                                                0.1.0
                                                source batch sha256
                                                fc39a8c5cf96bf95ca20b85578140167b66b2741f7d9217f500d9ba0847ac058
                                                source defined aliases
                                                1. abbreviation
                                                  NSCLC
                                                  definition exact
                                                  Non-Small Cell Lung Cancer
                                                  definition span
                                                  end
                                                  380
                                                  end exclusive
                                                  true
                                                  exact text
                                                  Non-Small Cell Lung Cancer (NSCLC)
                                                  label id
                                                  228e1e3f-d207-481f-8e14-9fdcbd0470e9
                                                  offset unit
                                                  unicode_code_points
                                                  source array index
                                                  0
                                                  source field
                                                  indications_and_usage_exact
                                                  source text sha256
                                                  e526ba14c91f10737e6d3331fe23a6219f58c0eca6380bfce9bd78b573fea912
                                                  start
                                                  346
                                                2. abbreviation
                                                  CRC
                                                  definition exact
                                                  Colorectal Cancer
                                                  definition span
                                                  end
                                                  5042
                                                  end exclusive
                                                  true
                                                  exact text
                                                  Colorectal Cancer (CRC)
                                                  label id
                                                  228e1e3f-d207-481f-8e14-9fdcbd0470e9
                                                  offset unit
                                                  unicode_code_points
                                                  source array index
                                                  0
                                                  source field
                                                  indications_and_usage_exact
                                                  source text sha256
                                                  e526ba14c91f10737e6d3331fe23a6219f58c0eca6380bfce9bd78b573fea912
                                                  start
                                                  5019
                                                source span
                                                end
                                                2459
                                                end exclusive
                                                true
                                                exact text
                                                ( 1.4 )
                                                label id
                                                228e1e3f-d207-481f-8e14-9fdcbd0470e9
                                                offset unit
                                                unicode_code_points
                                                source array index
                                                0
                                                source field
                                                indications_and_usage_exact
                                                source text sha256
                                                e526ba14c91f10737e6d3331fe23a6219f58c0eca6380bfce9bd78b573fea912
                                                start
                                                2452
                                                source url
                                                https://api.fda.gov/drug/label.json?search=id%3A%22228e1e3f-d207-481f-8e14-9fdcbd0470e9%22
                                                spl effective date
                                                2026-07-10
                                                spl set id
                                                9333c79b-d487-4538-a9f0-71b91a02b287
                                                spl version
                                                228
                                                structured fields status
                                                not_extracted_no_values_inferred_from_mentions
                                                structured indication
                                                age
                                                Source null
                                                approval pathway
                                                Source null
                                                biomarker and test
                                                Source null
                                                disease stage
                                                Source null
                                                limitations
                                                Source null
                                                line
                                                Source null
                                                prior therapy
                                                Source null
                                                regimen
                                                Source null
                                                tumor histology
                                                Source null
                                                use intent
                                                unclear
                                                Passage 17 · unclassified context
                                                application numbers
                                                1. BLA125514
                                                brand names
                                                1. KEYTRUDA
                                                classification reasons
                                                1. no_unambiguous_positive_indication_predicate
                                                clinical review status
                                                pending
                                                content role
                                                unclassified_context
                                                context span
                                                end
                                                2791
                                                end exclusive
                                                true
                                                exact text
                                                an FDA-authorized test, as a single agent as neoadjuvant treatment, continued as adjuvant treatment in combination with radiotherapy (RT) with or without cisplatin and then as a single agent. ( 1.4 ) in combination with platinum and FU for the first-line treatment of patients with metastatic or with unresectable, recurrent HNSCC. ( 1.4 ) as a single agent for the first-line treatment of patients with metastatic or with unresectable, recurrent HNSCC whose tumors express PD-L1 [Combined Positive Score (CPS) ≥1] as determined by
                                                label id
                                                228e1e3f-d207-481f-8e14-9fdcbd0470e9
                                                offset unit
                                                unicode_code_points
                                                source array index
                                                0
                                                source field
                                                indications_and_usage_exact
                                                source text sha256
                                                e526ba14c91f10737e6d3331fe23a6219f58c0eca6380bfce9bd78b573fea912
                                                start
                                                2260
                                                current approval status
                                                not_reconciled
                                                duplicate text group
                                                dup-a7fbd5c636e9d561bac2
                                                extraction review status
                                                automated_candidate_pending_source_review
                                                generic names
                                                1. PEMBROLIZUMAB
                                                id
                                                ind-span-1063c042d5c92e3a7553
                                                label id
                                                228e1e3f-d207-481f-8e14-9fdcbd0470e9
                                                positive predicate support span
                                                Source null
                                                qualifier mentions
                                                1. context exact
                                                  atinum and FU for the first-line treatment of patients with metastatic or with unresectable, recurrent HNSCC.
                                                  kind
                                                  biomarker
                                                  polarity
                                                  not_inferred
                                                  span
                                                  end
                                                  2573
                                                  end exclusive
                                                  true
                                                  exact text
                                                  metastatic or with unresectable
                                                  label id
                                                  228e1e3f-d207-481f-8e14-9fdcbd0470e9
                                                  offset unit
                                                  unicode_code_points
                                                  source array index
                                                  0
                                                  source field
                                                  indications_and_usage_exact
                                                  source text sha256
                                                  e526ba14c91f10737e6d3331fe23a6219f58c0eca6380bfce9bd78b573fea912
                                                  start
                                                  2542
                                                2. context exact
                                                  atinum and FU for the first-line treatment of patients with metastatic or with unresectable, recurrent HNSCC.
                                                  kind
                                                  stage_or_setting
                                                  polarity
                                                  not_inferred
                                                  span
                                                  end
                                                  2573
                                                  end exclusive
                                                  true
                                                  exact text
                                                  metastatic or with unresectable
                                                  label id
                                                  228e1e3f-d207-481f-8e14-9fdcbd0470e9
                                                  offset unit
                                                  unicode_code_points
                                                  source array index
                                                  0
                                                  source field
                                                  indications_and_usage_exact
                                                  source text sha256
                                                  e526ba14c91f10737e6d3331fe23a6219f58c0eca6380bfce9bd78b573fea912
                                                  start
                                                  2542
                                                3. context exact
                                                  treatment of patients with metastatic or with unresectable, recurrent HNSCC.
                                                  kind
                                                  stage_or_setting
                                                  polarity
                                                  not_inferred
                                                  span
                                                  end
                                                  2590
                                                  end exclusive
                                                  true
                                                  exact text
                                                  recurrent HNSCC
                                                  label id
                                                  228e1e3f-d207-481f-8e14-9fdcbd0470e9
                                                  offset unit
                                                  unicode_code_points
                                                  source array index
                                                  0
                                                  source field
                                                  indications_and_usage_exact
                                                  source text sha256
                                                  e526ba14c91f10737e6d3331fe23a6219f58c0eca6380bfce9bd78b573fea912
                                                  start
                                                  2575
                                                4. context exact
                                                  in combination with platinum and FU for the first-line treatment of patients with metastatic or with unresectable, recurrent HNSCC.
                                                  kind
                                                  prior_therapy_or_line
                                                  polarity
                                                  not_inferred
                                                  span
                                                  end
                                                  2590
                                                  end exclusive
                                                  true
                                                  exact text
                                                  first-line treatment of patients with metastatic or with unresectable, recurrent HNSCC
                                                  label id
                                                  228e1e3f-d207-481f-8e14-9fdcbd0470e9
                                                  offset unit
                                                  unicode_code_points
                                                  source array index
                                                  0
                                                  source field
                                                  indications_and_usage_exact
                                                  source text sha256
                                                  e526ba14c91f10737e6d3331fe23a6219f58c0eca6380bfce9bd78b573fea912
                                                  start
                                                  2504
                                                5. context exact
                                                  in combination with platinum and FU for the first-line treatment of patients with metastatic or with unresectable, recurrent HNSCC.
                                                  kind
                                                  regimen
                                                  polarity
                                                  not_inferred
                                                  span
                                                  end
                                                  2590
                                                  end exclusive
                                                  true
                                                  exact text
                                                  in combination with platinum and FU for the first-line treatment of patients with metastatic or with unresectable, recurrent HNSCC
                                                  label id
                                                  228e1e3f-d207-481f-8e14-9fdcbd0470e9
                                                  offset unit
                                                  unicode_code_points
                                                  source array index
                                                  0
                                                  source field
                                                  indications_and_usage_exact
                                                  source text sha256
                                                  e526ba14c91f10737e6d3331fe23a6219f58c0eca6380bfce9bd78b573fea912
                                                  start
                                                  2460
                                                regulatory links
                                                  schema version
                                                  0.1.0
                                                  source batch sha256
                                                  fc39a8c5cf96bf95ca20b85578140167b66b2741f7d9217f500d9ba0847ac058
                                                  source defined aliases
                                                  1. abbreviation
                                                    NSCLC
                                                    definition exact
                                                    Non-Small Cell Lung Cancer
                                                    definition span
                                                    end
                                                    380
                                                    end exclusive
                                                    true
                                                    exact text
                                                    Non-Small Cell Lung Cancer (NSCLC)
                                                    label id
                                                    228e1e3f-d207-481f-8e14-9fdcbd0470e9
                                                    offset unit
                                                    unicode_code_points
                                                    source array index
                                                    0
                                                    source field
                                                    indications_and_usage_exact
                                                    source text sha256
                                                    e526ba14c91f10737e6d3331fe23a6219f58c0eca6380bfce9bd78b573fea912
                                                    start
                                                    346
                                                  2. abbreviation
                                                    CRC
                                                    definition exact
                                                    Colorectal Cancer
                                                    definition span
                                                    end
                                                    5042
                                                    end exclusive
                                                    true
                                                    exact text
                                                    Colorectal Cancer (CRC)
                                                    label id
                                                    228e1e3f-d207-481f-8e14-9fdcbd0470e9
                                                    offset unit
                                                    unicode_code_points
                                                    source array index
                                                    0
                                                    source field
                                                    indications_and_usage_exact
                                                    source text sha256
                                                    e526ba14c91f10737e6d3331fe23a6219f58c0eca6380bfce9bd78b573fea912
                                                    start
                                                    5019
                                                  source span
                                                  end
                                                  2591
                                                  end exclusive
                                                  true
                                                  exact text
                                                  in combination with platinum and FU for the first-line treatment of patients with metastatic or with unresectable, recurrent HNSCC.
                                                  label id
                                                  228e1e3f-d207-481f-8e14-9fdcbd0470e9
                                                  offset unit
                                                  unicode_code_points
                                                  source array index
                                                  0
                                                  source field
                                                  indications_and_usage_exact
                                                  source text sha256
                                                  e526ba14c91f10737e6d3331fe23a6219f58c0eca6380bfce9bd78b573fea912
                                                  start
                                                  2460
                                                  source url
                                                  https://api.fda.gov/drug/label.json?search=id%3A%22228e1e3f-d207-481f-8e14-9fdcbd0470e9%22
                                                  spl effective date
                                                  2026-07-10
                                                  spl set id
                                                  9333c79b-d487-4538-a9f0-71b91a02b287
                                                  spl version
                                                  228
                                                  structured fields status
                                                  not_extracted_no_values_inferred_from_mentions
                                                  structured indication
                                                  age
                                                  Source null
                                                  approval pathway
                                                  Source null
                                                  biomarker and test
                                                  Source null
                                                  disease stage
                                                  Source null
                                                  limitations
                                                  Source null
                                                  line
                                                  Source null
                                                  prior therapy
                                                  Source null
                                                  regimen
                                                  Source null
                                                  tumor histology
                                                  Source null
                                                  use intent
                                                  unclear
                                                  Passage 18 · unclassified context
                                                  application numbers
                                                  1. BLA125514
                                                  brand names
                                                  1. KEYTRUDA
                                                  classification reasons
                                                  1. no_unambiguous_positive_indication_predicate
                                                  clinical review status
                                                  pending
                                                  content role
                                                  unclassified_context
                                                  context span
                                                  end
                                                  2799
                                                  end exclusive
                                                  true
                                                  exact text
                                                  (RT) with or without cisplatin and then as a single agent. ( 1.4 ) in combination with platinum and FU for the first-line treatment of patients with metastatic or with unresectable, recurrent HNSCC. ( 1.4 ) as a single agent for the first-line treatment of patients with metastatic or with unresectable, recurrent HNSCC whose tumors express PD-L1 [Combined Positive Score (CPS) ≥1] as determined by an FDA-
                                                  label id
                                                  228e1e3f-d207-481f-8e14-9fdcbd0470e9
                                                  offset unit
                                                  unicode_code_points
                                                  source array index
                                                  0
                                                  source field
                                                  indications_and_usage_exact
                                                  source text sha256
                                                  e526ba14c91f10737e6d3331fe23a6219f58c0eca6380bfce9bd78b573fea912
                                                  start
                                                  2392
                                                  current approval status
                                                  not_reconciled
                                                  duplicate text group
                                                  dup-643d7acb74987b5a60b2
                                                  extraction review status
                                                  automated_candidate_pending_source_review
                                                  generic names
                                                  1. PEMBROLIZUMAB
                                                  id
                                                  ind-span-600a6ee241f36b3a02a3
                                                  label id
                                                  228e1e3f-d207-481f-8e14-9fdcbd0470e9
                                                  positive predicate support span
                                                  Source null
                                                  qualifier mentions
                                                    regulatory links
                                                      schema version
                                                      0.1.0
                                                      source batch sha256
                                                      fc39a8c5cf96bf95ca20b85578140167b66b2741f7d9217f500d9ba0847ac058
                                                      source defined aliases
                                                      1. abbreviation
                                                        NSCLC
                                                        definition exact
                                                        Non-Small Cell Lung Cancer
                                                        definition span
                                                        end
                                                        380
                                                        end exclusive
                                                        true
                                                        exact text
                                                        Non-Small Cell Lung Cancer (NSCLC)
                                                        label id
                                                        228e1e3f-d207-481f-8e14-9fdcbd0470e9
                                                        offset unit
                                                        unicode_code_points
                                                        source array index
                                                        0
                                                        source field
                                                        indications_and_usage_exact
                                                        source text sha256
                                                        e526ba14c91f10737e6d3331fe23a6219f58c0eca6380bfce9bd78b573fea912
                                                        start
                                                        346
                                                      2. abbreviation
                                                        CRC
                                                        definition exact
                                                        Colorectal Cancer
                                                        definition span
                                                        end
                                                        5042
                                                        end exclusive
                                                        true
                                                        exact text
                                                        Colorectal Cancer (CRC)
                                                        label id
                                                        228e1e3f-d207-481f-8e14-9fdcbd0470e9
                                                        offset unit
                                                        unicode_code_points
                                                        source array index
                                                        0
                                                        source field
                                                        indications_and_usage_exact
                                                        source text sha256
                                                        e526ba14c91f10737e6d3331fe23a6219f58c0eca6380bfce9bd78b573fea912
                                                        start
                                                        5019
                                                      source span
                                                      end
                                                      2599
                                                      end exclusive
                                                      true
                                                      exact text
                                                      ( 1.4 )
                                                      label id
                                                      228e1e3f-d207-481f-8e14-9fdcbd0470e9
                                                      offset unit
                                                      unicode_code_points
                                                      source array index
                                                      0
                                                      source field
                                                      indications_and_usage_exact
                                                      source text sha256
                                                      e526ba14c91f10737e6d3331fe23a6219f58c0eca6380bfce9bd78b573fea912
                                                      start
                                                      2592
                                                      source url
                                                      https://api.fda.gov/drug/label.json?search=id%3A%22228e1e3f-d207-481f-8e14-9fdcbd0470e9%22
                                                      spl effective date
                                                      2026-07-10
                                                      spl set id
                                                      9333c79b-d487-4538-a9f0-71b91a02b287
                                                      spl version
                                                      228
                                                      structured fields status
                                                      not_extracted_no_values_inferred_from_mentions
                                                      structured indication
                                                      age
                                                      Source null
                                                      approval pathway
                                                      Source null
                                                      biomarker and test
                                                      Source null
                                                      disease stage
                                                      Source null
                                                      limitations
                                                      Source null
                                                      line
                                                      Source null
                                                      prior therapy
                                                      Source null
                                                      regimen
                                                      Source null
                                                      tumor histology
                                                      Source null
                                                      use intent
                                                      unclear
                                                      Passage 19 · unclassified context
                                                      application numbers
                                                      1. BLA125514
                                                      brand names
                                                      1. KEYTRUDA
                                                      classification reasons
                                                      1. no_unambiguous_positive_indication_predicate
                                                      clinical review status
                                                      pending
                                                      content role
                                                      unclassified_context
                                                      context span
                                                      end
                                                      3015
                                                      end exclusive
                                                      true
                                                      exact text
                                                      th or without cisplatin and then as a single agent. ( 1.4 ) in combination with platinum and FU for the first-line treatment of patients with metastatic or with unresectable, recurrent HNSCC. ( 1.4 ) as a single agent for the first-line treatment of patients with metastatic or with unresectable, recurrent HNSCC whose tumors express PD-L1 [Combined Positive Score (CPS) ≥1] as determined by an FDA-authorized test. ( 1.4 , 2.1 ) as a single agent for the treatment of patients with recurrent or metastatic HNSCC with disease progression on or after platinum-containing chemotherapy. ( 1.4 ) Classical Hodgkin Lymph
                                                      label id
                                                      228e1e3f-d207-481f-8e14-9fdcbd0470e9
                                                      offset unit
                                                      unicode_code_points
                                                      source array index
                                                      0
                                                      source field
                                                      indications_and_usage_exact
                                                      source text sha256
                                                      e526ba14c91f10737e6d3331fe23a6219f58c0eca6380bfce9bd78b573fea912
                                                      start
                                                      2400
                                                      current approval status
                                                      not_reconciled
                                                      duplicate text group
                                                      dup-832576c39b27676e59b2
                                                      extraction review status
                                                      automated_candidate_pending_source_review
                                                      generic names
                                                      1. PEMBROLIZUMAB
                                                      id
                                                      ind-span-bb7aefacd08074f13396
                                                      label id
                                                      228e1e3f-d207-481f-8e14-9fdcbd0470e9
                                                      positive predicate support span
                                                      Source null
                                                      qualifier mentions
                                                      1. context exact
                                                        single agent for the first-line treatment of patients with metastatic or with unresectable, recurrent HNSCC whose tumors express PD-L1 [Combined Posit
                                                        kind
                                                        biomarker
                                                        polarity
                                                        not_inferred
                                                        span
                                                        end
                                                        2695
                                                        end exclusive
                                                        true
                                                        exact text
                                                        metastatic or with unresectable
                                                        label id
                                                        228e1e3f-d207-481f-8e14-9fdcbd0470e9
                                                        offset unit
                                                        unicode_code_points
                                                        source array index
                                                        0
                                                        source field
                                                        indications_and_usage_exact
                                                        source text sha256
                                                        e526ba14c91f10737e6d3331fe23a6219f58c0eca6380bfce9bd78b573fea912
                                                        start
                                                        2664
                                                      2. context exact
                                                        or with unresectable, recurrent HNSCC whose tumors express PD-L1 [Combined Positive Score (CPS) ≥1] as determined by an FDA-authorized test.
                                                        kind
                                                        biomarker
                                                        polarity
                                                        not_inferred
                                                        span
                                                        end
                                                        2779
                                                        end exclusive
                                                        true
                                                        exact text
                                                        PD-L1 [Combined Positive Score (CPS) ≥1] as d
                                                        label id
                                                        228e1e3f-d207-481f-8e14-9fdcbd0470e9
                                                        offset unit
                                                        unicode_code_points
                                                        source array index
                                                        0
                                                        source field
                                                        indications_and_usage_exact
                                                        source text sha256
                                                        e526ba14c91f10737e6d3331fe23a6219f58c0eca6380bfce9bd78b573fea912
                                                        start
                                                        2734
                                                      3. context exact
                                                        single agent for the first-line treatment of patients with metastatic or with unresectable, recurrent HNSCC whose tumors express PD-L1 [Combined Posit
                                                        kind
                                                        stage_or_setting
                                                        polarity
                                                        not_inferred
                                                        span
                                                        end
                                                        2695
                                                        end exclusive
                                                        true
                                                        exact text
                                                        metastatic or with unresectable
                                                        label id
                                                        228e1e3f-d207-481f-8e14-9fdcbd0470e9
                                                        offset unit
                                                        unicode_code_points
                                                        source array index
                                                        0
                                                        source field
                                                        indications_and_usage_exact
                                                        source text sha256
                                                        e526ba14c91f10737e6d3331fe23a6219f58c0eca6380bfce9bd78b573fea912
                                                        start
                                                        2664
                                                      4. context exact
                                                        treatment of patients with metastatic or with unresectable, recurrent HNSCC whose tumors express PD-L1 [Combined Positive Score (CPS) ≥1] as determined by an FDA-au
                                                        kind
                                                        stage_or_setting
                                                        polarity
                                                        not_inferred
                                                        span
                                                        end
                                                        2741
                                                        end exclusive
                                                        true
                                                        exact text
                                                        recurrent HNSCC whose tumors express PD-L1 [
                                                        label id
                                                        228e1e3f-d207-481f-8e14-9fdcbd0470e9
                                                        offset unit
                                                        unicode_code_points
                                                        source array index
                                                        0
                                                        source field
                                                        indications_and_usage_exact
                                                        source text sha256
                                                        e526ba14c91f10737e6d3331fe23a6219f58c0eca6380bfce9bd78b573fea912
                                                        start
                                                        2697
                                                      5. context exact
                                                        as a single agent for the first-line treatment of patients with metastatic or with unresectable, recurrent HNSCC whose tumors express PD-L1 [Combined Positive Score (CPS) ≥1] as determined by an FDA-authorized test.
                                                        kind
                                                        prior_therapy_or_line
                                                        polarity
                                                        not_inferred
                                                        span
                                                        end
                                                        2796
                                                        end exclusive
                                                        true
                                                        exact text
                                                        first-line treatment of patients with metastatic or with unresectable, recurrent HNSCC whose tumors express PD-L1 [Combined Positive Score (CPS) ≥1] as determined by an F
                                                        label id
                                                        228e1e3f-d207-481f-8e14-9fdcbd0470e9
                                                        offset unit
                                                        unicode_code_points
                                                        source array index
                                                        0
                                                        source field
                                                        indications_and_usage_exact
                                                        source text sha256
                                                        e526ba14c91f10737e6d3331fe23a6219f58c0eca6380bfce9bd78b573fea912
                                                        start
                                                        2626
                                                      6. context exact
                                                        as a single agent for the first-line treatment of patients with metastatic or with unresectable, recurrent HNSCC whose tumors express PD-L1 [Combined Positive Score (CPS) ≥1] as determined by an FDA-authorized test.
                                                        kind
                                                        regimen
                                                        polarity
                                                        not_inferred
                                                        span
                                                        end
                                                        2777
                                                        end exclusive
                                                        true
                                                        exact text
                                                        as a single agent for the first-line treatment of patients with metastatic or with unresectable, recurrent HNSCC whose tumors express PD-L1 [Combined Positive Score (CPS) ≥1] as
                                                        label id
                                                        228e1e3f-d207-481f-8e14-9fdcbd0470e9
                                                        offset unit
                                                        unicode_code_points
                                                        source array index
                                                        0
                                                        source field
                                                        indications_and_usage_exact
                                                        source text sha256
                                                        e526ba14c91f10737e6d3331fe23a6219f58c0eca6380bfce9bd78b573fea912
                                                        start
                                                        2600
                                                      regulatory links
                                                        schema version
                                                        0.1.0
                                                        source batch sha256
                                                        fc39a8c5cf96bf95ca20b85578140167b66b2741f7d9217f500d9ba0847ac058
                                                        source defined aliases
                                                        1. abbreviation
                                                          NSCLC
                                                          definition exact
                                                          Non-Small Cell Lung Cancer
                                                          definition span
                                                          end
                                                          380
                                                          end exclusive
                                                          true
                                                          exact text
                                                          Non-Small Cell Lung Cancer (NSCLC)
                                                          label id
                                                          228e1e3f-d207-481f-8e14-9fdcbd0470e9
                                                          offset unit
                                                          unicode_code_points
                                                          source array index
                                                          0
                                                          source field
                                                          indications_and_usage_exact
                                                          source text sha256
                                                          e526ba14c91f10737e6d3331fe23a6219f58c0eca6380bfce9bd78b573fea912
                                                          start
                                                          346
                                                        2. abbreviation
                                                          CRC
                                                          definition exact
                                                          Colorectal Cancer
                                                          definition span
                                                          end
                                                          5042
                                                          end exclusive
                                                          true
                                                          exact text
                                                          Colorectal Cancer (CRC)
                                                          label id
                                                          228e1e3f-d207-481f-8e14-9fdcbd0470e9
                                                          offset unit
                                                          unicode_code_points
                                                          source array index
                                                          0
                                                          source field
                                                          indications_and_usage_exact
                                                          source text sha256
                                                          e526ba14c91f10737e6d3331fe23a6219f58c0eca6380bfce9bd78b573fea912
                                                          start
                                                          5019
                                                        source span
                                                        end
                                                        2815
                                                        end exclusive
                                                        true
                                                        exact text
                                                        as a single agent for the first-line treatment of patients with metastatic or with unresectable, recurrent HNSCC whose tumors express PD-L1 [Combined Positive Score (CPS) ≥1] as determined by an FDA-authorized test.
                                                        label id
                                                        228e1e3f-d207-481f-8e14-9fdcbd0470e9
                                                        offset unit
                                                        unicode_code_points
                                                        source array index
                                                        0
                                                        source field
                                                        indications_and_usage_exact
                                                        source text sha256
                                                        e526ba14c91f10737e6d3331fe23a6219f58c0eca6380bfce9bd78b573fea912
                                                        start
                                                        2600
                                                        source url
                                                        https://api.fda.gov/drug/label.json?search=id%3A%22228e1e3f-d207-481f-8e14-9fdcbd0470e9%22
                                                        spl effective date
                                                        2026-07-10
                                                        spl set id
                                                        9333c79b-d487-4538-a9f0-71b91a02b287
                                                        spl version
                                                        228
                                                        structured fields status
                                                        not_extracted_no_values_inferred_from_mentions
                                                        structured indication
                                                        age
                                                        Source null
                                                        approval pathway
                                                        Source null
                                                        biomarker and test
                                                        Source null
                                                        disease stage
                                                        Source null
                                                        limitations
                                                        Source null
                                                        line
                                                        Source null
                                                        prior therapy
                                                        Source null
                                                        regimen
                                                        Source null
                                                        tumor histology
                                                        Source null
                                                        use intent
                                                        unclear
                                                        Passage 20 · unclassified context
                                                        application numbers
                                                        1. BLA125514
                                                        brand names
                                                        1. KEYTRUDA
                                                        classification reasons
                                                        1. no_unambiguous_positive_indication_predicate
                                                        clinical review status
                                                        pending
                                                        content role
                                                        unclassified_context
                                                        context span
                                                        end
                                                        3183
                                                        end exclusive
                                                        true
                                                        exact text
                                                        t for the first-line treatment of patients with metastatic or with unresectable, recurrent HNSCC whose tumors express PD-L1 [Combined Positive Score (CPS) ≥1] as determined by an FDA-authorized test. ( 1.4 , 2.1 ) as a single agent for the treatment of patients with recurrent or metastatic HNSCC with disease progression on or after platinum-containing chemotherapy. ( 1.4 ) Classical Hodgkin Lymphoma (cHL) for the treatment of adult patients with relapsed or refractory cHL. ( 1.5 ) for the treatment of pediatric patients with refractory cHL, or cHL that has rela
                                                        label id
                                                        228e1e3f-d207-481f-8e14-9fdcbd0470e9
                                                        offset unit
                                                        unicode_code_points
                                                        source array index
                                                        0
                                                        source field
                                                        indications_and_usage_exact
                                                        source text sha256
                                                        e526ba14c91f10737e6d3331fe23a6219f58c0eca6380bfce9bd78b573fea912
                                                        start
                                                        2616
                                                        current approval status
                                                        not_reconciled
                                                        duplicate text group
                                                        dup-d0b22f95c0e6418875bb
                                                        extraction review status
                                                        automated_candidate_pending_source_review
                                                        generic names
                                                        1. PEMBROLIZUMAB
                                                        id
                                                        ind-span-be900f87ff091e52fa2a
                                                        label id
                                                        228e1e3f-d207-481f-8e14-9fdcbd0470e9
                                                        positive predicate support span
                                                        Source null
                                                        qualifier mentions
                                                        1. context exact
                                                          ingle agent for the treatment of patients with recurrent or metastatic HNSCC with disease progression on or after platinum-containing chemotherapy.
                                                          kind
                                                          biomarker
                                                          polarity
                                                          not_inferred
                                                          span
                                                          end
                                                          2939
                                                          end exclusive
                                                          true
                                                          exact text
                                                          metastatic HNSCC with disease progression o
                                                          label id
                                                          228e1e3f-d207-481f-8e14-9fdcbd0470e9
                                                          offset unit
                                                          unicode_code_points
                                                          source array index
                                                          0
                                                          source field
                                                          indications_and_usage_exact
                                                          source text sha256
                                                          e526ba14c91f10737e6d3331fe23a6219f58c0eca6380bfce9bd78b573fea912
                                                          start
                                                          2896
                                                        2. context exact
                                                          2.1 ) as a single agent for the treatment of patients with recurrent or metastatic HNSCC with disease progression on or after platinum-containing chemotherapy.
                                                          kind
                                                          stage_or_setting
                                                          polarity
                                                          not_inferred
                                                          span
                                                          end
                                                          2927
                                                          end exclusive
                                                          true
                                                          exact text
                                                          recurrent or metastatic HNSCC with disease p
                                                          label id
                                                          228e1e3f-d207-481f-8e14-9fdcbd0470e9
                                                          offset unit
                                                          unicode_code_points
                                                          source array index
                                                          0
                                                          source field
                                                          indications_and_usage_exact
                                                          source text sha256
                                                          e526ba14c91f10737e6d3331fe23a6219f58c0eca6380bfce9bd78b573fea912
                                                          start
                                                          2883
                                                        3. context exact
                                                          ( 1.4 , 2.1 ) as a single agent for the treatment of patients with recurrent or metastatic HNSCC with disease progression on or after platinum-containing chemotherapy.
                                                          kind
                                                          regimen
                                                          polarity
                                                          not_inferred
                                                          span
                                                          end
                                                          2982
                                                          end exclusive
                                                          true
                                                          exact text
                                                          as a single agent for the treatment of patients with recurrent or metastatic HNSCC with disease progression on or after platinum-containing chemotherapy
                                                          label id
                                                          228e1e3f-d207-481f-8e14-9fdcbd0470e9
                                                          offset unit
                                                          unicode_code_points
                                                          source array index
                                                          0
                                                          source field
                                                          indications_and_usage_exact
                                                          source text sha256
                                                          e526ba14c91f10737e6d3331fe23a6219f58c0eca6380bfce9bd78b573fea912
                                                          start
                                                          2830
                                                        regulatory links
                                                          schema version
                                                          0.1.0
                                                          source batch sha256
                                                          fc39a8c5cf96bf95ca20b85578140167b66b2741f7d9217f500d9ba0847ac058
                                                          source defined aliases
                                                          1. abbreviation
                                                            NSCLC
                                                            definition exact
                                                            Non-Small Cell Lung Cancer
                                                            definition span
                                                            end
                                                            380
                                                            end exclusive
                                                            true
                                                            exact text
                                                            Non-Small Cell Lung Cancer (NSCLC)
                                                            label id
                                                            228e1e3f-d207-481f-8e14-9fdcbd0470e9
                                                            offset unit
                                                            unicode_code_points
                                                            source array index
                                                            0
                                                            source field
                                                            indications_and_usage_exact
                                                            source text sha256
                                                            e526ba14c91f10737e6d3331fe23a6219f58c0eca6380bfce9bd78b573fea912
                                                            start
                                                            346
                                                          2. abbreviation
                                                            CRC
                                                            definition exact
                                                            Colorectal Cancer
                                                            definition span
                                                            end
                                                            5042
                                                            end exclusive
                                                            true
                                                            exact text
                                                            Colorectal Cancer (CRC)
                                                            label id
                                                            228e1e3f-d207-481f-8e14-9fdcbd0470e9
                                                            offset unit
                                                            unicode_code_points
                                                            source array index
                                                            0
                                                            source field
                                                            indications_and_usage_exact
                                                            source text sha256
                                                            e526ba14c91f10737e6d3331fe23a6219f58c0eca6380bfce9bd78b573fea912
                                                            start
                                                            5019
                                                          source span
                                                          end
                                                          2983
                                                          end exclusive
                                                          true
                                                          exact text
                                                          ( 1.4 , 2.1 ) as a single agent for the treatment of patients with recurrent or metastatic HNSCC with disease progression on or after platinum-containing chemotherapy.
                                                          label id
                                                          228e1e3f-d207-481f-8e14-9fdcbd0470e9
                                                          offset unit
                                                          unicode_code_points
                                                          source array index
                                                          0
                                                          source field
                                                          indications_and_usage_exact
                                                          source text sha256
                                                          e526ba14c91f10737e6d3331fe23a6219f58c0eca6380bfce9bd78b573fea912
                                                          start
                                                          2816
                                                          source url
                                                          https://api.fda.gov/drug/label.json?search=id%3A%22228e1e3f-d207-481f-8e14-9fdcbd0470e9%22
                                                          spl effective date
                                                          2026-07-10
                                                          spl set id
                                                          9333c79b-d487-4538-a9f0-71b91a02b287
                                                          spl version
                                                          228
                                                          structured fields status
                                                          not_extracted_no_values_inferred_from_mentions
                                                          structured indication
                                                          age
                                                          Source null
                                                          approval pathway
                                                          Source null
                                                          biomarker and test
                                                          Source null
                                                          disease stage
                                                          Source null
                                                          limitations
                                                          Source null
                                                          line
                                                          Source null
                                                          prior therapy
                                                          Source null
                                                          regimen
                                                          Source null
                                                          tumor histology
                                                          Source null
                                                          use intent
                                                          unclear
                                                          Passage 21 · unclassified context
                                                          application numbers
                                                          1. BLA125514
                                                          brand names
                                                          1. KEYTRUDA
                                                          classification reasons
                                                          1. no_unambiguous_positive_indication_predicate
                                                          clinical review status
                                                          pending
                                                          content role
                                                          unclassified_context
                                                          context span
                                                          end
                                                          3293
                                                          end exclusive
                                                          true
                                                          exact text
                                                          ined by an FDA-authorized test. ( 1.4 , 2.1 ) as a single agent for the treatment of patients with recurrent or metastatic HNSCC with disease progression on or after platinum-containing chemotherapy. ( 1.4 ) Classical Hodgkin Lymphoma (cHL) for the treatment of adult patients with relapsed or refractory cHL. ( 1.5 ) for the treatment of pediatric patients with refractory cHL, or cHL that has relapsed after 2 or more lines of therapy. ( 1.5 ) Primary Mediastinal Large B-Cell Lymphoma (PMBCL) for the treat
                                                          label id
                                                          228e1e3f-d207-481f-8e14-9fdcbd0470e9
                                                          offset unit
                                                          unicode_code_points
                                                          source array index
                                                          0
                                                          source field
                                                          indications_and_usage_exact
                                                          source text sha256
                                                          e526ba14c91f10737e6d3331fe23a6219f58c0eca6380bfce9bd78b573fea912
                                                          start
                                                          2784
                                                          current approval status
                                                          not_reconciled
                                                          duplicate text group
                                                          dup-7b5b7f378deef935215a
                                                          extraction review status
                                                          automated_candidate_pending_source_review
                                                          generic names
                                                          1. PEMBROLIZUMAB
                                                          id
                                                          ind-span-1cab51f3c3f6d27be27b
                                                          label id
                                                          228e1e3f-d207-481f-8e14-9fdcbd0470e9
                                                          positive predicate support span
                                                          Source null
                                                          qualifier mentions
                                                          1. context exact
                                                            1.4 ) Classical Hodgkin Lymphoma (cHL) for the treatment of adult patients with relapsed or refractory cHL.
                                                            kind
                                                            age
                                                            polarity
                                                            not_inferred
                                                            span
                                                            end
                                                            3060
                                                            end exclusive
                                                            true
                                                            exact text
                                                            adult patients
                                                            label id
                                                            228e1e3f-d207-481f-8e14-9fdcbd0470e9
                                                            offset unit
                                                            unicode_code_points
                                                            source array index
                                                            0
                                                            source field
                                                            indications_and_usage_exact
                                                            source text sha256
                                                            e526ba14c91f10737e6d3331fe23a6219f58c0eca6380bfce9bd78b573fea912
                                                            start
                                                            3046
                                                          2. context exact
                                                            kin Lymphoma (cHL) for the treatment of adult patients with relapsed or refractory cHL.
                                                            kind
                                                            stage_or_setting
                                                            polarity
                                                            not_inferred
                                                            span
                                                            end
                                                            3092
                                                            end exclusive
                                                            true
                                                            exact text
                                                            relapsed or refractory cHL
                                                            label id
                                                            228e1e3f-d207-481f-8e14-9fdcbd0470e9
                                                            offset unit
                                                            unicode_code_points
                                                            source array index
                                                            0
                                                            source field
                                                            indications_and_usage_exact
                                                            source text sha256
                                                            e526ba14c91f10737e6d3331fe23a6219f58c0eca6380bfce9bd78b573fea912
                                                            start
                                                            3066
                                                          regulatory links
                                                            schema version
                                                            0.1.0
                                                            source batch sha256
                                                            fc39a8c5cf96bf95ca20b85578140167b66b2741f7d9217f500d9ba0847ac058
                                                            source defined aliases
                                                            1. abbreviation
                                                              NSCLC
                                                              definition exact
                                                              Non-Small Cell Lung Cancer
                                                              definition span
                                                              end
                                                              380
                                                              end exclusive
                                                              true
                                                              exact text
                                                              Non-Small Cell Lung Cancer (NSCLC)
                                                              label id
                                                              228e1e3f-d207-481f-8e14-9fdcbd0470e9
                                                              offset unit
                                                              unicode_code_points
                                                              source array index
                                                              0
                                                              source field
                                                              indications_and_usage_exact
                                                              source text sha256
                                                              e526ba14c91f10737e6d3331fe23a6219f58c0eca6380bfce9bd78b573fea912
                                                              start
                                                              346
                                                            2. abbreviation
                                                              CRC
                                                              definition exact
                                                              Colorectal Cancer
                                                              definition span
                                                              end
                                                              5042
                                                              end exclusive
                                                              true
                                                              exact text
                                                              Colorectal Cancer (CRC)
                                                              label id
                                                              228e1e3f-d207-481f-8e14-9fdcbd0470e9
                                                              offset unit
                                                              unicode_code_points
                                                              source array index
                                                              0
                                                              source field
                                                              indications_and_usage_exact
                                                              source text sha256
                                                              e526ba14c91f10737e6d3331fe23a6219f58c0eca6380bfce9bd78b573fea912
                                                              start
                                                              5019
                                                            source span
                                                            end
                                                            3093
                                                            end exclusive
                                                            true
                                                            exact text
                                                            ( 1.4 ) Classical Hodgkin Lymphoma (cHL) for the treatment of adult patients with relapsed or refractory cHL.
                                                            label id
                                                            228e1e3f-d207-481f-8e14-9fdcbd0470e9
                                                            offset unit
                                                            unicode_code_points
                                                            source array index
                                                            0
                                                            source field
                                                            indications_and_usage_exact
                                                            source text sha256
                                                            e526ba14c91f10737e6d3331fe23a6219f58c0eca6380bfce9bd78b573fea912
                                                            start
                                                            2984
                                                            source url
                                                            https://api.fda.gov/drug/label.json?search=id%3A%22228e1e3f-d207-481f-8e14-9fdcbd0470e9%22
                                                            spl effective date
                                                            2026-07-10
                                                            spl set id
                                                            9333c79b-d487-4538-a9f0-71b91a02b287
                                                            spl version
                                                            228
                                                            structured fields status
                                                            not_extracted_no_values_inferred_from_mentions
                                                            structured indication
                                                            age
                                                            Source null
                                                            approval pathway
                                                            Source null
                                                            biomarker and test
                                                            Source null
                                                            disease stage
                                                            Source null
                                                            limitations
                                                            Source null
                                                            line
                                                            Source null
                                                            prior therapy
                                                            Source null
                                                            regimen
                                                            Source null
                                                            tumor histology
                                                            Source null
                                                            use intent
                                                            unclear
                                                            Passage 22 · unclassified context
                                                            application numbers
                                                            1. BLA125514
                                                            brand names
                                                            1. KEYTRUDA
                                                            classification reasons
                                                            1. no_unambiguous_positive_indication_predicate
                                                            clinical review status
                                                            pending
                                                            content role
                                                            unclassified_context
                                                            context span
                                                            end
                                                            3301
                                                            end exclusive
                                                            true
                                                            exact text
                                                            r metastatic HNSCC with disease progression on or after platinum-containing chemotherapy. ( 1.4 ) Classical Hodgkin Lymphoma (cHL) for the treatment of adult patients with relapsed or refractory cHL. ( 1.5 ) for the treatment of pediatric patients with refractory cHL, or cHL that has relapsed after 2 or more lines of therapy. ( 1.5 ) Primary Mediastinal Large B-Cell Lymphoma (PMBCL) for the treatment of
                                                            label id
                                                            228e1e3f-d207-481f-8e14-9fdcbd0470e9
                                                            offset unit
                                                            unicode_code_points
                                                            source array index
                                                            0
                                                            source field
                                                            indications_and_usage_exact
                                                            source text sha256
                                                            e526ba14c91f10737e6d3331fe23a6219f58c0eca6380bfce9bd78b573fea912
                                                            start
                                                            2894
                                                            current approval status
                                                            not_reconciled
                                                            duplicate text group
                                                            dup-2b910a539db37eda31b8
                                                            extraction review status
                                                            automated_candidate_pending_source_review
                                                            generic names
                                                            1. PEMBROLIZUMAB
                                                            id
                                                            ind-span-be7750631d2457cb827c
                                                            label id
                                                            228e1e3f-d207-481f-8e14-9fdcbd0470e9
                                                            positive predicate support span
                                                            Source null
                                                            qualifier mentions
                                                              regulatory links
                                                                schema version
                                                                0.1.0
                                                                source batch sha256
                                                                fc39a8c5cf96bf95ca20b85578140167b66b2741f7d9217f500d9ba0847ac058
                                                                source defined aliases
                                                                1. abbreviation
                                                                  NSCLC
                                                                  definition exact
                                                                  Non-Small Cell Lung Cancer
                                                                  definition span
                                                                  end
                                                                  380
                                                                  end exclusive
                                                                  true
                                                                  exact text
                                                                  Non-Small Cell Lung Cancer (NSCLC)
                                                                  label id
                                                                  228e1e3f-d207-481f-8e14-9fdcbd0470e9
                                                                  offset unit
                                                                  unicode_code_points
                                                                  source array index
                                                                  0
                                                                  source field
                                                                  indications_and_usage_exact
                                                                  source text sha256
                                                                  e526ba14c91f10737e6d3331fe23a6219f58c0eca6380bfce9bd78b573fea912
                                                                  start
                                                                  346
                                                                2. abbreviation
                                                                  CRC
                                                                  definition exact
                                                                  Colorectal Cancer
                                                                  definition span
                                                                  end
                                                                  5042
                                                                  end exclusive
                                                                  true
                                                                  exact text
                                                                  Colorectal Cancer (CRC)
                                                                  label id
                                                                  228e1e3f-d207-481f-8e14-9fdcbd0470e9
                                                                  offset unit
                                                                  unicode_code_points
                                                                  source array index
                                                                  0
                                                                  source field
                                                                  indications_and_usage_exact
                                                                  source text sha256
                                                                  e526ba14c91f10737e6d3331fe23a6219f58c0eca6380bfce9bd78b573fea912
                                                                  start
                                                                  5019
                                                                source span
                                                                end
                                                                3101
                                                                end exclusive
                                                                true
                                                                exact text
                                                                ( 1.5 )
                                                                label id
                                                                228e1e3f-d207-481f-8e14-9fdcbd0470e9
                                                                offset unit
                                                                unicode_code_points
                                                                source array index
                                                                0
                                                                source field
                                                                indications_and_usage_exact
                                                                source text sha256
                                                                e526ba14c91f10737e6d3331fe23a6219f58c0eca6380bfce9bd78b573fea912
                                                                start
                                                                3094
                                                                source url
                                                                https://api.fda.gov/drug/label.json?search=id%3A%22228e1e3f-d207-481f-8e14-9fdcbd0470e9%22
                                                                spl effective date
                                                                2026-07-10
                                                                spl set id
                                                                9333c79b-d487-4538-a9f0-71b91a02b287
                                                                spl version
                                                                228
                                                                structured fields status
                                                                not_extracted_no_values_inferred_from_mentions
                                                                structured indication
                                                                age
                                                                Source null
                                                                approval pathway
                                                                Source null
                                                                biomarker and test
                                                                Source null
                                                                disease stage
                                                                Source null
                                                                limitations
                                                                Source null
                                                                line
                                                                Source null
                                                                prior therapy
                                                                Source null
                                                                regimen
                                                                Source null
                                                                tumor histology
                                                                Source null
                                                                use intent
                                                                unclear
                                                                Passage 23 · unclassified context
                                                                application numbers
                                                                1. BLA125514
                                                                brand names
                                                                1. KEYTRUDA
                                                                classification reasons
                                                                1. no_unambiguous_positive_indication_predicate
                                                                clinical review status
                                                                pending
                                                                content role
                                                                unclassified_context
                                                                context span
                                                                end
                                                                3421
                                                                end exclusive
                                                                true
                                                                exact text
                                                                atic HNSCC with disease progression on or after platinum-containing chemotherapy. ( 1.4 ) Classical Hodgkin Lymphoma (cHL) for the treatment of adult patients with relapsed or refractory cHL. ( 1.5 ) for the treatment of pediatric patients with refractory cHL, or cHL that has relapsed after 2 or more lines of therapy. ( 1.5 ) Primary Mediastinal Large B-Cell Lymphoma (PMBCL) for the treatment of adult and pediatric patients with refractory PMBCL, or who have relapsed after 2 or more prior lines of therapy. ( 1.6 )
                                                                label id
                                                                228e1e3f-d207-481f-8e14-9fdcbd0470e9
                                                                offset unit
                                                                unicode_code_points
                                                                source array index
                                                                0
                                                                source field
                                                                indications_and_usage_exact
                                                                source text sha256
                                                                e526ba14c91f10737e6d3331fe23a6219f58c0eca6380bfce9bd78b573fea912
                                                                start
                                                                2902
                                                                current approval status
                                                                not_reconciled
                                                                duplicate text group
                                                                dup-1d989b5613ba8b7ea7a8
                                                                extraction review status
                                                                automated_candidate_pending_source_review
                                                                generic names
                                                                1. PEMBROLIZUMAB
                                                                id
                                                                ind-span-ea2b1cfd51726aa9ca31
                                                                label id
                                                                228e1e3f-d207-481f-8e14-9fdcbd0470e9
                                                                positive predicate support span
                                                                Source null
                                                                qualifier mentions
                                                                1. context exact
                                                                  for the treatment of pediatric patients with refractory cHL, or cHL that has relapsed after 2 or mo
                                                                  kind
                                                                  age
                                                                  polarity
                                                                  not_inferred
                                                                  span
                                                                  end
                                                                  3141
                                                                  end exclusive
                                                                  true
                                                                  exact text
                                                                  pediatric patients
                                                                  label id
                                                                  228e1e3f-d207-481f-8e14-9fdcbd0470e9
                                                                  offset unit
                                                                  unicode_code_points
                                                                  source array index
                                                                  0
                                                                  source field
                                                                  indications_and_usage_exact
                                                                  source text sha256
                                                                  e526ba14c91f10737e6d3331fe23a6219f58c0eca6380bfce9bd78b573fea912
                                                                  start
                                                                  3123
                                                                2. context exact
                                                                  for the treatment of pediatric patients with refractory cHL, or cHL that has relapsed after 2 or more lines of therapy.
                                                                  kind
                                                                  stage_or_setting
                                                                  polarity
                                                                  not_inferred
                                                                  span
                                                                  end
                                                                  3161
                                                                  end exclusive
                                                                  true
                                                                  exact text
                                                                  refractory cHL
                                                                  label id
                                                                  228e1e3f-d207-481f-8e14-9fdcbd0470e9
                                                                  offset unit
                                                                  unicode_code_points
                                                                  source array index
                                                                  0
                                                                  source field
                                                                  indications_and_usage_exact
                                                                  source text sha256
                                                                  e526ba14c91f10737e6d3331fe23a6219f58c0eca6380bfce9bd78b573fea912
                                                                  start
                                                                  3147
                                                                3. context exact
                                                                  of pediatric patients with refractory cHL, or cHL that has relapsed after 2 or more lines of therapy.
                                                                  kind
                                                                  stage_or_setting
                                                                  polarity
                                                                  not_inferred
                                                                  span
                                                                  end
                                                                  3220
                                                                  end exclusive
                                                                  true
                                                                  exact text
                                                                  relapsed after 2 or more lines of therapy
                                                                  label id
                                                                  228e1e3f-d207-481f-8e14-9fdcbd0470e9
                                                                  offset unit
                                                                  unicode_code_points
                                                                  source array index
                                                                  0
                                                                  source field
                                                                  indications_and_usage_exact
                                                                  source text sha256
                                                                  e526ba14c91f10737e6d3331fe23a6219f58c0eca6380bfce9bd78b573fea912
                                                                  start
                                                                  3179
                                                                regulatory links
                                                                  schema version
                                                                  0.1.0
                                                                  source batch sha256
                                                                  fc39a8c5cf96bf95ca20b85578140167b66b2741f7d9217f500d9ba0847ac058
                                                                  source defined aliases
                                                                  1. abbreviation
                                                                    NSCLC
                                                                    definition exact
                                                                    Non-Small Cell Lung Cancer
                                                                    definition span
                                                                    end
                                                                    380
                                                                    end exclusive
                                                                    true
                                                                    exact text
                                                                    Non-Small Cell Lung Cancer (NSCLC)
                                                                    label id
                                                                    228e1e3f-d207-481f-8e14-9fdcbd0470e9
                                                                    offset unit
                                                                    unicode_code_points
                                                                    source array index
                                                                    0
                                                                    source field
                                                                    indications_and_usage_exact
                                                                    source text sha256
                                                                    e526ba14c91f10737e6d3331fe23a6219f58c0eca6380bfce9bd78b573fea912
                                                                    start
                                                                    346
                                                                  2. abbreviation
                                                                    CRC
                                                                    definition exact
                                                                    Colorectal Cancer
                                                                    definition span
                                                                    end
                                                                    5042
                                                                    end exclusive
                                                                    true
                                                                    exact text
                                                                    Colorectal Cancer (CRC)
                                                                    label id
                                                                    228e1e3f-d207-481f-8e14-9fdcbd0470e9
                                                                    offset unit
                                                                    unicode_code_points
                                                                    source array index
                                                                    0
                                                                    source field
                                                                    indications_and_usage_exact
                                                                    source text sha256
                                                                    e526ba14c91f10737e6d3331fe23a6219f58c0eca6380bfce9bd78b573fea912
                                                                    start
                                                                    5019
                                                                  source span
                                                                  end
                                                                  3221
                                                                  end exclusive
                                                                  true
                                                                  exact text
                                                                  for the treatment of pediatric patients with refractory cHL, or cHL that has relapsed after 2 or more lines of therapy.
                                                                  label id
                                                                  228e1e3f-d207-481f-8e14-9fdcbd0470e9
                                                                  offset unit
                                                                  unicode_code_points
                                                                  source array index
                                                                  0
                                                                  source field
                                                                  indications_and_usage_exact
                                                                  source text sha256
                                                                  e526ba14c91f10737e6d3331fe23a6219f58c0eca6380bfce9bd78b573fea912
                                                                  start
                                                                  3102
                                                                  source url
                                                                  https://api.fda.gov/drug/label.json?search=id%3A%22228e1e3f-d207-481f-8e14-9fdcbd0470e9%22
                                                                  spl effective date
                                                                  2026-07-10
                                                                  spl set id
                                                                  9333c79b-d487-4538-a9f0-71b91a02b287
                                                                  spl version
                                                                  228
                                                                  structured fields status
                                                                  not_extracted_no_values_inferred_from_mentions
                                                                  structured indication
                                                                  age
                                                                  Source null
                                                                  approval pathway
                                                                  Source null
                                                                  biomarker and test
                                                                  Source null
                                                                  disease stage
                                                                  Source null
                                                                  limitations
                                                                  Source null
                                                                  line
                                                                  Source null
                                                                  prior therapy
                                                                  Source null
                                                                  regimen
                                                                  Source null
                                                                  tumor histology
                                                                  Source null
                                                                  use intent
                                                                  unclear
                                                                  Passage 24 · unclassified context
                                                                  application numbers
                                                                  1. BLA125514
                                                                  brand names
                                                                  1. KEYTRUDA
                                                                  classification reasons
                                                                  1. no_unambiguous_positive_indication_predicate
                                                                  clinical review status
                                                                  pending
                                                                  content role
                                                                  unclassified_context
                                                                  context span
                                                                  end
                                                                  3613
                                                                  end exclusive
                                                                  true
                                                                  exact text
                                                                  L) for the treatment of adult patients with relapsed or refractory cHL. ( 1.5 ) for the treatment of pediatric patients with refractory cHL, or cHL that has relapsed after 2 or more lines of therapy. ( 1.5 ) Primary Mediastinal Large B-Cell Lymphoma (PMBCL) for the treatment of adult and pediatric patients with refractory PMBCL, or who have relapsed after 2 or more prior lines of therapy. ( 1.6 ) Limitations of Use : KEYTRUDA is not recommended for treatment of patients with PMBCL who require urgent cytoreductive therapy. Urothelial Cancer in combination with enfortumab vedotin-ejfv,
                                                                  label id
                                                                  228e1e3f-d207-481f-8e14-9fdcbd0470e9
                                                                  offset unit
                                                                  unicode_code_points
                                                                  source array index
                                                                  0
                                                                  source field
                                                                  indications_and_usage_exact
                                                                  source text sha256
                                                                  e526ba14c91f10737e6d3331fe23a6219f58c0eca6380bfce9bd78b573fea912
                                                                  start
                                                                  3022
                                                                  current approval status
                                                                  not_reconciled
                                                                  duplicate text group
                                                                  dup-eccb80aeb3dfcca100bd
                                                                  extraction review status
                                                                  automated_candidate_pending_source_review
                                                                  generic names
                                                                  1. PEMBROLIZUMAB
                                                                  id
                                                                  ind-span-c60fc84a1a71eb61d91e
                                                                  label id
                                                                  228e1e3f-d207-481f-8e14-9fdcbd0470e9
                                                                  positive predicate support span
                                                                  Source null
                                                                  qualifier mentions
                                                                  1. context exact
                                                                    iastinal Large B-Cell Lymphoma (PMBCL) for the treatment of adult and pediatric patients with refractory PMBCL, or who have r
                                                                    kind
                                                                    age
                                                                    polarity
                                                                    not_inferred
                                                                    span
                                                                    end
                                                                    3306
                                                                    end exclusive
                                                                    true
                                                                    exact text
                                                                    adult
                                                                    label id
                                                                    228e1e3f-d207-481f-8e14-9fdcbd0470e9
                                                                    offset unit
                                                                    unicode_code_points
                                                                    source array index
                                                                    0
                                                                    source field
                                                                    indications_and_usage_exact
                                                                    source text sha256
                                                                    e526ba14c91f10737e6d3331fe23a6219f58c0eca6380bfce9bd78b573fea912
                                                                    start
                                                                    3301
                                                                  2. context exact
                                                                    arge B-Cell Lymphoma (PMBCL) for the treatment of adult and pediatric patients with refractory PMBCL, or who have relapsed after 2 or more
                                                                    kind
                                                                    age
                                                                    polarity
                                                                    not_inferred
                                                                    span
                                                                    end
                                                                    3329
                                                                    end exclusive
                                                                    true
                                                                    exact text
                                                                    pediatric patients
                                                                    label id
                                                                    228e1e3f-d207-481f-8e14-9fdcbd0470e9
                                                                    offset unit
                                                                    unicode_code_points
                                                                    source array index
                                                                    0
                                                                    source field
                                                                    indications_and_usage_exact
                                                                    source text sha256
                                                                    e526ba14c91f10737e6d3331fe23a6219f58c0eca6380bfce9bd78b573fea912
                                                                    start
                                                                    3311
                                                                  3. context exact
                                                                    BCL) for the treatment of adult and pediatric patients with refractory PMBCL, or who have relapsed after 2 or more prior lines of therap
                                                                    kind
                                                                    stage_or_setting
                                                                    polarity
                                                                    not_inferred
                                                                    span
                                                                    end
                                                                    3351
                                                                    end exclusive
                                                                    true
                                                                    exact text
                                                                    refractory PMBCL
                                                                    label id
                                                                    228e1e3f-d207-481f-8e14-9fdcbd0470e9
                                                                    offset unit
                                                                    unicode_code_points
                                                                    source array index
                                                                    0
                                                                    source field
                                                                    indications_and_usage_exact
                                                                    source text sha256
                                                                    e526ba14c91f10737e6d3331fe23a6219f58c0eca6380bfce9bd78b573fea912
                                                                    start
                                                                    3335
                                                                  4. context exact
                                                                    t and pediatric patients with refractory PMBCL, or who have relapsed after 2 or more prior lines of therapy.
                                                                    kind
                                                                    stage_or_setting
                                                                    polarity
                                                                    not_inferred
                                                                    span
                                                                    end
                                                                    3408
                                                                    end exclusive
                                                                    true
                                                                    exact text
                                                                    relapsed after 2 or more prior lines of the
                                                                    label id
                                                                    228e1e3f-d207-481f-8e14-9fdcbd0470e9
                                                                    offset unit
                                                                    unicode_code_points
                                                                    source array index
                                                                    0
                                                                    source field
                                                                    indications_and_usage_exact
                                                                    source text sha256
                                                                    e526ba14c91f10737e6d3331fe23a6219f58c0eca6380bfce9bd78b573fea912
                                                                    start
                                                                    3365
                                                                  regulatory links
                                                                    schema version
                                                                    0.1.0
                                                                    source batch sha256
                                                                    fc39a8c5cf96bf95ca20b85578140167b66b2741f7d9217f500d9ba0847ac058
                                                                    source defined aliases
                                                                    1. abbreviation
                                                                      NSCLC
                                                                      definition exact
                                                                      Non-Small Cell Lung Cancer
                                                                      definition span
                                                                      end
                                                                      380
                                                                      end exclusive
                                                                      true
                                                                      exact text
                                                                      Non-Small Cell Lung Cancer (NSCLC)
                                                                      label id
                                                                      228e1e3f-d207-481f-8e14-9fdcbd0470e9
                                                                      offset unit
                                                                      unicode_code_points
                                                                      source array index
                                                                      0
                                                                      source field
                                                                      indications_and_usage_exact
                                                                      source text sha256
                                                                      e526ba14c91f10737e6d3331fe23a6219f58c0eca6380bfce9bd78b573fea912
                                                                      start
                                                                      346
                                                                    2. abbreviation
                                                                      CRC
                                                                      definition exact
                                                                      Colorectal Cancer
                                                                      definition span
                                                                      end
                                                                      5042
                                                                      end exclusive
                                                                      true
                                                                      exact text
                                                                      Colorectal Cancer (CRC)
                                                                      label id
                                                                      228e1e3f-d207-481f-8e14-9fdcbd0470e9
                                                                      offset unit
                                                                      unicode_code_points
                                                                      source array index
                                                                      0
                                                                      source field
                                                                      indications_and_usage_exact
                                                                      source text sha256
                                                                      e526ba14c91f10737e6d3331fe23a6219f58c0eca6380bfce9bd78b573fea912
                                                                      start
                                                                      5019
                                                                    source span
                                                                    end
                                                                    3413
                                                                    end exclusive
                                                                    true
                                                                    exact text
                                                                    ( 1.5 ) Primary Mediastinal Large B-Cell Lymphoma (PMBCL) for the treatment of adult and pediatric patients with refractory PMBCL, or who have relapsed after 2 or more prior lines of therapy.
                                                                    label id
                                                                    228e1e3f-d207-481f-8e14-9fdcbd0470e9
                                                                    offset unit
                                                                    unicode_code_points
                                                                    source array index
                                                                    0
                                                                    source field
                                                                    indications_and_usage_exact
                                                                    source text sha256
                                                                    e526ba14c91f10737e6d3331fe23a6219f58c0eca6380bfce9bd78b573fea912
                                                                    start
                                                                    3222
                                                                    source url
                                                                    https://api.fda.gov/drug/label.json?search=id%3A%22228e1e3f-d207-481f-8e14-9fdcbd0470e9%22
                                                                    spl effective date
                                                                    2026-07-10
                                                                    spl set id
                                                                    9333c79b-d487-4538-a9f0-71b91a02b287
                                                                    spl version
                                                                    228
                                                                    structured fields status
                                                                    not_extracted_no_values_inferred_from_mentions
                                                                    structured indication
                                                                    age
                                                                    Source null
                                                                    approval pathway
                                                                    Source null
                                                                    biomarker and test
                                                                    Source null
                                                                    disease stage
                                                                    Source null
                                                                    limitations
                                                                    Source null
                                                                    line
                                                                    Source null
                                                                    prior therapy
                                                                    Source null
                                                                    regimen
                                                                    Source null
                                                                    tumor histology
                                                                    Source null
                                                                    use intent
                                                                    unclear
                                                                    Passage 25 · limitation of use
                                                                    application numbers
                                                                    1. BLA125514
                                                                    brand names
                                                                    1. KEYTRUDA
                                                                    classification reasons
                                                                    1. negative_or_not_established_clause
                                                                    clinical review status
                                                                    pending
                                                                    content role
                                                                    limitation_of_use
                                                                    context span
                                                                    end
                                                                    3749
                                                                    end exclusive
                                                                    true
                                                                    exact text
                                                                    herapy. ( 1.5 ) Primary Mediastinal Large B-Cell Lymphoma (PMBCL) for the treatment of adult and pediatric patients with refractory PMBCL, or who have relapsed after 2 or more prior lines of therapy. ( 1.6 ) Limitations of Use : KEYTRUDA is not recommended for treatment of patients with PMBCL who require urgent cytoreductive therapy. Urothelial Cancer in combination with enfortumab vedotin-ejfv, for the treatment of adult patients with locally advanced or metastatic urothelial cancer. ( 1.7 ) as a single agent for the treatment o
                                                                    label id
                                                                    228e1e3f-d207-481f-8e14-9fdcbd0470e9
                                                                    offset unit
                                                                    unicode_code_points
                                                                    source array index
                                                                    0
                                                                    source field
                                                                    indications_and_usage_exact
                                                                    source text sha256
                                                                    e526ba14c91f10737e6d3331fe23a6219f58c0eca6380bfce9bd78b573fea912
                                                                    start
                                                                    3214
                                                                    current approval status
                                                                    not_reconciled
                                                                    duplicate text group
                                                                    dup-2127162361c4f81adbc4
                                                                    extraction review status
                                                                    automated_candidate_pending_source_review
                                                                    generic names
                                                                    1. PEMBROLIZUMAB
                                                                    id
                                                                    ind-span-84382ff4e227f51ae527
                                                                    label id
                                                                    228e1e3f-d207-481f-8e14-9fdcbd0470e9
                                                                    positive predicate support span
                                                                    Source null
                                                                    qualifier mentions
                                                                      regulatory links
                                                                        schema version
                                                                        0.1.0
                                                                        source batch sha256
                                                                        fc39a8c5cf96bf95ca20b85578140167b66b2741f7d9217f500d9ba0847ac058
                                                                        source defined aliases
                                                                        1. abbreviation
                                                                          NSCLC
                                                                          definition exact
                                                                          Non-Small Cell Lung Cancer
                                                                          definition span
                                                                          end
                                                                          380
                                                                          end exclusive
                                                                          true
                                                                          exact text
                                                                          Non-Small Cell Lung Cancer (NSCLC)
                                                                          label id
                                                                          228e1e3f-d207-481f-8e14-9fdcbd0470e9
                                                                          offset unit
                                                                          unicode_code_points
                                                                          source array index
                                                                          0
                                                                          source field
                                                                          indications_and_usage_exact
                                                                          source text sha256
                                                                          e526ba14c91f10737e6d3331fe23a6219f58c0eca6380bfce9bd78b573fea912
                                                                          start
                                                                          346
                                                                        2. abbreviation
                                                                          CRC
                                                                          definition exact
                                                                          Colorectal Cancer
                                                                          definition span
                                                                          end
                                                                          5042
                                                                          end exclusive
                                                                          true
                                                                          exact text
                                                                          Colorectal Cancer (CRC)
                                                                          label id
                                                                          228e1e3f-d207-481f-8e14-9fdcbd0470e9
                                                                          offset unit
                                                                          unicode_code_points
                                                                          source array index
                                                                          0
                                                                          source field
                                                                          indications_and_usage_exact
                                                                          source text sha256
                                                                          e526ba14c91f10737e6d3331fe23a6219f58c0eca6380bfce9bd78b573fea912
                                                                          start
                                                                          5019
                                                                        source span
                                                                        end
                                                                        3549
                                                                        end exclusive
                                                                        true
                                                                        exact text
                                                                        ( 1.6 ) Limitations of Use : KEYTRUDA is not recommended for treatment of patients with PMBCL who require urgent cytoreductive therapy.
                                                                        label id
                                                                        228e1e3f-d207-481f-8e14-9fdcbd0470e9
                                                                        offset unit
                                                                        unicode_code_points
                                                                        source array index
                                                                        0
                                                                        source field
                                                                        indications_and_usage_exact
                                                                        source text sha256
                                                                        e526ba14c91f10737e6d3331fe23a6219f58c0eca6380bfce9bd78b573fea912
                                                                        start
                                                                        3414
                                                                        source url
                                                                        https://api.fda.gov/drug/label.json?search=id%3A%22228e1e3f-d207-481f-8e14-9fdcbd0470e9%22
                                                                        spl effective date
                                                                        2026-07-10
                                                                        spl set id
                                                                        9333c79b-d487-4538-a9f0-71b91a02b287
                                                                        spl version
                                                                        228
                                                                        structured fields status
                                                                        not_extracted_no_values_inferred_from_mentions
                                                                        structured indication
                                                                        age
                                                                        Source null
                                                                        approval pathway
                                                                        Source null
                                                                        biomarker and test
                                                                        Source null
                                                                        disease stage
                                                                        Source null
                                                                        limitations
                                                                        Source null
                                                                        line
                                                                        Source null
                                                                        prior therapy
                                                                        Source null
                                                                        regimen
                                                                        Source null
                                                                        tumor histology
                                                                        Source null
                                                                        use intent
                                                                        not_applicable
                                                                        Passage 26 · unclassified context
                                                                        application numbers
                                                                        1. BLA125514
                                                                        brand names
                                                                        1. KEYTRUDA
                                                                        classification reasons
                                                                        1. no_unambiguous_positive_indication_predicate
                                                                        clinical review status
                                                                        pending
                                                                        content role
                                                                        unclassified_context
                                                                        context span
                                                                        end
                                                                        3903
                                                                        end exclusive
                                                                        true
                                                                        exact text
                                                                        L, or who have relapsed after 2 or more prior lines of therapy. ( 1.6 ) Limitations of Use : KEYTRUDA is not recommended for treatment of patients with PMBCL who require urgent cytoreductive therapy. Urothelial Cancer in combination with enfortumab vedotin-ejfv, for the treatment of adult patients with locally advanced or metastatic urothelial cancer. ( 1.7 ) as a single agent for the treatment of patients with locally advanced or metastatic urothelial carcinoma who: are not eligible for any platinum-containing chemotherapy, or who have disease pr
                                                                        label id
                                                                        228e1e3f-d207-481f-8e14-9fdcbd0470e9
                                                                        offset unit
                                                                        unicode_code_points
                                                                        source array index
                                                                        0
                                                                        source field
                                                                        indications_and_usage_exact
                                                                        source text sha256
                                                                        e526ba14c91f10737e6d3331fe23a6219f58c0eca6380bfce9bd78b573fea912
                                                                        start
                                                                        3350
                                                                        current approval status
                                                                        not_reconciled
                                                                        duplicate text group
                                                                        dup-f36b0048b2aaef188db0
                                                                        extraction review status
                                                                        automated_candidate_pending_source_review
                                                                        generic names
                                                                        1. PEMBROLIZUMAB
                                                                        id
                                                                        ind-span-5e4fd4a3a94b790942ab
                                                                        label id
                                                                        228e1e3f-d207-481f-8e14-9fdcbd0470e9
                                                                        positive predicate support span
                                                                        Source null
                                                                        qualifier mentions
                                                                        1. context exact
                                                                          bination with enfortumab vedotin-ejfv, for the treatment of adult patients with locally advanced or metastatic urothelial cancer.
                                                                          kind
                                                                          age
                                                                          polarity
                                                                          not_inferred
                                                                          span
                                                                          end
                                                                          3648
                                                                          end exclusive
                                                                          true
                                                                          exact text
                                                                          adult patients
                                                                          label id
                                                                          228e1e3f-d207-481f-8e14-9fdcbd0470e9
                                                                          offset unit
                                                                          unicode_code_points
                                                                          source array index
                                                                          0
                                                                          source field
                                                                          indications_and_usage_exact
                                                                          source text sha256
                                                                          e526ba14c91f10737e6d3331fe23a6219f58c0eca6380bfce9bd78b573fea912
                                                                          start
                                                                          3634
                                                                        2. context exact
                                                                          or the treatment of adult patients with locally advanced or metastatic urothelial cancer.
                                                                          kind
                                                                          biomarker
                                                                          polarity
                                                                          not_inferred
                                                                          span
                                                                          end
                                                                          3702
                                                                          end exclusive
                                                                          true
                                                                          exact text
                                                                          metastatic urothelial cancer
                                                                          label id
                                                                          228e1e3f-d207-481f-8e14-9fdcbd0470e9
                                                                          offset unit
                                                                          unicode_code_points
                                                                          source array index
                                                                          0
                                                                          source field
                                                                          indications_and_usage_exact
                                                                          source text sha256
                                                                          e526ba14c91f10737e6d3331fe23a6219f58c0eca6380bfce9bd78b573fea912
                                                                          start
                                                                          3674
                                                                        3. context exact
                                                                          umab vedotin-ejfv, for the treatment of adult patients with locally advanced or metastatic urothelial cancer.
                                                                          kind
                                                                          stage_or_setting
                                                                          polarity
                                                                          not_inferred
                                                                          span
                                                                          end
                                                                          3702
                                                                          end exclusive
                                                                          true
                                                                          exact text
                                                                          locally advanced or metastatic urothelial cancer
                                                                          label id
                                                                          228e1e3f-d207-481f-8e14-9fdcbd0470e9
                                                                          offset unit
                                                                          unicode_code_points
                                                                          source array index
                                                                          0
                                                                          source field
                                                                          indications_and_usage_exact
                                                                          source text sha256
                                                                          e526ba14c91f10737e6d3331fe23a6219f58c0eca6380bfce9bd78b573fea912
                                                                          start
                                                                          3654
                                                                        4. context exact
                                                                          Urothelial Cancer in combination with enfortumab vedotin-ejfv, for the treatment of adult patients with locally advanced or metastatic urothelial cancer.
                                                                          kind
                                                                          regimen
                                                                          polarity
                                                                          not_inferred
                                                                          span
                                                                          end
                                                                          3702
                                                                          end exclusive
                                                                          true
                                                                          exact text
                                                                          in combination with enfortumab vedotin-ejfv, for the treatment of adult patients with locally advanced or metastatic urothelial cancer
                                                                          label id
                                                                          228e1e3f-d207-481f-8e14-9fdcbd0470e9
                                                                          offset unit
                                                                          unicode_code_points
                                                                          source array index
                                                                          0
                                                                          source field
                                                                          indications_and_usage_exact
                                                                          source text sha256
                                                                          e526ba14c91f10737e6d3331fe23a6219f58c0eca6380bfce9bd78b573fea912
                                                                          start
                                                                          3568
                                                                        regulatory links
                                                                          schema version
                                                                          0.1.0
                                                                          source batch sha256
                                                                          fc39a8c5cf96bf95ca20b85578140167b66b2741f7d9217f500d9ba0847ac058
                                                                          source defined aliases
                                                                          1. abbreviation
                                                                            NSCLC
                                                                            definition exact
                                                                            Non-Small Cell Lung Cancer
                                                                            definition span
                                                                            end
                                                                            380
                                                                            end exclusive
                                                                            true
                                                                            exact text
                                                                            Non-Small Cell Lung Cancer (NSCLC)
                                                                            label id
                                                                            228e1e3f-d207-481f-8e14-9fdcbd0470e9
                                                                            offset unit
                                                                            unicode_code_points
                                                                            source array index
                                                                            0
                                                                            source field
                                                                            indications_and_usage_exact
                                                                            source text sha256
                                                                            e526ba14c91f10737e6d3331fe23a6219f58c0eca6380bfce9bd78b573fea912
                                                                            start
                                                                            346
                                                                          2. abbreviation
                                                                            CRC
                                                                            definition exact
                                                                            Colorectal Cancer
                                                                            definition span
                                                                            end
                                                                            5042
                                                                            end exclusive
                                                                            true
                                                                            exact text
                                                                            Colorectal Cancer (CRC)
                                                                            label id
                                                                            228e1e3f-d207-481f-8e14-9fdcbd0470e9
                                                                            offset unit
                                                                            unicode_code_points
                                                                            source array index
                                                                            0
                                                                            source field
                                                                            indications_and_usage_exact
                                                                            source text sha256
                                                                            e526ba14c91f10737e6d3331fe23a6219f58c0eca6380bfce9bd78b573fea912
                                                                            start
                                                                            5019
                                                                          source span
                                                                          end
                                                                          3703
                                                                          end exclusive
                                                                          true
                                                                          exact text
                                                                          Urothelial Cancer in combination with enfortumab vedotin-ejfv, for the treatment of adult patients with locally advanced or metastatic urothelial cancer.
                                                                          label id
                                                                          228e1e3f-d207-481f-8e14-9fdcbd0470e9
                                                                          offset unit
                                                                          unicode_code_points
                                                                          source array index
                                                                          0
                                                                          source field
                                                                          indications_and_usage_exact
                                                                          source text sha256
                                                                          e526ba14c91f10737e6d3331fe23a6219f58c0eca6380bfce9bd78b573fea912
                                                                          start
                                                                          3550
                                                                          source url
                                                                          https://api.fda.gov/drug/label.json?search=id%3A%22228e1e3f-d207-481f-8e14-9fdcbd0470e9%22
                                                                          spl effective date
                                                                          2026-07-10
                                                                          spl set id
                                                                          9333c79b-d487-4538-a9f0-71b91a02b287
                                                                          spl version
                                                                          228
                                                                          structured fields status
                                                                          not_extracted_no_values_inferred_from_mentions
                                                                          structured indication
                                                                          age
                                                                          Source null
                                                                          approval pathway
                                                                          Source null
                                                                          biomarker and test
                                                                          Source null
                                                                          disease stage
                                                                          Source null
                                                                          limitations
                                                                          Source null
                                                                          line
                                                                          Source null
                                                                          prior therapy
                                                                          Source null
                                                                          regimen
                                                                          Source null
                                                                          tumor histology
                                                                          Source null
                                                                          use intent
                                                                          unclear
                                                                          Passage 27 · unclassified context
                                                                          application numbers
                                                                          1. BLA125514
                                                                          brand names
                                                                          1. KEYTRUDA
                                                                          classification reasons
                                                                          1. no_unambiguous_positive_indication_predicate
                                                                          clinical review status
                                                                          pending
                                                                          content role
                                                                          unclassified_context
                                                                          context span
                                                                          end
                                                                          3911
                                                                          end exclusive
                                                                          true
                                                                          exact text
                                                                          BCL who require urgent cytoreductive therapy. Urothelial Cancer in combination with enfortumab vedotin-ejfv, for the treatment of adult patients with locally advanced or metastatic urothelial cancer. ( 1.7 ) as a single agent for the treatment of patients with locally advanced or metastatic urothelial carcinoma who: are not eligible for any platinum-containing chemotherapy, or who have disease progressio
                                                                          label id
                                                                          228e1e3f-d207-481f-8e14-9fdcbd0470e9
                                                                          offset unit
                                                                          unicode_code_points
                                                                          source array index
                                                                          0
                                                                          source field
                                                                          indications_and_usage_exact
                                                                          source text sha256
                                                                          e526ba14c91f10737e6d3331fe23a6219f58c0eca6380bfce9bd78b573fea912
                                                                          start
                                                                          3504
                                                                          current approval status
                                                                          not_reconciled
                                                                          duplicate text group
                                                                          dup-9bc82f6b7083214ae7dc
                                                                          extraction review status
                                                                          automated_candidate_pending_source_review
                                                                          generic names
                                                                          1. PEMBROLIZUMAB
                                                                          id
                                                                          ind-span-da459c1b8101bcccbc31
                                                                          label id
                                                                          228e1e3f-d207-481f-8e14-9fdcbd0470e9
                                                                          positive predicate support span
                                                                          Source null
                                                                          qualifier mentions
                                                                            regulatory links
                                                                              schema version
                                                                              0.1.0
                                                                              source batch sha256
                                                                              fc39a8c5cf96bf95ca20b85578140167b66b2741f7d9217f500d9ba0847ac058
                                                                              source defined aliases
                                                                              1. abbreviation
                                                                                NSCLC
                                                                                definition exact
                                                                                Non-Small Cell Lung Cancer
                                                                                definition span
                                                                                end
                                                                                380
                                                                                end exclusive
                                                                                true
                                                                                exact text
                                                                                Non-Small Cell Lung Cancer (NSCLC)
                                                                                label id
                                                                                228e1e3f-d207-481f-8e14-9fdcbd0470e9
                                                                                offset unit
                                                                                unicode_code_points
                                                                                source array index
                                                                                0
                                                                                source field
                                                                                indications_and_usage_exact
                                                                                source text sha256
                                                                                e526ba14c91f10737e6d3331fe23a6219f58c0eca6380bfce9bd78b573fea912
                                                                                start
                                                                                346
                                                                              2. abbreviation
                                                                                CRC
                                                                                definition exact
                                                                                Colorectal Cancer
                                                                                definition span
                                                                                end
                                                                                5042
                                                                                end exclusive
                                                                                true
                                                                                exact text
                                                                                Colorectal Cancer (CRC)
                                                                                label id
                                                                                228e1e3f-d207-481f-8e14-9fdcbd0470e9
                                                                                offset unit
                                                                                unicode_code_points
                                                                                source array index
                                                                                0
                                                                                source field
                                                                                indications_and_usage_exact
                                                                                source text sha256
                                                                                e526ba14c91f10737e6d3331fe23a6219f58c0eca6380bfce9bd78b573fea912
                                                                                start
                                                                                5019
                                                                              source span
                                                                              end
                                                                              3711
                                                                              end exclusive
                                                                              true
                                                                              exact text
                                                                              ( 1.7 )
                                                                              label id
                                                                              228e1e3f-d207-481f-8e14-9fdcbd0470e9
                                                                              offset unit
                                                                              unicode_code_points
                                                                              source array index
                                                                              0
                                                                              source field
                                                                              indications_and_usage_exact
                                                                              source text sha256
                                                                              e526ba14c91f10737e6d3331fe23a6219f58c0eca6380bfce9bd78b573fea912
                                                                              start
                                                                              3704
                                                                              source url
                                                                              https://api.fda.gov/drug/label.json?search=id%3A%22228e1e3f-d207-481f-8e14-9fdcbd0470e9%22
                                                                              spl effective date
                                                                              2026-07-10
                                                                              spl set id
                                                                              9333c79b-d487-4538-a9f0-71b91a02b287
                                                                              spl version
                                                                              228
                                                                              structured fields status
                                                                              not_extracted_no_values_inferred_from_mentions
                                                                              structured indication
                                                                              age
                                                                              Source null
                                                                              approval pathway
                                                                              Source null
                                                                              biomarker and test
                                                                              Source null
                                                                              disease stage
                                                                              Source null
                                                                              limitations
                                                                              Source null
                                                                              line
                                                                              Source null
                                                                              prior therapy
                                                                              Source null
                                                                              regimen
                                                                              Source null
                                                                              tumor histology
                                                                              Source null
                                                                              use intent
                                                                              unclear
                                                                              Passage 28 · unclassified context
                                                                              application numbers
                                                                              1. BLA125514
                                                                              brand names
                                                                              1. KEYTRUDA
                                                                              classification reasons
                                                                              1. no_unambiguous_positive_indication_predicate
                                                                              clinical review status
                                                                              pending
                                                                              content role
                                                                              unclassified_context
                                                                              context span
                                                                              end
                                                                              4261
                                                                              end exclusive
                                                                              true
                                                                              exact text
                                                                              require urgent cytoreductive therapy. Urothelial Cancer in combination with enfortumab vedotin-ejfv, for the treatment of adult patients with locally advanced or metastatic urothelial cancer. ( 1.7 ) as a single agent for the treatment of patients with locally advanced or metastatic urothelial carcinoma who: are not eligible for any platinum-containing chemotherapy, or who have disease progression during or following platinum-containing chemotherapy or within 12 months of neoadjuvant or adjuvant treatment with platinum-containing chemotherapy. ( 1.7 ) in combination with enfortumab vedotin-ejfv, as neoadjuvant treatment and then continued after cystectomy as adjuvant treatment of adult patients with muscle invasive bladder cancer (MIBC). (
                                                                              label id
                                                                              228e1e3f-d207-481f-8e14-9fdcbd0470e9
                                                                              offset unit
                                                                              unicode_code_points
                                                                              source array index
                                                                              0
                                                                              source field
                                                                              indications_and_usage_exact
                                                                              source text sha256
                                                                              e526ba14c91f10737e6d3331fe23a6219f58c0eca6380bfce9bd78b573fea912
                                                                              start
                                                                              3512
                                                                              current approval status
                                                                              not_reconciled
                                                                              duplicate text group
                                                                              dup-fa6e37400c7a8df902ba
                                                                              extraction review status
                                                                              automated_candidate_pending_source_review
                                                                              generic names
                                                                              1. PEMBROLIZUMAB
                                                                              id
                                                                              ind-span-5bbac07fcd64d7c36ccb
                                                                              label id
                                                                              228e1e3f-d207-481f-8e14-9fdcbd0470e9
                                                                              positive predicate support span
                                                                              Source null
                                                                              qualifier mentions
                                                                              1. context exact
                                                                                gent for the treatment of patients with locally advanced or metastatic urothelial carcinoma who: are not eligible for any platinum-containing chemotherapy, or who
                                                                                kind
                                                                                biomarker
                                                                                polarity
                                                                                not_inferred
                                                                                span
                                                                                end
                                                                                3828
                                                                                end exclusive
                                                                                true
                                                                                exact text
                                                                                metastatic urothelial carcinoma who: are no
                                                                                label id
                                                                                228e1e3f-d207-481f-8e14-9fdcbd0470e9
                                                                                offset unit
                                                                                unicode_code_points
                                                                                source array index
                                                                                0
                                                                                source field
                                                                                indications_and_usage_exact
                                                                                source text sha256
                                                                                e526ba14c91f10737e6d3331fe23a6219f58c0eca6380bfce9bd78b573fea912
                                                                                start
                                                                                3785
                                                                              2. context exact
                                                                                as a single agent for the treatment of patients with locally advanced or metastatic urothelial carcinoma who: are not eligible for any platinum-containing chemother
                                                                                kind
                                                                                stage_or_setting
                                                                                polarity
                                                                                not_inferred
                                                                                span
                                                                                end
                                                                                3816
                                                                                end exclusive
                                                                                true
                                                                                exact text
                                                                                locally advanced or metastatic urothelial carcinoma
                                                                                label id
                                                                                228e1e3f-d207-481f-8e14-9fdcbd0470e9
                                                                                offset unit
                                                                                unicode_code_points
                                                                                source array index
                                                                                0
                                                                                source field
                                                                                indications_and_usage_exact
                                                                                source text sha256
                                                                                e526ba14c91f10737e6d3331fe23a6219f58c0eca6380bfce9bd78b573fea912
                                                                                start
                                                                                3765
                                                                              3. context exact
                                                                                ing platinum-containing chemotherapy or within 12 months of neoadjuvant or adjuvant treatment with platinum-containing chemotherapy.
                                                                                kind
                                                                                stage_or_setting
                                                                                polarity
                                                                                not_inferred
                                                                                span
                                                                                end
                                                                                4035
                                                                                end exclusive
                                                                                true
                                                                                exact text
                                                                                neoadjuvant or adjuvant treatment with platinu
                                                                                label id
                                                                                228e1e3f-d207-481f-8e14-9fdcbd0470e9
                                                                                offset unit
                                                                                unicode_code_points
                                                                                source array index
                                                                                0
                                                                                source field
                                                                                indications_and_usage_exact
                                                                                source text sha256
                                                                                e526ba14c91f10737e6d3331fe23a6219f58c0eca6380bfce9bd78b573fea912
                                                                                start
                                                                                3989
                                                                              4. context exact
                                                                                as a single agent for the treatment of patients with locally advanced or metastatic urothelial carcinoma who: are not eligible for any platinum-containing chemotherapy, or who have disease progression during or following platinum-contain
                                                                                kind
                                                                                regimen
                                                                                polarity
                                                                                not_inferred
                                                                                span
                                                                                end
                                                                                3889
                                                                                end exclusive
                                                                                true
                                                                                exact text
                                                                                as a single agent for the treatment of patients with locally advanced or metastatic urothelial carcinoma who: are not eligible for any platinum-containing chemotherapy, or who h
                                                                                label id
                                                                                228e1e3f-d207-481f-8e14-9fdcbd0470e9
                                                                                offset unit
                                                                                unicode_code_points
                                                                                source array index
                                                                                0
                                                                                source field
                                                                                indications_and_usage_exact
                                                                                source text sha256
                                                                                e526ba14c91f10737e6d3331fe23a6219f58c0eca6380bfce9bd78b573fea912
                                                                                start
                                                                                3712
                                                                              regulatory links
                                                                                schema version
                                                                                0.1.0
                                                                                source batch sha256
                                                                                fc39a8c5cf96bf95ca20b85578140167b66b2741f7d9217f500d9ba0847ac058
                                                                                source defined aliases
                                                                                1. abbreviation
                                                                                  NSCLC
                                                                                  definition exact
                                                                                  Non-Small Cell Lung Cancer
                                                                                  definition span
                                                                                  end
                                                                                  380
                                                                                  end exclusive
                                                                                  true
                                                                                  exact text
                                                                                  Non-Small Cell Lung Cancer (NSCLC)
                                                                                  label id
                                                                                  228e1e3f-d207-481f-8e14-9fdcbd0470e9
                                                                                  offset unit
                                                                                  unicode_code_points
                                                                                  source array index
                                                                                  0
                                                                                  source field
                                                                                  indications_and_usage_exact
                                                                                  source text sha256
                                                                                  e526ba14c91f10737e6d3331fe23a6219f58c0eca6380bfce9bd78b573fea912
                                                                                  start
                                                                                  346
                                                                                2. abbreviation
                                                                                  CRC
                                                                                  definition exact
                                                                                  Colorectal Cancer
                                                                                  definition span
                                                                                  end
                                                                                  5042
                                                                                  end exclusive
                                                                                  true
                                                                                  exact text
                                                                                  Colorectal Cancer (CRC)
                                                                                  label id
                                                                                  228e1e3f-d207-481f-8e14-9fdcbd0470e9
                                                                                  offset unit
                                                                                  unicode_code_points
                                                                                  source array index
                                                                                  0
                                                                                  source field
                                                                                  indications_and_usage_exact
                                                                                  source text sha256
                                                                                  e526ba14c91f10737e6d3331fe23a6219f58c0eca6380bfce9bd78b573fea912
                                                                                  start
                                                                                  5019
                                                                                source span
                                                                                end
                                                                                4061
                                                                                end exclusive
                                                                                true
                                                                                exact text
                                                                                as a single agent for the treatment of patients with locally advanced or metastatic urothelial carcinoma who: are not eligible for any platinum-containing chemotherapy, or who have disease progression during or following platinum-containing chemotherapy or within 12 months of neoadjuvant or adjuvant treatment with platinum-containing chemotherapy.
                                                                                label id
                                                                                228e1e3f-d207-481f-8e14-9fdcbd0470e9
                                                                                offset unit
                                                                                unicode_code_points
                                                                                source array index
                                                                                0
                                                                                source field
                                                                                indications_and_usage_exact
                                                                                source text sha256
                                                                                e526ba14c91f10737e6d3331fe23a6219f58c0eca6380bfce9bd78b573fea912
                                                                                start
                                                                                3712
                                                                                source url
                                                                                https://api.fda.gov/drug/label.json?search=id%3A%22228e1e3f-d207-481f-8e14-9fdcbd0470e9%22
                                                                                spl effective date
                                                                                2026-07-10
                                                                                spl set id
                                                                                9333c79b-d487-4538-a9f0-71b91a02b287
                                                                                spl version
                                                                                228
                                                                                structured fields status
                                                                                not_extracted_no_values_inferred_from_mentions
                                                                                structured indication
                                                                                age
                                                                                Source null
                                                                                approval pathway
                                                                                Source null
                                                                                biomarker and test
                                                                                Source null
                                                                                disease stage
                                                                                Source null
                                                                                limitations
                                                                                Source null
                                                                                line
                                                                                Source null
                                                                                prior therapy
                                                                                Source null
                                                                                regimen
                                                                                Source null
                                                                                tumor histology
                                                                                Source null
                                                                                use intent
                                                                                unclear
                                                                                Passage 29 · unclassified context
                                                                                application numbers
                                                                                1. BLA125514
                                                                                brand names
                                                                                1. KEYTRUDA
                                                                                classification reasons
                                                                                1. no_unambiguous_positive_indication_predicate
                                                                                clinical review status
                                                                                pending
                                                                                content role
                                                                                unclassified_context
                                                                                context span
                                                                                end
                                                                                4269
                                                                                end exclusive
                                                                                true
                                                                                exact text
                                                                                ning chemotherapy, or who have disease progression during or following platinum-containing chemotherapy or within 12 months of neoadjuvant or adjuvant treatment with platinum-containing chemotherapy. ( 1.7 ) in combination with enfortumab vedotin-ejfv, as neoadjuvant treatment and then continued after cystectomy as adjuvant treatment of adult patients with muscle invasive bladder cancer (MIBC). ( 1.7 ) a
                                                                                label id
                                                                                228e1e3f-d207-481f-8e14-9fdcbd0470e9
                                                                                offset unit
                                                                                unicode_code_points
                                                                                source array index
                                                                                0
                                                                                source field
                                                                                indications_and_usage_exact
                                                                                source text sha256
                                                                                e526ba14c91f10737e6d3331fe23a6219f58c0eca6380bfce9bd78b573fea912
                                                                                start
                                                                                3862
                                                                                current approval status
                                                                                not_reconciled
                                                                                duplicate text group
                                                                                dup-9bc82f6b7083214ae7dc
                                                                                extraction review status
                                                                                automated_candidate_pending_source_review
                                                                                generic names
                                                                                1. PEMBROLIZUMAB
                                                                                id
                                                                                ind-span-aa0587adadb100b40043
                                                                                label id
                                                                                228e1e3f-d207-481f-8e14-9fdcbd0470e9
                                                                                positive predicate support span
                                                                                Source null
                                                                                qualifier mentions
                                                                                  regulatory links
                                                                                    schema version
                                                                                    0.1.0
                                                                                    source batch sha256
                                                                                    fc39a8c5cf96bf95ca20b85578140167b66b2741f7d9217f500d9ba0847ac058
                                                                                    source defined aliases
                                                                                    1. abbreviation
                                                                                      NSCLC
                                                                                      definition exact
                                                                                      Non-Small Cell Lung Cancer
                                                                                      definition span
                                                                                      end
                                                                                      380
                                                                                      end exclusive
                                                                                      true
                                                                                      exact text
                                                                                      Non-Small Cell Lung Cancer (NSCLC)
                                                                                      label id
                                                                                      228e1e3f-d207-481f-8e14-9fdcbd0470e9
                                                                                      offset unit
                                                                                      unicode_code_points
                                                                                      source array index
                                                                                      0
                                                                                      source field
                                                                                      indications_and_usage_exact
                                                                                      source text sha256
                                                                                      e526ba14c91f10737e6d3331fe23a6219f58c0eca6380bfce9bd78b573fea912
                                                                                      start
                                                                                      346
                                                                                    2. abbreviation
                                                                                      CRC
                                                                                      definition exact
                                                                                      Colorectal Cancer
                                                                                      definition span
                                                                                      end
                                                                                      5042
                                                                                      end exclusive
                                                                                      true
                                                                                      exact text
                                                                                      Colorectal Cancer (CRC)
                                                                                      label id
                                                                                      228e1e3f-d207-481f-8e14-9fdcbd0470e9
                                                                                      offset unit
                                                                                      unicode_code_points
                                                                                      source array index
                                                                                      0
                                                                                      source field
                                                                                      indications_and_usage_exact
                                                                                      source text sha256
                                                                                      e526ba14c91f10737e6d3331fe23a6219f58c0eca6380bfce9bd78b573fea912
                                                                                      start
                                                                                      5019
                                                                                    source span
                                                                                    end
                                                                                    4069
                                                                                    end exclusive
                                                                                    true
                                                                                    exact text
                                                                                    ( 1.7 )
                                                                                    label id
                                                                                    228e1e3f-d207-481f-8e14-9fdcbd0470e9
                                                                                    offset unit
                                                                                    unicode_code_points
                                                                                    source array index
                                                                                    0
                                                                                    source field
                                                                                    indications_and_usage_exact
                                                                                    source text sha256
                                                                                    e526ba14c91f10737e6d3331fe23a6219f58c0eca6380bfce9bd78b573fea912
                                                                                    start
                                                                                    4062
                                                                                    source url
                                                                                    https://api.fda.gov/drug/label.json?search=id%3A%22228e1e3f-d207-481f-8e14-9fdcbd0470e9%22
                                                                                    spl effective date
                                                                                    2026-07-10
                                                                                    spl set id
                                                                                    9333c79b-d487-4538-a9f0-71b91a02b287
                                                                                    spl version
                                                                                    228
                                                                                    structured fields status
                                                                                    not_extracted_no_values_inferred_from_mentions
                                                                                    structured indication
                                                                                    age
                                                                                    Source null
                                                                                    approval pathway
                                                                                    Source null
                                                                                    biomarker and test
                                                                                    Source null
                                                                                    disease stage
                                                                                    Source null
                                                                                    limitations
                                                                                    Source null
                                                                                    line
                                                                                    Source null
                                                                                    prior therapy
                                                                                    Source null
                                                                                    regimen
                                                                                    Source null
                                                                                    tumor histology
                                                                                    Source null
                                                                                    use intent
                                                                                    unclear
                                                                                    Passage 30 · unclassified context
                                                                                    application numbers
                                                                                    1. BLA125514
                                                                                    brand names
                                                                                    1. KEYTRUDA
                                                                                    classification reasons
                                                                                    1. no_unambiguous_positive_indication_predicate
                                                                                    clinical review status
                                                                                    pending
                                                                                    content role
                                                                                    unclassified_context
                                                                                    context span
                                                                                    end
                                                                                    4459
                                                                                    end exclusive
                                                                                    true
                                                                                    exact text
                                                                                    motherapy, or who have disease progression during or following platinum-containing chemotherapy or within 12 months of neoadjuvant or adjuvant treatment with platinum-containing chemotherapy. ( 1.7 ) in combination with enfortumab vedotin-ejfv, as neoadjuvant treatment and then continued after cystectomy as adjuvant treatment of adult patients with muscle invasive bladder cancer (MIBC). ( 1.7 ) as a single agent for the treatment of patients with Bacillus Calmette-Guerin (BCG)-unresponsive, high-risk, non-muscle invasive bladder cancer (NMIBC) with carcinoma in situ (CIS) with or wi
                                                                                    label id
                                                                                    228e1e3f-d207-481f-8e14-9fdcbd0470e9
                                                                                    offset unit
                                                                                    unicode_code_points
                                                                                    source array index
                                                                                    0
                                                                                    source field
                                                                                    indications_and_usage_exact
                                                                                    source text sha256
                                                                                    e526ba14c91f10737e6d3331fe23a6219f58c0eca6380bfce9bd78b573fea912
                                                                                    start
                                                                                    3870
                                                                                    current approval status
                                                                                    not_reconciled
                                                                                    duplicate text group
                                                                                    dup-67211352c80cd7656cf3
                                                                                    extraction review status
                                                                                    automated_candidate_pending_source_review
                                                                                    generic names
                                                                                    1. PEMBROLIZUMAB
                                                                                    id
                                                                                    ind-span-00186473950da1032d71
                                                                                    label id
                                                                                    228e1e3f-d207-481f-8e14-9fdcbd0470e9
                                                                                    positive predicate support span
                                                                                    Source null
                                                                                    qualifier mentions
                                                                                    1. context exact
                                                                                      nd then continued after cystectomy as adjuvant treatment of adult patients with muscle invasive bladder cancer (MIBC).
                                                                                      kind
                                                                                      age
                                                                                      polarity
                                                                                      not_inferred
                                                                                      span
                                                                                      end
                                                                                      4215
                                                                                      end exclusive
                                                                                      true
                                                                                      exact text
                                                                                      adult patients
                                                                                      label id
                                                                                      228e1e3f-d207-481f-8e14-9fdcbd0470e9
                                                                                      offset unit
                                                                                      unicode_code_points
                                                                                      source array index
                                                                                      0
                                                                                      source field
                                                                                      indications_and_usage_exact
                                                                                      source text sha256
                                                                                      e526ba14c91f10737e6d3331fe23a6219f58c0eca6380bfce9bd78b573fea912
                                                                                      start
                                                                                      4201
                                                                                    2. context exact
                                                                                      in combination with enfortumab vedotin-ejfv, as neoadjuvant treatment and then continued after cystectomy as adjuvant treatment of adult patients with mus
                                                                                      kind
                                                                                      stage_or_setting
                                                                                      polarity
                                                                                      not_inferred
                                                                                      span
                                                                                      end
                                                                                      4164
                                                                                      end exclusive
                                                                                      true
                                                                                      exact text
                                                                                      neoadjuvant treatment and then continued after
                                                                                      label id
                                                                                      228e1e3f-d207-481f-8e14-9fdcbd0470e9
                                                                                      offset unit
                                                                                      unicode_code_points
                                                                                      source array index
                                                                                      0
                                                                                      source field
                                                                                      indications_and_usage_exact
                                                                                      source text sha256
                                                                                      e526ba14c91f10737e6d3331fe23a6219f58c0eca6380bfce9bd78b573fea912
                                                                                      start
                                                                                      4118
                                                                                    3. context exact
                                                                                      eoadjuvant treatment and then continued after cystectomy as adjuvant treatment of adult patients with muscle invasive bladder cancer (MIBC).
                                                                                      kind
                                                                                      stage_or_setting
                                                                                      polarity
                                                                                      not_inferred
                                                                                      span
                                                                                      end
                                                                                      4222
                                                                                      end exclusive
                                                                                      true
                                                                                      exact text
                                                                                      adjuvant treatment of adult patients with m
                                                                                      label id
                                                                                      228e1e3f-d207-481f-8e14-9fdcbd0470e9
                                                                                      offset unit
                                                                                      unicode_code_points
                                                                                      source array index
                                                                                      0
                                                                                      source field
                                                                                      indications_and_usage_exact
                                                                                      source text sha256
                                                                                      e526ba14c91f10737e6d3331fe23a6219f58c0eca6380bfce9bd78b573fea912
                                                                                      start
                                                                                      4179
                                                                                    4. context exact
                                                                                      in combination with enfortumab vedotin-ejfv, as neoadjuvant treatment and then continued after cystectomy as adjuvant treatment of adult patients with muscle invasive bladder cancer (MIBC).
                                                                                      kind
                                                                                      regimen
                                                                                      polarity
                                                                                      not_inferred
                                                                                      span
                                                                                      end
                                                                                      4249
                                                                                      end exclusive
                                                                                      true
                                                                                      exact text
                                                                                      in combination with enfortumab vedotin-ejfv, as neoadjuvant treatment and then continued after cystectomy as adjuvant treatment of adult patients with muscle invasive bladder canc
                                                                                      label id
                                                                                      228e1e3f-d207-481f-8e14-9fdcbd0470e9
                                                                                      offset unit
                                                                                      unicode_code_points
                                                                                      source array index
                                                                                      0
                                                                                      source field
                                                                                      indications_and_usage_exact
                                                                                      source text sha256
                                                                                      e526ba14c91f10737e6d3331fe23a6219f58c0eca6380bfce9bd78b573fea912
                                                                                      start
                                                                                      4070
                                                                                    regulatory links
                                                                                      schema version
                                                                                      0.1.0
                                                                                      source batch sha256
                                                                                      fc39a8c5cf96bf95ca20b85578140167b66b2741f7d9217f500d9ba0847ac058
                                                                                      source defined aliases
                                                                                      1. abbreviation
                                                                                        NSCLC
                                                                                        definition exact
                                                                                        Non-Small Cell Lung Cancer
                                                                                        definition span
                                                                                        end
                                                                                        380
                                                                                        end exclusive
                                                                                        true
                                                                                        exact text
                                                                                        Non-Small Cell Lung Cancer (NSCLC)
                                                                                        label id
                                                                                        228e1e3f-d207-481f-8e14-9fdcbd0470e9
                                                                                        offset unit
                                                                                        unicode_code_points
                                                                                        source array index
                                                                                        0
                                                                                        source field
                                                                                        indications_and_usage_exact
                                                                                        source text sha256
                                                                                        e526ba14c91f10737e6d3331fe23a6219f58c0eca6380bfce9bd78b573fea912
                                                                                        start
                                                                                        346
                                                                                      2. abbreviation
                                                                                        CRC
                                                                                        definition exact
                                                                                        Colorectal Cancer
                                                                                        definition span
                                                                                        end
                                                                                        5042
                                                                                        end exclusive
                                                                                        true
                                                                                        exact text
                                                                                        Colorectal Cancer (CRC)
                                                                                        label id
                                                                                        228e1e3f-d207-481f-8e14-9fdcbd0470e9
                                                                                        offset unit
                                                                                        unicode_code_points
                                                                                        source array index
                                                                                        0
                                                                                        source field
                                                                                        indications_and_usage_exact
                                                                                        source text sha256
                                                                                        e526ba14c91f10737e6d3331fe23a6219f58c0eca6380bfce9bd78b573fea912
                                                                                        start
                                                                                        5019
                                                                                      source span
                                                                                      end
                                                                                      4259
                                                                                      end exclusive
                                                                                      true
                                                                                      exact text
                                                                                      in combination with enfortumab vedotin-ejfv, as neoadjuvant treatment and then continued after cystectomy as adjuvant treatment of adult patients with muscle invasive bladder cancer (MIBC).
                                                                                      label id
                                                                                      228e1e3f-d207-481f-8e14-9fdcbd0470e9
                                                                                      offset unit
                                                                                      unicode_code_points
                                                                                      source array index
                                                                                      0
                                                                                      source field
                                                                                      indications_and_usage_exact
                                                                                      source text sha256
                                                                                      e526ba14c91f10737e6d3331fe23a6219f58c0eca6380bfce9bd78b573fea912
                                                                                      start
                                                                                      4070
                                                                                      source url
                                                                                      https://api.fda.gov/drug/label.json?search=id%3A%22228e1e3f-d207-481f-8e14-9fdcbd0470e9%22
                                                                                      spl effective date
                                                                                      2026-07-10
                                                                                      spl set id
                                                                                      9333c79b-d487-4538-a9f0-71b91a02b287
                                                                                      spl version
                                                                                      228
                                                                                      structured fields status
                                                                                      not_extracted_no_values_inferred_from_mentions
                                                                                      structured indication
                                                                                      age
                                                                                      Source null
                                                                                      approval pathway
                                                                                      Source null
                                                                                      biomarker and test
                                                                                      Source null
                                                                                      disease stage
                                                                                      Source null
                                                                                      limitations
                                                                                      Source null
                                                                                      line
                                                                                      Source null
                                                                                      prior therapy
                                                                                      Source null
                                                                                      regimen
                                                                                      Source null
                                                                                      tumor histology
                                                                                      Source null
                                                                                      use intent
                                                                                      unclear
                                                                                      Passage 31 · unclassified context
                                                                                      application numbers
                                                                                      1. BLA125514
                                                                                      brand names
                                                                                      1. KEYTRUDA
                                                                                      classification reasons
                                                                                      1. no_unambiguous_positive_indication_predicate
                                                                                      clinical review status
                                                                                      pending
                                                                                      content role
                                                                                      unclassified_context
                                                                                      context span
                                                                                      end
                                                                                      4467
                                                                                      end exclusive
                                                                                      true
                                                                                      exact text
                                                                                      . ( 1.7 ) in combination with enfortumab vedotin-ejfv, as neoadjuvant treatment and then continued after cystectomy as adjuvant treatment of adult patients with muscle invasive bladder cancer (MIBC). ( 1.7 ) as a single agent for the treatment of patients with Bacillus Calmette-Guerin (BCG)-unresponsive, high-risk, non-muscle invasive bladder cancer (NMIBC) with carcinoma in situ (CIS) with or without pa
                                                                                      label id
                                                                                      228e1e3f-d207-481f-8e14-9fdcbd0470e9
                                                                                      offset unit
                                                                                      unicode_code_points
                                                                                      source array index
                                                                                      0
                                                                                      source field
                                                                                      indications_and_usage_exact
                                                                                      source text sha256
                                                                                      e526ba14c91f10737e6d3331fe23a6219f58c0eca6380bfce9bd78b573fea912
                                                                                      start
                                                                                      4060
                                                                                      current approval status
                                                                                      not_reconciled
                                                                                      duplicate text group
                                                                                      dup-9bc82f6b7083214ae7dc
                                                                                      extraction review status
                                                                                      automated_candidate_pending_source_review
                                                                                      generic names
                                                                                      1. PEMBROLIZUMAB
                                                                                      id
                                                                                      ind-span-3227dfb9b0341fcc9f9d
                                                                                      label id
                                                                                      228e1e3f-d207-481f-8e14-9fdcbd0470e9
                                                                                      positive predicate support span
                                                                                      Source null
                                                                                      qualifier mentions
                                                                                        regulatory links
                                                                                          schema version
                                                                                          0.1.0
                                                                                          source batch sha256
                                                                                          fc39a8c5cf96bf95ca20b85578140167b66b2741f7d9217f500d9ba0847ac058
                                                                                          source defined aliases
                                                                                          1. abbreviation
                                                                                            NSCLC
                                                                                            definition exact
                                                                                            Non-Small Cell Lung Cancer
                                                                                            definition span
                                                                                            end
                                                                                            380
                                                                                            end exclusive
                                                                                            true
                                                                                            exact text
                                                                                            Non-Small Cell Lung Cancer (NSCLC)
                                                                                            label id
                                                                                            228e1e3f-d207-481f-8e14-9fdcbd0470e9
                                                                                            offset unit
                                                                                            unicode_code_points
                                                                                            source array index
                                                                                            0
                                                                                            source field
                                                                                            indications_and_usage_exact
                                                                                            source text sha256
                                                                                            e526ba14c91f10737e6d3331fe23a6219f58c0eca6380bfce9bd78b573fea912
                                                                                            start
                                                                                            346
                                                                                          2. abbreviation
                                                                                            CRC
                                                                                            definition exact
                                                                                            Colorectal Cancer
                                                                                            definition span
                                                                                            end
                                                                                            5042
                                                                                            end exclusive
                                                                                            true
                                                                                            exact text
                                                                                            Colorectal Cancer (CRC)
                                                                                            label id
                                                                                            228e1e3f-d207-481f-8e14-9fdcbd0470e9
                                                                                            offset unit
                                                                                            unicode_code_points
                                                                                            source array index
                                                                                            0
                                                                                            source field
                                                                                            indications_and_usage_exact
                                                                                            source text sha256
                                                                                            e526ba14c91f10737e6d3331fe23a6219f58c0eca6380bfce9bd78b573fea912
                                                                                            start
                                                                                            5019
                                                                                          source span
                                                                                          end
                                                                                          4267
                                                                                          end exclusive
                                                                                          true
                                                                                          exact text
                                                                                          ( 1.7 )
                                                                                          label id
                                                                                          228e1e3f-d207-481f-8e14-9fdcbd0470e9
                                                                                          offset unit
                                                                                          unicode_code_points
                                                                                          source array index
                                                                                          0
                                                                                          source field
                                                                                          indications_and_usage_exact
                                                                                          source text sha256
                                                                                          e526ba14c91f10737e6d3331fe23a6219f58c0eca6380bfce9bd78b573fea912
                                                                                          start
                                                                                          4260
                                                                                          source url
                                                                                          https://api.fda.gov/drug/label.json?search=id%3A%22228e1e3f-d207-481f-8e14-9fdcbd0470e9%22
                                                                                          spl effective date
                                                                                          2026-07-10
                                                                                          spl set id
                                                                                          9333c79b-d487-4538-a9f0-71b91a02b287
                                                                                          spl version
                                                                                          228
                                                                                          structured fields status
                                                                                          not_extracted_no_values_inferred_from_mentions
                                                                                          structured indication
                                                                                          age
                                                                                          Source null
                                                                                          approval pathway
                                                                                          Source null
                                                                                          biomarker and test
                                                                                          Source null
                                                                                          disease stage
                                                                                          Source null
                                                                                          limitations
                                                                                          Source null
                                                                                          line
                                                                                          Source null
                                                                                          prior therapy
                                                                                          Source null
                                                                                          regimen
                                                                                          Source null
                                                                                          tumor histology
                                                                                          Source null
                                                                                          use intent
                                                                                          unclear
                                                                                          Passage 32 · unclassified context
                                                                                          application numbers
                                                                                          1. BLA125514
                                                                                          brand names
                                                                                          1. KEYTRUDA
                                                                                          classification reasons
                                                                                          1. no_unambiguous_positive_indication_predicate
                                                                                          clinical review status
                                                                                          pending
                                                                                          content role
                                                                                          unclassified_context
                                                                                          context span
                                                                                          end
                                                                                          4747
                                                                                          end exclusive
                                                                                          true
                                                                                          exact text
                                                                                          ) in combination with enfortumab vedotin-ejfv, as neoadjuvant treatment and then continued after cystectomy as adjuvant treatment of adult patients with muscle invasive bladder cancer (MIBC). ( 1.7 ) as a single agent for the treatment of patients with Bacillus Calmette-Guerin (BCG)-unresponsive, high-risk, non-muscle invasive bladder cancer (NMIBC) with carcinoma in situ (CIS) with or without papillary tumors who are ineligible for or have elected not to undergo cystectomy. ( 1.7 ) Microsatellite Instability-High or Mismatch Repair Deficient Cancer for the treatment of adult and pediatric patients with unresectable or metastatic microsatellite instability-high (MSI-H) o
                                                                                          label id
                                                                                          228e1e3f-d207-481f-8e14-9fdcbd0470e9
                                                                                          offset unit
                                                                                          unicode_code_points
                                                                                          source array index
                                                                                          0
                                                                                          source field
                                                                                          indications_and_usage_exact
                                                                                          source text sha256
                                                                                          e526ba14c91f10737e6d3331fe23a6219f58c0eca6380bfce9bd78b573fea912
                                                                                          start
                                                                                          4068
                                                                                          current approval status
                                                                                          not_reconciled
                                                                                          duplicate text group
                                                                                          dup-da08f030759f010770ce
                                                                                          extraction review status
                                                                                          automated_candidate_pending_source_review
                                                                                          generic names
                                                                                          1. PEMBROLIZUMAB
                                                                                          id
                                                                                          ind-span-2110bf1f1b3c0744f7e6
                                                                                          label id
                                                                                          228e1e3f-d207-481f-8e14-9fdcbd0470e9
                                                                                          positive predicate support span
                                                                                          Source null
                                                                                          qualifier mentions
                                                                                          1. context exact
                                                                                            as a single agent for the treatment of patients with Bacillus Calmette-Guerin (BCG)-unresponsive, high-risk, non-muscle invasive bladder cancer (NMIBC) with carcinoma in situ (CIS) with or without papillary tumors who are ineligible for
                                                                                            kind
                                                                                            regimen
                                                                                            polarity
                                                                                            not_inferred
                                                                                            span
                                                                                            end
                                                                                            4445
                                                                                            end exclusive
                                                                                            true
                                                                                            exact text
                                                                                            as a single agent for the treatment of patients with Bacillus Calmette-Guerin (BCG)-unresponsive, high-risk, non-muscle invasive bladder cancer (NMIBC) with carcinoma in situ (C
                                                                                            label id
                                                                                            228e1e3f-d207-481f-8e14-9fdcbd0470e9
                                                                                            offset unit
                                                                                            unicode_code_points
                                                                                            source array index
                                                                                            0
                                                                                            source field
                                                                                            indications_and_usage_exact
                                                                                            source text sha256
                                                                                            e526ba14c91f10737e6d3331fe23a6219f58c0eca6380bfce9bd78b573fea912
                                                                                            start
                                                                                            4268
                                                                                          2. context exact
                                                                                            nvasive bladder cancer (NMIBC) with carcinoma in situ (CIS) with or without papillary tumors who are ineligible for or have elected not to undergo cystectomy.
                                                                                            kind
                                                                                            regimen
                                                                                            polarity
                                                                                            not_inferred
                                                                                            span
                                                                                            end
                                                                                            4546
                                                                                            end exclusive
                                                                                            true
                                                                                            exact text
                                                                                            with or without papillary tumors who are ineligible for or have elected not to undergo cystectomy
                                                                                            label id
                                                                                            228e1e3f-d207-481f-8e14-9fdcbd0470e9
                                                                                            offset unit
                                                                                            unicode_code_points
                                                                                            source array index
                                                                                            0
                                                                                            source field
                                                                                            indications_and_usage_exact
                                                                                            source text sha256
                                                                                            e526ba14c91f10737e6d3331fe23a6219f58c0eca6380bfce9bd78b573fea912
                                                                                            start
                                                                                            4449
                                                                                          regulatory links
                                                                                            schema version
                                                                                            0.1.0
                                                                                            source batch sha256
                                                                                            fc39a8c5cf96bf95ca20b85578140167b66b2741f7d9217f500d9ba0847ac058
                                                                                            source defined aliases
                                                                                            1. abbreviation
                                                                                              NSCLC
                                                                                              definition exact
                                                                                              Non-Small Cell Lung Cancer
                                                                                              definition span
                                                                                              end
                                                                                              380
                                                                                              end exclusive
                                                                                              true
                                                                                              exact text
                                                                                              Non-Small Cell Lung Cancer (NSCLC)
                                                                                              label id
                                                                                              228e1e3f-d207-481f-8e14-9fdcbd0470e9
                                                                                              offset unit
                                                                                              unicode_code_points
                                                                                              source array index
                                                                                              0
                                                                                              source field
                                                                                              indications_and_usage_exact
                                                                                              source text sha256
                                                                                              e526ba14c91f10737e6d3331fe23a6219f58c0eca6380bfce9bd78b573fea912
                                                                                              start
                                                                                              346
                                                                                            2. abbreviation
                                                                                              CRC
                                                                                              definition exact
                                                                                              Colorectal Cancer
                                                                                              definition span
                                                                                              end
                                                                                              5042
                                                                                              end exclusive
                                                                                              true
                                                                                              exact text
                                                                                              Colorectal Cancer (CRC)
                                                                                              label id
                                                                                              228e1e3f-d207-481f-8e14-9fdcbd0470e9
                                                                                              offset unit
                                                                                              unicode_code_points
                                                                                              source array index
                                                                                              0
                                                                                              source field
                                                                                              indications_and_usage_exact
                                                                                              source text sha256
                                                                                              e526ba14c91f10737e6d3331fe23a6219f58c0eca6380bfce9bd78b573fea912
                                                                                              start
                                                                                              5019
                                                                                            source span
                                                                                            end
                                                                                            4547
                                                                                            end exclusive
                                                                                            true
                                                                                            exact text
                                                                                            as a single agent for the treatment of patients with Bacillus Calmette-Guerin (BCG)-unresponsive, high-risk, non-muscle invasive bladder cancer (NMIBC) with carcinoma in situ (CIS) with or without papillary tumors who are ineligible for or have elected not to undergo cystectomy.
                                                                                            label id
                                                                                            228e1e3f-d207-481f-8e14-9fdcbd0470e9
                                                                                            offset unit
                                                                                            unicode_code_points
                                                                                            source array index
                                                                                            0
                                                                                            source field
                                                                                            indications_and_usage_exact
                                                                                            source text sha256
                                                                                            e526ba14c91f10737e6d3331fe23a6219f58c0eca6380bfce9bd78b573fea912
                                                                                            start
                                                                                            4268
                                                                                            source url
                                                                                            https://api.fda.gov/drug/label.json?search=id%3A%22228e1e3f-d207-481f-8e14-9fdcbd0470e9%22
                                                                                            spl effective date
                                                                                            2026-07-10
                                                                                            spl set id
                                                                                            9333c79b-d487-4538-a9f0-71b91a02b287
                                                                                            spl version
                                                                                            228
                                                                                            structured fields status
                                                                                            not_extracted_no_values_inferred_from_mentions
                                                                                            structured indication
                                                                                            age
                                                                                            Source null
                                                                                            approval pathway
                                                                                            Source null
                                                                                            biomarker and test
                                                                                            Source null
                                                                                            disease stage
                                                                                            Source null
                                                                                            limitations
                                                                                            Source null
                                                                                            line
                                                                                            Source null
                                                                                            prior therapy
                                                                                            Source null
                                                                                            regimen
                                                                                            Source null
                                                                                            tumor histology
                                                                                            Source null
                                                                                            use intent
                                                                                            unclear
                                                                                            Passage 33 · unclassified context
                                                                                            application numbers
                                                                                            1. BLA125514
                                                                                            brand names
                                                                                            1. KEYTRUDA
                                                                                            classification reasons
                                                                                            1. no_unambiguous_positive_indication_predicate
                                                                                            clinical review status
                                                                                            pending
                                                                                            content role
                                                                                            unclassified_context
                                                                                            context span
                                                                                            end
                                                                                            5143
                                                                                            end exclusive
                                                                                            true
                                                                                            exact text
                                                                                            CG)-unresponsive, high-risk, non-muscle invasive bladder cancer (NMIBC) with carcinoma in situ (CIS) with or without papillary tumors who are ineligible for or have elected not to undergo cystectomy. ( 1.7 ) Microsatellite Instability-High or Mismatch Repair Deficient Cancer for the treatment of adult and pediatric patients with unresectable or metastatic microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) solid tumors, as determined by an FDA-authorized test, that have progressed following prior treatment and who have no satisfactory alternative treatment options. ( 1.8 , 2.1 ) Microsatellite Instability-High or Mismatch Repair Deficient Colorectal Cancer (CRC) for the treatment of patients with unresectable or metastatic MSI-H or dMMR colorectal cancer (CRC)
                                                                                            label id
                                                                                            228e1e3f-d207-481f-8e14-9fdcbd0470e9
                                                                                            offset unit
                                                                                            unicode_code_points
                                                                                            source array index
                                                                                            0
                                                                                            source field
                                                                                            indications_and_usage_exact
                                                                                            source text sha256
                                                                                            e526ba14c91f10737e6d3331fe23a6219f58c0eca6380bfce9bd78b573fea912
                                                                                            start
                                                                                            4348
                                                                                            current approval status
                                                                                            not_reconciled
                                                                                            duplicate text group
                                                                                            dup-7178aa0b42f09c07d2c4
                                                                                            extraction review status
                                                                                            automated_candidate_pending_source_review
                                                                                            generic names
                                                                                            1. PEMBROLIZUMAB
                                                                                            id
                                                                                            ind-span-1c248cc682f819fc4a05
                                                                                            label id
                                                                                            228e1e3f-d207-481f-8e14-9fdcbd0470e9
                                                                                            positive predicate support span
                                                                                            Source null
                                                                                            qualifier mentions
                                                                                            1. context exact
                                                                                              gh or Mismatch Repair Deficient Cancer for the treatment of adult and pediatric patients with unresectable or metastatic micr
                                                                                              kind
                                                                                              age
                                                                                              polarity
                                                                                              not_inferred
                                                                                              span
                                                                                              end
                                                                                              4650
                                                                                              end exclusive
                                                                                              true
                                                                                              exact text
                                                                                              adult
                                                                                              label id
                                                                                              228e1e3f-d207-481f-8e14-9fdcbd0470e9
                                                                                              offset unit
                                                                                              unicode_code_points
                                                                                              source array index
                                                                                              0
                                                                                              source field
                                                                                              indications_and_usage_exact
                                                                                              source text sha256
                                                                                              e526ba14c91f10737e6d3331fe23a6219f58c0eca6380bfce9bd78b573fea912
                                                                                              start
                                                                                              4645
                                                                                            2. context exact
                                                                                              atch Repair Deficient Cancer for the treatment of adult and pediatric patients with unresectable or metastatic microsatellite instability-
                                                                                              kind
                                                                                              age
                                                                                              polarity
                                                                                              not_inferred
                                                                                              span
                                                                                              end
                                                                                              4673
                                                                                              end exclusive
                                                                                              true
                                                                                              exact text
                                                                                              pediatric patients
                                                                                              label id
                                                                                              228e1e3f-d207-481f-8e14-9fdcbd0470e9
                                                                                              offset unit
                                                                                              unicode_code_points
                                                                                              source array index
                                                                                              0
                                                                                              source field
                                                                                              indications_and_usage_exact
                                                                                              source text sha256
                                                                                              e526ba14c91f10737e6d3331fe23a6219f58c0eca6380bfce9bd78b573fea912
                                                                                              start
                                                                                              4655
                                                                                            3. context exact
                                                                                              atment of adult and pediatric patients with unresectable or metastatic microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) solid tumors, as
                                                                                              kind
                                                                                              biomarker
                                                                                              polarity
                                                                                              not_inferred
                                                                                              span
                                                                                              end
                                                                                              4738
                                                                                              end exclusive
                                                                                              true
                                                                                              exact text
                                                                                              metastatic microsatellite instability-high
                                                                                              label id
                                                                                              228e1e3f-d207-481f-8e14-9fdcbd0470e9
                                                                                              offset unit
                                                                                              unicode_code_points
                                                                                              source array index
                                                                                              0
                                                                                              source field
                                                                                              indications_and_usage_exact
                                                                                              source text sha256
                                                                                              e526ba14c91f10737e6d3331fe23a6219f58c0eca6380bfce9bd78b573fea912
                                                                                              start
                                                                                              4695
                                                                                            4. context exact
                                                                                              unresectable or metastatic microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) solid tumors, as determined by an FDA-authorized test, that ha
                                                                                              kind
                                                                                              biomarker
                                                                                              polarity
                                                                                              not_inferred
                                                                                              span
                                                                                              end
                                                                                              4784
                                                                                              end exclusive
                                                                                              true
                                                                                              exact text
                                                                                              MSI-H) or mismatch repair deficient (dMMR) so
                                                                                              label id
                                                                                              228e1e3f-d207-481f-8e14-9fdcbd0470e9
                                                                                              offset unit
                                                                                              unicode_code_points
                                                                                              source array index
                                                                                              0
                                                                                              source field
                                                                                              indications_and_usage_exact
                                                                                              source text sha256
                                                                                              e526ba14c91f10737e6d3331fe23a6219f58c0eca6380bfce9bd78b573fea912
                                                                                              start
                                                                                              4739
                                                                                            5. context exact
                                                                                              ncer for the treatment of adult and pediatric patients with unresectable or metastatic microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) soli
                                                                                              kind
                                                                                              stage_or_setting
                                                                                              polarity
                                                                                              not_inferred
                                                                                              span
                                                                                              end
                                                                                              4726
                                                                                              end exclusive
                                                                                              true
                                                                                              exact text
                                                                                              unresectable or metastatic microsatellite insta
                                                                                              label id
                                                                                              228e1e3f-d207-481f-8e14-9fdcbd0470e9
                                                                                              offset unit
                                                                                              unicode_code_points
                                                                                              source array index
                                                                                              0
                                                                                              source field
                                                                                              indications_and_usage_exact
                                                                                              source text sha256
                                                                                              e526ba14c91f10737e6d3331fe23a6219f58c0eca6380bfce9bd78b573fea912
                                                                                              start
                                                                                              4679
                                                                                            6. context exact
                                                                                              d by an FDA-authorized test, that have progressed following prior treatment and who have no satisfactory alternative treatment options.
                                                                                              kind
                                                                                              prior_therapy_or_line
                                                                                              polarity
                                                                                              not_inferred
                                                                                              span
                                                                                              end
                                                                                              4942
                                                                                              end exclusive
                                                                                              true
                                                                                              exact text
                                                                                              prior treatment and who have no satisfactory alternative treatment options
                                                                                              label id
                                                                                              228e1e3f-d207-481f-8e14-9fdcbd0470e9
                                                                                              offset unit
                                                                                              unicode_code_points
                                                                                              source array index
                                                                                              0
                                                                                              source field
                                                                                              indications_and_usage_exact
                                                                                              source text sha256
                                                                                              e526ba14c91f10737e6d3331fe23a6219f58c0eca6380bfce9bd78b573fea912
                                                                                              start
                                                                                              4868
                                                                                            regulatory links
                                                                                              schema version
                                                                                              0.1.0
                                                                                              source batch sha256
                                                                                              fc39a8c5cf96bf95ca20b85578140167b66b2741f7d9217f500d9ba0847ac058
                                                                                              source defined aliases
                                                                                              1. abbreviation
                                                                                                NSCLC
                                                                                                definition exact
                                                                                                Non-Small Cell Lung Cancer
                                                                                                definition span
                                                                                                end
                                                                                                380
                                                                                                end exclusive
                                                                                                true
                                                                                                exact text
                                                                                                Non-Small Cell Lung Cancer (NSCLC)
                                                                                                label id
                                                                                                228e1e3f-d207-481f-8e14-9fdcbd0470e9
                                                                                                offset unit
                                                                                                unicode_code_points
                                                                                                source array index
                                                                                                0
                                                                                                source field
                                                                                                indications_and_usage_exact
                                                                                                source text sha256
                                                                                                e526ba14c91f10737e6d3331fe23a6219f58c0eca6380bfce9bd78b573fea912
                                                                                                start
                                                                                                346
                                                                                              2. abbreviation
                                                                                                CRC
                                                                                                definition exact
                                                                                                Colorectal Cancer
                                                                                                definition span
                                                                                                end
                                                                                                5042
                                                                                                end exclusive
                                                                                                true
                                                                                                exact text
                                                                                                Colorectal Cancer (CRC)
                                                                                                label id
                                                                                                228e1e3f-d207-481f-8e14-9fdcbd0470e9
                                                                                                offset unit
                                                                                                unicode_code_points
                                                                                                source array index
                                                                                                0
                                                                                                source field
                                                                                                indications_and_usage_exact
                                                                                                source text sha256
                                                                                                e526ba14c91f10737e6d3331fe23a6219f58c0eca6380bfce9bd78b573fea912
                                                                                                start
                                                                                                5019
                                                                                              source span
                                                                                              end
                                                                                              4943
                                                                                              end exclusive
                                                                                              true
                                                                                              exact text
                                                                                              ( 1.7 ) Microsatellite Instability-High or Mismatch Repair Deficient Cancer for the treatment of adult and pediatric patients with unresectable or metastatic microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) solid tumors, as determined by an FDA-authorized test, that have progressed following prior treatment and who have no satisfactory alternative treatment options.
                                                                                              label id
                                                                                              228e1e3f-d207-481f-8e14-9fdcbd0470e9
                                                                                              offset unit
                                                                                              unicode_code_points
                                                                                              source array index
                                                                                              0
                                                                                              source field
                                                                                              indications_and_usage_exact
                                                                                              source text sha256
                                                                                              e526ba14c91f10737e6d3331fe23a6219f58c0eca6380bfce9bd78b573fea912
                                                                                              start
                                                                                              4548
                                                                                              source url
                                                                                              https://api.fda.gov/drug/label.json?search=id%3A%22228e1e3f-d207-481f-8e14-9fdcbd0470e9%22
                                                                                              spl effective date
                                                                                              2026-07-10
                                                                                              spl set id
                                                                                              9333c79b-d487-4538-a9f0-71b91a02b287
                                                                                              spl version
                                                                                              228
                                                                                              structured fields status
                                                                                              not_extracted_no_values_inferred_from_mentions
                                                                                              structured indication
                                                                                              age
                                                                                              Source null
                                                                                              approval pathway
                                                                                              Source null
                                                                                              biomarker and test
                                                                                              Source null
                                                                                              disease stage
                                                                                              Source null
                                                                                              limitations
                                                                                              Source null
                                                                                              line
                                                                                              Source null
                                                                                              prior therapy
                                                                                              Source null
                                                                                              regimen
                                                                                              Source null
                                                                                              tumor histology
                                                                                              Source null
                                                                                              use intent
                                                                                              unclear
                                                                                              Passage 34 · unclassified context
                                                                                              application numbers
                                                                                              1. BLA125514
                                                                                              brand names
                                                                                              1. KEYTRUDA
                                                                                              classification reasons
                                                                                              1. no_unambiguous_positive_indication_predicate
                                                                                              clinical review status
                                                                                              pending
                                                                                              content role
                                                                                              unclassified_context
                                                                                              context span
                                                                                              end
                                                                                              5383
                                                                                              end exclusive
                                                                                              true
                                                                                              exact text
                                                                                              ) or mismatch repair deficient (dMMR) solid tumors, as determined by an FDA-authorized test, that have progressed following prior treatment and who have no satisfactory alternative treatment options. ( 1.8 , 2.1 ) Microsatellite Instability-High or Mismatch Repair Deficient Colorectal Cancer (CRC) for the treatment of patients with unresectable or metastatic MSI-H or dMMR colorectal cancer (CRC) as determined by an FDA-authorized test. ( 1.9 , 2.1 ) Gastric Cancer in combination with trastuzumab, fluoropyrimidine- and platinum-containing chemotherapy, for the first-line treatment of adults with locally advanced unresectable or meta
                                                                                              label id
                                                                                              228e1e3f-d207-481f-8e14-9fdcbd0470e9
                                                                                              offset unit
                                                                                              unicode_code_points
                                                                                              source array index
                                                                                              0
                                                                                              source field
                                                                                              indications_and_usage_exact
                                                                                              source text sha256
                                                                                              e526ba14c91f10737e6d3331fe23a6219f58c0eca6380bfce9bd78b573fea912
                                                                                              start
                                                                                              4744
                                                                                              current approval status
                                                                                              not_reconciled
                                                                                              duplicate text group
                                                                                              dup-b0fea78a82cc508f33e3
                                                                                              extraction review status
                                                                                              automated_candidate_pending_source_review
                                                                                              generic names
                                                                                              1. PEMBROLIZUMAB
                                                                                              id
                                                                                              ind-span-69485f801d79abfb64d7
                                                                                              label id
                                                                                              228e1e3f-d207-481f-8e14-9fdcbd0470e9
                                                                                              positive predicate support span
                                                                                              Source null
                                                                                              qualifier mentions
                                                                                              1. context exact
                                                                                                er (CRC) for the treatment of patients with unresectable or metastatic MSI-H or dMMR colorectal cancer (CRC) as determined by an FDA-authorized test.
                                                                                                kind
                                                                                                biomarker
                                                                                                polarity
                                                                                                not_inferred
                                                                                                span
                                                                                                end
                                                                                                5137
                                                                                                end exclusive
                                                                                                true
                                                                                                exact text
                                                                                                metastatic MSI-H or dMMR colorectal cancer
                                                                                                label id
                                                                                                228e1e3f-d207-481f-8e14-9fdcbd0470e9
                                                                                                offset unit
                                                                                                unicode_code_points
                                                                                                source array index
                                                                                                0
                                                                                                source field
                                                                                                indications_and_usage_exact
                                                                                                source text sha256
                                                                                                e526ba14c91f10737e6d3331fe23a6219f58c0eca6380bfce9bd78b573fea912
                                                                                                start
                                                                                                5094
                                                                                              2. context exact
                                                                                                Colorectal Cancer (CRC) for the treatment of patients with unresectable or metastatic MSI-H or dMMR colorectal cancer (CRC) as determined by an FDA-authorized test.
                                                                                                kind
                                                                                                stage_or_setting
                                                                                                polarity
                                                                                                not_inferred
                                                                                                span
                                                                                                end
                                                                                                5125
                                                                                                end exclusive
                                                                                                true
                                                                                                exact text
                                                                                                unresectable or metastatic MSI-H or dMMR colore
                                                                                                label id
                                                                                                228e1e3f-d207-481f-8e14-9fdcbd0470e9
                                                                                                offset unit
                                                                                                unicode_code_points
                                                                                                source array index
                                                                                                0
                                                                                                source field
                                                                                                indications_and_usage_exact
                                                                                                source text sha256
                                                                                                e526ba14c91f10737e6d3331fe23a6219f58c0eca6380bfce9bd78b573fea912
                                                                                                start
                                                                                                5078
                                                                                              regulatory links
                                                                                                schema version
                                                                                                0.1.0
                                                                                                source batch sha256
                                                                                                fc39a8c5cf96bf95ca20b85578140167b66b2741f7d9217f500d9ba0847ac058
                                                                                                source defined aliases
                                                                                                1. abbreviation
                                                                                                  NSCLC
                                                                                                  definition exact
                                                                                                  Non-Small Cell Lung Cancer
                                                                                                  definition span
                                                                                                  end
                                                                                                  380
                                                                                                  end exclusive
                                                                                                  true
                                                                                                  exact text
                                                                                                  Non-Small Cell Lung Cancer (NSCLC)
                                                                                                  label id
                                                                                                  228e1e3f-d207-481f-8e14-9fdcbd0470e9
                                                                                                  offset unit
                                                                                                  unicode_code_points
                                                                                                  source array index
                                                                                                  0
                                                                                                  source field
                                                                                                  indications_and_usage_exact
                                                                                                  source text sha256
                                                                                                  e526ba14c91f10737e6d3331fe23a6219f58c0eca6380bfce9bd78b573fea912
                                                                                                  start
                                                                                                  346
                                                                                                2. abbreviation
                                                                                                  CRC
                                                                                                  definition exact
                                                                                                  Colorectal Cancer
                                                                                                  definition span
                                                                                                  end
                                                                                                  5042
                                                                                                  end exclusive
                                                                                                  true
                                                                                                  exact text
                                                                                                  Colorectal Cancer (CRC)
                                                                                                  label id
                                                                                                  228e1e3f-d207-481f-8e14-9fdcbd0470e9
                                                                                                  offset unit
                                                                                                  unicode_code_points
                                                                                                  source array index
                                                                                                  0
                                                                                                  source field
                                                                                                  indications_and_usage_exact
                                                                                                  source text sha256
                                                                                                  e526ba14c91f10737e6d3331fe23a6219f58c0eca6380bfce9bd78b573fea912
                                                                                                  start
                                                                                                  5019
                                                                                                source span
                                                                                                end
                                                                                                5183
                                                                                                end exclusive
                                                                                                true
                                                                                                exact text
                                                                                                ( 1.8 , 2.1 ) Microsatellite Instability-High or Mismatch Repair Deficient Colorectal Cancer (CRC) for the treatment of patients with unresectable or metastatic MSI-H or dMMR colorectal cancer (CRC) as determined by an FDA-authorized test.
                                                                                                label id
                                                                                                228e1e3f-d207-481f-8e14-9fdcbd0470e9
                                                                                                offset unit
                                                                                                unicode_code_points
                                                                                                source array index
                                                                                                0
                                                                                                source field
                                                                                                indications_and_usage_exact
                                                                                                source text sha256
                                                                                                e526ba14c91f10737e6d3331fe23a6219f58c0eca6380bfce9bd78b573fea912
                                                                                                start
                                                                                                4944
                                                                                                source url
                                                                                                https://api.fda.gov/drug/label.json?search=id%3A%22228e1e3f-d207-481f-8e14-9fdcbd0470e9%22
                                                                                                spl effective date
                                                                                                2026-07-10
                                                                                                spl set id
                                                                                                9333c79b-d487-4538-a9f0-71b91a02b287
                                                                                                spl version
                                                                                                228
                                                                                                structured fields status
                                                                                                not_extracted_no_values_inferred_from_mentions
                                                                                                structured indication
                                                                                                age
                                                                                                Source null
                                                                                                approval pathway
                                                                                                Source null
                                                                                                biomarker and test
                                                                                                Source null
                                                                                                disease stage
                                                                                                Source null
                                                                                                limitations
                                                                                                Source null
                                                                                                line
                                                                                                Source null
                                                                                                prior therapy
                                                                                                Source null
                                                                                                regimen
                                                                                                Source null
                                                                                                tumor histology
                                                                                                Source null
                                                                                                use intent
                                                                                                unclear
                                                                                                Passage 35 · unclassified context
                                                                                                application numbers
                                                                                                1. BLA125514
                                                                                                brand names
                                                                                                1. KEYTRUDA
                                                                                                classification reasons
                                                                                                1. no_unambiguous_positive_indication_predicate
                                                                                                clinical review status
                                                                                                pending
                                                                                                content role
                                                                                                unclassified_context
                                                                                                context span
                                                                                                end
                                                                                                5738
                                                                                                end exclusive
                                                                                                true
                                                                                                exact text
                                                                                                -High or Mismatch Repair Deficient Colorectal Cancer (CRC) for the treatment of patients with unresectable or metastatic MSI-H or dMMR colorectal cancer (CRC) as determined by an FDA-authorized test. ( 1.9 , 2.1 ) Gastric Cancer in combination with trastuzumab, fluoropyrimidine- and platinum-containing chemotherapy, for the first-line treatment of adults with locally advanced unresectable or metastatic HER2-positive gastric or gastroesophageal junction (GEJ) adenocarcinoma whose tumors express PD-L1 (CPS ≥1) as determined by an FDA-authorized test. ( 1.10 ) in combination with fluoropyrimidine- and platinum-containing chemotherapy, for the first-line treatment of adults with locally advanced unresectable or metastatic HER2-negative gastric or g
                                                                                                label id
                                                                                                228e1e3f-d207-481f-8e14-9fdcbd0470e9
                                                                                                offset unit
                                                                                                unicode_code_points
                                                                                                source array index
                                                                                                0
                                                                                                source field
                                                                                                indications_and_usage_exact
                                                                                                source text sha256
                                                                                                e526ba14c91f10737e6d3331fe23a6219f58c0eca6380bfce9bd78b573fea912
                                                                                                start
                                                                                                4984
                                                                                                current approval status
                                                                                                not_reconciled
                                                                                                duplicate text group
                                                                                                dup-6697e06cae73934c8881
                                                                                                extraction review status
                                                                                                automated_candidate_pending_source_review
                                                                                                generic names
                                                                                                1. PEMBROLIZUMAB
                                                                                                id
                                                                                                ind-span-fc2ac0899494521466bb
                                                                                                label id
                                                                                                228e1e3f-d207-481f-8e14-9fdcbd0470e9
                                                                                                positive predicate support span
                                                                                                Source null
                                                                                                qualifier mentions
                                                                                                1. context exact
                                                                                                  um-containing chemotherapy, for the first-line treatment of adults with locally advanced unresectable or metastatic HER2-posit
                                                                                                  kind
                                                                                                  age
                                                                                                  polarity
                                                                                                  not_inferred
                                                                                                  span
                                                                                                  end
                                                                                                  5340
                                                                                                  end exclusive
                                                                                                  true
                                                                                                  exact text
                                                                                                  adults
                                                                                                  label id
                                                                                                  228e1e3f-d207-481f-8e14-9fdcbd0470e9
                                                                                                  offset unit
                                                                                                  unicode_code_points
                                                                                                  source array index
                                                                                                  0
                                                                                                  source field
                                                                                                  indications_and_usage_exact
                                                                                                  source text sha256
                                                                                                  e526ba14c91f10737e6d3331fe23a6219f58c0eca6380bfce9bd78b573fea912
                                                                                                  start
                                                                                                  5334
                                                                                                2. context exact
                                                                                                  e treatment of adults with locally advanced unresectable or metastatic HER2-positive gastric or gastroesophageal junction (GEJ) adenocarcinoma whose tumors express
                                                                                                  kind
                                                                                                  biomarker
                                                                                                  polarity
                                                                                                  not_inferred
                                                                                                  span
                                                                                                  end
                                                                                                  5422
                                                                                                  end exclusive
                                                                                                  true
                                                                                                  exact text
                                                                                                  metastatic HER2-positive gastric or gastroe
                                                                                                  label id
                                                                                                  228e1e3f-d207-481f-8e14-9fdcbd0470e9
                                                                                                  offset unit
                                                                                                  unicode_code_points
                                                                                                  source array index
                                                                                                  0
                                                                                                  source field
                                                                                                  indications_and_usage_exact
                                                                                                  source text sha256
                                                                                                  e526ba14c91f10737e6d3331fe23a6219f58c0eca6380bfce9bd78b573fea912
                                                                                                  start
                                                                                                  5379
                                                                                                3. context exact
                                                                                                  ophageal junction (GEJ) adenocarcinoma whose tumors express PD-L1 (CPS ≥1) as determined by an FDA-authorized test.
                                                                                                  kind
                                                                                                  biomarker
                                                                                                  polarity
                                                                                                  not_inferred
                                                                                                  span
                                                                                                  end
                                                                                                  5528
                                                                                                  end exclusive
                                                                                                  true
                                                                                                  exact text
                                                                                                  PD-L1 (CPS ≥1) as determined by an FDA-author
                                                                                                  label id
                                                                                                  228e1e3f-d207-481f-8e14-9fdcbd0470e9
                                                                                                  offset unit
                                                                                                  unicode_code_points
                                                                                                  source array index
                                                                                                  0
                                                                                                  source field
                                                                                                  indications_and_usage_exact
                                                                                                  source text sha256
                                                                                                  e526ba14c91f10737e6d3331fe23a6219f58c0eca6380bfce9bd78b573fea912
                                                                                                  start
                                                                                                  5483
                                                                                                4. context exact
                                                                                                  g chemotherapy, for the first-line treatment of adults with locally advanced unresectable or metastatic HER2-positive gastric or gastroesophageal junction (GEJ) adenocarci
                                                                                                  kind
                                                                                                  stage_or_setting
                                                                                                  polarity
                                                                                                  not_inferred
                                                                                                  span
                                                                                                  end
                                                                                                  5397
                                                                                                  end exclusive
                                                                                                  true
                                                                                                  exact text
                                                                                                  locally advanced unresectable or metastatic HER2-po
                                                                                                  label id
                                                                                                  228e1e3f-d207-481f-8e14-9fdcbd0470e9
                                                                                                  offset unit
                                                                                                  unicode_code_points
                                                                                                  source array index
                                                                                                  0
                                                                                                  source field
                                                                                                  indications_and_usage_exact
                                                                                                  source text sha256
                                                                                                  e526ba14c91f10737e6d3331fe23a6219f58c0eca6380bfce9bd78b573fea912
                                                                                                  start
                                                                                                  5346
                                                                                                5. context exact
                                                                                                  ropyrimidine- and platinum-containing chemotherapy, for the first-line treatment of adults with locally advanced unresectable or metastatic HER2-positive gastric or gastroesophageal junction (GEJ) adenocarcinoma whose tumors express PD-L1 (CPS ≥1) as determined by an FDA-authorized test.
                                                                                                  kind
                                                                                                  prior_therapy_or_line
                                                                                                  polarity
                                                                                                  not_inferred
                                                                                                  span
                                                                                                  end
                                                                                                  5480
                                                                                                  end exclusive
                                                                                                  true
                                                                                                  exact text
                                                                                                  first-line treatment of adults with locally advanced unresectable or metastatic HER2-positive gastric or gastroesophageal junction (GEJ) adenocarcinoma whose tumors expre
                                                                                                  label id
                                                                                                  228e1e3f-d207-481f-8e14-9fdcbd0470e9
                                                                                                  offset unit
                                                                                                  unicode_code_points
                                                                                                  source array index
                                                                                                  0
                                                                                                  source field
                                                                                                  indications_and_usage_exact
                                                                                                  source text sha256
                                                                                                  e526ba14c91f10737e6d3331fe23a6219f58c0eca6380bfce9bd78b573fea912
                                                                                                  start
                                                                                                  5310
                                                                                                6. context exact
                                                                                                  ( 1.9 , 2.1 ) Gastric Cancer in combination with trastuzumab, fluoropyrimidine- and platinum-containing chemotherapy, for the first-line treatment of adults with locally advanced unresectable or metastatic HER2-positive gastric or gastroesophageal junction (GEJ) adeno
                                                                                                  kind
                                                                                                  regimen
                                                                                                  polarity
                                                                                                  not_inferred
                                                                                                  span
                                                                                                  end
                                                                                                  5392
                                                                                                  end exclusive
                                                                                                  true
                                                                                                  exact text
                                                                                                  in combination with trastuzumab, fluoropyrimidine- and platinum-containing chemotherapy, for the first-line treatment of adults with locally advanced unresectable or metastatic HE
                                                                                                  label id
                                                                                                  228e1e3f-d207-481f-8e14-9fdcbd0470e9
                                                                                                  offset unit
                                                                                                  unicode_code_points
                                                                                                  source array index
                                                                                                  0
                                                                                                  source field
                                                                                                  indications_and_usage_exact
                                                                                                  source text sha256
                                                                                                  e526ba14c91f10737e6d3331fe23a6219f58c0eca6380bfce9bd78b573fea912
                                                                                                  start
                                                                                                  5213
                                                                                                regulatory links
                                                                                                  schema version
                                                                                                  0.1.0
                                                                                                  source batch sha256
                                                                                                  fc39a8c5cf96bf95ca20b85578140167b66b2741f7d9217f500d9ba0847ac058
                                                                                                  source defined aliases
                                                                                                  1. abbreviation
                                                                                                    NSCLC
                                                                                                    definition exact
                                                                                                    Non-Small Cell Lung Cancer
                                                                                                    definition span
                                                                                                    end
                                                                                                    380
                                                                                                    end exclusive
                                                                                                    true
                                                                                                    exact text
                                                                                                    Non-Small Cell Lung Cancer (NSCLC)
                                                                                                    label id
                                                                                                    228e1e3f-d207-481f-8e14-9fdcbd0470e9
                                                                                                    offset unit
                                                                                                    unicode_code_points
                                                                                                    source array index
                                                                                                    0
                                                                                                    source field
                                                                                                    indications_and_usage_exact
                                                                                                    source text sha256
                                                                                                    e526ba14c91f10737e6d3331fe23a6219f58c0eca6380bfce9bd78b573fea912
                                                                                                    start
                                                                                                    346
                                                                                                  2. abbreviation
                                                                                                    CRC
                                                                                                    definition exact
                                                                                                    Colorectal Cancer
                                                                                                    definition span
                                                                                                    end
                                                                                                    5042
                                                                                                    end exclusive
                                                                                                    true
                                                                                                    exact text
                                                                                                    Colorectal Cancer (CRC)
                                                                                                    label id
                                                                                                    228e1e3f-d207-481f-8e14-9fdcbd0470e9
                                                                                                    offset unit
                                                                                                    unicode_code_points
                                                                                                    source array index
                                                                                                    0
                                                                                                    source field
                                                                                                    indications_and_usage_exact
                                                                                                    source text sha256
                                                                                                    e526ba14c91f10737e6d3331fe23a6219f58c0eca6380bfce9bd78b573fea912
                                                                                                    start
                                                                                                    5019
                                                                                                  source span
                                                                                                  end
                                                                                                  5538
                                                                                                  end exclusive
                                                                                                  true
                                                                                                  exact text
                                                                                                  ( 1.9 , 2.1 ) Gastric Cancer in combination with trastuzumab, fluoropyrimidine- and platinum-containing chemotherapy, for the first-line treatment of adults with locally advanced unresectable or metastatic HER2-positive gastric or gastroesophageal junction (GEJ) adenocarcinoma whose tumors express PD-L1 (CPS ≥1) as determined by an FDA-authorized test.
                                                                                                  label id
                                                                                                  228e1e3f-d207-481f-8e14-9fdcbd0470e9
                                                                                                  offset unit
                                                                                                  unicode_code_points
                                                                                                  source array index
                                                                                                  0
                                                                                                  source field
                                                                                                  indications_and_usage_exact
                                                                                                  source text sha256
                                                                                                  e526ba14c91f10737e6d3331fe23a6219f58c0eca6380bfce9bd78b573fea912
                                                                                                  start
                                                                                                  5184
                                                                                                  source url
                                                                                                  https://api.fda.gov/drug/label.json?search=id%3A%22228e1e3f-d207-481f-8e14-9fdcbd0470e9%22
                                                                                                  spl effective date
                                                                                                  2026-07-10
                                                                                                  spl set id
                                                                                                  9333c79b-d487-4538-a9f0-71b91a02b287
                                                                                                  spl version
                                                                                                  228
                                                                                                  structured fields status
                                                                                                  not_extracted_no_values_inferred_from_mentions
                                                                                                  structured indication
                                                                                                  age
                                                                                                  Source null
                                                                                                  approval pathway
                                                                                                  Source null
                                                                                                  biomarker and test
                                                                                                  Source null
                                                                                                  disease stage
                                                                                                  Source null
                                                                                                  limitations
                                                                                                  Source null
                                                                                                  line
                                                                                                  Source null
                                                                                                  prior therapy
                                                                                                  Source null
                                                                                                  regimen
                                                                                                  Source null
                                                                                                  tumor histology
                                                                                                  Source null
                                                                                                  use intent
                                                                                                  unclear
                                                                                                  Passage 36 · unclassified context
                                                                                                  application numbers
                                                                                                  1. BLA125514
                                                                                                  brand names
                                                                                                  1. KEYTRUDA
                                                                                                  classification reasons
                                                                                                  1. no_unambiguous_positive_indication_predicate
                                                                                                  clinical review status
                                                                                                  pending
                                                                                                  content role
                                                                                                  unclassified_context
                                                                                                  context span
                                                                                                  end
                                                                                                  5747
                                                                                                  end exclusive
                                                                                                  true
                                                                                                  exact text
                                                                                                  s with locally advanced unresectable or metastatic HER2-positive gastric or gastroesophageal junction (GEJ) adenocarcinoma whose tumors express PD-L1 (CPS ≥1) as determined by an FDA-authorized test. ( 1.10 ) in combination with fluoropyrimidine- and platinum-containing chemotherapy, for the first-line treatment of adults with locally advanced unresectable or metastatic HER2-negative gastric or gastroesop
                                                                                                  label id
                                                                                                  228e1e3f-d207-481f-8e14-9fdcbd0470e9
                                                                                                  offset unit
                                                                                                  unicode_code_points
                                                                                                  source array index
                                                                                                  0
                                                                                                  source field
                                                                                                  indications_and_usage_exact
                                                                                                  source text sha256
                                                                                                  e526ba14c91f10737e6d3331fe23a6219f58c0eca6380bfce9bd78b573fea912
                                                                                                  start
                                                                                                  5339
                                                                                                  current approval status
                                                                                                  not_reconciled
                                                                                                  duplicate text group
                                                                                                  dup-b1f57464a5d8491238d1
                                                                                                  extraction review status
                                                                                                  automated_candidate_pending_source_review
                                                                                                  generic names
                                                                                                  1. PEMBROLIZUMAB
                                                                                                  id
                                                                                                  ind-span-d495e0b48c704b1ed852
                                                                                                  label id
                                                                                                  228e1e3f-d207-481f-8e14-9fdcbd0470e9
                                                                                                  positive predicate support span
                                                                                                  Source null
                                                                                                  qualifier mentions
                                                                                                    regulatory links
                                                                                                      schema version
                                                                                                      0.1.0
                                                                                                      source batch sha256
                                                                                                      fc39a8c5cf96bf95ca20b85578140167b66b2741f7d9217f500d9ba0847ac058
                                                                                                      source defined aliases
                                                                                                      1. abbreviation
                                                                                                        NSCLC
                                                                                                        definition exact
                                                                                                        Non-Small Cell Lung Cancer
                                                                                                        definition span
                                                                                                        end
                                                                                                        380
                                                                                                        end exclusive
                                                                                                        true
                                                                                                        exact text
                                                                                                        Non-Small Cell Lung Cancer (NSCLC)
                                                                                                        label id
                                                                                                        228e1e3f-d207-481f-8e14-9fdcbd0470e9
                                                                                                        offset unit
                                                                                                        unicode_code_points
                                                                                                        source array index
                                                                                                        0
                                                                                                        source field
                                                                                                        indications_and_usage_exact
                                                                                                        source text sha256
                                                                                                        e526ba14c91f10737e6d3331fe23a6219f58c0eca6380bfce9bd78b573fea912
                                                                                                        start
                                                                                                        346
                                                                                                      2. abbreviation
                                                                                                        CRC
                                                                                                        definition exact
                                                                                                        Colorectal Cancer
                                                                                                        definition span
                                                                                                        end
                                                                                                        5042
                                                                                                        end exclusive
                                                                                                        true
                                                                                                        exact text
                                                                                                        Colorectal Cancer (CRC)
                                                                                                        label id
                                                                                                        228e1e3f-d207-481f-8e14-9fdcbd0470e9
                                                                                                        offset unit
                                                                                                        unicode_code_points
                                                                                                        source array index
                                                                                                        0
                                                                                                        source field
                                                                                                        indications_and_usage_exact
                                                                                                        source text sha256
                                                                                                        e526ba14c91f10737e6d3331fe23a6219f58c0eca6380bfce9bd78b573fea912
                                                                                                        start
                                                                                                        5019
                                                                                                      source span
                                                                                                      end
                                                                                                      5547
                                                                                                      end exclusive
                                                                                                      true
                                                                                                      exact text
                                                                                                      ( 1.10 )
                                                                                                      label id
                                                                                                      228e1e3f-d207-481f-8e14-9fdcbd0470e9
                                                                                                      offset unit
                                                                                                      unicode_code_points
                                                                                                      source array index
                                                                                                      0
                                                                                                      source field
                                                                                                      indications_and_usage_exact
                                                                                                      source text sha256
                                                                                                      e526ba14c91f10737e6d3331fe23a6219f58c0eca6380bfce9bd78b573fea912
                                                                                                      start
                                                                                                      5539
                                                                                                      source url
                                                                                                      https://api.fda.gov/drug/label.json?search=id%3A%22228e1e3f-d207-481f-8e14-9fdcbd0470e9%22
                                                                                                      spl effective date
                                                                                                      2026-07-10
                                                                                                      spl set id
                                                                                                      9333c79b-d487-4538-a9f0-71b91a02b287
                                                                                                      spl version
                                                                                                      228
                                                                                                      structured fields status
                                                                                                      not_extracted_no_values_inferred_from_mentions
                                                                                                      structured indication
                                                                                                      age
                                                                                                      Source null
                                                                                                      approval pathway
                                                                                                      Source null
                                                                                                      biomarker and test
                                                                                                      Source null
                                                                                                      disease stage
                                                                                                      Source null
                                                                                                      limitations
                                                                                                      Source null
                                                                                                      line
                                                                                                      Source null
                                                                                                      prior therapy
                                                                                                      Source null
                                                                                                      regimen
                                                                                                      Source null
                                                                                                      tumor histology
                                                                                                      Source null
                                                                                                      use intent
                                                                                                      unclear
                                                                                                      Passage 37 · unclassified context
                                                                                                      application numbers
                                                                                                      1. BLA125514
                                                                                                      brand names
                                                                                                      1. KEYTRUDA
                                                                                                      classification reasons
                                                                                                      1. no_unambiguous_positive_indication_predicate
                                                                                                      clinical review status
                                                                                                      pending
                                                                                                      content role
                                                                                                      unclassified_context
                                                                                                      context span
                                                                                                      end
                                                                                                      6060
                                                                                                      end exclusive
                                                                                                      true
                                                                                                      exact text
                                                                                                      cally advanced unresectable or metastatic HER2-positive gastric or gastroesophageal junction (GEJ) adenocarcinoma whose tumors express PD-L1 (CPS ≥1) as determined by an FDA-authorized test. ( 1.10 ) in combination with fluoropyrimidine- and platinum-containing chemotherapy, for the first-line treatment of adults with locally advanced unresectable or metastatic HER2-negative gastric or gastroesophageal junction (GEJ) adenocarcinoma whose tumors express PD-L1 (CPS ≥1) as determined by an FDA-authorized test. ( 1.10 ) Esophageal Cancer for the treatment of patients with locally advanced or metastatic esophageal or gastroesophageal junction (GEJ) (tumors with epicenter 1 to 5 centimeters above the GEJ) car
                                                                                                      label id
                                                                                                      228e1e3f-d207-481f-8e14-9fdcbd0470e9
                                                                                                      offset unit
                                                                                                      unicode_code_points
                                                                                                      source array index
                                                                                                      0
                                                                                                      source field
                                                                                                      indications_and_usage_exact
                                                                                                      source text sha256
                                                                                                      e526ba14c91f10737e6d3331fe23a6219f58c0eca6380bfce9bd78b573fea912
                                                                                                      start
                                                                                                      5348
                                                                                                      current approval status
                                                                                                      not_reconciled
                                                                                                      duplicate text group
                                                                                                      dup-35cedd752224cffde7f5
                                                                                                      extraction review status
                                                                                                      automated_candidate_pending_source_review
                                                                                                      generic names
                                                                                                      1. PEMBROLIZUMAB
                                                                                                      id
                                                                                                      ind-span-59344f6de4a700f4db51
                                                                                                      label id
                                                                                                      228e1e3f-d207-481f-8e14-9fdcbd0470e9
                                                                                                      positive predicate support span
                                                                                                      Source null
                                                                                                      qualifier mentions
                                                                                                      1. context exact
                                                                                                        um-containing chemotherapy, for the first-line treatment of adults with locally advanced unresectable or metastatic HER2-negat
                                                                                                        kind
                                                                                                        age
                                                                                                        polarity
                                                                                                        not_inferred
                                                                                                        span
                                                                                                        end
                                                                                                        5662
                                                                                                        end exclusive
                                                                                                        true
                                                                                                        exact text
                                                                                                        adults
                                                                                                        label id
                                                                                                        228e1e3f-d207-481f-8e14-9fdcbd0470e9
                                                                                                        offset unit
                                                                                                        unicode_code_points
                                                                                                        source array index
                                                                                                        0
                                                                                                        source field
                                                                                                        indications_and_usage_exact
                                                                                                        source text sha256
                                                                                                        e526ba14c91f10737e6d3331fe23a6219f58c0eca6380bfce9bd78b573fea912
                                                                                                        start
                                                                                                        5656
                                                                                                      2. context exact
                                                                                                        e treatment of adults with locally advanced unresectable or metastatic HER2-negative gastric or gastroesophageal junction (GEJ) adenocarcinoma whose tumors express
                                                                                                        kind
                                                                                                        biomarker
                                                                                                        polarity
                                                                                                        not_inferred
                                                                                                        span
                                                                                                        end
                                                                                                        5744
                                                                                                        end exclusive
                                                                                                        true
                                                                                                        exact text
                                                                                                        metastatic HER2-negative gastric or gastroe
                                                                                                        label id
                                                                                                        228e1e3f-d207-481f-8e14-9fdcbd0470e9
                                                                                                        offset unit
                                                                                                        unicode_code_points
                                                                                                        source array index
                                                                                                        0
                                                                                                        source field
                                                                                                        indications_and_usage_exact
                                                                                                        source text sha256
                                                                                                        e526ba14c91f10737e6d3331fe23a6219f58c0eca6380bfce9bd78b573fea912
                                                                                                        start
                                                                                                        5701
                                                                                                      3. context exact
                                                                                                        ophageal junction (GEJ) adenocarcinoma whose tumors express PD-L1 (CPS ≥1) as determined by an FDA-authorized test.
                                                                                                        kind
                                                                                                        biomarker
                                                                                                        polarity
                                                                                                        not_inferred
                                                                                                        span
                                                                                                        end
                                                                                                        5850
                                                                                                        end exclusive
                                                                                                        true
                                                                                                        exact text
                                                                                                        PD-L1 (CPS ≥1) as determined by an FDA-author
                                                                                                        label id
                                                                                                        228e1e3f-d207-481f-8e14-9fdcbd0470e9
                                                                                                        offset unit
                                                                                                        unicode_code_points
                                                                                                        source array index
                                                                                                        0
                                                                                                        source field
                                                                                                        indications_and_usage_exact
                                                                                                        source text sha256
                                                                                                        e526ba14c91f10737e6d3331fe23a6219f58c0eca6380bfce9bd78b573fea912
                                                                                                        start
                                                                                                        5805
                                                                                                      4. context exact
                                                                                                        g chemotherapy, for the first-line treatment of adults with locally advanced unresectable or metastatic HER2-negative gastric or gastroesophageal junction (GEJ) adenocarci
                                                                                                        kind
                                                                                                        stage_or_setting
                                                                                                        polarity
                                                                                                        not_inferred
                                                                                                        span
                                                                                                        end
                                                                                                        5719
                                                                                                        end exclusive
                                                                                                        true
                                                                                                        exact text
                                                                                                        locally advanced unresectable or metastatic HER2-ne
                                                                                                        label id
                                                                                                        228e1e3f-d207-481f-8e14-9fdcbd0470e9
                                                                                                        offset unit
                                                                                                        unicode_code_points
                                                                                                        source array index
                                                                                                        0
                                                                                                        source field
                                                                                                        indications_and_usage_exact
                                                                                                        source text sha256
                                                                                                        e526ba14c91f10737e6d3331fe23a6219f58c0eca6380bfce9bd78b573fea912
                                                                                                        start
                                                                                                        5668
                                                                                                      5. context exact
                                                                                                        ropyrimidine- and platinum-containing chemotherapy, for the first-line treatment of adults with locally advanced unresectable or metastatic HER2-negative gastric or gastroesophageal junction (GEJ) adenocarcinoma whose tumors express PD-L1 (CPS ≥1) as determined by an FDA-authorized test.
                                                                                                        kind
                                                                                                        prior_therapy_or_line
                                                                                                        polarity
                                                                                                        not_inferred
                                                                                                        span
                                                                                                        end
                                                                                                        5802
                                                                                                        end exclusive
                                                                                                        true
                                                                                                        exact text
                                                                                                        first-line treatment of adults with locally advanced unresectable or metastatic HER2-negative gastric or gastroesophageal junction (GEJ) adenocarcinoma whose tumors expre
                                                                                                        label id
                                                                                                        228e1e3f-d207-481f-8e14-9fdcbd0470e9
                                                                                                        offset unit
                                                                                                        unicode_code_points
                                                                                                        source array index
                                                                                                        0
                                                                                                        source field
                                                                                                        indications_and_usage_exact
                                                                                                        source text sha256
                                                                                                        e526ba14c91f10737e6d3331fe23a6219f58c0eca6380bfce9bd78b573fea912
                                                                                                        start
                                                                                                        5632
                                                                                                      6. context exact
                                                                                                        in combination with fluoropyrimidine- and platinum-containing chemotherapy, for the first-line treatment of adults with locally advanced unresectable or metastatic HER2-negative gastric or gastroesophageal junction (GEJ) adenocarcinoma who
                                                                                                        kind
                                                                                                        regimen
                                                                                                        polarity
                                                                                                        not_inferred
                                                                                                        span
                                                                                                        end
                                                                                                        5727
                                                                                                        end exclusive
                                                                                                        true
                                                                                                        exact text
                                                                                                        in combination with fluoropyrimidine- and platinum-containing chemotherapy, for the first-line treatment of adults with locally advanced unresectable or metastatic HER2-negative g
                                                                                                        label id
                                                                                                        228e1e3f-d207-481f-8e14-9fdcbd0470e9
                                                                                                        offset unit
                                                                                                        unicode_code_points
                                                                                                        source array index
                                                                                                        0
                                                                                                        source field
                                                                                                        indications_and_usage_exact
                                                                                                        source text sha256
                                                                                                        e526ba14c91f10737e6d3331fe23a6219f58c0eca6380bfce9bd78b573fea912
                                                                                                        start
                                                                                                        5548
                                                                                                      regulatory links
                                                                                                        schema version
                                                                                                        0.1.0
                                                                                                        source batch sha256
                                                                                                        fc39a8c5cf96bf95ca20b85578140167b66b2741f7d9217f500d9ba0847ac058
                                                                                                        source defined aliases
                                                                                                        1. abbreviation
                                                                                                          NSCLC
                                                                                                          definition exact
                                                                                                          Non-Small Cell Lung Cancer
                                                                                                          definition span
                                                                                                          end
                                                                                                          380
                                                                                                          end exclusive
                                                                                                          true
                                                                                                          exact text
                                                                                                          Non-Small Cell Lung Cancer (NSCLC)
                                                                                                          label id
                                                                                                          228e1e3f-d207-481f-8e14-9fdcbd0470e9
                                                                                                          offset unit
                                                                                                          unicode_code_points
                                                                                                          source array index
                                                                                                          0
                                                                                                          source field
                                                                                                          indications_and_usage_exact
                                                                                                          source text sha256
                                                                                                          e526ba14c91f10737e6d3331fe23a6219f58c0eca6380bfce9bd78b573fea912
                                                                                                          start
                                                                                                          346
                                                                                                        2. abbreviation
                                                                                                          CRC
                                                                                                          definition exact
                                                                                                          Colorectal Cancer
                                                                                                          definition span
                                                                                                          end
                                                                                                          5042
                                                                                                          end exclusive
                                                                                                          true
                                                                                                          exact text
                                                                                                          Colorectal Cancer (CRC)
                                                                                                          label id
                                                                                                          228e1e3f-d207-481f-8e14-9fdcbd0470e9
                                                                                                          offset unit
                                                                                                          unicode_code_points
                                                                                                          source array index
                                                                                                          0
                                                                                                          source field
                                                                                                          indications_and_usage_exact
                                                                                                          source text sha256
                                                                                                          e526ba14c91f10737e6d3331fe23a6219f58c0eca6380bfce9bd78b573fea912
                                                                                                          start
                                                                                                          5019
                                                                                                        source span
                                                                                                        end
                                                                                                        5860
                                                                                                        end exclusive
                                                                                                        true
                                                                                                        exact text
                                                                                                        in combination with fluoropyrimidine- and platinum-containing chemotherapy, for the first-line treatment of adults with locally advanced unresectable or metastatic HER2-negative gastric or gastroesophageal junction (GEJ) adenocarcinoma whose tumors express PD-L1 (CPS ≥1) as determined by an FDA-authorized test.
                                                                                                        label id
                                                                                                        228e1e3f-d207-481f-8e14-9fdcbd0470e9
                                                                                                        offset unit
                                                                                                        unicode_code_points
                                                                                                        source array index
                                                                                                        0
                                                                                                        source field
                                                                                                        indications_and_usage_exact
                                                                                                        source text sha256
                                                                                                        e526ba14c91f10737e6d3331fe23a6219f58c0eca6380bfce9bd78b573fea912
                                                                                                        start
                                                                                                        5548
                                                                                                        source url
                                                                                                        https://api.fda.gov/drug/label.json?search=id%3A%22228e1e3f-d207-481f-8e14-9fdcbd0470e9%22
                                                                                                        spl effective date
                                                                                                        2026-07-10
                                                                                                        spl set id
                                                                                                        9333c79b-d487-4538-a9f0-71b91a02b287
                                                                                                        spl version
                                                                                                        228
                                                                                                        structured fields status
                                                                                                        not_extracted_no_values_inferred_from_mentions
                                                                                                        structured indication
                                                                                                        age
                                                                                                        Source null
                                                                                                        approval pathway
                                                                                                        Source null
                                                                                                        biomarker and test
                                                                                                        Source null
                                                                                                        disease stage
                                                                                                        Source null
                                                                                                        limitations
                                                                                                        Source null
                                                                                                        line
                                                                                                        Source null
                                                                                                        prior therapy
                                                                                                        Source null
                                                                                                        regimen
                                                                                                        Source null
                                                                                                        tumor histology
                                                                                                        Source null
                                                                                                        use intent
                                                                                                        unclear
                                                                                                        Passage 38 · unclassified context
                                                                                                        application numbers
                                                                                                        1. BLA125514
                                                                                                        brand names
                                                                                                        1. KEYTRUDA
                                                                                                        classification reasons
                                                                                                        1. no_unambiguous_positive_indication_predicate
                                                                                                        clinical review status
                                                                                                        pending
                                                                                                        content role
                                                                                                        unclassified_context
                                                                                                        context span
                                                                                                        end
                                                                                                        6699
                                                                                                        end exclusive
                                                                                                        true
                                                                                                        exact text
                                                                                                        s with locally advanced unresectable or metastatic HER2-negative gastric or gastroesophageal junction (GEJ) adenocarcinoma whose tumors express PD-L1 (CPS ≥1) as determined by an FDA-authorized test. ( 1.10 ) Esophageal Cancer for the treatment of patients with locally advanced or metastatic esophageal or gastroesophageal junction (GEJ) (tumors with epicenter 1 to 5 centimeters above the GEJ) carcinoma that is not amenable to surgical resection or definitive chemoradiation either: in combination with platinum- and fluoropyrimidine-based chemotherapy for patients whose tumors express PD-L1 (CPS ≥1) as determined by an FDA-authorized test, or as a single agent after one or more prior lines of systemic therapy for patients with tumors of squamous cell histology that express PD-L1 (CPS ≥10) as determined by an FDA-authorized test. ( 1.11 , 2.1 ) Cervical Cancer in combination with chemoradiotherapy, for the treatment of patients with locally advanced cervical cancer involving the lower third of the vagina, with or without exte
                                                                                                        label id
                                                                                                        228e1e3f-d207-481f-8e14-9fdcbd0470e9
                                                                                                        offset unit
                                                                                                        unicode_code_points
                                                                                                        source array index
                                                                                                        0
                                                                                                        source field
                                                                                                        indications_and_usage_exact
                                                                                                        source text sha256
                                                                                                        e526ba14c91f10737e6d3331fe23a6219f58c0eca6380bfce9bd78b573fea912
                                                                                                        start
                                                                                                        5661
                                                                                                        current approval status
                                                                                                        not_reconciled
                                                                                                        duplicate text group
                                                                                                        dup-2d83746b1e846fbbe00c
                                                                                                        extraction review status
                                                                                                        automated_candidate_pending_source_review
                                                                                                        generic names
                                                                                                        1. PEMBROLIZUMAB
                                                                                                        id
                                                                                                        ind-span-195df99a7e48286450c1
                                                                                                        label id
                                                                                                        228e1e3f-d207-481f-8e14-9fdcbd0470e9
                                                                                                        positive predicate support span
                                                                                                        Source null
                                                                                                        qualifier mentions
                                                                                                        1. context exact
                                                                                                          ncer for the treatment of patients with locally advanced or metastatic esophageal or gastroesophageal junction (GEJ) (tumors with epicenter 1 to 5 centimeters abov
                                                                                                          kind
                                                                                                          biomarker
                                                                                                          polarity
                                                                                                          not_inferred
                                                                                                          span
                                                                                                          end
                                                                                                          5986
                                                                                                          end exclusive
                                                                                                          true
                                                                                                          exact text
                                                                                                          metastatic esophageal or gastroesophageal j
                                                                                                          label id
                                                                                                          228e1e3f-d207-481f-8e14-9fdcbd0470e9
                                                                                                          offset unit
                                                                                                          unicode_code_points
                                                                                                          source array index
                                                                                                          0
                                                                                                          source field
                                                                                                          indications_and_usage_exact
                                                                                                          source text sha256
                                                                                                          e526ba14c91f10737e6d3331fe23a6219f58c0eca6380bfce9bd78b573fea912
                                                                                                          start
                                                                                                          5943
                                                                                                        2. context exact
                                                                                                          midine-based chemotherapy for patients whose tumors express PD-L1 (CPS ≥1) as determined by an FDA-authorized test, or as a single agent after one or more prior line
                                                                                                          kind
                                                                                                          biomarker
                                                                                                          polarity
                                                                                                          not_inferred
                                                                                                          span
                                                                                                          end
                                                                                                          6296
                                                                                                          end exclusive
                                                                                                          true
                                                                                                          exact text
                                                                                                          PD-L1 (CPS ≥1) as determined by an FDA-author
                                                                                                          label id
                                                                                                          228e1e3f-d207-481f-8e14-9fdcbd0470e9
                                                                                                          offset unit
                                                                                                          unicode_code_points
                                                                                                          source array index
                                                                                                          0
                                                                                                          source field
                                                                                                          indications_and_usage_exact
                                                                                                          source text sha256
                                                                                                          e526ba14c91f10737e6d3331fe23a6219f58c0eca6380bfce9bd78b573fea912
                                                                                                          start
                                                                                                          6251
                                                                                                        3. context exact
                                                                                                          atients with tumors of squamous cell histology that express PD-L1 (CPS ≥10) as determined by an FDA-authorized test.
                                                                                                          kind
                                                                                                          biomarker
                                                                                                          polarity
                                                                                                          not_inferred
                                                                                                          span
                                                                                                          end
                                                                                                          6488
                                                                                                          end exclusive
                                                                                                          true
                                                                                                          exact text
                                                                                                          PD-L1 (CPS ≥10) as determined by an FDA-autho
                                                                                                          label id
                                                                                                          228e1e3f-d207-481f-8e14-9fdcbd0470e9
                                                                                                          offset unit
                                                                                                          unicode_code_points
                                                                                                          source array index
                                                                                                          0
                                                                                                          source field
                                                                                                          indications_and_usage_exact
                                                                                                          source text sha256
                                                                                                          e526ba14c91f10737e6d3331fe23a6219f58c0eca6380bfce9bd78b573fea912
                                                                                                          start
                                                                                                          6443
                                                                                                        4. context exact
                                                                                                          1.10 ) Esophageal Cancer for the treatment of patients with locally advanced or metastatic esophageal or gastroesophageal junction (GEJ) (tumors with epicenter 1 to 5 cent
                                                                                                          kind
                                                                                                          stage_or_setting
                                                                                                          polarity
                                                                                                          not_inferred
                                                                                                          span
                                                                                                          end
                                                                                                          5974
                                                                                                          end exclusive
                                                                                                          true
                                                                                                          exact text
                                                                                                          locally advanced or metastatic esophageal or gastro
                                                                                                          label id
                                                                                                          228e1e3f-d207-481f-8e14-9fdcbd0470e9
                                                                                                          offset unit
                                                                                                          unicode_code_points
                                                                                                          source array index
                                                                                                          0
                                                                                                          source field
                                                                                                          indications_and_usage_exact
                                                                                                          source text sha256
                                                                                                          e526ba14c91f10737e6d3331fe23a6219f58c0eca6380bfce9bd78b573fea912
                                                                                                          start
                                                                                                          5923
                                                                                                        5. context exact
                                                                                                          to surgical resection or definitive chemoradiation either: in combination with platinum- and fluoropyrimidine-based chemotherapy for patients whose tumors express PD-L1 (CPS ≥1) as determined by an FDA-authorized test, or as a single agent after one or more prior lines of systemic therapy for pati
                                                                                                          kind
                                                                                                          regimen
                                                                                                          polarity
                                                                                                          not_inferred
                                                                                                          span
                                                                                                          end
                                                                                                          6326
                                                                                                          end exclusive
                                                                                                          true
                                                                                                          exact text
                                                                                                          in combination with platinum- and fluoropyrimidine-based chemotherapy for patients whose tumors express PD-L1 (CPS ≥1) as determined by an FDA-authorized test, or as a single agen
                                                                                                          label id
                                                                                                          228e1e3f-d207-481f-8e14-9fdcbd0470e9
                                                                                                          offset unit
                                                                                                          unicode_code_points
                                                                                                          source array index
                                                                                                          0
                                                                                                          source field
                                                                                                          indications_and_usage_exact
                                                                                                          source text sha256
                                                                                                          e526ba14c91f10737e6d3331fe23a6219f58c0eca6380bfce9bd78b573fea912
                                                                                                          start
                                                                                                          6147
                                                                                                        regulatory links
                                                                                                          schema version
                                                                                                          0.1.0
                                                                                                          source batch sha256
                                                                                                          fc39a8c5cf96bf95ca20b85578140167b66b2741f7d9217f500d9ba0847ac058
                                                                                                          source defined aliases
                                                                                                          1. abbreviation
                                                                                                            NSCLC
                                                                                                            definition exact
                                                                                                            Non-Small Cell Lung Cancer
                                                                                                            definition span
                                                                                                            end
                                                                                                            380
                                                                                                            end exclusive
                                                                                                            true
                                                                                                            exact text
                                                                                                            Non-Small Cell Lung Cancer (NSCLC)
                                                                                                            label id
                                                                                                            228e1e3f-d207-481f-8e14-9fdcbd0470e9
                                                                                                            offset unit
                                                                                                            unicode_code_points
                                                                                                            source array index
                                                                                                            0
                                                                                                            source field
                                                                                                            indications_and_usage_exact
                                                                                                            source text sha256
                                                                                                            e526ba14c91f10737e6d3331fe23a6219f58c0eca6380bfce9bd78b573fea912
                                                                                                            start
                                                                                                            346
                                                                                                          2. abbreviation
                                                                                                            CRC
                                                                                                            definition exact
                                                                                                            Colorectal Cancer
                                                                                                            definition span
                                                                                                            end
                                                                                                            5042
                                                                                                            end exclusive
                                                                                                            true
                                                                                                            exact text
                                                                                                            Colorectal Cancer (CRC)
                                                                                                            label id
                                                                                                            228e1e3f-d207-481f-8e14-9fdcbd0470e9
                                                                                                            offset unit
                                                                                                            unicode_code_points
                                                                                                            source array index
                                                                                                            0
                                                                                                            source field
                                                                                                            indications_and_usage_exact
                                                                                                            source text sha256
                                                                                                            e526ba14c91f10737e6d3331fe23a6219f58c0eca6380bfce9bd78b573fea912
                                                                                                            start
                                                                                                            5019
                                                                                                          source span
                                                                                                          end
                                                                                                          6499
                                                                                                          end exclusive
                                                                                                          true
                                                                                                          exact text
                                                                                                          ( 1.10 ) Esophageal Cancer for the treatment of patients with locally advanced or metastatic esophageal or gastroesophageal junction (GEJ) (tumors with epicenter 1 to 5 centimeters above the GEJ) carcinoma that is not amenable to surgical resection or definitive chemoradiation either: in combination with platinum- and fluoropyrimidine-based chemotherapy for patients whose tumors express PD-L1 (CPS ≥1) as determined by an FDA-authorized test, or as a single agent after one or more prior lines of systemic therapy for patients with tumors of squamous cell histology that express PD-L1 (CPS ≥10) as determined by an FDA-authorized test.
                                                                                                          label id
                                                                                                          228e1e3f-d207-481f-8e14-9fdcbd0470e9
                                                                                                          offset unit
                                                                                                          unicode_code_points
                                                                                                          source array index
                                                                                                          0
                                                                                                          source field
                                                                                                          indications_and_usage_exact
                                                                                                          source text sha256
                                                                                                          e526ba14c91f10737e6d3331fe23a6219f58c0eca6380bfce9bd78b573fea912
                                                                                                          start
                                                                                                          5861
                                                                                                          source url
                                                                                                          https://api.fda.gov/drug/label.json?search=id%3A%22228e1e3f-d207-481f-8e14-9fdcbd0470e9%22
                                                                                                          spl effective date
                                                                                                          2026-07-10
                                                                                                          spl set id
                                                                                                          9333c79b-d487-4538-a9f0-71b91a02b287
                                                                                                          spl version
                                                                                                          228
                                                                                                          structured fields status
                                                                                                          not_extracted_no_values_inferred_from_mentions
                                                                                                          structured indication
                                                                                                          age
                                                                                                          Source null
                                                                                                          approval pathway
                                                                                                          Source null
                                                                                                          biomarker and test
                                                                                                          Source null
                                                                                                          disease stage
                                                                                                          Source null
                                                                                                          limitations
                                                                                                          Source null
                                                                                                          line
                                                                                                          Source null
                                                                                                          prior therapy
                                                                                                          Source null
                                                                                                          regimen
                                                                                                          Source null
                                                                                                          tumor histology
                                                                                                          Source null
                                                                                                          use intent
                                                                                                          unclear
                                                                                                          Passage 39 · unclassified context
                                                                                                          application numbers
                                                                                                          1. BLA125514
                                                                                                          brand names
                                                                                                          1. KEYTRUDA
                                                                                                          classification reasons
                                                                                                          1. no_unambiguous_positive_indication_predicate
                                                                                                          clinical review status
                                                                                                          pending
                                                                                                          content role
                                                                                                          unclassified_context
                                                                                                          context span
                                                                                                          end
                                                                                                          7029
                                                                                                          end exclusive
                                                                                                          true
                                                                                                          exact text
                                                                                                          test, or as a single agent after one or more prior lines of systemic therapy for patients with tumors of squamous cell histology that express PD-L1 (CPS ≥10) as determined by an FDA-authorized test. ( 1.11 , 2.1 ) Cervical Cancer in combination with chemoradiotherapy, for the treatment of patients with locally advanced cervical cancer involving the lower third of the vagina, with or without extension to pelvic sidewall, or hydronephrosis/non-functioning kidney, or spread to adjacent pelvic organs (FIGO 2014 Stage III-IVA). ( 1.12 ) in combination with chemotherapy, with or without bevacizumab, for the treatment of patients with persistent, recurrent, or metastatic cervical cancer whose tumors express PD-L1 (CPS ≥1) as
                                                                                                          label id
                                                                                                          228e1e3f-d207-481f-8e14-9fdcbd0470e9
                                                                                                          offset unit
                                                                                                          unicode_code_points
                                                                                                          source array index
                                                                                                          0
                                                                                                          source field
                                                                                                          indications_and_usage_exact
                                                                                                          source text sha256
                                                                                                          e526ba14c91f10737e6d3331fe23a6219f58c0eca6380bfce9bd78b573fea912
                                                                                                          start
                                                                                                          6300
                                                                                                          current approval status
                                                                                                          not_reconciled
                                                                                                          duplicate text group
                                                                                                          dup-9cb67807b61cd5f9d5fc
                                                                                                          extraction review status
                                                                                                          automated_candidate_pending_source_review
                                                                                                          generic names
                                                                                                          1. PEMBROLIZUMAB
                                                                                                          id
                                                                                                          ind-span-d5e13754411bcbb31aae
                                                                                                          label id
                                                                                                          228e1e3f-d207-481f-8e14-9fdcbd0470e9
                                                                                                          positive predicate support span
                                                                                                          Source null
                                                                                                          qualifier mentions
                                                                                                          1. context exact
                                                                                                            with chemoradiotherapy, for the treatment of patients with locally advanced cervical cancer involving the lower third of the vagina, with or without extension to pelvic s
                                                                                                            kind
                                                                                                            stage_or_setting
                                                                                                            polarity
                                                                                                            not_inferred
                                                                                                            span
                                                                                                            end
                                                                                                            6656
                                                                                                            end exclusive
                                                                                                            true
                                                                                                            exact text
                                                                                                            locally advanced cervical cancer involving the lowe
                                                                                                            label id
                                                                                                            228e1e3f-d207-481f-8e14-9fdcbd0470e9
                                                                                                            offset unit
                                                                                                            unicode_code_points
                                                                                                            source array index
                                                                                                            0
                                                                                                            source field
                                                                                                            indications_and_usage_exact
                                                                                                            source text sha256
                                                                                                            e526ba14c91f10737e6d3331fe23a6219f58c0eca6380bfce9bd78b573fea912
                                                                                                            start
                                                                                                            6605
                                                                                                          2. context exact
                                                                                                            ( 1.11 , 2.1 ) Cervical Cancer in combination with chemoradiotherapy, for the treatment of patients with locally advanced cervical cancer involving the lower third of the vagina, with or without extension to pelvic sidewall, or hydronephrosis/non-functioning kidney, or
                                                                                                            kind
                                                                                                            regimen
                                                                                                            polarity
                                                                                                            not_inferred
                                                                                                            span
                                                                                                            end
                                                                                                            6710
                                                                                                            end exclusive
                                                                                                            true
                                                                                                            exact text
                                                                                                            in combination with chemoradiotherapy, for the treatment of patients with locally advanced cervical cancer involving the lower third of the vagina, with or without extension to pe
                                                                                                            label id
                                                                                                            228e1e3f-d207-481f-8e14-9fdcbd0470e9
                                                                                                            offset unit
                                                                                                            unicode_code_points
                                                                                                            source array index
                                                                                                            0
                                                                                                            source field
                                                                                                            indications_and_usage_exact
                                                                                                            source text sha256
                                                                                                            e526ba14c91f10737e6d3331fe23a6219f58c0eca6380bfce9bd78b573fea912
                                                                                                            start
                                                                                                            6531
                                                                                                          regulatory links
                                                                                                            schema version
                                                                                                            0.1.0
                                                                                                            source batch sha256
                                                                                                            fc39a8c5cf96bf95ca20b85578140167b66b2741f7d9217f500d9ba0847ac058
                                                                                                            source defined aliases
                                                                                                            1. abbreviation
                                                                                                              NSCLC
                                                                                                              definition exact
                                                                                                              Non-Small Cell Lung Cancer
                                                                                                              definition span
                                                                                                              end
                                                                                                              380
                                                                                                              end exclusive
                                                                                                              true
                                                                                                              exact text
                                                                                                              Non-Small Cell Lung Cancer (NSCLC)
                                                                                                              label id
                                                                                                              228e1e3f-d207-481f-8e14-9fdcbd0470e9
                                                                                                              offset unit
                                                                                                              unicode_code_points
                                                                                                              source array index
                                                                                                              0
                                                                                                              source field
                                                                                                              indications_and_usage_exact
                                                                                                              source text sha256
                                                                                                              e526ba14c91f10737e6d3331fe23a6219f58c0eca6380bfce9bd78b573fea912
                                                                                                              start
                                                                                                              346
                                                                                                            2. abbreviation
                                                                                                              CRC
                                                                                                              definition exact
                                                                                                              Colorectal Cancer
                                                                                                              definition span
                                                                                                              end
                                                                                                              5042
                                                                                                              end exclusive
                                                                                                              true
                                                                                                              exact text
                                                                                                              Colorectal Cancer (CRC)
                                                                                                              label id
                                                                                                              228e1e3f-d207-481f-8e14-9fdcbd0470e9
                                                                                                              offset unit
                                                                                                              unicode_code_points
                                                                                                              source array index
                                                                                                              0
                                                                                                              source field
                                                                                                              indications_and_usage_exact
                                                                                                              source text sha256
                                                                                                              e526ba14c91f10737e6d3331fe23a6219f58c0eca6380bfce9bd78b573fea912
                                                                                                              start
                                                                                                              5019
                                                                                                            source span
                                                                                                            end
                                                                                                            6829
                                                                                                            end exclusive
                                                                                                            true
                                                                                                            exact text
                                                                                                            ( 1.11 , 2.1 ) Cervical Cancer in combination with chemoradiotherapy, for the treatment of patients with locally advanced cervical cancer involving the lower third of the vagina, with or without extension to pelvic sidewall, or hydronephrosis/non-functioning kidney, or spread to adjacent pelvic organs (FIGO 2014 Stage III-IVA).
                                                                                                            label id
                                                                                                            228e1e3f-d207-481f-8e14-9fdcbd0470e9
                                                                                                            offset unit
                                                                                                            unicode_code_points
                                                                                                            source array index
                                                                                                            0
                                                                                                            source field
                                                                                                            indications_and_usage_exact
                                                                                                            source text sha256
                                                                                                            e526ba14c91f10737e6d3331fe23a6219f58c0eca6380bfce9bd78b573fea912
                                                                                                            start
                                                                                                            6500
                                                                                                            source url
                                                                                                            https://api.fda.gov/drug/label.json?search=id%3A%22228e1e3f-d207-481f-8e14-9fdcbd0470e9%22
                                                                                                            spl effective date
                                                                                                            2026-07-10
                                                                                                            spl set id
                                                                                                            9333c79b-d487-4538-a9f0-71b91a02b287
                                                                                                            spl version
                                                                                                            228
                                                                                                            structured fields status
                                                                                                            not_extracted_no_values_inferred_from_mentions
                                                                                                            structured indication
                                                                                                            age
                                                                                                            Source null
                                                                                                            approval pathway
                                                                                                            Source null
                                                                                                            biomarker and test
                                                                                                            Source null
                                                                                                            disease stage
                                                                                                            Source null
                                                                                                            limitations
                                                                                                            Source null
                                                                                                            line
                                                                                                            Source null
                                                                                                            prior therapy
                                                                                                            Source null
                                                                                                            regimen
                                                                                                            Source null
                                                                                                            tumor histology
                                                                                                            Source null
                                                                                                            use intent
                                                                                                            unclear
                                                                                                            Passage 40 · unclassified context
                                                                                                            application numbers
                                                                                                            1. BLA125514
                                                                                                            brand names
                                                                                                            1. KEYTRUDA
                                                                                                            classification reasons
                                                                                                            1. no_unambiguous_positive_indication_predicate
                                                                                                            clinical review status
                                                                                                            pending
                                                                                                            content role
                                                                                                            unclassified_context
                                                                                                            context span
                                                                                                            end
                                                                                                            7038
                                                                                                            end exclusive
                                                                                                            true
                                                                                                            exact text
                                                                                                            cancer involving the lower third of the vagina, with or without extension to pelvic sidewall, or hydronephrosis/non-functioning kidney, or spread to adjacent pelvic organs (FIGO 2014 Stage III-IVA). ( 1.12 ) in combination with chemotherapy, with or without bevacizumab, for the treatment of patients with persistent, recurrent, or metastatic cervical cancer whose tumors express PD-L1 (CPS ≥1) as determine
                                                                                                            label id
                                                                                                            228e1e3f-d207-481f-8e14-9fdcbd0470e9
                                                                                                            offset unit
                                                                                                            unicode_code_points
                                                                                                            source array index
                                                                                                            0
                                                                                                            source field
                                                                                                            indications_and_usage_exact
                                                                                                            source text sha256
                                                                                                            e526ba14c91f10737e6d3331fe23a6219f58c0eca6380bfce9bd78b573fea912
                                                                                                            start
                                                                                                            6630
                                                                                                            current approval status
                                                                                                            not_reconciled
                                                                                                            duplicate text group
                                                                                                            dup-c2ef1c49bc72c10ac74a
                                                                                                            extraction review status
                                                                                                            automated_candidate_pending_source_review
                                                                                                            generic names
                                                                                                            1. PEMBROLIZUMAB
                                                                                                            id
                                                                                                            ind-span-ea4e0fcf3230ed99197d
                                                                                                            label id
                                                                                                            228e1e3f-d207-481f-8e14-9fdcbd0470e9
                                                                                                            positive predicate support span
                                                                                                            Source null
                                                                                                            qualifier mentions
                                                                                                              regulatory links
                                                                                                                schema version
                                                                                                                0.1.0
                                                                                                                source batch sha256
                                                                                                                fc39a8c5cf96bf95ca20b85578140167b66b2741f7d9217f500d9ba0847ac058
                                                                                                                source defined aliases
                                                                                                                1. abbreviation
                                                                                                                  NSCLC
                                                                                                                  definition exact
                                                                                                                  Non-Small Cell Lung Cancer
                                                                                                                  definition span
                                                                                                                  end
                                                                                                                  380
                                                                                                                  end exclusive
                                                                                                                  true
                                                                                                                  exact text
                                                                                                                  Non-Small Cell Lung Cancer (NSCLC)
                                                                                                                  label id
                                                                                                                  228e1e3f-d207-481f-8e14-9fdcbd0470e9
                                                                                                                  offset unit
                                                                                                                  unicode_code_points
                                                                                                                  source array index
                                                                                                                  0
                                                                                                                  source field
                                                                                                                  indications_and_usage_exact
                                                                                                                  source text sha256
                                                                                                                  e526ba14c91f10737e6d3331fe23a6219f58c0eca6380bfce9bd78b573fea912
                                                                                                                  start
                                                                                                                  346
                                                                                                                2. abbreviation
                                                                                                                  CRC
                                                                                                                  definition exact
                                                                                                                  Colorectal Cancer
                                                                                                                  definition span
                                                                                                                  end
                                                                                                                  5042
                                                                                                                  end exclusive
                                                                                                                  true
                                                                                                                  exact text
                                                                                                                  Colorectal Cancer (CRC)
                                                                                                                  label id
                                                                                                                  228e1e3f-d207-481f-8e14-9fdcbd0470e9
                                                                                                                  offset unit
                                                                                                                  unicode_code_points
                                                                                                                  source array index
                                                                                                                  0
                                                                                                                  source field
                                                                                                                  indications_and_usage_exact
                                                                                                                  source text sha256
                                                                                                                  e526ba14c91f10737e6d3331fe23a6219f58c0eca6380bfce9bd78b573fea912
                                                                                                                  start
                                                                                                                  5019
                                                                                                                source span
                                                                                                                end
                                                                                                                6838
                                                                                                                end exclusive
                                                                                                                true
                                                                                                                exact text
                                                                                                                ( 1.12 )
                                                                                                                label id
                                                                                                                228e1e3f-d207-481f-8e14-9fdcbd0470e9
                                                                                                                offset unit
                                                                                                                unicode_code_points
                                                                                                                source array index
                                                                                                                0
                                                                                                                source field
                                                                                                                indications_and_usage_exact
                                                                                                                source text sha256
                                                                                                                e526ba14c91f10737e6d3331fe23a6219f58c0eca6380bfce9bd78b573fea912
                                                                                                                start
                                                                                                                6830
                                                                                                                source url
                                                                                                                https://api.fda.gov/drug/label.json?search=id%3A%22228e1e3f-d207-481f-8e14-9fdcbd0470e9%22
                                                                                                                spl effective date
                                                                                                                2026-07-10
                                                                                                                spl set id
                                                                                                                9333c79b-d487-4538-a9f0-71b91a02b287
                                                                                                                spl version
                                                                                                                228
                                                                                                                structured fields status
                                                                                                                not_extracted_no_values_inferred_from_mentions
                                                                                                                structured indication
                                                                                                                age
                                                                                                                Source null
                                                                                                                approval pathway
                                                                                                                Source null
                                                                                                                biomarker and test
                                                                                                                Source null
                                                                                                                disease stage
                                                                                                                Source null
                                                                                                                limitations
                                                                                                                Source null
                                                                                                                line
                                                                                                                Source null
                                                                                                                prior therapy
                                                                                                                Source null
                                                                                                                regimen
                                                                                                                Source null
                                                                                                                tumor histology
                                                                                                                Source null
                                                                                                                use intent
                                                                                                                unclear
                                                                                                                Passage 41 · unclassified context
                                                                                                                application numbers
                                                                                                                1. BLA125514
                                                                                                                brand names
                                                                                                                1. KEYTRUDA
                                                                                                                classification reasons
                                                                                                                1. no_unambiguous_positive_indication_predicate
                                                                                                                clinical review status
                                                                                                                pending
                                                                                                                content role
                                                                                                                unclassified_context
                                                                                                                context span
                                                                                                                end
                                                                                                                7266
                                                                                                                end exclusive
                                                                                                                true
                                                                                                                exact text
                                                                                                                nvolving the lower third of the vagina, with or without extension to pelvic sidewall, or hydronephrosis/non-functioning kidney, or spread to adjacent pelvic organs (FIGO 2014 Stage III-IVA). ( 1.12 ) in combination with chemotherapy, with or without bevacizumab, for the treatment of patients with persistent, recurrent, or metastatic cervical cancer whose tumors express PD-L1 (CPS ≥1) as determined by an FDA-authorized test. ( 1.12 , 2.1 ) as a single agent for the treatment of patients with recurrent or metastatic cervical cancer with disease progression on or after chemotherapy whose tumors express PD-L1 (CPS ≥1) as de
                                                                                                                label id
                                                                                                                228e1e3f-d207-481f-8e14-9fdcbd0470e9
                                                                                                                offset unit
                                                                                                                unicode_code_points
                                                                                                                source array index
                                                                                                                0
                                                                                                                source field
                                                                                                                indications_and_usage_exact
                                                                                                                source text sha256
                                                                                                                e526ba14c91f10737e6d3331fe23a6219f58c0eca6380bfce9bd78b573fea912
                                                                                                                start
                                                                                                                6639
                                                                                                                current approval status
                                                                                                                not_reconciled
                                                                                                                duplicate text group
                                                                                                                dup-24c0fe7b25b00d1bd2dc
                                                                                                                extraction review status
                                                                                                                automated_candidate_pending_source_review
                                                                                                                generic names
                                                                                                                1. PEMBROLIZUMAB
                                                                                                                id
                                                                                                                ind-span-69ff98d92def39d8a7ca
                                                                                                                label id
                                                                                                                228e1e3f-d207-481f-8e14-9fdcbd0470e9
                                                                                                                positive predicate support span
                                                                                                                Source null
                                                                                                                qualifier mentions
                                                                                                                1. context exact
                                                                                                                  or the treatment of patients with persistent, recurrent, or metastatic cervical cancer whose tumors express PD-L1 (CPS ≥1) as determined by an FDA-authorized test.
                                                                                                                  kind
                                                                                                                  biomarker
                                                                                                                  polarity
                                                                                                                  not_inferred
                                                                                                                  span
                                                                                                                  end
                                                                                                                  7006
                                                                                                                  end exclusive
                                                                                                                  true
                                                                                                                  exact text
                                                                                                                  metastatic cervical cancer whose tumors exp
                                                                                                                  label id
                                                                                                                  228e1e3f-d207-481f-8e14-9fdcbd0470e9
                                                                                                                  offset unit
                                                                                                                  unicode_code_points
                                                                                                                  source array index
                                                                                                                  0
                                                                                                                  source field
                                                                                                                  indications_and_usage_exact
                                                                                                                  source text sha256
                                                                                                                  e526ba14c91f10737e6d3331fe23a6219f58c0eca6380bfce9bd78b573fea912
                                                                                                                  start
                                                                                                                  6963
                                                                                                                2. context exact
                                                                                                                  current, or metastatic cervical cancer whose tumors express PD-L1 (CPS ≥1) as determined by an FDA-authorized test.
                                                                                                                  kind
                                                                                                                  biomarker
                                                                                                                  polarity
                                                                                                                  not_inferred
                                                                                                                  span
                                                                                                                  end
                                                                                                                  7056
                                                                                                                  end exclusive
                                                                                                                  true
                                                                                                                  exact text
                                                                                                                  PD-L1 (CPS ≥1) as determined by an FDA-author
                                                                                                                  label id
                                                                                                                  228e1e3f-d207-481f-8e14-9fdcbd0470e9
                                                                                                                  offset unit
                                                                                                                  unicode_code_points
                                                                                                                  source array index
                                                                                                                  0
                                                                                                                  source field
                                                                                                                  indications_and_usage_exact
                                                                                                                  source text sha256
                                                                                                                  e526ba14c91f10737e6d3331fe23a6219f58c0eca6380bfce9bd78b573fea912
                                                                                                                  start
                                                                                                                  7011
                                                                                                                3. context exact
                                                                                                                  bevacizumab, for the treatment of patients with persistent, recurrent, or metastatic cervical cancer whose tumors express PD-L1 (
                                                                                                                  kind
                                                                                                                  stage_or_setting
                                                                                                                  polarity
                                                                                                                  not_inferred
                                                                                                                  span
                                                                                                                  end
                                                                                                                  6958
                                                                                                                  end exclusive
                                                                                                                  true
                                                                                                                  exact text
                                                                                                                  recurrent
                                                                                                                  label id
                                                                                                                  228e1e3f-d207-481f-8e14-9fdcbd0470e9
                                                                                                                  offset unit
                                                                                                                  unicode_code_points
                                                                                                                  source array index
                                                                                                                  0
                                                                                                                  source field
                                                                                                                  indications_and_usage_exact
                                                                                                                  source text sha256
                                                                                                                  e526ba14c91f10737e6d3331fe23a6219f58c0eca6380bfce9bd78b573fea912
                                                                                                                  start
                                                                                                                  6949
                                                                                                                4. context exact
                                                                                                                  or the treatment of patients with persistent, recurrent, or metastatic cervical cancer whose tumors express PD-L1 (CPS ≥1) as determined by an FDA-authorized test.
                                                                                                                  kind
                                                                                                                  stage_or_setting
                                                                                                                  polarity
                                                                                                                  not_inferred
                                                                                                                  span
                                                                                                                  end
                                                                                                                  7008
                                                                                                                  end exclusive
                                                                                                                  true
                                                                                                                  exact text
                                                                                                                  metastatic cervical cancer whose tumors expre
                                                                                                                  label id
                                                                                                                  228e1e3f-d207-481f-8e14-9fdcbd0470e9
                                                                                                                  offset unit
                                                                                                                  unicode_code_points
                                                                                                                  source array index
                                                                                                                  0
                                                                                                                  source field
                                                                                                                  indications_and_usage_exact
                                                                                                                  source text sha256
                                                                                                                  e526ba14c91f10737e6d3331fe23a6219f58c0eca6380bfce9bd78b573fea912
                                                                                                                  start
                                                                                                                  6963
                                                                                                                5. context exact
                                                                                                                  in combination with chemotherapy, with or without bevacizumab, for the treatment of patients with persistent, recurrent, or metastatic cervical cancer whose tumors express PD-L1 (CPS ≥1) as determined by an FDA-authorized test.
                                                                                                                  kind
                                                                                                                  regimen
                                                                                                                  polarity
                                                                                                                  not_inferred
                                                                                                                  span
                                                                                                                  end
                                                                                                                  7018
                                                                                                                  end exclusive
                                                                                                                  true
                                                                                                                  exact text
                                                                                                                  in combination with chemotherapy, with or without bevacizumab, for the treatment of patients with persistent, recurrent, or metastatic cervical cancer whose tumors express PD-L1 (
                                                                                                                  label id
                                                                                                                  228e1e3f-d207-481f-8e14-9fdcbd0470e9
                                                                                                                  offset unit
                                                                                                                  unicode_code_points
                                                                                                                  source array index
                                                                                                                  0
                                                                                                                  source field
                                                                                                                  indications_and_usage_exact
                                                                                                                  source text sha256
                                                                                                                  e526ba14c91f10737e6d3331fe23a6219f58c0eca6380bfce9bd78b573fea912
                                                                                                                  start
                                                                                                                  6839
                                                                                                                regulatory links
                                                                                                                  schema version
                                                                                                                  0.1.0
                                                                                                                  source batch sha256
                                                                                                                  fc39a8c5cf96bf95ca20b85578140167b66b2741f7d9217f500d9ba0847ac058
                                                                                                                  source defined aliases
                                                                                                                  1. abbreviation
                                                                                                                    NSCLC
                                                                                                                    definition exact
                                                                                                                    Non-Small Cell Lung Cancer
                                                                                                                    definition span
                                                                                                                    end
                                                                                                                    380
                                                                                                                    end exclusive
                                                                                                                    true
                                                                                                                    exact text
                                                                                                                    Non-Small Cell Lung Cancer (NSCLC)
                                                                                                                    label id
                                                                                                                    228e1e3f-d207-481f-8e14-9fdcbd0470e9
                                                                                                                    offset unit
                                                                                                                    unicode_code_points
                                                                                                                    source array index
                                                                                                                    0
                                                                                                                    source field
                                                                                                                    indications_and_usage_exact
                                                                                                                    source text sha256
                                                                                                                    e526ba14c91f10737e6d3331fe23a6219f58c0eca6380bfce9bd78b573fea912
                                                                                                                    start
                                                                                                                    346
                                                                                                                  2. abbreviation
                                                                                                                    CRC
                                                                                                                    definition exact
                                                                                                                    Colorectal Cancer
                                                                                                                    definition span
                                                                                                                    end
                                                                                                                    5042
                                                                                                                    end exclusive
                                                                                                                    true
                                                                                                                    exact text
                                                                                                                    Colorectal Cancer (CRC)
                                                                                                                    label id
                                                                                                                    228e1e3f-d207-481f-8e14-9fdcbd0470e9
                                                                                                                    offset unit
                                                                                                                    unicode_code_points
                                                                                                                    source array index
                                                                                                                    0
                                                                                                                    source field
                                                                                                                    indications_and_usage_exact
                                                                                                                    source text sha256
                                                                                                                    e526ba14c91f10737e6d3331fe23a6219f58c0eca6380bfce9bd78b573fea912
                                                                                                                    start
                                                                                                                    5019
                                                                                                                  source span
                                                                                                                  end
                                                                                                                  7066
                                                                                                                  end exclusive
                                                                                                                  true
                                                                                                                  exact text
                                                                                                                  in combination with chemotherapy, with or without bevacizumab, for the treatment of patients with persistent, recurrent, or metastatic cervical cancer whose tumors express PD-L1 (CPS ≥1) as determined by an FDA-authorized test.
                                                                                                                  label id
                                                                                                                  228e1e3f-d207-481f-8e14-9fdcbd0470e9
                                                                                                                  offset unit
                                                                                                                  unicode_code_points
                                                                                                                  source array index
                                                                                                                  0
                                                                                                                  source field
                                                                                                                  indications_and_usage_exact
                                                                                                                  source text sha256
                                                                                                                  e526ba14c91f10737e6d3331fe23a6219f58c0eca6380bfce9bd78b573fea912
                                                                                                                  start
                                                                                                                  6839
                                                                                                                  source url
                                                                                                                  https://api.fda.gov/drug/label.json?search=id%3A%22228e1e3f-d207-481f-8e14-9fdcbd0470e9%22
                                                                                                                  spl effective date
                                                                                                                  2026-07-10
                                                                                                                  spl set id
                                                                                                                  9333c79b-d487-4538-a9f0-71b91a02b287
                                                                                                                  spl version
                                                                                                                  228
                                                                                                                  structured fields status
                                                                                                                  not_extracted_no_values_inferred_from_mentions
                                                                                                                  structured indication
                                                                                                                  age
                                                                                                                  Source null
                                                                                                                  approval pathway
                                                                                                                  Source null
                                                                                                                  biomarker and test
                                                                                                                  Source null
                                                                                                                  disease stage
                                                                                                                  Source null
                                                                                                                  limitations
                                                                                                                  Source null
                                                                                                                  line
                                                                                                                  Source null
                                                                                                                  prior therapy
                                                                                                                  Source null
                                                                                                                  regimen
                                                                                                                  Source null
                                                                                                                  tumor histology
                                                                                                                  Source null
                                                                                                                  use intent
                                                                                                                  unclear
                                                                                                                  Passage 42 · unclassified context
                                                                                                                  application numbers
                                                                                                                  1. BLA125514
                                                                                                                  brand names
                                                                                                                  1. KEYTRUDA
                                                                                                                  classification reasons
                                                                                                                  1. no_unambiguous_positive_indication_predicate
                                                                                                                  clinical review status
                                                                                                                  pending
                                                                                                                  content role
                                                                                                                  unclassified_context
                                                                                                                  context span
                                                                                                                  end
                                                                                                                  7501
                                                                                                                  end exclusive
                                                                                                                  true
                                                                                                                  exact text
                                                                                                                  rapy, with or without bevacizumab, for the treatment of patients with persistent, recurrent, or metastatic cervical cancer whose tumors express PD-L1 (CPS ≥1) as determined by an FDA-authorized test. ( 1.12 , 2.1 ) as a single agent for the treatment of patients with recurrent or metastatic cervical cancer with disease progression on or after chemotherapy whose tumors express PD-L1 (CPS ≥1) as determined by an FDA-authorized test. ( 1.12 , 2.1 ) Hepatocellular Carcinoma (HCC) for the treatment of patients with HCC secondary to hepatitis B who have received prior systemic therapy other than a PD-1/PD-L1-containing regimen. ( 1.
                                                                                                                  label id
                                                                                                                  228e1e3f-d207-481f-8e14-9fdcbd0470e9
                                                                                                                  offset unit
                                                                                                                  unicode_code_points
                                                                                                                  source array index
                                                                                                                  0
                                                                                                                  source field
                                                                                                                  indications_and_usage_exact
                                                                                                                  source text sha256
                                                                                                                  e526ba14c91f10737e6d3331fe23a6219f58c0eca6380bfce9bd78b573fea912
                                                                                                                  start
                                                                                                                  6867
                                                                                                                  current approval status
                                                                                                                  not_reconciled
                                                                                                                  duplicate text group
                                                                                                                  dup-5b3f89597b3eb9355523
                                                                                                                  extraction review status
                                                                                                                  automated_candidate_pending_source_review
                                                                                                                  generic names
                                                                                                                  1. PEMBROLIZUMAB
                                                                                                                  id
                                                                                                                  ind-span-bc08dcc7c0930061777e
                                                                                                                  label id
                                                                                                                  228e1e3f-d207-481f-8e14-9fdcbd0470e9
                                                                                                                  positive predicate support span
                                                                                                                  Source null
                                                                                                                  qualifier mentions
                                                                                                                  1. context exact
                                                                                                                    ingle agent for the treatment of patients with recurrent or metastatic cervical cancer with disease progression on or after chemotherapy whose tumors express PD-L1
                                                                                                                    kind
                                                                                                                    biomarker
                                                                                                                    polarity
                                                                                                                    not_inferred
                                                                                                                    span
                                                                                                                    end
                                                                                                                    7191
                                                                                                                    end exclusive
                                                                                                                    true
                                                                                                                    exact text
                                                                                                                    metastatic cervical cancer with disease pro
                                                                                                                    label id
                                                                                                                    228e1e3f-d207-481f-8e14-9fdcbd0470e9
                                                                                                                    offset unit
                                                                                                                    unicode_code_points
                                                                                                                    source array index
                                                                                                                    0
                                                                                                                    source field
                                                                                                                    indications_and_usage_exact
                                                                                                                    source text sha256
                                                                                                                    e526ba14c91f10737e6d3331fe23a6219f58c0eca6380bfce9bd78b573fea912
                                                                                                                    start
                                                                                                                    7148
                                                                                                                  2. context exact
                                                                                                                    e progression on or after chemotherapy whose tumors express PD-L1 (CPS ≥1) as determined by an FDA-authorized test.
                                                                                                                    kind
                                                                                                                    biomarker
                                                                                                                    polarity
                                                                                                                    not_inferred
                                                                                                                    span
                                                                                                                    end
                                                                                                                    7291
                                                                                                                    end exclusive
                                                                                                                    true
                                                                                                                    exact text
                                                                                                                    PD-L1 (CPS ≥1) as determined by an FDA-author
                                                                                                                    label id
                                                                                                                    228e1e3f-d207-481f-8e14-9fdcbd0470e9
                                                                                                                    offset unit
                                                                                                                    unicode_code_points
                                                                                                                    source array index
                                                                                                                    0
                                                                                                                    source field
                                                                                                                    indications_and_usage_exact
                                                                                                                    source text sha256
                                                                                                                    e526ba14c91f10737e6d3331fe23a6219f58c0eca6380bfce9bd78b573fea912
                                                                                                                    start
                                                                                                                    7246
                                                                                                                  3. context exact
                                                                                                                    2.1 ) as a single agent for the treatment of patients with recurrent or metastatic cervical cancer with disease progression on or after chemotherapy whose tumors e
                                                                                                                    kind
                                                                                                                    stage_or_setting
                                                                                                                    polarity
                                                                                                                    not_inferred
                                                                                                                    span
                                                                                                                    end
                                                                                                                    7179
                                                                                                                    end exclusive
                                                                                                                    true
                                                                                                                    exact text
                                                                                                                    recurrent or metastatic cervical cancer with
                                                                                                                    label id
                                                                                                                    228e1e3f-d207-481f-8e14-9fdcbd0470e9
                                                                                                                    offset unit
                                                                                                                    unicode_code_points
                                                                                                                    source array index
                                                                                                                    0
                                                                                                                    source field
                                                                                                                    indications_and_usage_exact
                                                                                                                    source text sha256
                                                                                                                    e526ba14c91f10737e6d3331fe23a6219f58c0eca6380bfce9bd78b573fea912
                                                                                                                    start
                                                                                                                    7135
                                                                                                                  4. context exact
                                                                                                                    ( 1.12 , 2.1 ) as a single agent for the treatment of patients with recurrent or metastatic cervical cancer with disease progression on or after chemotherapy whose tumors express PD-L1 (CPS ≥1) as determined by an FDA-authorized test.
                                                                                                                    kind
                                                                                                                    regimen
                                                                                                                    polarity
                                                                                                                    not_inferred
                                                                                                                    span
                                                                                                                    end
                                                                                                                    7259
                                                                                                                    end exclusive
                                                                                                                    true
                                                                                                                    exact text
                                                                                                                    as a single agent for the treatment of patients with recurrent or metastatic cervical cancer with disease progression on or after chemotherapy whose tumors express PD-L1 (CPS ≥1
                                                                                                                    label id
                                                                                                                    228e1e3f-d207-481f-8e14-9fdcbd0470e9
                                                                                                                    offset unit
                                                                                                                    unicode_code_points
                                                                                                                    source array index
                                                                                                                    0
                                                                                                                    source field
                                                                                                                    indications_and_usage_exact
                                                                                                                    source text sha256
                                                                                                                    e526ba14c91f10737e6d3331fe23a6219f58c0eca6380bfce9bd78b573fea912
                                                                                                                    start
                                                                                                                    7082
                                                                                                                  regulatory links
                                                                                                                    schema version
                                                                                                                    0.1.0
                                                                                                                    source batch sha256
                                                                                                                    fc39a8c5cf96bf95ca20b85578140167b66b2741f7d9217f500d9ba0847ac058
                                                                                                                    source defined aliases
                                                                                                                    1. abbreviation
                                                                                                                      NSCLC
                                                                                                                      definition exact
                                                                                                                      Non-Small Cell Lung Cancer
                                                                                                                      definition span
                                                                                                                      end
                                                                                                                      380
                                                                                                                      end exclusive
                                                                                                                      true
                                                                                                                      exact text
                                                                                                                      Non-Small Cell Lung Cancer (NSCLC)
                                                                                                                      label id
                                                                                                                      228e1e3f-d207-481f-8e14-9fdcbd0470e9
                                                                                                                      offset unit
                                                                                                                      unicode_code_points
                                                                                                                      source array index
                                                                                                                      0
                                                                                                                      source field
                                                                                                                      indications_and_usage_exact
                                                                                                                      source text sha256
                                                                                                                      e526ba14c91f10737e6d3331fe23a6219f58c0eca6380bfce9bd78b573fea912
                                                                                                                      start
                                                                                                                      346
                                                                                                                    2. abbreviation
                                                                                                                      CRC
                                                                                                                      definition exact
                                                                                                                      Colorectal Cancer
                                                                                                                      definition span
                                                                                                                      end
                                                                                                                      5042
                                                                                                                      end exclusive
                                                                                                                      true
                                                                                                                      exact text
                                                                                                                      Colorectal Cancer (CRC)
                                                                                                                      label id
                                                                                                                      228e1e3f-d207-481f-8e14-9fdcbd0470e9
                                                                                                                      offset unit
                                                                                                                      unicode_code_points
                                                                                                                      source array index
                                                                                                                      0
                                                                                                                      source field
                                                                                                                      indications_and_usage_exact
                                                                                                                      source text sha256
                                                                                                                      e526ba14c91f10737e6d3331fe23a6219f58c0eca6380bfce9bd78b573fea912
                                                                                                                      start
                                                                                                                      5019
                                                                                                                    source span
                                                                                                                    end
                                                                                                                    7301
                                                                                                                    end exclusive
                                                                                                                    true
                                                                                                                    exact text
                                                                                                                    ( 1.12 , 2.1 ) as a single agent for the treatment of patients with recurrent or metastatic cervical cancer with disease progression on or after chemotherapy whose tumors express PD-L1 (CPS ≥1) as determined by an FDA-authorized test.
                                                                                                                    label id
                                                                                                                    228e1e3f-d207-481f-8e14-9fdcbd0470e9
                                                                                                                    offset unit
                                                                                                                    unicode_code_points
                                                                                                                    source array index
                                                                                                                    0
                                                                                                                    source field
                                                                                                                    indications_and_usage_exact
                                                                                                                    source text sha256
                                                                                                                    e526ba14c91f10737e6d3331fe23a6219f58c0eca6380bfce9bd78b573fea912
                                                                                                                    start
                                                                                                                    7067
                                                                                                                    source url
                                                                                                                    https://api.fda.gov/drug/label.json?search=id%3A%22228e1e3f-d207-481f-8e14-9fdcbd0470e9%22
                                                                                                                    spl effective date
                                                                                                                    2026-07-10
                                                                                                                    spl set id
                                                                                                                    9333c79b-d487-4538-a9f0-71b91a02b287
                                                                                                                    spl version
                                                                                                                    228
                                                                                                                    structured fields status
                                                                                                                    not_extracted_no_values_inferred_from_mentions
                                                                                                                    structured indication
                                                                                                                    age
                                                                                                                    Source null
                                                                                                                    approval pathway
                                                                                                                    Source null
                                                                                                                    biomarker and test
                                                                                                                    Source null
                                                                                                                    disease stage
                                                                                                                    Source null
                                                                                                                    limitations
                                                                                                                    Source null
                                                                                                                    line
                                                                                                                    Source null
                                                                                                                    prior therapy
                                                                                                                    Source null
                                                                                                                    regimen
                                                                                                                    Source null
                                                                                                                    tumor histology
                                                                                                                    Source null
                                                                                                                    use intent
                                                                                                                    unclear
                                                                                                                    Passage 43 · unclassified context
                                                                                                                    application numbers
                                                                                                                    1. BLA125514
                                                                                                                    brand names
                                                                                                                    1. KEYTRUDA
                                                                                                                    classification reasons
                                                                                                                    1. no_unambiguous_positive_indication_predicate
                                                                                                                    clinical review status
                                                                                                                    pending
                                                                                                                    content role
                                                                                                                    unclassified_context
                                                                                                                    context span
                                                                                                                    end
                                                                                                                    7696
                                                                                                                    end exclusive
                                                                                                                    true
                                                                                                                    exact text
                                                                                                                    r the treatment of patients with recurrent or metastatic cervical cancer with disease progression on or after chemotherapy whose tumors express PD-L1 (CPS ≥1) as determined by an FDA-authorized test. ( 1.12 , 2.1 ) Hepatocellular Carcinoma (HCC) for the treatment of patients with HCC secondary to hepatitis B who have received prior systemic therapy other than a PD-1/PD-L1-containing regimen. ( 1.13 ) Biliary Tract Cancer (BTC) in combination with gemcitabine and cisplatin, for the treatment of patients with locally advanced unresectable or metastatic biliary tract cancer. ( 1.14 ) Merkel
                                                                                                                    label id
                                                                                                                    228e1e3f-d207-481f-8e14-9fdcbd0470e9
                                                                                                                    offset unit
                                                                                                                    unicode_code_points
                                                                                                                    source array index
                                                                                                                    0
                                                                                                                    source field
                                                                                                                    indications_and_usage_exact
                                                                                                                    source text sha256
                                                                                                                    e526ba14c91f10737e6d3331fe23a6219f58c0eca6380bfce9bd78b573fea912
                                                                                                                    start
                                                                                                                    7102
                                                                                                                    current approval status
                                                                                                                    not_reconciled
                                                                                                                    duplicate text group
                                                                                                                    dup-7ce900c89c4ebe4a1d68
                                                                                                                    extraction review status
                                                                                                                    automated_candidate_pending_source_review
                                                                                                                    generic names
                                                                                                                    1. PEMBROLIZUMAB
                                                                                                                    id
                                                                                                                    ind-span-f9394f05deeb026102e1
                                                                                                                    label id
                                                                                                                    228e1e3f-d207-481f-8e14-9fdcbd0470e9
                                                                                                                    positive predicate support span
                                                                                                                    Source null
                                                                                                                    qualifier mentions
                                                                                                                    1. context exact
                                                                                                                      who have received prior systemic therapy other than a PD-1/PD-L1-containing regimen.
                                                                                                                      kind
                                                                                                                      biomarker
                                                                                                                      polarity
                                                                                                                      not_inferred
                                                                                                                      span
                                                                                                                      end
                                                                                                                      7495
                                                                                                                      end exclusive
                                                                                                                      true
                                                                                                                      exact text
                                                                                                                      PD-L1-containing regimen
                                                                                                                      label id
                                                                                                                      228e1e3f-d207-481f-8e14-9fdcbd0470e9
                                                                                                                      offset unit
                                                                                                                      unicode_code_points
                                                                                                                      source array index
                                                                                                                      0
                                                                                                                      source field
                                                                                                                      indications_and_usage_exact
                                                                                                                      source text sha256
                                                                                                                      e526ba14c91f10737e6d3331fe23a6219f58c0eca6380bfce9bd78b573fea912
                                                                                                                      start
                                                                                                                      7471
                                                                                                                    2. context exact
                                                                                                                      the treatment of patients with HCC secondary to hepatitis B who have received prior systemic therapy other than a PD-1/PD-L1-containing regimen.
                                                                                                                      kind
                                                                                                                      prior_therapy_or_line
                                                                                                                      polarity
                                                                                                                      not_inferred
                                                                                                                      span
                                                                                                                      end
                                                                                                                      7495
                                                                                                                      end exclusive
                                                                                                                      true
                                                                                                                      exact text
                                                                                                                      who have received prior systemic therapy other than a PD-1/PD-L1-containing regimen
                                                                                                                      label id
                                                                                                                      228e1e3f-d207-481f-8e14-9fdcbd0470e9
                                                                                                                      offset unit
                                                                                                                      unicode_code_points
                                                                                                                      source array index
                                                                                                                      0
                                                                                                                      source field
                                                                                                                      indications_and_usage_exact
                                                                                                                      source text sha256
                                                                                                                      e526ba14c91f10737e6d3331fe23a6219f58c0eca6380bfce9bd78b573fea912
                                                                                                                      start
                                                                                                                      7412
                                                                                                                    regulatory links
                                                                                                                      schema version
                                                                                                                      0.1.0
                                                                                                                      source batch sha256
                                                                                                                      fc39a8c5cf96bf95ca20b85578140167b66b2741f7d9217f500d9ba0847ac058
                                                                                                                      source defined aliases
                                                                                                                      1. abbreviation
                                                                                                                        NSCLC
                                                                                                                        definition exact
                                                                                                                        Non-Small Cell Lung Cancer
                                                                                                                        definition span
                                                                                                                        end
                                                                                                                        380
                                                                                                                        end exclusive
                                                                                                                        true
                                                                                                                        exact text
                                                                                                                        Non-Small Cell Lung Cancer (NSCLC)
                                                                                                                        label id
                                                                                                                        228e1e3f-d207-481f-8e14-9fdcbd0470e9
                                                                                                                        offset unit
                                                                                                                        unicode_code_points
                                                                                                                        source array index
                                                                                                                        0
                                                                                                                        source field
                                                                                                                        indications_and_usage_exact
                                                                                                                        source text sha256
                                                                                                                        e526ba14c91f10737e6d3331fe23a6219f58c0eca6380bfce9bd78b573fea912
                                                                                                                        start
                                                                                                                        346
                                                                                                                      2. abbreviation
                                                                                                                        CRC
                                                                                                                        definition exact
                                                                                                                        Colorectal Cancer
                                                                                                                        definition span
                                                                                                                        end
                                                                                                                        5042
                                                                                                                        end exclusive
                                                                                                                        true
                                                                                                                        exact text
                                                                                                                        Colorectal Cancer (CRC)
                                                                                                                        label id
                                                                                                                        228e1e3f-d207-481f-8e14-9fdcbd0470e9
                                                                                                                        offset unit
                                                                                                                        unicode_code_points
                                                                                                                        source array index
                                                                                                                        0
                                                                                                                        source field
                                                                                                                        indications_and_usage_exact
                                                                                                                        source text sha256
                                                                                                                        e526ba14c91f10737e6d3331fe23a6219f58c0eca6380bfce9bd78b573fea912
                                                                                                                        start
                                                                                                                        5019
                                                                                                                      source span
                                                                                                                      end
                                                                                                                      7496
                                                                                                                      end exclusive
                                                                                                                      true
                                                                                                                      exact text
                                                                                                                      ( 1.12 , 2.1 ) Hepatocellular Carcinoma (HCC) for the treatment of patients with HCC secondary to hepatitis B who have received prior systemic therapy other than a PD-1/PD-L1-containing regimen.
                                                                                                                      label id
                                                                                                                      228e1e3f-d207-481f-8e14-9fdcbd0470e9
                                                                                                                      offset unit
                                                                                                                      unicode_code_points
                                                                                                                      source array index
                                                                                                                      0
                                                                                                                      source field
                                                                                                                      indications_and_usage_exact
                                                                                                                      source text sha256
                                                                                                                      e526ba14c91f10737e6d3331fe23a6219f58c0eca6380bfce9bd78b573fea912
                                                                                                                      start
                                                                                                                      7302
                                                                                                                      source url
                                                                                                                      https://api.fda.gov/drug/label.json?search=id%3A%22228e1e3f-d207-481f-8e14-9fdcbd0470e9%22
                                                                                                                      spl effective date
                                                                                                                      2026-07-10
                                                                                                                      spl set id
                                                                                                                      9333c79b-d487-4538-a9f0-71b91a02b287
                                                                                                                      spl version
                                                                                                                      228
                                                                                                                      structured fields status
                                                                                                                      not_extracted_no_values_inferred_from_mentions
                                                                                                                      structured indication
                                                                                                                      age
                                                                                                                      Source null
                                                                                                                      approval pathway
                                                                                                                      Source null
                                                                                                                      biomarker and test
                                                                                                                      Source null
                                                                                                                      disease stage
                                                                                                                      Source null
                                                                                                                      limitations
                                                                                                                      Source null
                                                                                                                      line
                                                                                                                      Source null
                                                                                                                      prior therapy
                                                                                                                      Source null
                                                                                                                      regimen
                                                                                                                      Source null
                                                                                                                      tumor histology
                                                                                                                      Source null
                                                                                                                      use intent
                                                                                                                      unclear
                                                                                                                      Passage 44 · unclassified context
                                                                                                                      application numbers
                                                                                                                      1. BLA125514
                                                                                                                      brand names
                                                                                                                      1. KEYTRUDA
                                                                                                                      classification reasons
                                                                                                                      1. no_unambiguous_positive_indication_predicate
                                                                                                                      clinical review status
                                                                                                                      pending
                                                                                                                      content role
                                                                                                                      unclassified_context
                                                                                                                      context span
                                                                                                                      end
                                                                                                                      7880
                                                                                                                      end exclusive
                                                                                                                      true
                                                                                                                      exact text
                                                                                                                      est. ( 1.12 , 2.1 ) Hepatocellular Carcinoma (HCC) for the treatment of patients with HCC secondary to hepatitis B who have received prior systemic therapy other than a PD-1/PD-L1-containing regimen. ( 1.13 ) Biliary Tract Cancer (BTC) in combination with gemcitabine and cisplatin, for the treatment of patients with locally advanced unresectable or metastatic biliary tract cancer. ( 1.14 ) Merkel Cell Carcinoma (MCC) for the treatment of adult and pediatric patients with recurrent locally advanced or metastatic Merkel cell carcinoma. ( 1.15 ) Renal Cell Carcinoma (RCC) in comb
                                                                                                                      label id
                                                                                                                      228e1e3f-d207-481f-8e14-9fdcbd0470e9
                                                                                                                      offset unit
                                                                                                                      unicode_code_points
                                                                                                                      source array index
                                                                                                                      0
                                                                                                                      source field
                                                                                                                      indications_and_usage_exact
                                                                                                                      source text sha256
                                                                                                                      e526ba14c91f10737e6d3331fe23a6219f58c0eca6380bfce9bd78b573fea912
                                                                                                                      start
                                                                                                                      7297
                                                                                                                      current approval status
                                                                                                                      not_reconciled
                                                                                                                      duplicate text group
                                                                                                                      dup-fe24f04cfc60a3e30b59
                                                                                                                      extraction review status
                                                                                                                      automated_candidate_pending_source_review
                                                                                                                      generic names
                                                                                                                      1. PEMBROLIZUMAB
                                                                                                                      id
                                                                                                                      ind-span-63977b1a39bd5a3abfb0
                                                                                                                      label id
                                                                                                                      228e1e3f-d207-481f-8e14-9fdcbd0470e9
                                                                                                                      positive predicate support span
                                                                                                                      Source null
                                                                                                                      qualifier mentions
                                                                                                                      1. context exact
                                                                                                                        treatment of patients with locally advanced unresectable or metastatic biliary tract cancer.
                                                                                                                        kind
                                                                                                                        biomarker
                                                                                                                        polarity
                                                                                                                        not_inferred
                                                                                                                        span
                                                                                                                        end
                                                                                                                        7679
                                                                                                                        end exclusive
                                                                                                                        true
                                                                                                                        exact text
                                                                                                                        metastatic biliary tract cancer
                                                                                                                        label id
                                                                                                                        228e1e3f-d207-481f-8e14-9fdcbd0470e9
                                                                                                                        offset unit
                                                                                                                        unicode_code_points
                                                                                                                        source array index
                                                                                                                        0
                                                                                                                        source field
                                                                                                                        indications_and_usage_exact
                                                                                                                        source text sha256
                                                                                                                        e526ba14c91f10737e6d3331fe23a6219f58c0eca6380bfce9bd78b573fea912
                                                                                                                        start
                                                                                                                        7648
                                                                                                                      2. context exact
                                                                                                                        mcitabine and cisplatin, for the treatment of patients with locally advanced unresectable or metastatic biliary tract cancer.
                                                                                                                        kind
                                                                                                                        stage_or_setting
                                                                                                                        polarity
                                                                                                                        not_inferred
                                                                                                                        span
                                                                                                                        end
                                                                                                                        7666
                                                                                                                        end exclusive
                                                                                                                        true
                                                                                                                        exact text
                                                                                                                        locally advanced unresectable or metastatic biliary
                                                                                                                        label id
                                                                                                                        228e1e3f-d207-481f-8e14-9fdcbd0470e9
                                                                                                                        offset unit
                                                                                                                        unicode_code_points
                                                                                                                        source array index
                                                                                                                        0
                                                                                                                        source field
                                                                                                                        indications_and_usage_exact
                                                                                                                        source text sha256
                                                                                                                        e526ba14c91f10737e6d3331fe23a6219f58c0eca6380bfce9bd78b573fea912
                                                                                                                        start
                                                                                                                        7615
                                                                                                                      3. context exact
                                                                                                                        ( 1.13 ) Biliary Tract Cancer (BTC) in combination with gemcitabine and cisplatin, for the treatment of patients with locally advanced unresectable or metastatic biliary tract cancer.
                                                                                                                        kind
                                                                                                                        regimen
                                                                                                                        polarity
                                                                                                                        not_inferred
                                                                                                                        span
                                                                                                                        end
                                                                                                                        7679
                                                                                                                        end exclusive
                                                                                                                        true
                                                                                                                        exact text
                                                                                                                        in combination with gemcitabine and cisplatin, for the treatment of patients with locally advanced unresectable or metastatic biliary tract cancer
                                                                                                                        label id
                                                                                                                        228e1e3f-d207-481f-8e14-9fdcbd0470e9
                                                                                                                        offset unit
                                                                                                                        unicode_code_points
                                                                                                                        source array index
                                                                                                                        0
                                                                                                                        source field
                                                                                                                        indications_and_usage_exact
                                                                                                                        source text sha256
                                                                                                                        e526ba14c91f10737e6d3331fe23a6219f58c0eca6380bfce9bd78b573fea912
                                                                                                                        start
                                                                                                                        7533
                                                                                                                      regulatory links
                                                                                                                        schema version
                                                                                                                        0.1.0
                                                                                                                        source batch sha256
                                                                                                                        fc39a8c5cf96bf95ca20b85578140167b66b2741f7d9217f500d9ba0847ac058
                                                                                                                        source defined aliases
                                                                                                                        1. abbreviation
                                                                                                                          NSCLC
                                                                                                                          definition exact
                                                                                                                          Non-Small Cell Lung Cancer
                                                                                                                          definition span
                                                                                                                          end
                                                                                                                          380
                                                                                                                          end exclusive
                                                                                                                          true
                                                                                                                          exact text
                                                                                                                          Non-Small Cell Lung Cancer (NSCLC)
                                                                                                                          label id
                                                                                                                          228e1e3f-d207-481f-8e14-9fdcbd0470e9
                                                                                                                          offset unit
                                                                                                                          unicode_code_points
                                                                                                                          source array index
                                                                                                                          0
                                                                                                                          source field
                                                                                                                          indications_and_usage_exact
                                                                                                                          source text sha256
                                                                                                                          e526ba14c91f10737e6d3331fe23a6219f58c0eca6380bfce9bd78b573fea912
                                                                                                                          start
                                                                                                                          346
                                                                                                                        2. abbreviation
                                                                                                                          CRC
                                                                                                                          definition exact
                                                                                                                          Colorectal Cancer
                                                                                                                          definition span
                                                                                                                          end
                                                                                                                          5042
                                                                                                                          end exclusive
                                                                                                                          true
                                                                                                                          exact text
                                                                                                                          Colorectal Cancer (CRC)
                                                                                                                          label id
                                                                                                                          228e1e3f-d207-481f-8e14-9fdcbd0470e9
                                                                                                                          offset unit
                                                                                                                          unicode_code_points
                                                                                                                          source array index
                                                                                                                          0
                                                                                                                          source field
                                                                                                                          indications_and_usage_exact
                                                                                                                          source text sha256
                                                                                                                          e526ba14c91f10737e6d3331fe23a6219f58c0eca6380bfce9bd78b573fea912
                                                                                                                          start
                                                                                                                          5019
                                                                                                                        source span
                                                                                                                        end
                                                                                                                        7680
                                                                                                                        end exclusive
                                                                                                                        true
                                                                                                                        exact text
                                                                                                                        ( 1.13 ) Biliary Tract Cancer (BTC) in combination with gemcitabine and cisplatin, for the treatment of patients with locally advanced unresectable or metastatic biliary tract cancer.
                                                                                                                        label id
                                                                                                                        228e1e3f-d207-481f-8e14-9fdcbd0470e9
                                                                                                                        offset unit
                                                                                                                        unicode_code_points
                                                                                                                        source array index
                                                                                                                        0
                                                                                                                        source field
                                                                                                                        indications_and_usage_exact
                                                                                                                        source text sha256
                                                                                                                        e526ba14c91f10737e6d3331fe23a6219f58c0eca6380bfce9bd78b573fea912
                                                                                                                        start
                                                                                                                        7497
                                                                                                                        source url
                                                                                                                        https://api.fda.gov/drug/label.json?search=id%3A%22228e1e3f-d207-481f-8e14-9fdcbd0470e9%22
                                                                                                                        spl effective date
                                                                                                                        2026-07-10
                                                                                                                        spl set id
                                                                                                                        9333c79b-d487-4538-a9f0-71b91a02b287
                                                                                                                        spl version
                                                                                                                        228
                                                                                                                        structured fields status
                                                                                                                        not_extracted_no_values_inferred_from_mentions
                                                                                                                        structured indication
                                                                                                                        age
                                                                                                                        Source null
                                                                                                                        approval pathway
                                                                                                                        Source null
                                                                                                                        biomarker and test
                                                                                                                        Source null
                                                                                                                        disease stage
                                                                                                                        Source null
                                                                                                                        limitations
                                                                                                                        Source null
                                                                                                                        line
                                                                                                                        Source null
                                                                                                                        prior therapy
                                                                                                                        Source null
                                                                                                                        regimen
                                                                                                                        Source null
                                                                                                                        tumor histology
                                                                                                                        Source null
                                                                                                                        use intent
                                                                                                                        unclear
                                                                                                                        Passage 45 · unclassified context
                                                                                                                        application numbers
                                                                                                                        1. BLA125514
                                                                                                                        brand names
                                                                                                                        1. KEYTRUDA
                                                                                                                        classification reasons
                                                                                                                        1. no_unambiguous_positive_indication_predicate
                                                                                                                        clinical review status
                                                                                                                        pending
                                                                                                                        content role
                                                                                                                        unclassified_context
                                                                                                                        context span
                                                                                                                        end
                                                                                                                        8036
                                                                                                                        end exclusive
                                                                                                                        true
                                                                                                                        exact text
                                                                                                                        aining regimen. ( 1.13 ) Biliary Tract Cancer (BTC) in combination with gemcitabine and cisplatin, for the treatment of patients with locally advanced unresectable or metastatic biliary tract cancer. ( 1.14 ) Merkel Cell Carcinoma (MCC) for the treatment of adult and pediatric patients with recurrent locally advanced or metastatic Merkel cell carcinoma. ( 1.15 ) Renal Cell Carcinoma (RCC) in combination with axitinib, for the first-line treatment of adult patients with advanced RCC. ( 1.16 ) in combination with lenvatinib, for the first-line treatme
                                                                                                                        label id
                                                                                                                        228e1e3f-d207-481f-8e14-9fdcbd0470e9
                                                                                                                        offset unit
                                                                                                                        unicode_code_points
                                                                                                                        source array index
                                                                                                                        0
                                                                                                                        source field
                                                                                                                        indications_and_usage_exact
                                                                                                                        source text sha256
                                                                                                                        e526ba14c91f10737e6d3331fe23a6219f58c0eca6380bfce9bd78b573fea912
                                                                                                                        start
                                                                                                                        7481
                                                                                                                        current approval status
                                                                                                                        not_reconciled
                                                                                                                        duplicate text group
                                                                                                                        dup-b3b74e82ef2f7cfd97fd
                                                                                                                        extraction review status
                                                                                                                        automated_candidate_pending_source_review
                                                                                                                        generic names
                                                                                                                        1. PEMBROLIZUMAB
                                                                                                                        id
                                                                                                                        ind-span-f3bf1efb090647ddf229
                                                                                                                        label id
                                                                                                                        228e1e3f-d207-481f-8e14-9fdcbd0470e9
                                                                                                                        positive predicate support span
                                                                                                                        Source null
                                                                                                                        qualifier mentions
                                                                                                                        1. context exact
                                                                                                                          ( 1.14 ) Merkel Cell Carcinoma (MCC) for the treatment of adult and pediatric patients with recurrent locally advanced or m
                                                                                                                          kind
                                                                                                                          age
                                                                                                                          polarity
                                                                                                                          not_inferred
                                                                                                                          span
                                                                                                                          end
                                                                                                                          7744
                                                                                                                          end exclusive
                                                                                                                          true
                                                                                                                          exact text
                                                                                                                          adult
                                                                                                                          label id
                                                                                                                          228e1e3f-d207-481f-8e14-9fdcbd0470e9
                                                                                                                          offset unit
                                                                                                                          unicode_code_points
                                                                                                                          source array index
                                                                                                                          0
                                                                                                                          source field
                                                                                                                          indications_and_usage_exact
                                                                                                                          source text sha256
                                                                                                                          e526ba14c91f10737e6d3331fe23a6219f58c0eca6380bfce9bd78b573fea912
                                                                                                                          start
                                                                                                                          7739
                                                                                                                        2. context exact
                                                                                                                          Merkel Cell Carcinoma (MCC) for the treatment of adult and pediatric patients with recurrent locally advanced or metastatic Merkel cell c
                                                                                                                          kind
                                                                                                                          age
                                                                                                                          polarity
                                                                                                                          not_inferred
                                                                                                                          span
                                                                                                                          end
                                                                                                                          7767
                                                                                                                          end exclusive
                                                                                                                          true
                                                                                                                          exact text
                                                                                                                          pediatric patients
                                                                                                                          label id
                                                                                                                          228e1e3f-d207-481f-8e14-9fdcbd0470e9
                                                                                                                          offset unit
                                                                                                                          unicode_code_points
                                                                                                                          source array index
                                                                                                                          0
                                                                                                                          source field
                                                                                                                          indications_and_usage_exact
                                                                                                                          source text sha256
                                                                                                                          e526ba14c91f10737e6d3331fe23a6219f58c0eca6380bfce9bd78b573fea912
                                                                                                                          start
                                                                                                                          7749
                                                                                                                        3. context exact
                                                                                                                          t and pediatric patients with recurrent locally advanced or metastatic Merkel cell carcinoma.
                                                                                                                          kind
                                                                                                                          biomarker
                                                                                                                          polarity
                                                                                                                          not_inferred
                                                                                                                          span
                                                                                                                          end
                                                                                                                          7835
                                                                                                                          end exclusive
                                                                                                                          true
                                                                                                                          exact text
                                                                                                                          metastatic Merkel cell carcinoma
                                                                                                                          label id
                                                                                                                          228e1e3f-d207-481f-8e14-9fdcbd0470e9
                                                                                                                          offset unit
                                                                                                                          unicode_code_points
                                                                                                                          source array index
                                                                                                                          0
                                                                                                                          source field
                                                                                                                          indications_and_usage_exact
                                                                                                                          source text sha256
                                                                                                                          e526ba14c91f10737e6d3331fe23a6219f58c0eca6380bfce9bd78b573fea912
                                                                                                                          start
                                                                                                                          7803
                                                                                                                        4. context exact
                                                                                                                          MCC) for the treatment of adult and pediatric patients with recurrent locally advanced or metastatic Merkel cell carcinoma.
                                                                                                                          kind
                                                                                                                          stage_or_setting
                                                                                                                          polarity
                                                                                                                          not_inferred
                                                                                                                          span
                                                                                                                          end
                                                                                                                          7817
                                                                                                                          end exclusive
                                                                                                                          true
                                                                                                                          exact text
                                                                                                                          recurrent locally advanced or metastatic Mer
                                                                                                                          label id
                                                                                                                          228e1e3f-d207-481f-8e14-9fdcbd0470e9
                                                                                                                          offset unit
                                                                                                                          unicode_code_points
                                                                                                                          source array index
                                                                                                                          0
                                                                                                                          source field
                                                                                                                          indications_and_usage_exact
                                                                                                                          source text sha256
                                                                                                                          e526ba14c91f10737e6d3331fe23a6219f58c0eca6380bfce9bd78b573fea912
                                                                                                                          start
                                                                                                                          7773
                                                                                                                        regulatory links
                                                                                                                          schema version
                                                                                                                          0.1.0
                                                                                                                          source batch sha256
                                                                                                                          fc39a8c5cf96bf95ca20b85578140167b66b2741f7d9217f500d9ba0847ac058
                                                                                                                          source defined aliases
                                                                                                                          1. abbreviation
                                                                                                                            NSCLC
                                                                                                                            definition exact
                                                                                                                            Non-Small Cell Lung Cancer
                                                                                                                            definition span
                                                                                                                            end
                                                                                                                            380
                                                                                                                            end exclusive
                                                                                                                            true
                                                                                                                            exact text
                                                                                                                            Non-Small Cell Lung Cancer (NSCLC)
                                                                                                                            label id
                                                                                                                            228e1e3f-d207-481f-8e14-9fdcbd0470e9
                                                                                                                            offset unit
                                                                                                                            unicode_code_points
                                                                                                                            source array index
                                                                                                                            0
                                                                                                                            source field
                                                                                                                            indications_and_usage_exact
                                                                                                                            source text sha256
                                                                                                                            e526ba14c91f10737e6d3331fe23a6219f58c0eca6380bfce9bd78b573fea912
                                                                                                                            start
                                                                                                                            346
                                                                                                                          2. abbreviation
                                                                                                                            CRC
                                                                                                                            definition exact
                                                                                                                            Colorectal Cancer
                                                                                                                            definition span
                                                                                                                            end
                                                                                                                            5042
                                                                                                                            end exclusive
                                                                                                                            true
                                                                                                                            exact text
                                                                                                                            Colorectal Cancer (CRC)
                                                                                                                            label id
                                                                                                                            228e1e3f-d207-481f-8e14-9fdcbd0470e9
                                                                                                                            offset unit
                                                                                                                            unicode_code_points
                                                                                                                            source array index
                                                                                                                            0
                                                                                                                            source field
                                                                                                                            indications_and_usage_exact
                                                                                                                            source text sha256
                                                                                                                            e526ba14c91f10737e6d3331fe23a6219f58c0eca6380bfce9bd78b573fea912
                                                                                                                            start
                                                                                                                            5019
                                                                                                                          source span
                                                                                                                          end
                                                                                                                          7836
                                                                                                                          end exclusive
                                                                                                                          true
                                                                                                                          exact text
                                                                                                                          ( 1.14 ) Merkel Cell Carcinoma (MCC) for the treatment of adult and pediatric patients with recurrent locally advanced or metastatic Merkel cell carcinoma.
                                                                                                                          label id
                                                                                                                          228e1e3f-d207-481f-8e14-9fdcbd0470e9
                                                                                                                          offset unit
                                                                                                                          unicode_code_points
                                                                                                                          source array index
                                                                                                                          0
                                                                                                                          source field
                                                                                                                          indications_and_usage_exact
                                                                                                                          source text sha256
                                                                                                                          e526ba14c91f10737e6d3331fe23a6219f58c0eca6380bfce9bd78b573fea912
                                                                                                                          start
                                                                                                                          7681
                                                                                                                          source url
                                                                                                                          https://api.fda.gov/drug/label.json?search=id%3A%22228e1e3f-d207-481f-8e14-9fdcbd0470e9%22
                                                                                                                          spl effective date
                                                                                                                          2026-07-10
                                                                                                                          spl set id
                                                                                                                          9333c79b-d487-4538-a9f0-71b91a02b287
                                                                                                                          spl version
                                                                                                                          228
                                                                                                                          structured fields status
                                                                                                                          not_extracted_no_values_inferred_from_mentions
                                                                                                                          structured indication
                                                                                                                          age
                                                                                                                          Source null
                                                                                                                          approval pathway
                                                                                                                          Source null
                                                                                                                          biomarker and test
                                                                                                                          Source null
                                                                                                                          disease stage
                                                                                                                          Source null
                                                                                                                          limitations
                                                                                                                          Source null
                                                                                                                          line
                                                                                                                          Source null
                                                                                                                          prior therapy
                                                                                                                          Source null
                                                                                                                          regimen
                                                                                                                          Source null
                                                                                                                          tumor histology
                                                                                                                          Source null
                                                                                                                          use intent
                                                                                                                          unclear
                                                                                                                          Passage 46 · unclassified context
                                                                                                                          application numbers
                                                                                                                          1. BLA125514
                                                                                                                          brand names
                                                                                                                          1. KEYTRUDA
                                                                                                                          classification reasons
                                                                                                                          1. no_unambiguous_positive_indication_predicate
                                                                                                                          clinical review status
                                                                                                                          pending
                                                                                                                          content role
                                                                                                                          unclassified_context
                                                                                                                          context span
                                                                                                                          end
                                                                                                                          8168
                                                                                                                          end exclusive
                                                                                                                          true
                                                                                                                          exact text
                                                                                                                          ectable or metastatic biliary tract cancer. ( 1.14 ) Merkel Cell Carcinoma (MCC) for the treatment of adult and pediatric patients with recurrent locally advanced or metastatic Merkel cell carcinoma. ( 1.15 ) Renal Cell Carcinoma (RCC) in combination with axitinib, for the first-line treatment of adult patients with advanced RCC. ( 1.16 ) in combination with lenvatinib, for the first-line treatment of adult patients with advanced RCC. ( 1.16 ) for the adjuvant treatment of patients with RCC at intermediate-high or high risk o
                                                                                                                          label id
                                                                                                                          228e1e3f-d207-481f-8e14-9fdcbd0470e9
                                                                                                                          offset unit
                                                                                                                          unicode_code_points
                                                                                                                          source array index
                                                                                                                          0
                                                                                                                          source field
                                                                                                                          indications_and_usage_exact
                                                                                                                          source text sha256
                                                                                                                          e526ba14c91f10737e6d3331fe23a6219f58c0eca6380bfce9bd78b573fea912
                                                                                                                          start
                                                                                                                          7637
                                                                                                                          current approval status
                                                                                                                          not_reconciled
                                                                                                                          duplicate text group
                                                                                                                          dup-978686476807a8c8b03b
                                                                                                                          extraction review status
                                                                                                                          automated_candidate_pending_source_review
                                                                                                                          generic names
                                                                                                                          1. PEMBROLIZUMAB
                                                                                                                          id
                                                                                                                          ind-span-06593788b53de3c2936d
                                                                                                                          label id
                                                                                                                          228e1e3f-d207-481f-8e14-9fdcbd0470e9
                                                                                                                          positive predicate support span
                                                                                                                          Source null
                                                                                                                          qualifier mentions
                                                                                                                          1. context exact
                                                                                                                            combination with axitinib, for the first-line treatment of adult patients with advanced RCC.
                                                                                                                            kind
                                                                                                                            age
                                                                                                                            polarity
                                                                                                                            not_inferred
                                                                                                                            span
                                                                                                                            end
                                                                                                                            7949
                                                                                                                            end exclusive
                                                                                                                            true
                                                                                                                            exact text
                                                                                                                            adult patients
                                                                                                                            label id
                                                                                                                            228e1e3f-d207-481f-8e14-9fdcbd0470e9
                                                                                                                            offset unit
                                                                                                                            unicode_code_points
                                                                                                                            source array index
                                                                                                                            0
                                                                                                                            source field
                                                                                                                            indications_and_usage_exact
                                                                                                                            source text sha256
                                                                                                                            e526ba14c91f10737e6d3331fe23a6219f58c0eca6380bfce9bd78b573fea912
                                                                                                                            start
                                                                                                                            7935
                                                                                                                          2. context exact
                                                                                                                            itinib, for the first-line treatment of adult patients with advanced RCC.
                                                                                                                            kind
                                                                                                                            stage_or_setting
                                                                                                                            polarity
                                                                                                                            not_inferred
                                                                                                                            span
                                                                                                                            end
                                                                                                                            7967
                                                                                                                            end exclusive
                                                                                                                            true
                                                                                                                            exact text
                                                                                                                            advanced RCC
                                                                                                                            label id
                                                                                                                            228e1e3f-d207-481f-8e14-9fdcbd0470e9
                                                                                                                            offset unit
                                                                                                                            unicode_code_points
                                                                                                                            source array index
                                                                                                                            0
                                                                                                                            source field
                                                                                                                            indications_and_usage_exact
                                                                                                                            source text sha256
                                                                                                                            e526ba14c91f10737e6d3331fe23a6219f58c0eca6380bfce9bd78b573fea912
                                                                                                                            start
                                                                                                                            7955
                                                                                                                          3. context exact
                                                                                                                            Cell Carcinoma (RCC) in combination with axitinib, for the first-line treatment of adult patients with advanced RCC.
                                                                                                                            kind
                                                                                                                            prior_therapy_or_line
                                                                                                                            polarity
                                                                                                                            not_inferred
                                                                                                                            span
                                                                                                                            end
                                                                                                                            7967
                                                                                                                            end exclusive
                                                                                                                            true
                                                                                                                            exact text
                                                                                                                            first-line treatment of adult patients with advanced RCC
                                                                                                                            label id
                                                                                                                            228e1e3f-d207-481f-8e14-9fdcbd0470e9
                                                                                                                            offset unit
                                                                                                                            unicode_code_points
                                                                                                                            source array index
                                                                                                                            0
                                                                                                                            source field
                                                                                                                            indications_and_usage_exact
                                                                                                                            source text sha256
                                                                                                                            e526ba14c91f10737e6d3331fe23a6219f58c0eca6380bfce9bd78b573fea912
                                                                                                                            start
                                                                                                                            7911
                                                                                                                          4. context exact
                                                                                                                            ( 1.15 ) Renal Cell Carcinoma (RCC) in combination with axitinib, for the first-line treatment of adult patients with advanced RCC.
                                                                                                                            kind
                                                                                                                            regimen
                                                                                                                            polarity
                                                                                                                            not_inferred
                                                                                                                            span
                                                                                                                            end
                                                                                                                            7967
                                                                                                                            end exclusive
                                                                                                                            true
                                                                                                                            exact text
                                                                                                                            in combination with axitinib, for the first-line treatment of adult patients with advanced RCC
                                                                                                                            label id
                                                                                                                            228e1e3f-d207-481f-8e14-9fdcbd0470e9
                                                                                                                            offset unit
                                                                                                                            unicode_code_points
                                                                                                                            source array index
                                                                                                                            0
                                                                                                                            source field
                                                                                                                            indications_and_usage_exact
                                                                                                                            source text sha256
                                                                                                                            e526ba14c91f10737e6d3331fe23a6219f58c0eca6380bfce9bd78b573fea912
                                                                                                                            start
                                                                                                                            7873
                                                                                                                          regulatory links
                                                                                                                            schema version
                                                                                                                            0.1.0
                                                                                                                            source batch sha256
                                                                                                                            fc39a8c5cf96bf95ca20b85578140167b66b2741f7d9217f500d9ba0847ac058
                                                                                                                            source defined aliases
                                                                                                                            1. abbreviation
                                                                                                                              NSCLC
                                                                                                                              definition exact
                                                                                                                              Non-Small Cell Lung Cancer
                                                                                                                              definition span
                                                                                                                              end
                                                                                                                              380
                                                                                                                              end exclusive
                                                                                                                              true
                                                                                                                              exact text
                                                                                                                              Non-Small Cell Lung Cancer (NSCLC)
                                                                                                                              label id
                                                                                                                              228e1e3f-d207-481f-8e14-9fdcbd0470e9
                                                                                                                              offset unit
                                                                                                                              unicode_code_points
                                                                                                                              source array index
                                                                                                                              0
                                                                                                                              source field
                                                                                                                              indications_and_usage_exact
                                                                                                                              source text sha256
                                                                                                                              e526ba14c91f10737e6d3331fe23a6219f58c0eca6380bfce9bd78b573fea912
                                                                                                                              start
                                                                                                                              346
                                                                                                                            2. abbreviation
                                                                                                                              CRC
                                                                                                                              definition exact
                                                                                                                              Colorectal Cancer
                                                                                                                              definition span
                                                                                                                              end
                                                                                                                              5042
                                                                                                                              end exclusive
                                                                                                                              true
                                                                                                                              exact text
                                                                                                                              Colorectal Cancer (CRC)
                                                                                                                              label id
                                                                                                                              228e1e3f-d207-481f-8e14-9fdcbd0470e9
                                                                                                                              offset unit
                                                                                                                              unicode_code_points
                                                                                                                              source array index
                                                                                                                              0
                                                                                                                              source field
                                                                                                                              indications_and_usage_exact
                                                                                                                              source text sha256
                                                                                                                              e526ba14c91f10737e6d3331fe23a6219f58c0eca6380bfce9bd78b573fea912
                                                                                                                              start
                                                                                                                              5019
                                                                                                                            source span
                                                                                                                            end
                                                                                                                            7968
                                                                                                                            end exclusive
                                                                                                                            true
                                                                                                                            exact text
                                                                                                                            ( 1.15 ) Renal Cell Carcinoma (RCC) in combination with axitinib, for the first-line treatment of adult patients with advanced RCC.
                                                                                                                            label id
                                                                                                                            228e1e3f-d207-481f-8e14-9fdcbd0470e9
                                                                                                                            offset unit
                                                                                                                            unicode_code_points
                                                                                                                            source array index
                                                                                                                            0
                                                                                                                            source field
                                                                                                                            indications_and_usage_exact
                                                                                                                            source text sha256
                                                                                                                            e526ba14c91f10737e6d3331fe23a6219f58c0eca6380bfce9bd78b573fea912
                                                                                                                            start
                                                                                                                            7837
                                                                                                                            source url
                                                                                                                            https://api.fda.gov/drug/label.json?search=id%3A%22228e1e3f-d207-481f-8e14-9fdcbd0470e9%22
                                                                                                                            spl effective date
                                                                                                                            2026-07-10
                                                                                                                            spl set id
                                                                                                                            9333c79b-d487-4538-a9f0-71b91a02b287
                                                                                                                            spl version
                                                                                                                            228
                                                                                                                            structured fields status
                                                                                                                            not_extracted_no_values_inferred_from_mentions
                                                                                                                            structured indication
                                                                                                                            age
                                                                                                                            Source null
                                                                                                                            approval pathway
                                                                                                                            Source null
                                                                                                                            biomarker and test
                                                                                                                            Source null
                                                                                                                            disease stage
                                                                                                                            Source null
                                                                                                                            limitations
                                                                                                                            Source null
                                                                                                                            line
                                                                                                                            Source null
                                                                                                                            prior therapy
                                                                                                                            Source null
                                                                                                                            regimen
                                                                                                                            Source null
                                                                                                                            tumor histology
                                                                                                                            Source null
                                                                                                                            use intent
                                                                                                                            unclear
                                                                                                                            Passage 47 · unclassified context
                                                                                                                            application numbers
                                                                                                                            1. BLA125514
                                                                                                                            brand names
                                                                                                                            1. KEYTRUDA
                                                                                                                            classification reasons
                                                                                                                            1. no_unambiguous_positive_indication_predicate
                                                                                                                            clinical review status
                                                                                                                            pending
                                                                                                                            content role
                                                                                                                            unclassified_context
                                                                                                                            context span
                                                                                                                            end
                                                                                                                            8177
                                                                                                                            end exclusive
                                                                                                                            true
                                                                                                                            exact text
                                                                                                                            ith recurrent locally advanced or metastatic Merkel cell carcinoma. ( 1.15 ) Renal Cell Carcinoma (RCC) in combination with axitinib, for the first-line treatment of adult patients with advanced RCC. ( 1.16 ) in combination with lenvatinib, for the first-line treatment of adult patients with advanced RCC. ( 1.16 ) for the adjuvant treatment of patients with RCC at intermediate-high or high risk of recurre
                                                                                                                            label id
                                                                                                                            228e1e3f-d207-481f-8e14-9fdcbd0470e9
                                                                                                                            offset unit
                                                                                                                            unicode_code_points
                                                                                                                            source array index
                                                                                                                            0
                                                                                                                            source field
                                                                                                                            indications_and_usage_exact
                                                                                                                            source text sha256
                                                                                                                            e526ba14c91f10737e6d3331fe23a6219f58c0eca6380bfce9bd78b573fea912
                                                                                                                            start
                                                                                                                            7769
                                                                                                                            current approval status
                                                                                                                            not_reconciled
                                                                                                                            duplicate text group
                                                                                                                            dup-6e34857f45270be23dec
                                                                                                                            extraction review status
                                                                                                                            automated_candidate_pending_source_review
                                                                                                                            generic names
                                                                                                                            1. PEMBROLIZUMAB
                                                                                                                            id
                                                                                                                            ind-span-7eb56795d76eafec404f
                                                                                                                            label id
                                                                                                                            228e1e3f-d207-481f-8e14-9fdcbd0470e9
                                                                                                                            positive predicate support span
                                                                                                                            Source null
                                                                                                                            qualifier mentions
                                                                                                                              regulatory links
                                                                                                                                schema version
                                                                                                                                0.1.0
                                                                                                                                source batch sha256
                                                                                                                                fc39a8c5cf96bf95ca20b85578140167b66b2741f7d9217f500d9ba0847ac058
                                                                                                                                source defined aliases
                                                                                                                                1. abbreviation
                                                                                                                                  NSCLC
                                                                                                                                  definition exact
                                                                                                                                  Non-Small Cell Lung Cancer
                                                                                                                                  definition span
                                                                                                                                  end
                                                                                                                                  380
                                                                                                                                  end exclusive
                                                                                                                                  true
                                                                                                                                  exact text
                                                                                                                                  Non-Small Cell Lung Cancer (NSCLC)
                                                                                                                                  label id
                                                                                                                                  228e1e3f-d207-481f-8e14-9fdcbd0470e9
                                                                                                                                  offset unit
                                                                                                                                  unicode_code_points
                                                                                                                                  source array index
                                                                                                                                  0
                                                                                                                                  source field
                                                                                                                                  indications_and_usage_exact
                                                                                                                                  source text sha256
                                                                                                                                  e526ba14c91f10737e6d3331fe23a6219f58c0eca6380bfce9bd78b573fea912
                                                                                                                                  start
                                                                                                                                  346
                                                                                                                                2. abbreviation
                                                                                                                                  CRC
                                                                                                                                  definition exact
                                                                                                                                  Colorectal Cancer
                                                                                                                                  definition span
                                                                                                                                  end
                                                                                                                                  5042
                                                                                                                                  end exclusive
                                                                                                                                  true
                                                                                                                                  exact text
                                                                                                                                  Colorectal Cancer (CRC)
                                                                                                                                  label id
                                                                                                                                  228e1e3f-d207-481f-8e14-9fdcbd0470e9
                                                                                                                                  offset unit
                                                                                                                                  unicode_code_points
                                                                                                                                  source array index
                                                                                                                                  0
                                                                                                                                  source field
                                                                                                                                  indications_and_usage_exact
                                                                                                                                  source text sha256
                                                                                                                                  e526ba14c91f10737e6d3331fe23a6219f58c0eca6380bfce9bd78b573fea912
                                                                                                                                  start
                                                                                                                                  5019
                                                                                                                                source span
                                                                                                                                end
                                                                                                                                7977
                                                                                                                                end exclusive
                                                                                                                                true
                                                                                                                                exact text
                                                                                                                                ( 1.16 )
                                                                                                                                label id
                                                                                                                                228e1e3f-d207-481f-8e14-9fdcbd0470e9
                                                                                                                                offset unit
                                                                                                                                unicode_code_points
                                                                                                                                source array index
                                                                                                                                0
                                                                                                                                source field
                                                                                                                                indications_and_usage_exact
                                                                                                                                source text sha256
                                                                                                                                e526ba14c91f10737e6d3331fe23a6219f58c0eca6380bfce9bd78b573fea912
                                                                                                                                start
                                                                                                                                7969
                                                                                                                                source url
                                                                                                                                https://api.fda.gov/drug/label.json?search=id%3A%22228e1e3f-d207-481f-8e14-9fdcbd0470e9%22
                                                                                                                                spl effective date
                                                                                                                                2026-07-10
                                                                                                                                spl set id
                                                                                                                                9333c79b-d487-4538-a9f0-71b91a02b287
                                                                                                                                spl version
                                                                                                                                228
                                                                                                                                structured fields status
                                                                                                                                not_extracted_no_values_inferred_from_mentions
                                                                                                                                structured indication
                                                                                                                                age
                                                                                                                                Source null
                                                                                                                                approval pathway
                                                                                                                                Source null
                                                                                                                                biomarker and test
                                                                                                                                Source null
                                                                                                                                disease stage
                                                                                                                                Source null
                                                                                                                                limitations
                                                                                                                                Source null
                                                                                                                                line
                                                                                                                                Source null
                                                                                                                                prior therapy
                                                                                                                                Source null
                                                                                                                                regimen
                                                                                                                                Source null
                                                                                                                                tumor histology
                                                                                                                                Source null
                                                                                                                                use intent
                                                                                                                                unclear
                                                                                                                                Passage 48 · unclassified context
                                                                                                                                application numbers
                                                                                                                                1. BLA125514
                                                                                                                                brand names
                                                                                                                                1. KEYTRUDA
                                                                                                                                classification reasons
                                                                                                                                1. no_unambiguous_positive_indication_predicate
                                                                                                                                clinical review status
                                                                                                                                pending
                                                                                                                                content role
                                                                                                                                unclassified_context
                                                                                                                                context span
                                                                                                                                end
                                                                                                                                8275
                                                                                                                                end exclusive
                                                                                                                                true
                                                                                                                                exact text
                                                                                                                                rent locally advanced or metastatic Merkel cell carcinoma. ( 1.15 ) Renal Cell Carcinoma (RCC) in combination with axitinib, for the first-line treatment of adult patients with advanced RCC. ( 1.16 ) in combination with lenvatinib, for the first-line treatment of adult patients with advanced RCC. ( 1.16 ) for the adjuvant treatment of patients with RCC at intermediate-high or high risk of recurrence following nephrectomy, or following nephrectomy and resection of metastatic lesions. ( 1.16 )
                                                                                                                                label id
                                                                                                                                228e1e3f-d207-481f-8e14-9fdcbd0470e9
                                                                                                                                offset unit
                                                                                                                                unicode_code_points
                                                                                                                                source array index
                                                                                                                                0
                                                                                                                                source field
                                                                                                                                indications_and_usage_exact
                                                                                                                                source text sha256
                                                                                                                                e526ba14c91f10737e6d3331fe23a6219f58c0eca6380bfce9bd78b573fea912
                                                                                                                                start
                                                                                                                                7778
                                                                                                                                current approval status
                                                                                                                                not_reconciled
                                                                                                                                duplicate text group
                                                                                                                                dup-30e412d1dbacc125101f
                                                                                                                                extraction review status
                                                                                                                                automated_candidate_pending_source_review
                                                                                                                                generic names
                                                                                                                                1. PEMBROLIZUMAB
                                                                                                                                id
                                                                                                                                ind-span-7c19295bfc53386a5580
                                                                                                                                label id
                                                                                                                                228e1e3f-d207-481f-8e14-9fdcbd0470e9
                                                                                                                                positive predicate support span
                                                                                                                                Source null
                                                                                                                                qualifier mentions
                                                                                                                                1. context exact
                                                                                                                                  ombination with lenvatinib, for the first-line treatment of adult patients with advanced RCC.
                                                                                                                                  kind
                                                                                                                                  age
                                                                                                                                  polarity
                                                                                                                                  not_inferred
                                                                                                                                  span
                                                                                                                                  end
                                                                                                                                  8056
                                                                                                                                  end exclusive
                                                                                                                                  true
                                                                                                                                  exact text
                                                                                                                                  adult patients
                                                                                                                                  label id
                                                                                                                                  228e1e3f-d207-481f-8e14-9fdcbd0470e9
                                                                                                                                  offset unit
                                                                                                                                  unicode_code_points
                                                                                                                                  source array index
                                                                                                                                  0
                                                                                                                                  source field
                                                                                                                                  indications_and_usage_exact
                                                                                                                                  source text sha256
                                                                                                                                  e526ba14c91f10737e6d3331fe23a6219f58c0eca6380bfce9bd78b573fea912
                                                                                                                                  start
                                                                                                                                  8042
                                                                                                                                2. context exact
                                                                                                                                  atinib, for the first-line treatment of adult patients with advanced RCC.
                                                                                                                                  kind
                                                                                                                                  stage_or_setting
                                                                                                                                  polarity
                                                                                                                                  not_inferred
                                                                                                                                  span
                                                                                                                                  end
                                                                                                                                  8074
                                                                                                                                  end exclusive
                                                                                                                                  true
                                                                                                                                  exact text
                                                                                                                                  advanced RCC
                                                                                                                                  label id
                                                                                                                                  228e1e3f-d207-481f-8e14-9fdcbd0470e9
                                                                                                                                  offset unit
                                                                                                                                  unicode_code_points
                                                                                                                                  source array index
                                                                                                                                  0
                                                                                                                                  source field
                                                                                                                                  indications_and_usage_exact
                                                                                                                                  source text sha256
                                                                                                                                  e526ba14c91f10737e6d3331fe23a6219f58c0eca6380bfce9bd78b573fea912
                                                                                                                                  start
                                                                                                                                  8062
                                                                                                                                3. context exact
                                                                                                                                  in combination with lenvatinib, for the first-line treatment of adult patients with advanced RCC.
                                                                                                                                  kind
                                                                                                                                  prior_therapy_or_line
                                                                                                                                  polarity
                                                                                                                                  not_inferred
                                                                                                                                  span
                                                                                                                                  end
                                                                                                                                  8074
                                                                                                                                  end exclusive
                                                                                                                                  true
                                                                                                                                  exact text
                                                                                                                                  first-line treatment of adult patients with advanced RCC
                                                                                                                                  label id
                                                                                                                                  228e1e3f-d207-481f-8e14-9fdcbd0470e9
                                                                                                                                  offset unit
                                                                                                                                  unicode_code_points
                                                                                                                                  source array index
                                                                                                                                  0
                                                                                                                                  source field
                                                                                                                                  indications_and_usage_exact
                                                                                                                                  source text sha256
                                                                                                                                  e526ba14c91f10737e6d3331fe23a6219f58c0eca6380bfce9bd78b573fea912
                                                                                                                                  start
                                                                                                                                  8018
                                                                                                                                4. context exact
                                                                                                                                  in combination with lenvatinib, for the first-line treatment of adult patients with advanced RCC.
                                                                                                                                  kind
                                                                                                                                  regimen
                                                                                                                                  polarity
                                                                                                                                  not_inferred
                                                                                                                                  span
                                                                                                                                  end
                                                                                                                                  8074
                                                                                                                                  end exclusive
                                                                                                                                  true
                                                                                                                                  exact text
                                                                                                                                  in combination with lenvatinib, for the first-line treatment of adult patients with advanced RCC
                                                                                                                                  label id
                                                                                                                                  228e1e3f-d207-481f-8e14-9fdcbd0470e9
                                                                                                                                  offset unit
                                                                                                                                  unicode_code_points
                                                                                                                                  source array index
                                                                                                                                  0
                                                                                                                                  source field
                                                                                                                                  indications_and_usage_exact
                                                                                                                                  source text sha256
                                                                                                                                  e526ba14c91f10737e6d3331fe23a6219f58c0eca6380bfce9bd78b573fea912
                                                                                                                                  start
                                                                                                                                  7978
                                                                                                                                regulatory links
                                                                                                                                  schema version
                                                                                                                                  0.1.0
                                                                                                                                  source batch sha256
                                                                                                                                  fc39a8c5cf96bf95ca20b85578140167b66b2741f7d9217f500d9ba0847ac058
                                                                                                                                  source defined aliases
                                                                                                                                  1. abbreviation
                                                                                                                                    NSCLC
                                                                                                                                    definition exact
                                                                                                                                    Non-Small Cell Lung Cancer
                                                                                                                                    definition span
                                                                                                                                    end
                                                                                                                                    380
                                                                                                                                    end exclusive
                                                                                                                                    true
                                                                                                                                    exact text
                                                                                                                                    Non-Small Cell Lung Cancer (NSCLC)
                                                                                                                                    label id
                                                                                                                                    228e1e3f-d207-481f-8e14-9fdcbd0470e9
                                                                                                                                    offset unit
                                                                                                                                    unicode_code_points
                                                                                                                                    source array index
                                                                                                                                    0
                                                                                                                                    source field
                                                                                                                                    indications_and_usage_exact
                                                                                                                                    source text sha256
                                                                                                                                    e526ba14c91f10737e6d3331fe23a6219f58c0eca6380bfce9bd78b573fea912
                                                                                                                                    start
                                                                                                                                    346
                                                                                                                                  2. abbreviation
                                                                                                                                    CRC
                                                                                                                                    definition exact
                                                                                                                                    Colorectal Cancer
                                                                                                                                    definition span
                                                                                                                                    end
                                                                                                                                    5042
                                                                                                                                    end exclusive
                                                                                                                                    true
                                                                                                                                    exact text
                                                                                                                                    Colorectal Cancer (CRC)
                                                                                                                                    label id
                                                                                                                                    228e1e3f-d207-481f-8e14-9fdcbd0470e9
                                                                                                                                    offset unit
                                                                                                                                    unicode_code_points
                                                                                                                                    source array index
                                                                                                                                    0
                                                                                                                                    source field
                                                                                                                                    indications_and_usage_exact
                                                                                                                                    source text sha256
                                                                                                                                    e526ba14c91f10737e6d3331fe23a6219f58c0eca6380bfce9bd78b573fea912
                                                                                                                                    start
                                                                                                                                    5019
                                                                                                                                  source span
                                                                                                                                  end
                                                                                                                                  8075
                                                                                                                                  end exclusive
                                                                                                                                  true
                                                                                                                                  exact text
                                                                                                                                  in combination with lenvatinib, for the first-line treatment of adult patients with advanced RCC.
                                                                                                                                  label id
                                                                                                                                  228e1e3f-d207-481f-8e14-9fdcbd0470e9
                                                                                                                                  offset unit
                                                                                                                                  unicode_code_points
                                                                                                                                  source array index
                                                                                                                                  0
                                                                                                                                  source field
                                                                                                                                  indications_and_usage_exact
                                                                                                                                  source text sha256
                                                                                                                                  e526ba14c91f10737e6d3331fe23a6219f58c0eca6380bfce9bd78b573fea912
                                                                                                                                  start
                                                                                                                                  7978
                                                                                                                                  source url
                                                                                                                                  https://api.fda.gov/drug/label.json?search=id%3A%22228e1e3f-d207-481f-8e14-9fdcbd0470e9%22
                                                                                                                                  spl effective date
                                                                                                                                  2026-07-10
                                                                                                                                  spl set id
                                                                                                                                  9333c79b-d487-4538-a9f0-71b91a02b287
                                                                                                                                  spl version
                                                                                                                                  228
                                                                                                                                  structured fields status
                                                                                                                                  not_extracted_no_values_inferred_from_mentions
                                                                                                                                  structured indication
                                                                                                                                  age
                                                                                                                                  Source null
                                                                                                                                  approval pathway
                                                                                                                                  Source null
                                                                                                                                  biomarker and test
                                                                                                                                  Source null
                                                                                                                                  disease stage
                                                                                                                                  Source null
                                                                                                                                  limitations
                                                                                                                                  Source null
                                                                                                                                  line
                                                                                                                                  Source null
                                                                                                                                  prior therapy
                                                                                                                                  Source null
                                                                                                                                  regimen
                                                                                                                                  Source null
                                                                                                                                  tumor histology
                                                                                                                                  Source null
                                                                                                                                  use intent
                                                                                                                                  unclear
                                                                                                                                  Passage 49 · unclassified context
                                                                                                                                  application numbers
                                                                                                                                  1. BLA125514
                                                                                                                                  brand names
                                                                                                                                  1. KEYTRUDA
                                                                                                                                  classification reasons
                                                                                                                                  1. no_unambiguous_positive_indication_predicate
                                                                                                                                  clinical review status
                                                                                                                                  pending
                                                                                                                                  content role
                                                                                                                                  unclassified_context
                                                                                                                                  context span
                                                                                                                                  end
                                                                                                                                  8284
                                                                                                                                  end exclusive
                                                                                                                                  true
                                                                                                                                  exact text
                                                                                                                                  combination with axitinib, for the first-line treatment of adult patients with advanced RCC. ( 1.16 ) in combination with lenvatinib, for the first-line treatment of adult patients with advanced RCC. ( 1.16 ) for the adjuvant treatment of patients with RCC at intermediate-high or high risk of recurrence following nephrectomy, or following nephrectomy and resection of metastatic lesions. ( 1.16 ) in combin
                                                                                                                                  label id
                                                                                                                                  228e1e3f-d207-481f-8e14-9fdcbd0470e9
                                                                                                                                  offset unit
                                                                                                                                  unicode_code_points
                                                                                                                                  source array index
                                                                                                                                  0
                                                                                                                                  source field
                                                                                                                                  indications_and_usage_exact
                                                                                                                                  source text sha256
                                                                                                                                  e526ba14c91f10737e6d3331fe23a6219f58c0eca6380bfce9bd78b573fea912
                                                                                                                                  start
                                                                                                                                  7876
                                                                                                                                  current approval status
                                                                                                                                  not_reconciled
                                                                                                                                  duplicate text group
                                                                                                                                  dup-6e34857f45270be23dec
                                                                                                                                  extraction review status
                                                                                                                                  automated_candidate_pending_source_review
                                                                                                                                  generic names
                                                                                                                                  1. PEMBROLIZUMAB
                                                                                                                                  id
                                                                                                                                  ind-span-b10efef6002449da3be0
                                                                                                                                  label id
                                                                                                                                  228e1e3f-d207-481f-8e14-9fdcbd0470e9
                                                                                                                                  positive predicate support span
                                                                                                                                  Source null
                                                                                                                                  qualifier mentions
                                                                                                                                    regulatory links
                                                                                                                                      schema version
                                                                                                                                      0.1.0
                                                                                                                                      source batch sha256
                                                                                                                                      fc39a8c5cf96bf95ca20b85578140167b66b2741f7d9217f500d9ba0847ac058
                                                                                                                                      source defined aliases
                                                                                                                                      1. abbreviation
                                                                                                                                        NSCLC
                                                                                                                                        definition exact
                                                                                                                                        Non-Small Cell Lung Cancer
                                                                                                                                        definition span
                                                                                                                                        end
                                                                                                                                        380
                                                                                                                                        end exclusive
                                                                                                                                        true
                                                                                                                                        exact text
                                                                                                                                        Non-Small Cell Lung Cancer (NSCLC)
                                                                                                                                        label id
                                                                                                                                        228e1e3f-d207-481f-8e14-9fdcbd0470e9
                                                                                                                                        offset unit
                                                                                                                                        unicode_code_points
                                                                                                                                        source array index
                                                                                                                                        0
                                                                                                                                        source field
                                                                                                                                        indications_and_usage_exact
                                                                                                                                        source text sha256
                                                                                                                                        e526ba14c91f10737e6d3331fe23a6219f58c0eca6380bfce9bd78b573fea912
                                                                                                                                        start
                                                                                                                                        346
                                                                                                                                      2. abbreviation
                                                                                                                                        CRC
                                                                                                                                        definition exact
                                                                                                                                        Colorectal Cancer
                                                                                                                                        definition span
                                                                                                                                        end
                                                                                                                                        5042
                                                                                                                                        end exclusive
                                                                                                                                        true
                                                                                                                                        exact text
                                                                                                                                        Colorectal Cancer (CRC)
                                                                                                                                        label id
                                                                                                                                        228e1e3f-d207-481f-8e14-9fdcbd0470e9
                                                                                                                                        offset unit
                                                                                                                                        unicode_code_points
                                                                                                                                        source array index
                                                                                                                                        0
                                                                                                                                        source field
                                                                                                                                        indications_and_usage_exact
                                                                                                                                        source text sha256
                                                                                                                                        e526ba14c91f10737e6d3331fe23a6219f58c0eca6380bfce9bd78b573fea912
                                                                                                                                        start
                                                                                                                                        5019
                                                                                                                                      source span
                                                                                                                                      end
                                                                                                                                      8084
                                                                                                                                      end exclusive
                                                                                                                                      true
                                                                                                                                      exact text
                                                                                                                                      ( 1.16 )
                                                                                                                                      label id
                                                                                                                                      228e1e3f-d207-481f-8e14-9fdcbd0470e9
                                                                                                                                      offset unit
                                                                                                                                      unicode_code_points
                                                                                                                                      source array index
                                                                                                                                      0
                                                                                                                                      source field
                                                                                                                                      indications_and_usage_exact
                                                                                                                                      source text sha256
                                                                                                                                      e526ba14c91f10737e6d3331fe23a6219f58c0eca6380bfce9bd78b573fea912
                                                                                                                                      start
                                                                                                                                      8076
                                                                                                                                      source url
                                                                                                                                      https://api.fda.gov/drug/label.json?search=id%3A%22228e1e3f-d207-481f-8e14-9fdcbd0470e9%22
                                                                                                                                      spl effective date
                                                                                                                                      2026-07-10
                                                                                                                                      spl set id
                                                                                                                                      9333c79b-d487-4538-a9f0-71b91a02b287
                                                                                                                                      spl version
                                                                                                                                      228
                                                                                                                                      structured fields status
                                                                                                                                      not_extracted_no_values_inferred_from_mentions
                                                                                                                                      structured indication
                                                                                                                                      age
                                                                                                                                      Source null
                                                                                                                                      approval pathway
                                                                                                                                      Source null
                                                                                                                                      biomarker and test
                                                                                                                                      Source null
                                                                                                                                      disease stage
                                                                                                                                      Source null
                                                                                                                                      limitations
                                                                                                                                      Source null
                                                                                                                                      line
                                                                                                                                      Source null
                                                                                                                                      prior therapy
                                                                                                                                      Source null
                                                                                                                                      regimen
                                                                                                                                      Source null
                                                                                                                                      tumor histology
                                                                                                                                      Source null
                                                                                                                                      use intent
                                                                                                                                      unclear
                                                                                                                                      Passage 50 · risk or warning
                                                                                                                                      application numbers
                                                                                                                                      1. BLA125514
                                                                                                                                      brand names
                                                                                                                                      1. KEYTRUDA
                                                                                                                                      classification reasons
                                                                                                                                      1. risk_or_warning_words_without_positive_predicate
                                                                                                                                      clinical review status
                                                                                                                                      pending
                                                                                                                                      content role
                                                                                                                                      risk_or_warning
                                                                                                                                      context span
                                                                                                                                      end
                                                                                                                                      8465
                                                                                                                                      end exclusive
                                                                                                                                      true
                                                                                                                                      exact text
                                                                                                                                      on with axitinib, for the first-line treatment of adult patients with advanced RCC. ( 1.16 ) in combination with lenvatinib, for the first-line treatment of adult patients with advanced RCC. ( 1.16 ) for the adjuvant treatment of patients with RCC at intermediate-high or high risk of recurrence following nephrectomy, or following nephrectomy and resection of metastatic lesions. ( 1.16 ) in combination with belzutifan, for the adjuvant treatment of adult patients with RCC with a clear cell component (ccRCC) at intermediate-high or high risk of recurrence following nephrectom
                                                                                                                                      label id
                                                                                                                                      228e1e3f-d207-481f-8e14-9fdcbd0470e9
                                                                                                                                      offset unit
                                                                                                                                      unicode_code_points
                                                                                                                                      source array index
                                                                                                                                      0
                                                                                                                                      source field
                                                                                                                                      indications_and_usage_exact
                                                                                                                                      source text sha256
                                                                                                                                      e526ba14c91f10737e6d3331fe23a6219f58c0eca6380bfce9bd78b573fea912
                                                                                                                                      start
                                                                                                                                      7885
                                                                                                                                      current approval status
                                                                                                                                      not_reconciled
                                                                                                                                      duplicate text group
                                                                                                                                      dup-e5d2eda5083a3ee075bc
                                                                                                                                      extraction review status
                                                                                                                                      automated_candidate_pending_source_review
                                                                                                                                      generic names
                                                                                                                                      1. PEMBROLIZUMAB
                                                                                                                                      id
                                                                                                                                      ind-span-4326cb3f43658ae5d2cf
                                                                                                                                      label id
                                                                                                                                      228e1e3f-d207-481f-8e14-9fdcbd0470e9
                                                                                                                                      positive predicate support span
                                                                                                                                      Source null
                                                                                                                                      qualifier mentions
                                                                                                                                      1. context exact
                                                                                                                                        wing nephrectomy, or following nephrectomy and resection of metastatic lesions.
                                                                                                                                        kind
                                                                                                                                        biomarker
                                                                                                                                        polarity
                                                                                                                                        not_inferred
                                                                                                                                        span
                                                                                                                                        end
                                                                                                                                        8264
                                                                                                                                        end exclusive
                                                                                                                                        true
                                                                                                                                        exact text
                                                                                                                                        metastatic lesions
                                                                                                                                        label id
                                                                                                                                        228e1e3f-d207-481f-8e14-9fdcbd0470e9
                                                                                                                                        offset unit
                                                                                                                                        unicode_code_points
                                                                                                                                        source array index
                                                                                                                                        0
                                                                                                                                        source field
                                                                                                                                        indications_and_usage_exact
                                                                                                                                        source text sha256
                                                                                                                                        e526ba14c91f10737e6d3331fe23a6219f58c0eca6380bfce9bd78b573fea912
                                                                                                                                        start
                                                                                                                                        8246
                                                                                                                                      2. context exact
                                                                                                                                        for the adjuvant treatment of patients with RCC at intermediate-high or high risk of recurrence following nephr
                                                                                                                                        kind
                                                                                                                                        stage_or_setting
                                                                                                                                        polarity
                                                                                                                                        not_inferred
                                                                                                                                        span
                                                                                                                                        end
                                                                                                                                        8136
                                                                                                                                        end exclusive
                                                                                                                                        true
                                                                                                                                        exact text
                                                                                                                                        adjuvant treatment of patients with RCC at
                                                                                                                                        label id
                                                                                                                                        228e1e3f-d207-481f-8e14-9fdcbd0470e9
                                                                                                                                        offset unit
                                                                                                                                        unicode_code_points
                                                                                                                                        source array index
                                                                                                                                        0
                                                                                                                                        source field
                                                                                                                                        indications_and_usage_exact
                                                                                                                                        source text sha256
                                                                                                                                        e526ba14c91f10737e6d3331fe23a6219f58c0eca6380bfce9bd78b573fea912
                                                                                                                                        start
                                                                                                                                        8093
                                                                                                                                      3. context exact
                                                                                                                                        wing nephrectomy, or following nephrectomy and resection of metastatic lesions.
                                                                                                                                        kind
                                                                                                                                        stage_or_setting
                                                                                                                                        polarity
                                                                                                                                        not_inferred
                                                                                                                                        span
                                                                                                                                        end
                                                                                                                                        8264
                                                                                                                                        end exclusive
                                                                                                                                        true
                                                                                                                                        exact text
                                                                                                                                        metastatic lesions
                                                                                                                                        label id
                                                                                                                                        228e1e3f-d207-481f-8e14-9fdcbd0470e9
                                                                                                                                        offset unit
                                                                                                                                        unicode_code_points
                                                                                                                                        source array index
                                                                                                                                        0
                                                                                                                                        source field
                                                                                                                                        indications_and_usage_exact
                                                                                                                                        source text sha256
                                                                                                                                        e526ba14c91f10737e6d3331fe23a6219f58c0eca6380bfce9bd78b573fea912
                                                                                                                                        start
                                                                                                                                        8246
                                                                                                                                      regulatory links
                                                                                                                                        schema version
                                                                                                                                        0.1.0
                                                                                                                                        source batch sha256
                                                                                                                                        fc39a8c5cf96bf95ca20b85578140167b66b2741f7d9217f500d9ba0847ac058
                                                                                                                                        source defined aliases
                                                                                                                                        1. abbreviation
                                                                                                                                          NSCLC
                                                                                                                                          definition exact
                                                                                                                                          Non-Small Cell Lung Cancer
                                                                                                                                          definition span
                                                                                                                                          end
                                                                                                                                          380
                                                                                                                                          end exclusive
                                                                                                                                          true
                                                                                                                                          exact text
                                                                                                                                          Non-Small Cell Lung Cancer (NSCLC)
                                                                                                                                          label id
                                                                                                                                          228e1e3f-d207-481f-8e14-9fdcbd0470e9
                                                                                                                                          offset unit
                                                                                                                                          unicode_code_points
                                                                                                                                          source array index
                                                                                                                                          0
                                                                                                                                          source field
                                                                                                                                          indications_and_usage_exact
                                                                                                                                          source text sha256
                                                                                                                                          e526ba14c91f10737e6d3331fe23a6219f58c0eca6380bfce9bd78b573fea912
                                                                                                                                          start
                                                                                                                                          346
                                                                                                                                        2. abbreviation
                                                                                                                                          CRC
                                                                                                                                          definition exact
                                                                                                                                          Colorectal Cancer
                                                                                                                                          definition span
                                                                                                                                          end
                                                                                                                                          5042
                                                                                                                                          end exclusive
                                                                                                                                          true
                                                                                                                                          exact text
                                                                                                                                          Colorectal Cancer (CRC)
                                                                                                                                          label id
                                                                                                                                          228e1e3f-d207-481f-8e14-9fdcbd0470e9
                                                                                                                                          offset unit
                                                                                                                                          unicode_code_points
                                                                                                                                          source array index
                                                                                                                                          0
                                                                                                                                          source field
                                                                                                                                          indications_and_usage_exact
                                                                                                                                          source text sha256
                                                                                                                                          e526ba14c91f10737e6d3331fe23a6219f58c0eca6380bfce9bd78b573fea912
                                                                                                                                          start
                                                                                                                                          5019
                                                                                                                                        source span
                                                                                                                                        end
                                                                                                                                        8265
                                                                                                                                        end exclusive
                                                                                                                                        true
                                                                                                                                        exact text
                                                                                                                                        for the adjuvant treatment of patients with RCC at intermediate-high or high risk of recurrence following nephrectomy, or following nephrectomy and resection of metastatic lesions.
                                                                                                                                        label id
                                                                                                                                        228e1e3f-d207-481f-8e14-9fdcbd0470e9
                                                                                                                                        offset unit
                                                                                                                                        unicode_code_points
                                                                                                                                        source array index
                                                                                                                                        0
                                                                                                                                        source field
                                                                                                                                        indications_and_usage_exact
                                                                                                                                        source text sha256
                                                                                                                                        e526ba14c91f10737e6d3331fe23a6219f58c0eca6380bfce9bd78b573fea912
                                                                                                                                        start
                                                                                                                                        8085
                                                                                                                                        source url
                                                                                                                                        https://api.fda.gov/drug/label.json?search=id%3A%22228e1e3f-d207-481f-8e14-9fdcbd0470e9%22
                                                                                                                                        spl effective date
                                                                                                                                        2026-07-10
                                                                                                                                        spl set id
                                                                                                                                        9333c79b-d487-4538-a9f0-71b91a02b287
                                                                                                                                        spl version
                                                                                                                                        228
                                                                                                                                        structured fields status
                                                                                                                                        not_extracted_no_values_inferred_from_mentions
                                                                                                                                        structured indication
                                                                                                                                        age
                                                                                                                                        Source null
                                                                                                                                        approval pathway
                                                                                                                                        Source null
                                                                                                                                        biomarker and test
                                                                                                                                        Source null
                                                                                                                                        disease stage
                                                                                                                                        Source null
                                                                                                                                        limitations
                                                                                                                                        Source null
                                                                                                                                        line
                                                                                                                                        Source null
                                                                                                                                        prior therapy
                                                                                                                                        Source null
                                                                                                                                        regimen
                                                                                                                                        Source null
                                                                                                                                        tumor histology
                                                                                                                                        Source null
                                                                                                                                        use intent
                                                                                                                                        not_applicable
                                                                                                                                        Passage 51 · unclassified context
                                                                                                                                        application numbers
                                                                                                                                        1. BLA125514
                                                                                                                                        brand names
                                                                                                                                        1. KEYTRUDA
                                                                                                                                        classification reasons
                                                                                                                                        1. no_unambiguous_positive_indication_predicate
                                                                                                                                        clinical review status
                                                                                                                                        pending
                                                                                                                                        content role
                                                                                                                                        unclassified_context
                                                                                                                                        context span
                                                                                                                                        end
                                                                                                                                        8474
                                                                                                                                        end exclusive
                                                                                                                                        true
                                                                                                                                        exact text
                                                                                                                                        nced RCC. ( 1.16 ) for the adjuvant treatment of patients with RCC at intermediate-high or high risk of recurrence following nephrectomy, or following nephrectomy and resection of metastatic lesions. ( 1.16 ) in combination with belzutifan, for the adjuvant treatment of adult patients with RCC with a clear cell component (ccRCC) at intermediate-high or high risk of recurrence following nephrectomy, or fol
                                                                                                                                        label id
                                                                                                                                        228e1e3f-d207-481f-8e14-9fdcbd0470e9
                                                                                                                                        offset unit
                                                                                                                                        unicode_code_points
                                                                                                                                        source array index
                                                                                                                                        0
                                                                                                                                        source field
                                                                                                                                        indications_and_usage_exact
                                                                                                                                        source text sha256
                                                                                                                                        e526ba14c91f10737e6d3331fe23a6219f58c0eca6380bfce9bd78b573fea912
                                                                                                                                        start
                                                                                                                                        8066
                                                                                                                                        current approval status
                                                                                                                                        not_reconciled
                                                                                                                                        duplicate text group
                                                                                                                                        dup-6e34857f45270be23dec
                                                                                                                                        extraction review status
                                                                                                                                        automated_candidate_pending_source_review
                                                                                                                                        generic names
                                                                                                                                        1. PEMBROLIZUMAB
                                                                                                                                        id
                                                                                                                                        ind-span-ddcabb5e2ff372b5e480
                                                                                                                                        label id
                                                                                                                                        228e1e3f-d207-481f-8e14-9fdcbd0470e9
                                                                                                                                        positive predicate support span
                                                                                                                                        Source null
                                                                                                                                        qualifier mentions
                                                                                                                                          regulatory links
                                                                                                                                            schema version
                                                                                                                                            0.1.0
                                                                                                                                            source batch sha256
                                                                                                                                            fc39a8c5cf96bf95ca20b85578140167b66b2741f7d9217f500d9ba0847ac058
                                                                                                                                            source defined aliases
                                                                                                                                            1. abbreviation
                                                                                                                                              NSCLC
                                                                                                                                              definition exact
                                                                                                                                              Non-Small Cell Lung Cancer
                                                                                                                                              definition span
                                                                                                                                              end
                                                                                                                                              380
                                                                                                                                              end exclusive
                                                                                                                                              true
                                                                                                                                              exact text
                                                                                                                                              Non-Small Cell Lung Cancer (NSCLC)
                                                                                                                                              label id
                                                                                                                                              228e1e3f-d207-481f-8e14-9fdcbd0470e9
                                                                                                                                              offset unit
                                                                                                                                              unicode_code_points
                                                                                                                                              source array index
                                                                                                                                              0
                                                                                                                                              source field
                                                                                                                                              indications_and_usage_exact
                                                                                                                                              source text sha256
                                                                                                                                              e526ba14c91f10737e6d3331fe23a6219f58c0eca6380bfce9bd78b573fea912
                                                                                                                                              start
                                                                                                                                              346
                                                                                                                                            2. abbreviation
                                                                                                                                              CRC
                                                                                                                                              definition exact
                                                                                                                                              Colorectal Cancer
                                                                                                                                              definition span
                                                                                                                                              end
                                                                                                                                              5042
                                                                                                                                              end exclusive
                                                                                                                                              true
                                                                                                                                              exact text
                                                                                                                                              Colorectal Cancer (CRC)
                                                                                                                                              label id
                                                                                                                                              228e1e3f-d207-481f-8e14-9fdcbd0470e9
                                                                                                                                              offset unit
                                                                                                                                              unicode_code_points
                                                                                                                                              source array index
                                                                                                                                              0
                                                                                                                                              source field
                                                                                                                                              indications_and_usage_exact
                                                                                                                                              source text sha256
                                                                                                                                              e526ba14c91f10737e6d3331fe23a6219f58c0eca6380bfce9bd78b573fea912
                                                                                                                                              start
                                                                                                                                              5019
                                                                                                                                            source span
                                                                                                                                            end
                                                                                                                                            8274
                                                                                                                                            end exclusive
                                                                                                                                            true
                                                                                                                                            exact text
                                                                                                                                            ( 1.16 )
                                                                                                                                            label id
                                                                                                                                            228e1e3f-d207-481f-8e14-9fdcbd0470e9
                                                                                                                                            offset unit
                                                                                                                                            unicode_code_points
                                                                                                                                            source array index
                                                                                                                                            0
                                                                                                                                            source field
                                                                                                                                            indications_and_usage_exact
                                                                                                                                            source text sha256
                                                                                                                                            e526ba14c91f10737e6d3331fe23a6219f58c0eca6380bfce9bd78b573fea912
                                                                                                                                            start
                                                                                                                                            8266
                                                                                                                                            source url
                                                                                                                                            https://api.fda.gov/drug/label.json?search=id%3A%22228e1e3f-d207-481f-8e14-9fdcbd0470e9%22
                                                                                                                                            spl effective date
                                                                                                                                            2026-07-10
                                                                                                                                            spl set id
                                                                                                                                            9333c79b-d487-4538-a9f0-71b91a02b287
                                                                                                                                            spl version
                                                                                                                                            228
                                                                                                                                            structured fields status
                                                                                                                                            not_extracted_no_values_inferred_from_mentions
                                                                                                                                            structured indication
                                                                                                                                            age
                                                                                                                                            Source null
                                                                                                                                            approval pathway
                                                                                                                                            Source null
                                                                                                                                            biomarker and test
                                                                                                                                            Source null
                                                                                                                                            disease stage
                                                                                                                                            Source null
                                                                                                                                            limitations
                                                                                                                                            Source null
                                                                                                                                            line
                                                                                                                                            Source null
                                                                                                                                            prior therapy
                                                                                                                                            Source null
                                                                                                                                            regimen
                                                                                                                                            Source null
                                                                                                                                            tumor histology
                                                                                                                                            Source null
                                                                                                                                            use intent
                                                                                                                                            unclear
                                                                                                                                            Passage 52 · risk or warning
                                                                                                                                            application numbers
                                                                                                                                            1. BLA125514
                                                                                                                                            brand names
                                                                                                                                            1. KEYTRUDA
                                                                                                                                            classification reasons
                                                                                                                                            1. risk_or_warning_words_without_positive_predicate
                                                                                                                                            clinical review status
                                                                                                                                            pending
                                                                                                                                            content role
                                                                                                                                            risk_or_warning
                                                                                                                                            context span
                                                                                                                                            end
                                                                                                                                            8729
                                                                                                                                            end exclusive
                                                                                                                                            true
                                                                                                                                            exact text
                                                                                                                                            ( 1.16 ) for the adjuvant treatment of patients with RCC at intermediate-high or high risk of recurrence following nephrectomy, or following nephrectomy and resection of metastatic lesions. ( 1.16 ) in combination with belzutifan, for the adjuvant treatment of adult patients with RCC with a clear cell component (ccRCC) at intermediate-high or high risk of recurrence following nephrectomy, or following nephrectomy and resection of metastatic lesions. ( 1.16 ) Endometrial Carcinoma in combination with carboplatin and paclitaxel, followed by KEYTRUDA as a single agent, for the treatment of adult patients with primary advanced or recurrent endometri
                                                                                                                                            label id
                                                                                                                                            228e1e3f-d207-481f-8e14-9fdcbd0470e9
                                                                                                                                            offset unit
                                                                                                                                            unicode_code_points
                                                                                                                                            source array index
                                                                                                                                            0
                                                                                                                                            source field
                                                                                                                                            indications_and_usage_exact
                                                                                                                                            source text sha256
                                                                                                                                            e526ba14c91f10737e6d3331fe23a6219f58c0eca6380bfce9bd78b573fea912
                                                                                                                                            start
                                                                                                                                            8075
                                                                                                                                            current approval status
                                                                                                                                            not_reconciled
                                                                                                                                            duplicate text group
                                                                                                                                            dup-ef9c50a6eda640075e9a
                                                                                                                                            extraction review status
                                                                                                                                            automated_candidate_pending_source_review
                                                                                                                                            generic names
                                                                                                                                            1. PEMBROLIZUMAB
                                                                                                                                            id
                                                                                                                                            ind-span-7c8a2ff64d17f308145f
                                                                                                                                            label id
                                                                                                                                            228e1e3f-d207-481f-8e14-9fdcbd0470e9
                                                                                                                                            positive predicate support span
                                                                                                                                            Source null
                                                                                                                                            qualifier mentions
                                                                                                                                            1. context exact
                                                                                                                                              combination with belzutifan, for the adjuvant treatment of adult patients with RCC with a clear cell component (ccRCC) at intermediat
                                                                                                                                              kind
                                                                                                                                              age
                                                                                                                                              polarity
                                                                                                                                              not_inferred
                                                                                                                                              span
                                                                                                                                              end
                                                                                                                                              8351
                                                                                                                                              end exclusive
                                                                                                                                              true
                                                                                                                                              exact text
                                                                                                                                              adult patients
                                                                                                                                              label id
                                                                                                                                              228e1e3f-d207-481f-8e14-9fdcbd0470e9
                                                                                                                                              offset unit
                                                                                                                                              unicode_code_points
                                                                                                                                              source array index
                                                                                                                                              0
                                                                                                                                              source field
                                                                                                                                              indications_and_usage_exact
                                                                                                                                              source text sha256
                                                                                                                                              e526ba14c91f10737e6d3331fe23a6219f58c0eca6380bfce9bd78b573fea912
                                                                                                                                              start
                                                                                                                                              8337
                                                                                                                                            2. context exact
                                                                                                                                              wing nephrectomy, or following nephrectomy and resection of metastatic lesions.
                                                                                                                                              kind
                                                                                                                                              biomarker
                                                                                                                                              polarity
                                                                                                                                              not_inferred
                                                                                                                                              span
                                                                                                                                              end
                                                                                                                                              8528
                                                                                                                                              end exclusive
                                                                                                                                              true
                                                                                                                                              exact text
                                                                                                                                              metastatic lesions
                                                                                                                                              label id
                                                                                                                                              228e1e3f-d207-481f-8e14-9fdcbd0470e9
                                                                                                                                              offset unit
                                                                                                                                              unicode_code_points
                                                                                                                                              source array index
                                                                                                                                              0
                                                                                                                                              source field
                                                                                                                                              indications_and_usage_exact
                                                                                                                                              source text sha256
                                                                                                                                              e526ba14c91f10737e6d3331fe23a6219f58c0eca6380bfce9bd78b573fea912
                                                                                                                                              start
                                                                                                                                              8510
                                                                                                                                            3. context exact
                                                                                                                                              in combination with belzutifan, for the adjuvant treatment of adult patients with RCC with a clear cell component (ccRCC) at intermediate-high
                                                                                                                                              kind
                                                                                                                                              stage_or_setting
                                                                                                                                              polarity
                                                                                                                                              not_inferred
                                                                                                                                              span
                                                                                                                                              end
                                                                                                                                              8358
                                                                                                                                              end exclusive
                                                                                                                                              true
                                                                                                                                              exact text
                                                                                                                                              adjuvant treatment of adult patients with R
                                                                                                                                              label id
                                                                                                                                              228e1e3f-d207-481f-8e14-9fdcbd0470e9
                                                                                                                                              offset unit
                                                                                                                                              unicode_code_points
                                                                                                                                              source array index
                                                                                                                                              0
                                                                                                                                              source field
                                                                                                                                              indications_and_usage_exact
                                                                                                                                              source text sha256
                                                                                                                                              e526ba14c91f10737e6d3331fe23a6219f58c0eca6380bfce9bd78b573fea912
                                                                                                                                              start
                                                                                                                                              8315
                                                                                                                                            4. context exact
                                                                                                                                              wing nephrectomy, or following nephrectomy and resection of metastatic lesions.
                                                                                                                                              kind
                                                                                                                                              stage_or_setting
                                                                                                                                              polarity
                                                                                                                                              not_inferred
                                                                                                                                              span
                                                                                                                                              end
                                                                                                                                              8528
                                                                                                                                              end exclusive
                                                                                                                                              true
                                                                                                                                              exact text
                                                                                                                                              metastatic lesions
                                                                                                                                              label id
                                                                                                                                              228e1e3f-d207-481f-8e14-9fdcbd0470e9
                                                                                                                                              offset unit
                                                                                                                                              unicode_code_points
                                                                                                                                              source array index
                                                                                                                                              0
                                                                                                                                              source field
                                                                                                                                              indications_and_usage_exact
                                                                                                                                              source text sha256
                                                                                                                                              e526ba14c91f10737e6d3331fe23a6219f58c0eca6380bfce9bd78b573fea912
                                                                                                                                              start
                                                                                                                                              8510
                                                                                                                                            5. context exact
                                                                                                                                              in combination with belzutifan, for the adjuvant treatment of adult patients with RCC with a clear cell component (ccRCC) at intermediate-high or high risk of recurrence following nephrectomy, or following nephrectomy and resection of meta
                                                                                                                                              kind
                                                                                                                                              regimen
                                                                                                                                              polarity
                                                                                                                                              not_inferred
                                                                                                                                              span
                                                                                                                                              end
                                                                                                                                              8454
                                                                                                                                              end exclusive
                                                                                                                                              true
                                                                                                                                              exact text
                                                                                                                                              in combination with belzutifan, for the adjuvant treatment of adult patients with RCC with a clear cell component (ccRCC) at intermediate-high or high risk of recurrence following
                                                                                                                                              label id
                                                                                                                                              228e1e3f-d207-481f-8e14-9fdcbd0470e9
                                                                                                                                              offset unit
                                                                                                                                              unicode_code_points
                                                                                                                                              source array index
                                                                                                                                              0
                                                                                                                                              source field
                                                                                                                                              indications_and_usage_exact
                                                                                                                                              source text sha256
                                                                                                                                              e526ba14c91f10737e6d3331fe23a6219f58c0eca6380bfce9bd78b573fea912
                                                                                                                                              start
                                                                                                                                              8275
                                                                                                                                            regulatory links
                                                                                                                                              schema version
                                                                                                                                              0.1.0
                                                                                                                                              source batch sha256
                                                                                                                                              fc39a8c5cf96bf95ca20b85578140167b66b2741f7d9217f500d9ba0847ac058
                                                                                                                                              source defined aliases
                                                                                                                                              1. abbreviation
                                                                                                                                                NSCLC
                                                                                                                                                definition exact
                                                                                                                                                Non-Small Cell Lung Cancer
                                                                                                                                                definition span
                                                                                                                                                end
                                                                                                                                                380
                                                                                                                                                end exclusive
                                                                                                                                                true
                                                                                                                                                exact text
                                                                                                                                                Non-Small Cell Lung Cancer (NSCLC)
                                                                                                                                                label id
                                                                                                                                                228e1e3f-d207-481f-8e14-9fdcbd0470e9
                                                                                                                                                offset unit
                                                                                                                                                unicode_code_points
                                                                                                                                                source array index
                                                                                                                                                0
                                                                                                                                                source field
                                                                                                                                                indications_and_usage_exact
                                                                                                                                                source text sha256
                                                                                                                                                e526ba14c91f10737e6d3331fe23a6219f58c0eca6380bfce9bd78b573fea912
                                                                                                                                                start
                                                                                                                                                346
                                                                                                                                              2. abbreviation
                                                                                                                                                CRC
                                                                                                                                                definition exact
                                                                                                                                                Colorectal Cancer
                                                                                                                                                definition span
                                                                                                                                                end
                                                                                                                                                5042
                                                                                                                                                end exclusive
                                                                                                                                                true
                                                                                                                                                exact text
                                                                                                                                                Colorectal Cancer (CRC)
                                                                                                                                                label id
                                                                                                                                                228e1e3f-d207-481f-8e14-9fdcbd0470e9
                                                                                                                                                offset unit
                                                                                                                                                unicode_code_points
                                                                                                                                                source array index
                                                                                                                                                0
                                                                                                                                                source field
                                                                                                                                                indications_and_usage_exact
                                                                                                                                                source text sha256
                                                                                                                                                e526ba14c91f10737e6d3331fe23a6219f58c0eca6380bfce9bd78b573fea912
                                                                                                                                                start
                                                                                                                                                5019
                                                                                                                                              source span
                                                                                                                                              end
                                                                                                                                              8529
                                                                                                                                              end exclusive
                                                                                                                                              true
                                                                                                                                              exact text
                                                                                                                                              in combination with belzutifan, for the adjuvant treatment of adult patients with RCC with a clear cell component (ccRCC) at intermediate-high or high risk of recurrence following nephrectomy, or following nephrectomy and resection of metastatic lesions.
                                                                                                                                              label id
                                                                                                                                              228e1e3f-d207-481f-8e14-9fdcbd0470e9
                                                                                                                                              offset unit
                                                                                                                                              unicode_code_points
                                                                                                                                              source array index
                                                                                                                                              0
                                                                                                                                              source field
                                                                                                                                              indications_and_usage_exact
                                                                                                                                              source text sha256
                                                                                                                                              e526ba14c91f10737e6d3331fe23a6219f58c0eca6380bfce9bd78b573fea912
                                                                                                                                              start
                                                                                                                                              8275
                                                                                                                                              source url
                                                                                                                                              https://api.fda.gov/drug/label.json?search=id%3A%22228e1e3f-d207-481f-8e14-9fdcbd0470e9%22
                                                                                                                                              spl effective date
                                                                                                                                              2026-07-10
                                                                                                                                              spl set id
                                                                                                                                              9333c79b-d487-4538-a9f0-71b91a02b287
                                                                                                                                              spl version
                                                                                                                                              228
                                                                                                                                              structured fields status
                                                                                                                                              not_extracted_no_values_inferred_from_mentions
                                                                                                                                              structured indication
                                                                                                                                              age
                                                                                                                                              Source null
                                                                                                                                              approval pathway
                                                                                                                                              Source null
                                                                                                                                              biomarker and test
                                                                                                                                              Source null
                                                                                                                                              disease stage
                                                                                                                                              Source null
                                                                                                                                              limitations
                                                                                                                                              Source null
                                                                                                                                              line
                                                                                                                                              Source null
                                                                                                                                              prior therapy
                                                                                                                                              Source null
                                                                                                                                              regimen
                                                                                                                                              Source null
                                                                                                                                              tumor histology
                                                                                                                                              Source null
                                                                                                                                              use intent
                                                                                                                                              not_applicable
                                                                                                                                              Passage 53 · unclassified context
                                                                                                                                              application numbers
                                                                                                                                              1. BLA125514
                                                                                                                                              brand names
                                                                                                                                              1. KEYTRUDA
                                                                                                                                              classification reasons
                                                                                                                                              1. no_unambiguous_positive_indication_predicate
                                                                                                                                              clinical review status
                                                                                                                                              pending
                                                                                                                                              content role
                                                                                                                                              unclassified_context
                                                                                                                                              context span
                                                                                                                                              end
                                                                                                                                              8942
                                                                                                                                              end exclusive
                                                                                                                                              true
                                                                                                                                              exact text
                                                                                                                                              ent of adult patients with RCC with a clear cell component (ccRCC) at intermediate-high or high risk of recurrence following nephrectomy, or following nephrectomy and resection of metastatic lesions. ( 1.16 ) Endometrial Carcinoma in combination with carboplatin and paclitaxel, followed by KEYTRUDA as a single agent, for the treatment of adult patients with primary advanced or recurrent endometrial carcinoma. ( 1.17 ) in combination with lenvatinib, for the treatment of adult patients with advanced endometrial carcinoma that is mismatch repair proficient (pMMR) or not MSI-H as determined by an FDA-authori
                                                                                                                                              label id
                                                                                                                                              228e1e3f-d207-481f-8e14-9fdcbd0470e9
                                                                                                                                              offset unit
                                                                                                                                              unicode_code_points
                                                                                                                                              source array index
                                                                                                                                              0
                                                                                                                                              source field
                                                                                                                                              indications_and_usage_exact
                                                                                                                                              source text sha256
                                                                                                                                              e526ba14c91f10737e6d3331fe23a6219f58c0eca6380bfce9bd78b573fea912
                                                                                                                                              start
                                                                                                                                              8330
                                                                                                                                              current approval status
                                                                                                                                              not_reconciled
                                                                                                                                              duplicate text group
                                                                                                                                              dup-d8962a881252c4595eca
                                                                                                                                              extraction review status
                                                                                                                                              automated_candidate_pending_source_review
                                                                                                                                              generic names
                                                                                                                                              1. PEMBROLIZUMAB
                                                                                                                                              id
                                                                                                                                              ind-span-3bb6048a680fce5a6171
                                                                                                                                              label id
                                                                                                                                              228e1e3f-d207-481f-8e14-9fdcbd0470e9
                                                                                                                                              positive predicate support span
                                                                                                                                              Source null
                                                                                                                                              qualifier mentions
                                                                                                                                              1. context exact
                                                                                                                                                ollowed by KEYTRUDA as a single agent, for the treatment of adult patients with primary advanced or recurrent endometrial carcinoma.
                                                                                                                                                kind
                                                                                                                                                age
                                                                                                                                                polarity
                                                                                                                                                not_inferred
                                                                                                                                                span
                                                                                                                                                end
                                                                                                                                                8684
                                                                                                                                                end exclusive
                                                                                                                                                true
                                                                                                                                                exact text
                                                                                                                                                adult patients
                                                                                                                                                label id
                                                                                                                                                228e1e3f-d207-481f-8e14-9fdcbd0470e9
                                                                                                                                                offset unit
                                                                                                                                                unicode_code_points
                                                                                                                                                source array index
                                                                                                                                                0
                                                                                                                                                source field
                                                                                                                                                indications_and_usage_exact
                                                                                                                                                source text sha256
                                                                                                                                                e526ba14c91f10737e6d3331fe23a6219f58c0eca6380bfce9bd78b573fea912
                                                                                                                                                start
                                                                                                                                                8670
                                                                                                                                              2. context exact
                                                                                                                                                gle agent, for the treatment of adult patients with primary advanced or recurrent endometrial carcinoma.
                                                                                                                                                kind
                                                                                                                                                stage_or_setting
                                                                                                                                                polarity
                                                                                                                                                not_inferred
                                                                                                                                                span
                                                                                                                                                end
                                                                                                                                                8741
                                                                                                                                                end exclusive
                                                                                                                                                true
                                                                                                                                                exact text
                                                                                                                                                advanced or recurrent endometrial carcinoma
                                                                                                                                                label id
                                                                                                                                                228e1e3f-d207-481f-8e14-9fdcbd0470e9
                                                                                                                                                offset unit
                                                                                                                                                unicode_code_points
                                                                                                                                                source array index
                                                                                                                                                0
                                                                                                                                                source field
                                                                                                                                                indications_and_usage_exact
                                                                                                                                                source text sha256
                                                                                                                                                e526ba14c91f10737e6d3331fe23a6219f58c0eca6380bfce9bd78b573fea912
                                                                                                                                                start
                                                                                                                                                8698
                                                                                                                                              3. context exact
                                                                                                                                                ( 1.16 ) Endometrial Carcinoma in combination with carboplatin and paclitaxel, followed by KEYTRUDA as a single agent, for the treatment of adult patients with primary advanced or recurrent endometrial carcinoma.
                                                                                                                                                kind
                                                                                                                                                regimen
                                                                                                                                                polarity
                                                                                                                                                not_inferred
                                                                                                                                                span
                                                                                                                                                end
                                                                                                                                                8740
                                                                                                                                                end exclusive
                                                                                                                                                true
                                                                                                                                                exact text
                                                                                                                                                in combination with carboplatin and paclitaxel, followed by KEYTRUDA as a single agent, for the treatment of adult patients with primary advanced or recurrent endometrial carcinom
                                                                                                                                                label id
                                                                                                                                                228e1e3f-d207-481f-8e14-9fdcbd0470e9
                                                                                                                                                offset unit
                                                                                                                                                unicode_code_points
                                                                                                                                                source array index
                                                                                                                                                0
                                                                                                                                                source field
                                                                                                                                                indications_and_usage_exact
                                                                                                                                                source text sha256
                                                                                                                                                e526ba14c91f10737e6d3331fe23a6219f58c0eca6380bfce9bd78b573fea912
                                                                                                                                                start
                                                                                                                                                8561
                                                                                                                                              regulatory links
                                                                                                                                                schema version
                                                                                                                                                0.1.0
                                                                                                                                                source batch sha256
                                                                                                                                                fc39a8c5cf96bf95ca20b85578140167b66b2741f7d9217f500d9ba0847ac058
                                                                                                                                                source defined aliases
                                                                                                                                                1. abbreviation
                                                                                                                                                  NSCLC
                                                                                                                                                  definition exact
                                                                                                                                                  Non-Small Cell Lung Cancer
                                                                                                                                                  definition span
                                                                                                                                                  end
                                                                                                                                                  380
                                                                                                                                                  end exclusive
                                                                                                                                                  true
                                                                                                                                                  exact text
                                                                                                                                                  Non-Small Cell Lung Cancer (NSCLC)
                                                                                                                                                  label id
                                                                                                                                                  228e1e3f-d207-481f-8e14-9fdcbd0470e9
                                                                                                                                                  offset unit
                                                                                                                                                  unicode_code_points
                                                                                                                                                  source array index
                                                                                                                                                  0
                                                                                                                                                  source field
                                                                                                                                                  indications_and_usage_exact
                                                                                                                                                  source text sha256
                                                                                                                                                  e526ba14c91f10737e6d3331fe23a6219f58c0eca6380bfce9bd78b573fea912
                                                                                                                                                  start
                                                                                                                                                  346
                                                                                                                                                2. abbreviation
                                                                                                                                                  CRC
                                                                                                                                                  definition exact
                                                                                                                                                  Colorectal Cancer
                                                                                                                                                  definition span
                                                                                                                                                  end
                                                                                                                                                  5042
                                                                                                                                                  end exclusive
                                                                                                                                                  true
                                                                                                                                                  exact text
                                                                                                                                                  Colorectal Cancer (CRC)
                                                                                                                                                  label id
                                                                                                                                                  228e1e3f-d207-481f-8e14-9fdcbd0470e9
                                                                                                                                                  offset unit
                                                                                                                                                  unicode_code_points
                                                                                                                                                  source array index
                                                                                                                                                  0
                                                                                                                                                  source field
                                                                                                                                                  indications_and_usage_exact
                                                                                                                                                  source text sha256
                                                                                                                                                  e526ba14c91f10737e6d3331fe23a6219f58c0eca6380bfce9bd78b573fea912
                                                                                                                                                  start
                                                                                                                                                  5019
                                                                                                                                                source span
                                                                                                                                                end
                                                                                                                                                8742
                                                                                                                                                end exclusive
                                                                                                                                                true
                                                                                                                                                exact text
                                                                                                                                                ( 1.16 ) Endometrial Carcinoma in combination with carboplatin and paclitaxel, followed by KEYTRUDA as a single agent, for the treatment of adult patients with primary advanced or recurrent endometrial carcinoma.
                                                                                                                                                label id
                                                                                                                                                228e1e3f-d207-481f-8e14-9fdcbd0470e9
                                                                                                                                                offset unit
                                                                                                                                                unicode_code_points
                                                                                                                                                source array index
                                                                                                                                                0
                                                                                                                                                source field
                                                                                                                                                indications_and_usage_exact
                                                                                                                                                source text sha256
                                                                                                                                                e526ba14c91f10737e6d3331fe23a6219f58c0eca6380bfce9bd78b573fea912
                                                                                                                                                start
                                                                                                                                                8530
                                                                                                                                                source url
                                                                                                                                                https://api.fda.gov/drug/label.json?search=id%3A%22228e1e3f-d207-481f-8e14-9fdcbd0470e9%22
                                                                                                                                                spl effective date
                                                                                                                                                2026-07-10
                                                                                                                                                spl set id
                                                                                                                                                9333c79b-d487-4538-a9f0-71b91a02b287
                                                                                                                                                spl version
                                                                                                                                                228
                                                                                                                                                structured fields status
                                                                                                                                                not_extracted_no_values_inferred_from_mentions
                                                                                                                                                structured indication
                                                                                                                                                age
                                                                                                                                                Source null
                                                                                                                                                approval pathway
                                                                                                                                                Source null
                                                                                                                                                biomarker and test
                                                                                                                                                Source null
                                                                                                                                                disease stage
                                                                                                                                                Source null
                                                                                                                                                limitations
                                                                                                                                                Source null
                                                                                                                                                line
                                                                                                                                                Source null
                                                                                                                                                prior therapy
                                                                                                                                                Source null
                                                                                                                                                regimen
                                                                                                                                                Source null
                                                                                                                                                tumor histology
                                                                                                                                                Source null
                                                                                                                                                use intent
                                                                                                                                                unclear
                                                                                                                                                Passage 54 · unclassified context
                                                                                                                                                application numbers
                                                                                                                                                1. BLA125514
                                                                                                                                                brand names
                                                                                                                                                1. KEYTRUDA
                                                                                                                                                classification reasons
                                                                                                                                                1. no_unambiguous_positive_indication_predicate
                                                                                                                                                clinical review status
                                                                                                                                                pending
                                                                                                                                                content role
                                                                                                                                                unclassified_context
                                                                                                                                                context span
                                                                                                                                                end
                                                                                                                                                8951
                                                                                                                                                end exclusive
                                                                                                                                                true
                                                                                                                                                exact text
                                                                                                                                                metrial Carcinoma in combination with carboplatin and paclitaxel, followed by KEYTRUDA as a single agent, for the treatment of adult patients with primary advanced or recurrent endometrial carcinoma. ( 1.17 ) in combination with lenvatinib, for the treatment of adult patients with advanced endometrial carcinoma that is mismatch repair proficient (pMMR) or not MSI-H as determined by an FDA-authorized test,
                                                                                                                                                label id
                                                                                                                                                228e1e3f-d207-481f-8e14-9fdcbd0470e9
                                                                                                                                                offset unit
                                                                                                                                                unicode_code_points
                                                                                                                                                source array index
                                                                                                                                                0
                                                                                                                                                source field
                                                                                                                                                indications_and_usage_exact
                                                                                                                                                source text sha256
                                                                                                                                                e526ba14c91f10737e6d3331fe23a6219f58c0eca6380bfce9bd78b573fea912
                                                                                                                                                start
                                                                                                                                                8543
                                                                                                                                                current approval status
                                                                                                                                                not_reconciled
                                                                                                                                                duplicate text group
                                                                                                                                                dup-20b0e90823390e25be4a
                                                                                                                                                extraction review status
                                                                                                                                                automated_candidate_pending_source_review
                                                                                                                                                generic names
                                                                                                                                                1. PEMBROLIZUMAB
                                                                                                                                                id
                                                                                                                                                ind-span-14eca8fc21ba20abc77c
                                                                                                                                                label id
                                                                                                                                                228e1e3f-d207-481f-8e14-9fdcbd0470e9
                                                                                                                                                positive predicate support span
                                                                                                                                                Source null
                                                                                                                                                qualifier mentions
                                                                                                                                                  regulatory links
                                                                                                                                                    schema version
                                                                                                                                                    0.1.0
                                                                                                                                                    source batch sha256
                                                                                                                                                    fc39a8c5cf96bf95ca20b85578140167b66b2741f7d9217f500d9ba0847ac058
                                                                                                                                                    source defined aliases
                                                                                                                                                    1. abbreviation
                                                                                                                                                      NSCLC
                                                                                                                                                      definition exact
                                                                                                                                                      Non-Small Cell Lung Cancer
                                                                                                                                                      definition span
                                                                                                                                                      end
                                                                                                                                                      380
                                                                                                                                                      end exclusive
                                                                                                                                                      true
                                                                                                                                                      exact text
                                                                                                                                                      Non-Small Cell Lung Cancer (NSCLC)
                                                                                                                                                      label id
                                                                                                                                                      228e1e3f-d207-481f-8e14-9fdcbd0470e9
                                                                                                                                                      offset unit
                                                                                                                                                      unicode_code_points
                                                                                                                                                      source array index
                                                                                                                                                      0
                                                                                                                                                      source field
                                                                                                                                                      indications_and_usage_exact
                                                                                                                                                      source text sha256
                                                                                                                                                      e526ba14c91f10737e6d3331fe23a6219f58c0eca6380bfce9bd78b573fea912
                                                                                                                                                      start
                                                                                                                                                      346
                                                                                                                                                    2. abbreviation
                                                                                                                                                      CRC
                                                                                                                                                      definition exact
                                                                                                                                                      Colorectal Cancer
                                                                                                                                                      definition span
                                                                                                                                                      end
                                                                                                                                                      5042
                                                                                                                                                      end exclusive
                                                                                                                                                      true
                                                                                                                                                      exact text
                                                                                                                                                      Colorectal Cancer (CRC)
                                                                                                                                                      label id
                                                                                                                                                      228e1e3f-d207-481f-8e14-9fdcbd0470e9
                                                                                                                                                      offset unit
                                                                                                                                                      unicode_code_points
                                                                                                                                                      source array index
                                                                                                                                                      0
                                                                                                                                                      source field
                                                                                                                                                      indications_and_usage_exact
                                                                                                                                                      source text sha256
                                                                                                                                                      e526ba14c91f10737e6d3331fe23a6219f58c0eca6380bfce9bd78b573fea912
                                                                                                                                                      start
                                                                                                                                                      5019
                                                                                                                                                    source span
                                                                                                                                                    end
                                                                                                                                                    8751
                                                                                                                                                    end exclusive
                                                                                                                                                    true
                                                                                                                                                    exact text
                                                                                                                                                    ( 1.17 )
                                                                                                                                                    label id
                                                                                                                                                    228e1e3f-d207-481f-8e14-9fdcbd0470e9
                                                                                                                                                    offset unit
                                                                                                                                                    unicode_code_points
                                                                                                                                                    source array index
                                                                                                                                                    0
                                                                                                                                                    source field
                                                                                                                                                    indications_and_usage_exact
                                                                                                                                                    source text sha256
                                                                                                                                                    e526ba14c91f10737e6d3331fe23a6219f58c0eca6380bfce9bd78b573fea912
                                                                                                                                                    start
                                                                                                                                                    8743
                                                                                                                                                    source url
                                                                                                                                                    https://api.fda.gov/drug/label.json?search=id%3A%22228e1e3f-d207-481f-8e14-9fdcbd0470e9%22
                                                                                                                                                    spl effective date
                                                                                                                                                    2026-07-10
                                                                                                                                                    spl set id
                                                                                                                                                    9333c79b-d487-4538-a9f0-71b91a02b287
                                                                                                                                                    spl version
                                                                                                                                                    228
                                                                                                                                                    structured fields status
                                                                                                                                                    not_extracted_no_values_inferred_from_mentions
                                                                                                                                                    structured indication
                                                                                                                                                    age
                                                                                                                                                    Source null
                                                                                                                                                    approval pathway
                                                                                                                                                    Source null
                                                                                                                                                    biomarker and test
                                                                                                                                                    Source null
                                                                                                                                                    disease stage
                                                                                                                                                    Source null
                                                                                                                                                    limitations
                                                                                                                                                    Source null
                                                                                                                                                    line
                                                                                                                                                    Source null
                                                                                                                                                    prior therapy
                                                                                                                                                    Source null
                                                                                                                                                    regimen
                                                                                                                                                    Source null
                                                                                                                                                    tumor histology
                                                                                                                                                    Source null
                                                                                                                                                    use intent
                                                                                                                                                    unclear
                                                                                                                                                    Passage 55 · unclassified context
                                                                                                                                                    application numbers
                                                                                                                                                    1. BLA125514
                                                                                                                                                    brand names
                                                                                                                                                    1. KEYTRUDA
                                                                                                                                                    classification reasons
                                                                                                                                                    1. no_unambiguous_positive_indication_predicate
                                                                                                                                                    clinical review status
                                                                                                                                                    pending
                                                                                                                                                    content role
                                                                                                                                                    unclassified_context
                                                                                                                                                    context span
                                                                                                                                                    end
                                                                                                                                                    9286
                                                                                                                                                    end exclusive
                                                                                                                                                    true
                                                                                                                                                    exact text
                                                                                                                                                    arcinoma in combination with carboplatin and paclitaxel, followed by KEYTRUDA as a single agent, for the treatment of adult patients with primary advanced or recurrent endometrial carcinoma. ( 1.17 ) in combination with lenvatinib, for the treatment of adult patients with advanced endometrial carcinoma that is mismatch repair proficient (pMMR) or not MSI-H as determined by an FDA-authorized test, who have disease progression following prior systemic therapy in any setting and are not candidates for curative surgery or radiation. ( 1.17 , 2.1 ) as a single agent, for the treatment of adult patients with advanced endometrial carcinoma that is MSI-H or dMMR, as determined by an FDA-authorized test, who have disease progression
                                                                                                                                                    label id
                                                                                                                                                    228e1e3f-d207-481f-8e14-9fdcbd0470e9
                                                                                                                                                    offset unit
                                                                                                                                                    unicode_code_points
                                                                                                                                                    source array index
                                                                                                                                                    0
                                                                                                                                                    source field
                                                                                                                                                    indications_and_usage_exact
                                                                                                                                                    source text sha256
                                                                                                                                                    e526ba14c91f10737e6d3331fe23a6219f58c0eca6380bfce9bd78b573fea912
                                                                                                                                                    start
                                                                                                                                                    8552
                                                                                                                                                    current approval status
                                                                                                                                                    not_reconciled
                                                                                                                                                    duplicate text group
                                                                                                                                                    dup-67be8e39eb11755bb9a4
                                                                                                                                                    extraction review status
                                                                                                                                                    automated_candidate_pending_source_review
                                                                                                                                                    generic names
                                                                                                                                                    1. PEMBROLIZUMAB
                                                                                                                                                    id
                                                                                                                                                    ind-span-25bd98ee2e623a0da1a4
                                                                                                                                                    label id
                                                                                                                                                    228e1e3f-d207-481f-8e14-9fdcbd0470e9
                                                                                                                                                    positive predicate support span
                                                                                                                                                    Source null
                                                                                                                                                    qualifier mentions
                                                                                                                                                    1. context exact
                                                                                                                                                      in combination with lenvatinib, for the treatment of adult patients with advanced endometrial carcinoma that is mismatch repair
                                                                                                                                                      kind
                                                                                                                                                      age
                                                                                                                                                      polarity
                                                                                                                                                      not_inferred
                                                                                                                                                      span
                                                                                                                                                      end
                                                                                                                                                      8819
                                                                                                                                                      end exclusive
                                                                                                                                                      true
                                                                                                                                                      exact text
                                                                                                                                                      adult patients
                                                                                                                                                      label id
                                                                                                                                                      228e1e3f-d207-481f-8e14-9fdcbd0470e9
                                                                                                                                                      offset unit
                                                                                                                                                      unicode_code_points
                                                                                                                                                      source array index
                                                                                                                                                      0
                                                                                                                                                      source field
                                                                                                                                                      indications_and_usage_exact
                                                                                                                                                      source text sha256
                                                                                                                                                      e526ba14c91f10737e6d3331fe23a6219f58c0eca6380bfce9bd78b573fea912
                                                                                                                                                      start
                                                                                                                                                      8805
                                                                                                                                                    2. context exact
                                                                                                                                                      carcinoma that is mismatch repair proficient (pMMR) or not MSI-H as determined by an FDA-authorized test, who have disease progression following prior systemic ther
                                                                                                                                                      kind
                                                                                                                                                      biomarker
                                                                                                                                                      polarity
                                                                                                                                                      not_inferred
                                                                                                                                                      span
                                                                                                                                                      end
                                                                                                                                                      8950
                                                                                                                                                      end exclusive
                                                                                                                                                      true
                                                                                                                                                      exact text
                                                                                                                                                      MSI-H as determined by an FDA-authorized test
                                                                                                                                                      label id
                                                                                                                                                      228e1e3f-d207-481f-8e14-9fdcbd0470e9
                                                                                                                                                      offset unit
                                                                                                                                                      unicode_code_points
                                                                                                                                                      source array index
                                                                                                                                                      0
                                                                                                                                                      source field
                                                                                                                                                      indications_and_usage_exact
                                                                                                                                                      source text sha256
                                                                                                                                                      e526ba14c91f10737e6d3331fe23a6219f58c0eca6380bfce9bd78b573fea912
                                                                                                                                                      start
                                                                                                                                                      8905
                                                                                                                                                    3. context exact
                                                                                                                                                      n with lenvatinib, for the treatment of adult patients with advanced endometrial carcinoma that is mismatch repair proficient (pMMR) or not MSI-H as determined by
                                                                                                                                                      kind
                                                                                                                                                      stage_or_setting
                                                                                                                                                      polarity
                                                                                                                                                      not_inferred
                                                                                                                                                      span
                                                                                                                                                      end
                                                                                                                                                      8868
                                                                                                                                                      end exclusive
                                                                                                                                                      true
                                                                                                                                                      exact text
                                                                                                                                                      advanced endometrial carcinoma that is mism
                                                                                                                                                      label id
                                                                                                                                                      228e1e3f-d207-481f-8e14-9fdcbd0470e9
                                                                                                                                                      offset unit
                                                                                                                                                      unicode_code_points
                                                                                                                                                      source array index
                                                                                                                                                      0
                                                                                                                                                      source field
                                                                                                                                                      indications_and_usage_exact
                                                                                                                                                      source text sha256
                                                                                                                                                      e526ba14c91f10737e6d3331fe23a6219f58c0eca6380bfce9bd78b573fea912
                                                                                                                                                      start
                                                                                                                                                      8825
                                                                                                                                                    4. context exact
                                                                                                                                                      FDA-authorized test, who have disease progression following prior systemic therapy in any setting and are not candidates for curative surgery or radiation.
                                                                                                                                                      kind
                                                                                                                                                      prior_therapy_or_line
                                                                                                                                                      polarity
                                                                                                                                                      not_inferred
                                                                                                                                                      span
                                                                                                                                                      end
                                                                                                                                                      9085
                                                                                                                                                      end exclusive
                                                                                                                                                      true
                                                                                                                                                      exact text
                                                                                                                                                      prior systemic therapy in any setting and are not candidates for curative surgery or radiation
                                                                                                                                                      label id
                                                                                                                                                      228e1e3f-d207-481f-8e14-9fdcbd0470e9
                                                                                                                                                      offset unit
                                                                                                                                                      unicode_code_points
                                                                                                                                                      source array index
                                                                                                                                                      0
                                                                                                                                                      source field
                                                                                                                                                      indications_and_usage_exact
                                                                                                                                                      source text sha256
                                                                                                                                                      e526ba14c91f10737e6d3331fe23a6219f58c0eca6380bfce9bd78b573fea912
                                                                                                                                                      start
                                                                                                                                                      8991
                                                                                                                                                    5. context exact
                                                                                                                                                      in combination with lenvatinib, for the treatment of adult patients with advanced endometrial carcinoma that is mismatch repair proficient (pMMR) or not MSI-H as determined by an FDA-authorized test, who have disease progression following
                                                                                                                                                      kind
                                                                                                                                                      regimen
                                                                                                                                                      polarity
                                                                                                                                                      not_inferred
                                                                                                                                                      span
                                                                                                                                                      end
                                                                                                                                                      8931
                                                                                                                                                      end exclusive
                                                                                                                                                      true
                                                                                                                                                      exact text
                                                                                                                                                      in combination with lenvatinib, for the treatment of adult patients with advanced endometrial carcinoma that is mismatch repair proficient (pMMR) or not MSI-H as determined by an
                                                                                                                                                      label id
                                                                                                                                                      228e1e3f-d207-481f-8e14-9fdcbd0470e9
                                                                                                                                                      offset unit
                                                                                                                                                      unicode_code_points
                                                                                                                                                      source array index
                                                                                                                                                      0
                                                                                                                                                      source field
                                                                                                                                                      indications_and_usage_exact
                                                                                                                                                      source text sha256
                                                                                                                                                      e526ba14c91f10737e6d3331fe23a6219f58c0eca6380bfce9bd78b573fea912
                                                                                                                                                      start
                                                                                                                                                      8752
                                                                                                                                                    regulatory links
                                                                                                                                                      schema version
                                                                                                                                                      0.1.0
                                                                                                                                                      source batch sha256
                                                                                                                                                      fc39a8c5cf96bf95ca20b85578140167b66b2741f7d9217f500d9ba0847ac058
                                                                                                                                                      source defined aliases
                                                                                                                                                      1. abbreviation
                                                                                                                                                        NSCLC
                                                                                                                                                        definition exact
                                                                                                                                                        Non-Small Cell Lung Cancer
                                                                                                                                                        definition span
                                                                                                                                                        end
                                                                                                                                                        380
                                                                                                                                                        end exclusive
                                                                                                                                                        true
                                                                                                                                                        exact text
                                                                                                                                                        Non-Small Cell Lung Cancer (NSCLC)
                                                                                                                                                        label id
                                                                                                                                                        228e1e3f-d207-481f-8e14-9fdcbd0470e9
                                                                                                                                                        offset unit
                                                                                                                                                        unicode_code_points
                                                                                                                                                        source array index
                                                                                                                                                        0
                                                                                                                                                        source field
                                                                                                                                                        indications_and_usage_exact
                                                                                                                                                        source text sha256
                                                                                                                                                        e526ba14c91f10737e6d3331fe23a6219f58c0eca6380bfce9bd78b573fea912
                                                                                                                                                        start
                                                                                                                                                        346
                                                                                                                                                      2. abbreviation
                                                                                                                                                        CRC
                                                                                                                                                        definition exact
                                                                                                                                                        Colorectal Cancer
                                                                                                                                                        definition span
                                                                                                                                                        end
                                                                                                                                                        5042
                                                                                                                                                        end exclusive
                                                                                                                                                        true
                                                                                                                                                        exact text
                                                                                                                                                        Colorectal Cancer (CRC)
                                                                                                                                                        label id
                                                                                                                                                        228e1e3f-d207-481f-8e14-9fdcbd0470e9
                                                                                                                                                        offset unit
                                                                                                                                                        unicode_code_points
                                                                                                                                                        source array index
                                                                                                                                                        0
                                                                                                                                                        source field
                                                                                                                                                        indications_and_usage_exact
                                                                                                                                                        source text sha256
                                                                                                                                                        e526ba14c91f10737e6d3331fe23a6219f58c0eca6380bfce9bd78b573fea912
                                                                                                                                                        start
                                                                                                                                                        5019
                                                                                                                                                      source span
                                                                                                                                                      end
                                                                                                                                                      9086
                                                                                                                                                      end exclusive
                                                                                                                                                      true
                                                                                                                                                      exact text
                                                                                                                                                      in combination with lenvatinib, for the treatment of adult patients with advanced endometrial carcinoma that is mismatch repair proficient (pMMR) or not MSI-H as determined by an FDA-authorized test, who have disease progression following prior systemic therapy in any setting and are not candidates for curative surgery or radiation.
                                                                                                                                                      label id
                                                                                                                                                      228e1e3f-d207-481f-8e14-9fdcbd0470e9
                                                                                                                                                      offset unit
                                                                                                                                                      unicode_code_points
                                                                                                                                                      source array index
                                                                                                                                                      0
                                                                                                                                                      source field
                                                                                                                                                      indications_and_usage_exact
                                                                                                                                                      source text sha256
                                                                                                                                                      e526ba14c91f10737e6d3331fe23a6219f58c0eca6380bfce9bd78b573fea912
                                                                                                                                                      start
                                                                                                                                                      8752
                                                                                                                                                      source url
                                                                                                                                                      https://api.fda.gov/drug/label.json?search=id%3A%22228e1e3f-d207-481f-8e14-9fdcbd0470e9%22
                                                                                                                                                      spl effective date
                                                                                                                                                      2026-07-10
                                                                                                                                                      spl set id
                                                                                                                                                      9333c79b-d487-4538-a9f0-71b91a02b287
                                                                                                                                                      spl version
                                                                                                                                                      228
                                                                                                                                                      structured fields status
                                                                                                                                                      not_extracted_no_values_inferred_from_mentions
                                                                                                                                                      structured indication
                                                                                                                                                      age
                                                                                                                                                      Source null
                                                                                                                                                      approval pathway
                                                                                                                                                      Source null
                                                                                                                                                      biomarker and test
                                                                                                                                                      Source null
                                                                                                                                                      disease stage
                                                                                                                                                      Source null
                                                                                                                                                      limitations
                                                                                                                                                      Source null
                                                                                                                                                      line
                                                                                                                                                      Source null
                                                                                                                                                      prior therapy
                                                                                                                                                      Source null
                                                                                                                                                      regimen
                                                                                                                                                      Source null
                                                                                                                                                      tumor histology
                                                                                                                                                      Source null
                                                                                                                                                      use intent
                                                                                                                                                      unclear
                                                                                                                                                      Passage 56 · unclassified context
                                                                                                                                                      application numbers
                                                                                                                                                      1. BLA125514
                                                                                                                                                      brand names
                                                                                                                                                      1. KEYTRUDA
                                                                                                                                                      classification reasons
                                                                                                                                                      1. no_unambiguous_positive_indication_predicate
                                                                                                                                                      clinical review status
                                                                                                                                                      pending
                                                                                                                                                      content role
                                                                                                                                                      unclassified_context
                                                                                                                                                      context span
                                                                                                                                                      end
                                                                                                                                                      9591
                                                                                                                                                      end exclusive
                                                                                                                                                      true
                                                                                                                                                      exact text
                                                                                                                                                      ent (pMMR) or not MSI-H as determined by an FDA-authorized test, who have disease progression following prior systemic therapy in any setting and are not candidates for curative surgery or radiation. ( 1.17 , 2.1 ) as a single agent, for the treatment of adult patients with advanced endometrial carcinoma that is MSI-H or dMMR, as determined by an FDA-authorized test, who have disease progression following prior systemic therapy in any setting and are not candidates for curative surgery or radiation. ( 1.17 , 2.1 ) Tumor Mutational Burden-High (TMB-H) Cancer for the treatment of adult and pediatric patients with unresectable or metastatic tumor mutational burden-high (TMB-H) [≥10 mutations/megaba
                                                                                                                                                      label id
                                                                                                                                                      228e1e3f-d207-481f-8e14-9fdcbd0470e9
                                                                                                                                                      offset unit
                                                                                                                                                      unicode_code_points
                                                                                                                                                      source array index
                                                                                                                                                      0
                                                                                                                                                      source field
                                                                                                                                                      indications_and_usage_exact
                                                                                                                                                      source text sha256
                                                                                                                                                      e526ba14c91f10737e6d3331fe23a6219f58c0eca6380bfce9bd78b573fea912
                                                                                                                                                      start
                                                                                                                                                      8887
                                                                                                                                                      current approval status
                                                                                                                                                      not_reconciled
                                                                                                                                                      duplicate text group
                                                                                                                                                      dup-6b66781cf157bc7f12cd
                                                                                                                                                      extraction review status
                                                                                                                                                      automated_candidate_pending_source_review
                                                                                                                                                      generic names
                                                                                                                                                      1. PEMBROLIZUMAB
                                                                                                                                                      id
                                                                                                                                                      ind-span-980671690e65183f8a62
                                                                                                                                                      label id
                                                                                                                                                      228e1e3f-d207-481f-8e14-9fdcbd0470e9
                                                                                                                                                      positive predicate support span
                                                                                                                                                      Source null
                                                                                                                                                      qualifier mentions
                                                                                                                                                      1. context exact
                                                                                                                                                        ( 1.17 , 2.1 ) as a single agent, for the treatment of adult patients with advanced endometrial carcinoma that is MSI-H or dMMR,
                                                                                                                                                        kind
                                                                                                                                                        age
                                                                                                                                                        polarity
                                                                                                                                                        not_inferred
                                                                                                                                                        span
                                                                                                                                                        end
                                                                                                                                                        9156
                                                                                                                                                        end exclusive
                                                                                                                                                        true
                                                                                                                                                        exact text
                                                                                                                                                        adult patients
                                                                                                                                                        label id
                                                                                                                                                        228e1e3f-d207-481f-8e14-9fdcbd0470e9
                                                                                                                                                        offset unit
                                                                                                                                                        unicode_code_points
                                                                                                                                                        source array index
                                                                                                                                                        0
                                                                                                                                                        source field
                                                                                                                                                        indications_and_usage_exact
                                                                                                                                                        source text sha256
                                                                                                                                                        e526ba14c91f10737e6d3331fe23a6219f58c0eca6380bfce9bd78b573fea912
                                                                                                                                                        start
                                                                                                                                                        9142
                                                                                                                                                      2. context exact
                                                                                                                                                        adult patients with advanced endometrial carcinoma that is MSI-H or dMMR, as determined by an FDA-authorized test, who have disease
                                                                                                                                                        kind
                                                                                                                                                        biomarker
                                                                                                                                                        polarity
                                                                                                                                                        not_inferred
                                                                                                                                                        span
                                                                                                                                                        end
                                                                                                                                                        9214
                                                                                                                                                        end exclusive
                                                                                                                                                        true
                                                                                                                                                        exact text
                                                                                                                                                        MSI-H or dMMR
                                                                                                                                                        label id
                                                                                                                                                        228e1e3f-d207-481f-8e14-9fdcbd0470e9
                                                                                                                                                        offset unit
                                                                                                                                                        unicode_code_points
                                                                                                                                                        source array index
                                                                                                                                                        0
                                                                                                                                                        source field
                                                                                                                                                        indications_and_usage_exact
                                                                                                                                                        source text sha256
                                                                                                                                                        e526ba14c91f10737e6d3331fe23a6219f58c0eca6380bfce9bd78b573fea912
                                                                                                                                                        start
                                                                                                                                                        9201
                                                                                                                                                      3. context exact
                                                                                                                                                        as a single agent, for the treatment of adult patients with advanced endometrial carcinoma that is MSI-H or dMMR, as determined by an FDA-authorized test, who have
                                                                                                                                                        kind
                                                                                                                                                        stage_or_setting
                                                                                                                                                        polarity
                                                                                                                                                        not_inferred
                                                                                                                                                        span
                                                                                                                                                        end
                                                                                                                                                        9205
                                                                                                                                                        end exclusive
                                                                                                                                                        true
                                                                                                                                                        exact text
                                                                                                                                                        advanced endometrial carcinoma that is MSI-
                                                                                                                                                        label id
                                                                                                                                                        228e1e3f-d207-481f-8e14-9fdcbd0470e9
                                                                                                                                                        offset unit
                                                                                                                                                        unicode_code_points
                                                                                                                                                        source array index
                                                                                                                                                        0
                                                                                                                                                        source field
                                                                                                                                                        indications_and_usage_exact
                                                                                                                                                        source text sha256
                                                                                                                                                        e526ba14c91f10737e6d3331fe23a6219f58c0eca6380bfce9bd78b573fea912
                                                                                                                                                        start
                                                                                                                                                        9162
                                                                                                                                                      4. context exact
                                                                                                                                                        FDA-authorized test, who have disease progression following prior systemic therapy in any setting and are not candidates for curative surgery or radiation.
                                                                                                                                                        kind
                                                                                                                                                        prior_therapy_or_line
                                                                                                                                                        polarity
                                                                                                                                                        not_inferred
                                                                                                                                                        span
                                                                                                                                                        end
                                                                                                                                                        9390
                                                                                                                                                        end exclusive
                                                                                                                                                        true
                                                                                                                                                        exact text
                                                                                                                                                        prior systemic therapy in any setting and are not candidates for curative surgery or radiation
                                                                                                                                                        label id
                                                                                                                                                        228e1e3f-d207-481f-8e14-9fdcbd0470e9
                                                                                                                                                        offset unit
                                                                                                                                                        unicode_code_points
                                                                                                                                                        source array index
                                                                                                                                                        0
                                                                                                                                                        source field
                                                                                                                                                        indications_and_usage_exact
                                                                                                                                                        source text sha256
                                                                                                                                                        e526ba14c91f10737e6d3331fe23a6219f58c0eca6380bfce9bd78b573fea912
                                                                                                                                                        start
                                                                                                                                                        9296
                                                                                                                                                      5. context exact
                                                                                                                                                        ( 1.17 , 2.1 ) as a single agent, for the treatment of adult patients with advanced endometrial carcinoma that is MSI-H or dMMR, as determined by an FDA-authorized test, who have disease progression following prior systemic therapy in any setting and a
                                                                                                                                                        kind
                                                                                                                                                        regimen
                                                                                                                                                        polarity
                                                                                                                                                        not_inferred
                                                                                                                                                        span
                                                                                                                                                        end
                                                                                                                                                        9279
                                                                                                                                                        end exclusive
                                                                                                                                                        true
                                                                                                                                                        exact text
                                                                                                                                                        as a single agent, for the treatment of adult patients with advanced endometrial carcinoma that is MSI-H or dMMR, as determined by an FDA-authorized test, who have disease progr
                                                                                                                                                        label id
                                                                                                                                                        228e1e3f-d207-481f-8e14-9fdcbd0470e9
                                                                                                                                                        offset unit
                                                                                                                                                        unicode_code_points
                                                                                                                                                        source array index
                                                                                                                                                        0
                                                                                                                                                        source field
                                                                                                                                                        indications_and_usage_exact
                                                                                                                                                        source text sha256
                                                                                                                                                        e526ba14c91f10737e6d3331fe23a6219f58c0eca6380bfce9bd78b573fea912
                                                                                                                                                        start
                                                                                                                                                        9102
                                                                                                                                                      regulatory links
                                                                                                                                                        schema version
                                                                                                                                                        0.1.0
                                                                                                                                                        source batch sha256
                                                                                                                                                        fc39a8c5cf96bf95ca20b85578140167b66b2741f7d9217f500d9ba0847ac058
                                                                                                                                                        source defined aliases
                                                                                                                                                        1. abbreviation
                                                                                                                                                          NSCLC
                                                                                                                                                          definition exact
                                                                                                                                                          Non-Small Cell Lung Cancer
                                                                                                                                                          definition span
                                                                                                                                                          end
                                                                                                                                                          380
                                                                                                                                                          end exclusive
                                                                                                                                                          true
                                                                                                                                                          exact text
                                                                                                                                                          Non-Small Cell Lung Cancer (NSCLC)
                                                                                                                                                          label id
                                                                                                                                                          228e1e3f-d207-481f-8e14-9fdcbd0470e9
                                                                                                                                                          offset unit
                                                                                                                                                          unicode_code_points
                                                                                                                                                          source array index
                                                                                                                                                          0
                                                                                                                                                          source field
                                                                                                                                                          indications_and_usage_exact
                                                                                                                                                          source text sha256
                                                                                                                                                          e526ba14c91f10737e6d3331fe23a6219f58c0eca6380bfce9bd78b573fea912
                                                                                                                                                          start
                                                                                                                                                          346
                                                                                                                                                        2. abbreviation
                                                                                                                                                          CRC
                                                                                                                                                          definition exact
                                                                                                                                                          Colorectal Cancer
                                                                                                                                                          definition span
                                                                                                                                                          end
                                                                                                                                                          5042
                                                                                                                                                          end exclusive
                                                                                                                                                          true
                                                                                                                                                          exact text
                                                                                                                                                          Colorectal Cancer (CRC)
                                                                                                                                                          label id
                                                                                                                                                          228e1e3f-d207-481f-8e14-9fdcbd0470e9
                                                                                                                                                          offset unit
                                                                                                                                                          unicode_code_points
                                                                                                                                                          source array index
                                                                                                                                                          0
                                                                                                                                                          source field
                                                                                                                                                          indications_and_usage_exact
                                                                                                                                                          source text sha256
                                                                                                                                                          e526ba14c91f10737e6d3331fe23a6219f58c0eca6380bfce9bd78b573fea912
                                                                                                                                                          start
                                                                                                                                                          5019
                                                                                                                                                        source span
                                                                                                                                                        end
                                                                                                                                                        9391
                                                                                                                                                        end exclusive
                                                                                                                                                        true
                                                                                                                                                        exact text
                                                                                                                                                        ( 1.17 , 2.1 ) as a single agent, for the treatment of adult patients with advanced endometrial carcinoma that is MSI-H or dMMR, as determined by an FDA-authorized test, who have disease progression following prior systemic therapy in any setting and are not candidates for curative surgery or radiation.
                                                                                                                                                        label id
                                                                                                                                                        228e1e3f-d207-481f-8e14-9fdcbd0470e9
                                                                                                                                                        offset unit
                                                                                                                                                        unicode_code_points
                                                                                                                                                        source array index
                                                                                                                                                        0
                                                                                                                                                        source field
                                                                                                                                                        indications_and_usage_exact
                                                                                                                                                        source text sha256
                                                                                                                                                        e526ba14c91f10737e6d3331fe23a6219f58c0eca6380bfce9bd78b573fea912
                                                                                                                                                        start
                                                                                                                                                        9087
                                                                                                                                                        source url
                                                                                                                                                        https://api.fda.gov/drug/label.json?search=id%3A%22228e1e3f-d207-481f-8e14-9fdcbd0470e9%22
                                                                                                                                                        spl effective date
                                                                                                                                                        2026-07-10
                                                                                                                                                        spl set id
                                                                                                                                                        9333c79b-d487-4538-a9f0-71b91a02b287
                                                                                                                                                        spl version
                                                                                                                                                        228
                                                                                                                                                        structured fields status
                                                                                                                                                        not_extracted_no_values_inferred_from_mentions
                                                                                                                                                        structured indication
                                                                                                                                                        age
                                                                                                                                                        Source null
                                                                                                                                                        approval pathway
                                                                                                                                                        Source null
                                                                                                                                                        biomarker and test
                                                                                                                                                        Source null
                                                                                                                                                        disease stage
                                                                                                                                                        Source null
                                                                                                                                                        limitations
                                                                                                                                                        Source null
                                                                                                                                                        line
                                                                                                                                                        Source null
                                                                                                                                                        prior therapy
                                                                                                                                                        Source null
                                                                                                                                                        regimen
                                                                                                                                                        Source null
                                                                                                                                                        tumor histology
                                                                                                                                                        Source null
                                                                                                                                                        use intent
                                                                                                                                                        unclear
                                                                                                                                                        Passage 57 · limitation of use
                                                                                                                                                        application numbers
                                                                                                                                                        1. BLA125514
                                                                                                                                                        brand names
                                                                                                                                                        1. KEYTRUDA
                                                                                                                                                        classification reasons
                                                                                                                                                        1. negative_or_not_established_clause
                                                                                                                                                        clinical review status
                                                                                                                                                        pending
                                                                                                                                                        content role
                                                                                                                                                        limitation_of_use
                                                                                                                                                        context span
                                                                                                                                                        end
                                                                                                                                                        10135
                                                                                                                                                        end exclusive
                                                                                                                                                        true
                                                                                                                                                        exact text
                                                                                                                                                        that is MSI-H or dMMR, as determined by an FDA-authorized test, who have disease progression following prior systemic therapy in any setting and are not candidates for curative surgery or radiation. ( 1.17 , 2.1 ) Tumor Mutational Burden-High (TMB-H) Cancer for the treatment of adult and pediatric patients with unresectable or metastatic tumor mutational burden-high (TMB-H) [≥10 mutations/megabase (mut/Mb)] solid tumors, as determined by an FDA-authorized test, that have progressed following prior treatment and who have no satisfactory alternative treatment options. 1 ( 1.18 , 2.1 ) Limitations of Use : The safety and effectiveness of KEYTRUDA in pediatric patients with TMB-H central nervous system cancers have not been established. Cutaneous Squamous Cell Carcinoma (cSCC) for the treatment of patients with recurrent or metastatic cSCC or locally advanced cSCC that is not curable by surgery or radiation. ( 1.19 ) Triple-Negative
                                                                                                                                                        label id
                                                                                                                                                        228e1e3f-d207-481f-8e14-9fdcbd0470e9
                                                                                                                                                        offset unit
                                                                                                                                                        unicode_code_points
                                                                                                                                                        source array index
                                                                                                                                                        0
                                                                                                                                                        source field
                                                                                                                                                        indications_and_usage_exact
                                                                                                                                                        source text sha256
                                                                                                                                                        e526ba14c91f10737e6d3331fe23a6219f58c0eca6380bfce9bd78b573fea912
                                                                                                                                                        start
                                                                                                                                                        9192
                                                                                                                                                        current approval status
                                                                                                                                                        not_reconciled
                                                                                                                                                        duplicate text group
                                                                                                                                                        dup-297b045265e59e2f7f0c
                                                                                                                                                        extraction review status
                                                                                                                                                        automated_candidate_pending_source_review
                                                                                                                                                        generic names
                                                                                                                                                        1. PEMBROLIZUMAB
                                                                                                                                                        id
                                                                                                                                                        ind-span-80e8eab527fee0e0a8fe
                                                                                                                                                        label id
                                                                                                                                                        228e1e3f-d207-481f-8e14-9fdcbd0470e9
                                                                                                                                                        positive predicate support span
                                                                                                                                                        Source null
                                                                                                                                                        qualifier mentions
                                                                                                                                                        1. context exact
                                                                                                                                                          Mutational Burden-High (TMB-H) Cancer for the treatment of adult and pediatric patients with unresectable or metastatic tumo
                                                                                                                                                          kind
                                                                                                                                                          age
                                                                                                                                                          polarity
                                                                                                                                                          not_inferred
                                                                                                                                                          span
                                                                                                                                                          end
                                                                                                                                                          9477
                                                                                                                                                          end exclusive
                                                                                                                                                          true
                                                                                                                                                          exact text
                                                                                                                                                          adult
                                                                                                                                                          label id
                                                                                                                                                          228e1e3f-d207-481f-8e14-9fdcbd0470e9
                                                                                                                                                          offset unit
                                                                                                                                                          unicode_code_points
                                                                                                                                                          source array index
                                                                                                                                                          0
                                                                                                                                                          source field
                                                                                                                                                          indications_and_usage_exact
                                                                                                                                                          source text sha256
                                                                                                                                                          e526ba14c91f10737e6d3331fe23a6219f58c0eca6380bfce9bd78b573fea912
                                                                                                                                                          start
                                                                                                                                                          9472
                                                                                                                                                        2. context exact
                                                                                                                                                          l Burden-High (TMB-H) Cancer for the treatment of adult and pediatric patients with unresectable or metastatic tumor mutational burden-hig
                                                                                                                                                          kind
                                                                                                                                                          age
                                                                                                                                                          polarity
                                                                                                                                                          not_inferred
                                                                                                                                                          span
                                                                                                                                                          end
                                                                                                                                                          9500
                                                                                                                                                          end exclusive
                                                                                                                                                          true
                                                                                                                                                          exact text
                                                                                                                                                          pediatric patients
                                                                                                                                                          label id
                                                                                                                                                          228e1e3f-d207-481f-8e14-9fdcbd0470e9
                                                                                                                                                          offset unit
                                                                                                                                                          unicode_code_points
                                                                                                                                                          source array index
                                                                                                                                                          0
                                                                                                                                                          source field
                                                                                                                                                          indications_and_usage_exact
                                                                                                                                                          source text sha256
                                                                                                                                                          e526ba14c91f10737e6d3331fe23a6219f58c0eca6380bfce9bd78b573fea912
                                                                                                                                                          start
                                                                                                                                                          9482
                                                                                                                                                        3. context exact
                                                                                                                                                          ations of Use : The safety and effectiveness of KEYTRUDA in pediatric patients with TMB-H central nervous system cancers have not been est
                                                                                                                                                          kind
                                                                                                                                                          age
                                                                                                                                                          polarity
                                                                                                                                                          not_inferred
                                                                                                                                                          span
                                                                                                                                                          end
                                                                                                                                                          9866
                                                                                                                                                          end exclusive
                                                                                                                                                          true
                                                                                                                                                          exact text
                                                                                                                                                          pediatric patients
                                                                                                                                                          label id
                                                                                                                                                          228e1e3f-d207-481f-8e14-9fdcbd0470e9
                                                                                                                                                          offset unit
                                                                                                                                                          unicode_code_points
                                                                                                                                                          source array index
                                                                                                                                                          0
                                                                                                                                                          source field
                                                                                                                                                          indications_and_usage_exact
                                                                                                                                                          source text sha256
                                                                                                                                                          e526ba14c91f10737e6d3331fe23a6219f58c0eca6380bfce9bd78b573fea912
                                                                                                                                                          start
                                                                                                                                                          9848
                                                                                                                                                        4. context exact
                                                                                                                                                          ( 1.17 , 2.1 ) Tumor Mutational Burden-High (TMB-H) Cancer for the treatment of adult and pediatric patients with unresectable or metastatic tumor m
                                                                                                                                                          kind
                                                                                                                                                          biomarker
                                                                                                                                                          polarity
                                                                                                                                                          not_inferred
                                                                                                                                                          span
                                                                                                                                                          end
                                                                                                                                                          9480
                                                                                                                                                          end exclusive
                                                                                                                                                          true
                                                                                                                                                          exact text
                                                                                                                                                          TMB-H) Cancer for the treatment of adult an
                                                                                                                                                          label id
                                                                                                                                                          228e1e3f-d207-481f-8e14-9fdcbd0470e9
                                                                                                                                                          offset unit
                                                                                                                                                          unicode_code_points
                                                                                                                                                          source array index
                                                                                                                                                          0
                                                                                                                                                          source field
                                                                                                                                                          indications_and_usage_exact
                                                                                                                                                          source text sha256
                                                                                                                                                          e526ba14c91f10737e6d3331fe23a6219f58c0eca6380bfce9bd78b573fea912
                                                                                                                                                          start
                                                                                                                                                          9437
                                                                                                                                                        5. context exact
                                                                                                                                                          atment of adult and pediatric patients with unresectable or metastatic tumor mutational burden-high (TMB-H) [≥10 mutations/megabase (mut/Mb)] solid tumors, as dete
                                                                                                                                                          kind
                                                                                                                                                          biomarker
                                                                                                                                                          polarity
                                                                                                                                                          not_inferred
                                                                                                                                                          span
                                                                                                                                                          end
                                                                                                                                                          9565
                                                                                                                                                          end exclusive
                                                                                                                                                          true
                                                                                                                                                          exact text
                                                                                                                                                          metastatic tumor mutational burden-high (TM
                                                                                                                                                          label id
                                                                                                                                                          228e1e3f-d207-481f-8e14-9fdcbd0470e9
                                                                                                                                                          offset unit
                                                                                                                                                          unicode_code_points
                                                                                                                                                          source array index
                                                                                                                                                          0
                                                                                                                                                          source field
                                                                                                                                                          indications_and_usage_exact
                                                                                                                                                          source text sha256
                                                                                                                                                          e526ba14c91f10737e6d3331fe23a6219f58c0eca6380bfce9bd78b573fea912
                                                                                                                                                          start
                                                                                                                                                          9522
                                                                                                                                                        6. context exact
                                                                                                                                                          ty and effectiveness of KEYTRUDA in pediatric patients with TMB-H central nervous system cancers have not been established.
                                                                                                                                                          kind
                                                                                                                                                          biomarker
                                                                                                                                                          polarity
                                                                                                                                                          not_inferred
                                                                                                                                                          span
                                                                                                                                                          end
                                                                                                                                                          9915
                                                                                                                                                          end exclusive
                                                                                                                                                          true
                                                                                                                                                          exact text
                                                                                                                                                          TMB-H central nervous system cancers have n
                                                                                                                                                          label id
                                                                                                                                                          228e1e3f-d207-481f-8e14-9fdcbd0470e9
                                                                                                                                                          offset unit
                                                                                                                                                          unicode_code_points
                                                                                                                                                          source array index
                                                                                                                                                          0
                                                                                                                                                          source field
                                                                                                                                                          indications_and_usage_exact
                                                                                                                                                          source text sha256
                                                                                                                                                          e526ba14c91f10737e6d3331fe23a6219f58c0eca6380bfce9bd78b573fea912
                                                                                                                                                          start
                                                                                                                                                          9872
                                                                                                                                                        7. context exact
                                                                                                                                                          ncer for the treatment of adult and pediatric patients with unresectable or metastatic tumor mutational burden-high (TMB-H) [≥10 mutations/megabase (mut/Mb)] solid tum
                                                                                                                                                          kind
                                                                                                                                                          stage_or_setting
                                                                                                                                                          polarity
                                                                                                                                                          not_inferred
                                                                                                                                                          span
                                                                                                                                                          end
                                                                                                                                                          9553
                                                                                                                                                          end exclusive
                                                                                                                                                          true
                                                                                                                                                          exact text
                                                                                                                                                          unresectable or metastatic tumor mutational bur
                                                                                                                                                          label id
                                                                                                                                                          228e1e3f-d207-481f-8e14-9fdcbd0470e9
                                                                                                                                                          offset unit
                                                                                                                                                          unicode_code_points
                                                                                                                                                          source array index
                                                                                                                                                          0
                                                                                                                                                          source field
                                                                                                                                                          indications_and_usage_exact
                                                                                                                                                          source text sha256
                                                                                                                                                          e526ba14c91f10737e6d3331fe23a6219f58c0eca6380bfce9bd78b573fea912
                                                                                                                                                          start
                                                                                                                                                          9506
                                                                                                                                                        8. context exact
                                                                                                                                                          d by an FDA-authorized test, that have progressed following prior treatment and who have no satisfactory alternative treatment options. 1 ( 1.18 , 2.1 ) Limitations of Use : The safety and effec
                                                                                                                                                          kind
                                                                                                                                                          prior_therapy_or_line
                                                                                                                                                          polarity
                                                                                                                                                          not_inferred
                                                                                                                                                          span
                                                                                                                                                          end
                                                                                                                                                          9764
                                                                                                                                                          end exclusive
                                                                                                                                                          true
                                                                                                                                                          exact text
                                                                                                                                                          prior treatment and who have no satisfactory alternative treatment options
                                                                                                                                                          label id
                                                                                                                                                          228e1e3f-d207-481f-8e14-9fdcbd0470e9
                                                                                                                                                          offset unit
                                                                                                                                                          unicode_code_points
                                                                                                                                                          source array index
                                                                                                                                                          0
                                                                                                                                                          source field
                                                                                                                                                          indications_and_usage_exact
                                                                                                                                                          source text sha256
                                                                                                                                                          e526ba14c91f10737e6d3331fe23a6219f58c0eca6380bfce9bd78b573fea912
                                                                                                                                                          start
                                                                                                                                                          9690
                                                                                                                                                        regulatory links
                                                                                                                                                          schema version
                                                                                                                                                          0.1.0
                                                                                                                                                          source batch sha256
                                                                                                                                                          fc39a8c5cf96bf95ca20b85578140167b66b2741f7d9217f500d9ba0847ac058
                                                                                                                                                          source defined aliases
                                                                                                                                                          1. abbreviation
                                                                                                                                                            NSCLC
                                                                                                                                                            definition exact
                                                                                                                                                            Non-Small Cell Lung Cancer
                                                                                                                                                            definition span
                                                                                                                                                            end
                                                                                                                                                            380
                                                                                                                                                            end exclusive
                                                                                                                                                            true
                                                                                                                                                            exact text
                                                                                                                                                            Non-Small Cell Lung Cancer (NSCLC)
                                                                                                                                                            label id
                                                                                                                                                            228e1e3f-d207-481f-8e14-9fdcbd0470e9
                                                                                                                                                            offset unit
                                                                                                                                                            unicode_code_points
                                                                                                                                                            source array index
                                                                                                                                                            0
                                                                                                                                                            source field
                                                                                                                                                            indications_and_usage_exact
                                                                                                                                                            source text sha256
                                                                                                                                                            e526ba14c91f10737e6d3331fe23a6219f58c0eca6380bfce9bd78b573fea912
                                                                                                                                                            start
                                                                                                                                                            346
                                                                                                                                                          2. abbreviation
                                                                                                                                                            CRC
                                                                                                                                                            definition exact
                                                                                                                                                            Colorectal Cancer
                                                                                                                                                            definition span
                                                                                                                                                            end
                                                                                                                                                            5042
                                                                                                                                                            end exclusive
                                                                                                                                                            true
                                                                                                                                                            exact text
                                                                                                                                                            Colorectal Cancer (CRC)
                                                                                                                                                            label id
                                                                                                                                                            228e1e3f-d207-481f-8e14-9fdcbd0470e9
                                                                                                                                                            offset unit
                                                                                                                                                            unicode_code_points
                                                                                                                                                            source array index
                                                                                                                                                            0
                                                                                                                                                            source field
                                                                                                                                                            indications_and_usage_exact
                                                                                                                                                            source text sha256
                                                                                                                                                            e526ba14c91f10737e6d3331fe23a6219f58c0eca6380bfce9bd78b573fea912
                                                                                                                                                            start
                                                                                                                                                            5019
                                                                                                                                                          source span
                                                                                                                                                          end
                                                                                                                                                          9935
                                                                                                                                                          end exclusive
                                                                                                                                                          true
                                                                                                                                                          exact text
                                                                                                                                                          ( 1.17 , 2.1 ) Tumor Mutational Burden-High (TMB-H) Cancer for the treatment of adult and pediatric patients with unresectable or metastatic tumor mutational burden-high (TMB-H) [≥10 mutations/megabase (mut/Mb)] solid tumors, as determined by an FDA-authorized test, that have progressed following prior treatment and who have no satisfactory alternative treatment options. 1 ( 1.18 , 2.1 ) Limitations of Use : The safety and effectiveness of KEYTRUDA in pediatric patients with TMB-H central nervous system cancers have not been established.
                                                                                                                                                          label id
                                                                                                                                                          228e1e3f-d207-481f-8e14-9fdcbd0470e9
                                                                                                                                                          offset unit
                                                                                                                                                          unicode_code_points
                                                                                                                                                          source array index
                                                                                                                                                          0
                                                                                                                                                          source field
                                                                                                                                                          indications_and_usage_exact
                                                                                                                                                          source text sha256
                                                                                                                                                          e526ba14c91f10737e6d3331fe23a6219f58c0eca6380bfce9bd78b573fea912
                                                                                                                                                          start
                                                                                                                                                          9392
                                                                                                                                                          source url
                                                                                                                                                          https://api.fda.gov/drug/label.json?search=id%3A%22228e1e3f-d207-481f-8e14-9fdcbd0470e9%22
                                                                                                                                                          spl effective date
                                                                                                                                                          2026-07-10
                                                                                                                                                          spl set id
                                                                                                                                                          9333c79b-d487-4538-a9f0-71b91a02b287
                                                                                                                                                          spl version
                                                                                                                                                          228
                                                                                                                                                          structured fields status
                                                                                                                                                          not_extracted_no_values_inferred_from_mentions
                                                                                                                                                          structured indication
                                                                                                                                                          age
                                                                                                                                                          Source null
                                                                                                                                                          approval pathway
                                                                                                                                                          Source null
                                                                                                                                                          biomarker and test
                                                                                                                                                          Source null
                                                                                                                                                          disease stage
                                                                                                                                                          Source null
                                                                                                                                                          limitations
                                                                                                                                                          Source null
                                                                                                                                                          line
                                                                                                                                                          Source null
                                                                                                                                                          prior therapy
                                                                                                                                                          Source null
                                                                                                                                                          regimen
                                                                                                                                                          Source null
                                                                                                                                                          tumor histology
                                                                                                                                                          Source null
                                                                                                                                                          use intent
                                                                                                                                                          not_applicable
                                                                                                                                                          Passage 58 · unclassified context
                                                                                                                                                          application numbers
                                                                                                                                                          1. BLA125514
                                                                                                                                                          brand names
                                                                                                                                                          1. KEYTRUDA
                                                                                                                                                          classification reasons
                                                                                                                                                          1. no_unambiguous_positive_indication_predicate
                                                                                                                                                          clinical review status
                                                                                                                                                          pending
                                                                                                                                                          content role
                                                                                                                                                          unclassified_context
                                                                                                                                                          context span
                                                                                                                                                          end
                                                                                                                                                          10310
                                                                                                                                                          end exclusive
                                                                                                                                                          true
                                                                                                                                                          exact text
                                                                                                                                                          lternative treatment options. 1 ( 1.18 , 2.1 ) Limitations of Use : The safety and effectiveness of KEYTRUDA in pediatric patients with TMB-H central nervous system cancers have not been established. Cutaneous Squamous Cell Carcinoma (cSCC) for the treatment of patients with recurrent or metastatic cSCC or locally advanced cSCC that is not curable by surgery or radiation. ( 1.19 ) Triple-Negative Breast Cancer (TNBC) for the treatment of patients with high-risk early-stage TNBC in combination with chemotherapy as neoadjuvant treatment, and then continued as a single a
                                                                                                                                                          label id
                                                                                                                                                          228e1e3f-d207-481f-8e14-9fdcbd0470e9
                                                                                                                                                          offset unit
                                                                                                                                                          unicode_code_points
                                                                                                                                                          source array index
                                                                                                                                                          0
                                                                                                                                                          source field
                                                                                                                                                          indications_and_usage_exact
                                                                                                                                                          source text sha256
                                                                                                                                                          e526ba14c91f10737e6d3331fe23a6219f58c0eca6380bfce9bd78b573fea912
                                                                                                                                                          start
                                                                                                                                                          9736
                                                                                                                                                          current approval status
                                                                                                                                                          not_reconciled
                                                                                                                                                          duplicate text group
                                                                                                                                                          dup-a3a7b73a77918f8fd6ba
                                                                                                                                                          extraction review status
                                                                                                                                                          automated_candidate_pending_source_review
                                                                                                                                                          generic names
                                                                                                                                                          1. PEMBROLIZUMAB
                                                                                                                                                          id
                                                                                                                                                          ind-span-dbb6656a1389f1cb60d4
                                                                                                                                                          label id
                                                                                                                                                          228e1e3f-d207-481f-8e14-9fdcbd0470e9
                                                                                                                                                          positive predicate support span
                                                                                                                                                          Source null
                                                                                                                                                          qualifier mentions
                                                                                                                                                          1. context exact
                                                                                                                                                            noma (cSCC) for the treatment of patients with recurrent or metastatic cSCC or locally advanced cSCC that is not curable by surgery or radiation.
                                                                                                                                                            kind
                                                                                                                                                            biomarker
                                                                                                                                                            polarity
                                                                                                                                                            not_inferred
                                                                                                                                                            span
                                                                                                                                                            end
                                                                                                                                                            10068
                                                                                                                                                            end exclusive
                                                                                                                                                            true
                                                                                                                                                            exact text
                                                                                                                                                            metastatic cSCC or locally advanced cSCC th
                                                                                                                                                            label id
                                                                                                                                                            228e1e3f-d207-481f-8e14-9fdcbd0470e9
                                                                                                                                                            offset unit
                                                                                                                                                            unicode_code_points
                                                                                                                                                            source array index
                                                                                                                                                            0
                                                                                                                                                            source field
                                                                                                                                                            indications_and_usage_exact
                                                                                                                                                            source text sha256
                                                                                                                                                            e526ba14c91f10737e6d3331fe23a6219f58c0eca6380bfce9bd78b573fea912
                                                                                                                                                            start
                                                                                                                                                            10025
                                                                                                                                                          2. context exact
                                                                                                                                                            us Cell Carcinoma (cSCC) for the treatment of patients with recurrent or metastatic cSCC or locally advanced cSCC that is not curable by surgery or radiation.
                                                                                                                                                            kind
                                                                                                                                                            stage_or_setting
                                                                                                                                                            polarity
                                                                                                                                                            not_inferred
                                                                                                                                                            span
                                                                                                                                                            end
                                                                                                                                                            10056
                                                                                                                                                            end exclusive
                                                                                                                                                            true
                                                                                                                                                            exact text
                                                                                                                                                            recurrent or metastatic cSCC or locally adva
                                                                                                                                                            label id
                                                                                                                                                            228e1e3f-d207-481f-8e14-9fdcbd0470e9
                                                                                                                                                            offset unit
                                                                                                                                                            unicode_code_points
                                                                                                                                                            source array index
                                                                                                                                                            0
                                                                                                                                                            source field
                                                                                                                                                            indications_and_usage_exact
                                                                                                                                                            source text sha256
                                                                                                                                                            e526ba14c91f10737e6d3331fe23a6219f58c0eca6380bfce9bd78b573fea912
                                                                                                                                                            start
                                                                                                                                                            10012
                                                                                                                                                          regulatory links
                                                                                                                                                            schema version
                                                                                                                                                            0.1.0
                                                                                                                                                            source batch sha256
                                                                                                                                                            fc39a8c5cf96bf95ca20b85578140167b66b2741f7d9217f500d9ba0847ac058
                                                                                                                                                            source defined aliases
                                                                                                                                                            1. abbreviation
                                                                                                                                                              NSCLC
                                                                                                                                                              definition exact
                                                                                                                                                              Non-Small Cell Lung Cancer
                                                                                                                                                              definition span
                                                                                                                                                              end
                                                                                                                                                              380
                                                                                                                                                              end exclusive
                                                                                                                                                              true
                                                                                                                                                              exact text
                                                                                                                                                              Non-Small Cell Lung Cancer (NSCLC)
                                                                                                                                                              label id
                                                                                                                                                              228e1e3f-d207-481f-8e14-9fdcbd0470e9
                                                                                                                                                              offset unit
                                                                                                                                                              unicode_code_points
                                                                                                                                                              source array index
                                                                                                                                                              0
                                                                                                                                                              source field
                                                                                                                                                              indications_and_usage_exact
                                                                                                                                                              source text sha256
                                                                                                                                                              e526ba14c91f10737e6d3331fe23a6219f58c0eca6380bfce9bd78b573fea912
                                                                                                                                                              start
                                                                                                                                                              346
                                                                                                                                                            2. abbreviation
                                                                                                                                                              CRC
                                                                                                                                                              definition exact
                                                                                                                                                              Colorectal Cancer
                                                                                                                                                              definition span
                                                                                                                                                              end
                                                                                                                                                              5042
                                                                                                                                                              end exclusive
                                                                                                                                                              true
                                                                                                                                                              exact text
                                                                                                                                                              Colorectal Cancer (CRC)
                                                                                                                                                              label id
                                                                                                                                                              228e1e3f-d207-481f-8e14-9fdcbd0470e9
                                                                                                                                                              offset unit
                                                                                                                                                              unicode_code_points
                                                                                                                                                              source array index
                                                                                                                                                              0
                                                                                                                                                              source field
                                                                                                                                                              indications_and_usage_exact
                                                                                                                                                              source text sha256
                                                                                                                                                              e526ba14c91f10737e6d3331fe23a6219f58c0eca6380bfce9bd78b573fea912
                                                                                                                                                              start
                                                                                                                                                              5019
                                                                                                                                                            source span
                                                                                                                                                            end
                                                                                                                                                            10110
                                                                                                                                                            end exclusive
                                                                                                                                                            true
                                                                                                                                                            exact text
                                                                                                                                                            Cutaneous Squamous Cell Carcinoma (cSCC) for the treatment of patients with recurrent or metastatic cSCC or locally advanced cSCC that is not curable by surgery or radiation.
                                                                                                                                                            label id
                                                                                                                                                            228e1e3f-d207-481f-8e14-9fdcbd0470e9
                                                                                                                                                            offset unit
                                                                                                                                                            unicode_code_points
                                                                                                                                                            source array index
                                                                                                                                                            0
                                                                                                                                                            source field
                                                                                                                                                            indications_and_usage_exact
                                                                                                                                                            source text sha256
                                                                                                                                                            e526ba14c91f10737e6d3331fe23a6219f58c0eca6380bfce9bd78b573fea912
                                                                                                                                                            start
                                                                                                                                                            9936
                                                                                                                                                            source url
                                                                                                                                                            https://api.fda.gov/drug/label.json?search=id%3A%22228e1e3f-d207-481f-8e14-9fdcbd0470e9%22
                                                                                                                                                            spl effective date
                                                                                                                                                            2026-07-10
                                                                                                                                                            spl set id
                                                                                                                                                            9333c79b-d487-4538-a9f0-71b91a02b287
                                                                                                                                                            spl version
                                                                                                                                                            228
                                                                                                                                                            structured fields status
                                                                                                                                                            not_extracted_no_values_inferred_from_mentions
                                                                                                                                                            structured indication
                                                                                                                                                            age
                                                                                                                                                            Source null
                                                                                                                                                            approval pathway
                                                                                                                                                            Source null
                                                                                                                                                            biomarker and test
                                                                                                                                                            Source null
                                                                                                                                                            disease stage
                                                                                                                                                            Source null
                                                                                                                                                            limitations
                                                                                                                                                            Source null
                                                                                                                                                            line
                                                                                                                                                            Source null
                                                                                                                                                            prior therapy
                                                                                                                                                            Source null
                                                                                                                                                            regimen
                                                                                                                                                            Source null
                                                                                                                                                            tumor histology
                                                                                                                                                            Source null
                                                                                                                                                            use intent
                                                                                                                                                            unclear
                                                                                                                                                            Passage 59 · unclassified context
                                                                                                                                                            application numbers
                                                                                                                                                            1. BLA125514
                                                                                                                                                            brand names
                                                                                                                                                            1. KEYTRUDA
                                                                                                                                                            classification reasons
                                                                                                                                                            1. no_unambiguous_positive_indication_predicate
                                                                                                                                                            clinical review status
                                                                                                                                                            pending
                                                                                                                                                            content role
                                                                                                                                                            unclassified_context
                                                                                                                                                            context span
                                                                                                                                                            end
                                                                                                                                                            10551
                                                                                                                                                            end exclusive
                                                                                                                                                            true
                                                                                                                                                            exact text
                                                                                                                                                            ve not been established. Cutaneous Squamous Cell Carcinoma (cSCC) for the treatment of patients with recurrent or metastatic cSCC or locally advanced cSCC that is not curable by surgery or radiation. ( 1.19 ) Triple-Negative Breast Cancer (TNBC) for the treatment of patients with high-risk early-stage TNBC in combination with chemotherapy as neoadjuvant treatment, and then continued as a single agent as adjuvant treatment after surgery. ( 1.20 ) in combination with sacituzumab govitecan-hziy, for the first-line treatment of adult patients with unresectable locally advanced or metastatic TNBC whose tumors express PD-L1 (CPS ≥10) as d
                                                                                                                                                            label id
                                                                                                                                                            228e1e3f-d207-481f-8e14-9fdcbd0470e9
                                                                                                                                                            offset unit
                                                                                                                                                            unicode_code_points
                                                                                                                                                            source array index
                                                                                                                                                            0
                                                                                                                                                            source field
                                                                                                                                                            indications_and_usage_exact
                                                                                                                                                            source text sha256
                                                                                                                                                            e526ba14c91f10737e6d3331fe23a6219f58c0eca6380bfce9bd78b573fea912
                                                                                                                                                            start
                                                                                                                                                            9911
                                                                                                                                                            current approval status
                                                                                                                                                            not_reconciled
                                                                                                                                                            duplicate text group
                                                                                                                                                            dup-fff61b91c0217af0be92
                                                                                                                                                            extraction review status
                                                                                                                                                            automated_candidate_pending_source_review
                                                                                                                                                            generic names
                                                                                                                                                            1. PEMBROLIZUMAB
                                                                                                                                                            id
                                                                                                                                                            ind-span-02d51fb437c670628eeb
                                                                                                                                                            label id
                                                                                                                                                            228e1e3f-d207-481f-8e14-9fdcbd0470e9
                                                                                                                                                            positive predicate support span
                                                                                                                                                            Source null
                                                                                                                                                            qualifier mentions
                                                                                                                                                            1. context exact
                                                                                                                                                              Cancer (TNBC) for the treatment of patients with high-risk early-stage TNBC in combination with chemotherapy as neoadjuvant treatment, and then continued as a single
                                                                                                                                                              kind
                                                                                                                                                              stage_or_setting
                                                                                                                                                              polarity
                                                                                                                                                              not_inferred
                                                                                                                                                              span
                                                                                                                                                              end
                                                                                                                                                              10248
                                                                                                                                                              end exclusive
                                                                                                                                                              true
                                                                                                                                                              exact text
                                                                                                                                                              early-stage TNBC in combination with chemother
                                                                                                                                                              label id
                                                                                                                                                              228e1e3f-d207-481f-8e14-9fdcbd0470e9
                                                                                                                                                              offset unit
                                                                                                                                                              unicode_code_points
                                                                                                                                                              source array index
                                                                                                                                                              0
                                                                                                                                                              source field
                                                                                                                                                              indications_and_usage_exact
                                                                                                                                                              source text sha256
                                                                                                                                                              e526ba14c91f10737e6d3331fe23a6219f58c0eca6380bfce9bd78b573fea912
                                                                                                                                                              start
                                                                                                                                                              10202
                                                                                                                                                            2. context exact
                                                                                                                                                              h-risk early-stage TNBC in combination with chemotherapy as neoadjuvant treatment, and then continued as a single agent as adjuvant treatment
                                                                                                                                                              kind
                                                                                                                                                              stage_or_setting
                                                                                                                                                              polarity
                                                                                                                                                              not_inferred
                                                                                                                                                              span
                                                                                                                                                              end
                                                                                                                                                              10276
                                                                                                                                                              end exclusive
                                                                                                                                                              true
                                                                                                                                                              exact text
                                                                                                                                                              neoadjuvant treatment
                                                                                                                                                              label id
                                                                                                                                                              228e1e3f-d207-481f-8e14-9fdcbd0470e9
                                                                                                                                                              offset unit
                                                                                                                                                              unicode_code_points
                                                                                                                                                              source array index
                                                                                                                                                              0
                                                                                                                                                              source field
                                                                                                                                                              indications_and_usage_exact
                                                                                                                                                              source text sha256
                                                                                                                                                              e526ba14c91f10737e6d3331fe23a6219f58c0eca6380bfce9bd78b573fea912
                                                                                                                                                              start
                                                                                                                                                              10255
                                                                                                                                                            3. context exact
                                                                                                                                                              adjuvant treatment, and then continued as a single agent as adjuvant treatment after surgery.
                                                                                                                                                              kind
                                                                                                                                                              stage_or_setting
                                                                                                                                                              polarity
                                                                                                                                                              not_inferred
                                                                                                                                                              span
                                                                                                                                                              end
                                                                                                                                                              10350
                                                                                                                                                              end exclusive
                                                                                                                                                              true
                                                                                                                                                              exact text
                                                                                                                                                              adjuvant treatment after surgery
                                                                                                                                                              label id
                                                                                                                                                              228e1e3f-d207-481f-8e14-9fdcbd0470e9
                                                                                                                                                              offset unit
                                                                                                                                                              unicode_code_points
                                                                                                                                                              source array index
                                                                                                                                                              0
                                                                                                                                                              source field
                                                                                                                                                              indications_and_usage_exact
                                                                                                                                                              source text sha256
                                                                                                                                                              e526ba14c91f10737e6d3331fe23a6219f58c0eca6380bfce9bd78b573fea912
                                                                                                                                                              start
                                                                                                                                                              10318
                                                                                                                                                            4. context exact
                                                                                                                                                              r the treatment of patients with high-risk early-stage TNBC in combination with chemotherapy as neoadjuvant treatment, and then continued as a single agent as adjuvant treatment after surgery.
                                                                                                                                                              kind
                                                                                                                                                              regimen
                                                                                                                                                              polarity
                                                                                                                                                              not_inferred
                                                                                                                                                              span
                                                                                                                                                              end
                                                                                                                                                              10350
                                                                                                                                                              end exclusive
                                                                                                                                                              true
                                                                                                                                                              exact text
                                                                                                                                                              in combination with chemotherapy as neoadjuvant treatment, and then continued as a single agent as adjuvant treatment after surgery
                                                                                                                                                              label id
                                                                                                                                                              228e1e3f-d207-481f-8e14-9fdcbd0470e9
                                                                                                                                                              offset unit
                                                                                                                                                              unicode_code_points
                                                                                                                                                              source array index
                                                                                                                                                              0
                                                                                                                                                              source field
                                                                                                                                                              indications_and_usage_exact
                                                                                                                                                              source text sha256
                                                                                                                                                              e526ba14c91f10737e6d3331fe23a6219f58c0eca6380bfce9bd78b573fea912
                                                                                                                                                              start
                                                                                                                                                              10219
                                                                                                                                                            regulatory links
                                                                                                                                                              schema version
                                                                                                                                                              0.1.0
                                                                                                                                                              source batch sha256
                                                                                                                                                              fc39a8c5cf96bf95ca20b85578140167b66b2741f7d9217f500d9ba0847ac058
                                                                                                                                                              source defined aliases
                                                                                                                                                              1. abbreviation
                                                                                                                                                                NSCLC
                                                                                                                                                                definition exact
                                                                                                                                                                Non-Small Cell Lung Cancer
                                                                                                                                                                definition span
                                                                                                                                                                end
                                                                                                                                                                380
                                                                                                                                                                end exclusive
                                                                                                                                                                true
                                                                                                                                                                exact text
                                                                                                                                                                Non-Small Cell Lung Cancer (NSCLC)
                                                                                                                                                                label id
                                                                                                                                                                228e1e3f-d207-481f-8e14-9fdcbd0470e9
                                                                                                                                                                offset unit
                                                                                                                                                                unicode_code_points
                                                                                                                                                                source array index
                                                                                                                                                                0
                                                                                                                                                                source field
                                                                                                                                                                indications_and_usage_exact
                                                                                                                                                                source text sha256
                                                                                                                                                                e526ba14c91f10737e6d3331fe23a6219f58c0eca6380bfce9bd78b573fea912
                                                                                                                                                                start
                                                                                                                                                                346
                                                                                                                                                              2. abbreviation
                                                                                                                                                                CRC
                                                                                                                                                                definition exact
                                                                                                                                                                Colorectal Cancer
                                                                                                                                                                definition span
                                                                                                                                                                end
                                                                                                                                                                5042
                                                                                                                                                                end exclusive
                                                                                                                                                                true
                                                                                                                                                                exact text
                                                                                                                                                                Colorectal Cancer (CRC)
                                                                                                                                                                label id
                                                                                                                                                                228e1e3f-d207-481f-8e14-9fdcbd0470e9
                                                                                                                                                                offset unit
                                                                                                                                                                unicode_code_points
                                                                                                                                                                source array index
                                                                                                                                                                0
                                                                                                                                                                source field
                                                                                                                                                                indications_and_usage_exact
                                                                                                                                                                source text sha256
                                                                                                                                                                e526ba14c91f10737e6d3331fe23a6219f58c0eca6380bfce9bd78b573fea912
                                                                                                                                                                start
                                                                                                                                                                5019
                                                                                                                                                              source span
                                                                                                                                                              end
                                                                                                                                                              10351
                                                                                                                                                              end exclusive
                                                                                                                                                              true
                                                                                                                                                              exact text
                                                                                                                                                              ( 1.19 ) Triple-Negative Breast Cancer (TNBC) for the treatment of patients with high-risk early-stage TNBC in combination with chemotherapy as neoadjuvant treatment, and then continued as a single agent as adjuvant treatment after surgery.
                                                                                                                                                              label id
                                                                                                                                                              228e1e3f-d207-481f-8e14-9fdcbd0470e9
                                                                                                                                                              offset unit
                                                                                                                                                              unicode_code_points
                                                                                                                                                              source array index
                                                                                                                                                              0
                                                                                                                                                              source field
                                                                                                                                                              indications_and_usage_exact
                                                                                                                                                              source text sha256
                                                                                                                                                              e526ba14c91f10737e6d3331fe23a6219f58c0eca6380bfce9bd78b573fea912
                                                                                                                                                              start
                                                                                                                                                              10111
                                                                                                                                                              source url
                                                                                                                                                              https://api.fda.gov/drug/label.json?search=id%3A%22228e1e3f-d207-481f-8e14-9fdcbd0470e9%22
                                                                                                                                                              spl effective date
                                                                                                                                                              2026-07-10
                                                                                                                                                              spl set id
                                                                                                                                                              9333c79b-d487-4538-a9f0-71b91a02b287
                                                                                                                                                              spl version
                                                                                                                                                              228
                                                                                                                                                              structured fields status
                                                                                                                                                              not_extracted_no_values_inferred_from_mentions
                                                                                                                                                              structured indication
                                                                                                                                                              age
                                                                                                                                                              Source null
                                                                                                                                                              approval pathway
                                                                                                                                                              Source null
                                                                                                                                                              biomarker and test
                                                                                                                                                              Source null
                                                                                                                                                              disease stage
                                                                                                                                                              Source null
                                                                                                                                                              limitations
                                                                                                                                                              Source null
                                                                                                                                                              line
                                                                                                                                                              Source null
                                                                                                                                                              prior therapy
                                                                                                                                                              Source null
                                                                                                                                                              regimen
                                                                                                                                                              Source null
                                                                                                                                                              tumor histology
                                                                                                                                                              Source null
                                                                                                                                                              use intent
                                                                                                                                                              unclear
                                                                                                                                                              Passage 60 · unclassified context
                                                                                                                                                              application numbers
                                                                                                                                                              1. BLA125514
                                                                                                                                                              brand names
                                                                                                                                                              1. KEYTRUDA
                                                                                                                                                              classification reasons
                                                                                                                                                              1. no_unambiguous_positive_indication_predicate
                                                                                                                                                              clinical review status
                                                                                                                                                              pending
                                                                                                                                                              content role
                                                                                                                                                              unclassified_context
                                                                                                                                                              context span
                                                                                                                                                              end
                                                                                                                                                              10560
                                                                                                                                                              end exclusive
                                                                                                                                                              true
                                                                                                                                                              exact text
                                                                                                                                                              NBC) for the treatment of patients with high-risk early-stage TNBC in combination with chemotherapy as neoadjuvant treatment, and then continued as a single agent as adjuvant treatment after surgery. ( 1.20 ) in combination with sacituzumab govitecan-hziy, for the first-line treatment of adult patients with unresectable locally advanced or metastatic TNBC whose tumors express PD-L1 (CPS ≥10) as determined
                                                                                                                                                              label id
                                                                                                                                                              228e1e3f-d207-481f-8e14-9fdcbd0470e9
                                                                                                                                                              offset unit
                                                                                                                                                              unicode_code_points
                                                                                                                                                              source array index
                                                                                                                                                              0
                                                                                                                                                              source field
                                                                                                                                                              indications_and_usage_exact
                                                                                                                                                              source text sha256
                                                                                                                                                              e526ba14c91f10737e6d3331fe23a6219f58c0eca6380bfce9bd78b573fea912
                                                                                                                                                              start
                                                                                                                                                              10152
                                                                                                                                                              current approval status
                                                                                                                                                              not_reconciled
                                                                                                                                                              duplicate text group
                                                                                                                                                              dup-ad293a56057ec36b7812
                                                                                                                                                              extraction review status
                                                                                                                                                              automated_candidate_pending_source_review
                                                                                                                                                              generic names
                                                                                                                                                              1. PEMBROLIZUMAB
                                                                                                                                                              id
                                                                                                                                                              ind-span-aa8c48342dd02576d2ed
                                                                                                                                                              label id
                                                                                                                                                              228e1e3f-d207-481f-8e14-9fdcbd0470e9
                                                                                                                                                              positive predicate support span
                                                                                                                                                              Source null
                                                                                                                                                              qualifier mentions
                                                                                                                                                                regulatory links
                                                                                                                                                                  schema version
                                                                                                                                                                  0.1.0
                                                                                                                                                                  source batch sha256
                                                                                                                                                                  fc39a8c5cf96bf95ca20b85578140167b66b2741f7d9217f500d9ba0847ac058
                                                                                                                                                                  source defined aliases
                                                                                                                                                                  1. abbreviation
                                                                                                                                                                    NSCLC
                                                                                                                                                                    definition exact
                                                                                                                                                                    Non-Small Cell Lung Cancer
                                                                                                                                                                    definition span
                                                                                                                                                                    end
                                                                                                                                                                    380
                                                                                                                                                                    end exclusive
                                                                                                                                                                    true
                                                                                                                                                                    exact text
                                                                                                                                                                    Non-Small Cell Lung Cancer (NSCLC)
                                                                                                                                                                    label id
                                                                                                                                                                    228e1e3f-d207-481f-8e14-9fdcbd0470e9
                                                                                                                                                                    offset unit
                                                                                                                                                                    unicode_code_points
                                                                                                                                                                    source array index
                                                                                                                                                                    0
                                                                                                                                                                    source field
                                                                                                                                                                    indications_and_usage_exact
                                                                                                                                                                    source text sha256
                                                                                                                                                                    e526ba14c91f10737e6d3331fe23a6219f58c0eca6380bfce9bd78b573fea912
                                                                                                                                                                    start
                                                                                                                                                                    346
                                                                                                                                                                  2. abbreviation
                                                                                                                                                                    CRC
                                                                                                                                                                    definition exact
                                                                                                                                                                    Colorectal Cancer
                                                                                                                                                                    definition span
                                                                                                                                                                    end
                                                                                                                                                                    5042
                                                                                                                                                                    end exclusive
                                                                                                                                                                    true
                                                                                                                                                                    exact text
                                                                                                                                                                    Colorectal Cancer (CRC)
                                                                                                                                                                    label id
                                                                                                                                                                    228e1e3f-d207-481f-8e14-9fdcbd0470e9
                                                                                                                                                                    offset unit
                                                                                                                                                                    unicode_code_points
                                                                                                                                                                    source array index
                                                                                                                                                                    0
                                                                                                                                                                    source field
                                                                                                                                                                    indications_and_usage_exact
                                                                                                                                                                    source text sha256
                                                                                                                                                                    e526ba14c91f10737e6d3331fe23a6219f58c0eca6380bfce9bd78b573fea912
                                                                                                                                                                    start
                                                                                                                                                                    5019
                                                                                                                                                                  source span
                                                                                                                                                                  end
                                                                                                                                                                  10360
                                                                                                                                                                  end exclusive
                                                                                                                                                                  true
                                                                                                                                                                  exact text
                                                                                                                                                                  ( 1.20 )
                                                                                                                                                                  label id
                                                                                                                                                                  228e1e3f-d207-481f-8e14-9fdcbd0470e9
                                                                                                                                                                  offset unit
                                                                                                                                                                  unicode_code_points
                                                                                                                                                                  source array index
                                                                                                                                                                  0
                                                                                                                                                                  source field
                                                                                                                                                                  indications_and_usage_exact
                                                                                                                                                                  source text sha256
                                                                                                                                                                  e526ba14c91f10737e6d3331fe23a6219f58c0eca6380bfce9bd78b573fea912
                                                                                                                                                                  start
                                                                                                                                                                  10352
                                                                                                                                                                  source url
                                                                                                                                                                  https://api.fda.gov/drug/label.json?search=id%3A%22228e1e3f-d207-481f-8e14-9fdcbd0470e9%22
                                                                                                                                                                  spl effective date
                                                                                                                                                                  2026-07-10
                                                                                                                                                                  spl set id
                                                                                                                                                                  9333c79b-d487-4538-a9f0-71b91a02b287
                                                                                                                                                                  spl version
                                                                                                                                                                  228
                                                                                                                                                                  structured fields status
                                                                                                                                                                  not_extracted_no_values_inferred_from_mentions
                                                                                                                                                                  structured indication
                                                                                                                                                                  age
                                                                                                                                                                  Source null
                                                                                                                                                                  approval pathway
                                                                                                                                                                  Source null
                                                                                                                                                                  biomarker and test
                                                                                                                                                                  Source null
                                                                                                                                                                  disease stage
                                                                                                                                                                  Source null
                                                                                                                                                                  limitations
                                                                                                                                                                  Source null
                                                                                                                                                                  line
                                                                                                                                                                  Source null
                                                                                                                                                                  prior therapy
                                                                                                                                                                  Source null
                                                                                                                                                                  regimen
                                                                                                                                                                  Source null
                                                                                                                                                                  tumor histology
                                                                                                                                                                  Source null
                                                                                                                                                                  use intent
                                                                                                                                                                  unclear
                                                                                                                                                                  Passage 61 · unclassified context
                                                                                                                                                                  application numbers
                                                                                                                                                                  1. BLA125514
                                                                                                                                                                  brand names
                                                                                                                                                                  1. KEYTRUDA
                                                                                                                                                                  classification reasons
                                                                                                                                                                  1. no_unambiguous_positive_indication_predicate
                                                                                                                                                                  clinical review status
                                                                                                                                                                  pending
                                                                                                                                                                  content role
                                                                                                                                                                  unclassified_context
                                                                                                                                                                  context span
                                                                                                                                                                  end
                                                                                                                                                                  10787
                                                                                                                                                                  end exclusive
                                                                                                                                                                  true
                                                                                                                                                                  exact text
                                                                                                                                                                  the treatment of patients with high-risk early-stage TNBC in combination with chemotherapy as neoadjuvant treatment, and then continued as a single agent as adjuvant treatment after surgery. ( 1.20 ) in combination with sacituzumab govitecan-hziy, for the first-line treatment of adult patients with unresectable locally advanced or metastatic TNBC whose tumors express PD-L1 (CPS ≥10) as determined by an FDA-authorized test. ( 1.20 , 2.1 ) in combination with chemotherapy, for the treatment of patients with locally recurrent unresectable or metastatic TNBC whose tumors express PD-L1 (CPS ≥10) as determined by an FDA-auth
                                                                                                                                                                  label id
                                                                                                                                                                  228e1e3f-d207-481f-8e14-9fdcbd0470e9
                                                                                                                                                                  offset unit
                                                                                                                                                                  unicode_code_points
                                                                                                                                                                  source array index
                                                                                                                                                                  0
                                                                                                                                                                  source field
                                                                                                                                                                  indications_and_usage_exact
                                                                                                                                                                  source text sha256
                                                                                                                                                                  e526ba14c91f10737e6d3331fe23a6219f58c0eca6380bfce9bd78b573fea912
                                                                                                                                                                  start
                                                                                                                                                                  10161
                                                                                                                                                                  current approval status
                                                                                                                                                                  not_reconciled
                                                                                                                                                                  duplicate text group
                                                                                                                                                                  dup-06fa25afcef5ad63eedc
                                                                                                                                                                  extraction review status
                                                                                                                                                                  automated_candidate_pending_source_review
                                                                                                                                                                  generic names
                                                                                                                                                                  1. PEMBROLIZUMAB
                                                                                                                                                                  id
                                                                                                                                                                  ind-span-11204c83639dda1b0811
                                                                                                                                                                  label id
                                                                                                                                                                  228e1e3f-d207-481f-8e14-9fdcbd0470e9
                                                                                                                                                                  positive predicate support span
                                                                                                                                                                  Source null
                                                                                                                                                                  qualifier mentions
                                                                                                                                                                  1. context exact
                                                                                                                                                                    sacituzumab govitecan-hziy, for the first-line treatment of adult patients with unresectable locally advanced or metastatic TNBC whose
                                                                                                                                                                    kind
                                                                                                                                                                    age
                                                                                                                                                                    polarity
                                                                                                                                                                    not_inferred
                                                                                                                                                                    span
                                                                                                                                                                    end
                                                                                                                                                                    10455
                                                                                                                                                                    end exclusive
                                                                                                                                                                    true
                                                                                                                                                                    exact text
                                                                                                                                                                    adult patients
                                                                                                                                                                    label id
                                                                                                                                                                    228e1e3f-d207-481f-8e14-9fdcbd0470e9
                                                                                                                                                                    offset unit
                                                                                                                                                                    unicode_code_points
                                                                                                                                                                    source array index
                                                                                                                                                                    0
                                                                                                                                                                    source field
                                                                                                                                                                    indications_and_usage_exact
                                                                                                                                                                    source text sha256
                                                                                                                                                                    e526ba14c91f10737e6d3331fe23a6219f58c0eca6380bfce9bd78b573fea912
                                                                                                                                                                    start
                                                                                                                                                                    10441
                                                                                                                                                                  2. context exact
                                                                                                                                                                    ent of adult patients with unresectable locally advanced or metastatic TNBC whose tumors express PD-L1 (CPS ≥10) as determined by an FDA-authorized test.
                                                                                                                                                                    kind
                                                                                                                                                                    biomarker
                                                                                                                                                                    polarity
                                                                                                                                                                    not_inferred
                                                                                                                                                                    span
                                                                                                                                                                    end
                                                                                                                                                                    10537
                                                                                                                                                                    end exclusive
                                                                                                                                                                    true
                                                                                                                                                                    exact text
                                                                                                                                                                    metastatic TNBC whose tumors express PD-L1
                                                                                                                                                                    label id
                                                                                                                                                                    228e1e3f-d207-481f-8e14-9fdcbd0470e9
                                                                                                                                                                    offset unit
                                                                                                                                                                    unicode_code_points
                                                                                                                                                                    source array index
                                                                                                                                                                    0
                                                                                                                                                                    source field
                                                                                                                                                                    indications_and_usage_exact
                                                                                                                                                                    source text sha256
                                                                                                                                                                    e526ba14c91f10737e6d3331fe23a6219f58c0eca6380bfce9bd78b573fea912
                                                                                                                                                                    start
                                                                                                                                                                    10494
                                                                                                                                                                  3. context exact
                                                                                                                                                                    n-hziy, for the first-line treatment of adult patients with unresectable locally advanced or metastatic TNBC whose tumors express PD-L1 (CPS ≥10) as determined by an F
                                                                                                                                                                    kind
                                                                                                                                                                    stage_or_setting
                                                                                                                                                                    polarity
                                                                                                                                                                    not_inferred
                                                                                                                                                                    span
                                                                                                                                                                    end
                                                                                                                                                                    10508
                                                                                                                                                                    end exclusive
                                                                                                                                                                    true
                                                                                                                                                                    exact text
                                                                                                                                                                    unresectable locally advanced or metastatic TNB
                                                                                                                                                                    label id
                                                                                                                                                                    228e1e3f-d207-481f-8e14-9fdcbd0470e9
                                                                                                                                                                    offset unit
                                                                                                                                                                    unicode_code_points
                                                                                                                                                                    source array index
                                                                                                                                                                    0
                                                                                                                                                                    source field
                                                                                                                                                                    indications_and_usage_exact
                                                                                                                                                                    source text sha256
                                                                                                                                                                    e526ba14c91f10737e6d3331fe23a6219f58c0eca6380bfce9bd78b573fea912
                                                                                                                                                                    start
                                                                                                                                                                    10461
                                                                                                                                                                  4. context exact
                                                                                                                                                                    in combination with sacituzumab govitecan-hziy, for the first-line treatment of adult patients with unresectable locally advanced or metastatic TNBC whose tumors express PD-L1 (CPS ≥10) as determined by an FDA-authorized test.
                                                                                                                                                                    kind
                                                                                                                                                                    prior_therapy_or_line
                                                                                                                                                                    polarity
                                                                                                                                                                    not_inferred
                                                                                                                                                                    span
                                                                                                                                                                    end
                                                                                                                                                                    10586
                                                                                                                                                                    end exclusive
                                                                                                                                                                    true
                                                                                                                                                                    exact text
                                                                                                                                                                    first-line treatment of adult patients with unresectable locally advanced or metastatic TNBC whose tumors express PD-L1 (CPS ≥10) as determined by an FDA-authorized test
                                                                                                                                                                    label id
                                                                                                                                                                    228e1e3f-d207-481f-8e14-9fdcbd0470e9
                                                                                                                                                                    offset unit
                                                                                                                                                                    unicode_code_points
                                                                                                                                                                    source array index
                                                                                                                                                                    0
                                                                                                                                                                    source field
                                                                                                                                                                    indications_and_usage_exact
                                                                                                                                                                    source text sha256
                                                                                                                                                                    e526ba14c91f10737e6d3331fe23a6219f58c0eca6380bfce9bd78b573fea912
                                                                                                                                                                    start
                                                                                                                                                                    10417
                                                                                                                                                                  5. context exact
                                                                                                                                                                    in combination with sacituzumab govitecan-hziy, for the first-line treatment of adult patients with unresectable locally advanced or metastatic TNBC whose tumors express PD-L1 (CPS ≥10) as determined by an FDA-authorized test.
                                                                                                                                                                    kind
                                                                                                                                                                    regimen
                                                                                                                                                                    polarity
                                                                                                                                                                    not_inferred
                                                                                                                                                                    span
                                                                                                                                                                    end
                                                                                                                                                                    10540
                                                                                                                                                                    end exclusive
                                                                                                                                                                    true
                                                                                                                                                                    exact text
                                                                                                                                                                    in combination with sacituzumab govitecan-hziy, for the first-line treatment of adult patients with unresectable locally advanced or metastatic TNBC whose tumors express PD-L1 (CP
                                                                                                                                                                    label id
                                                                                                                                                                    228e1e3f-d207-481f-8e14-9fdcbd0470e9
                                                                                                                                                                    offset unit
                                                                                                                                                                    unicode_code_points
                                                                                                                                                                    source array index
                                                                                                                                                                    0
                                                                                                                                                                    source field
                                                                                                                                                                    indications_and_usage_exact
                                                                                                                                                                    source text sha256
                                                                                                                                                                    e526ba14c91f10737e6d3331fe23a6219f58c0eca6380bfce9bd78b573fea912
                                                                                                                                                                    start
                                                                                                                                                                    10361
                                                                                                                                                                  regulatory links
                                                                                                                                                                    schema version
                                                                                                                                                                    0.1.0
                                                                                                                                                                    source batch sha256
                                                                                                                                                                    fc39a8c5cf96bf95ca20b85578140167b66b2741f7d9217f500d9ba0847ac058
                                                                                                                                                                    source defined aliases
                                                                                                                                                                    1. abbreviation
                                                                                                                                                                      NSCLC
                                                                                                                                                                      definition exact
                                                                                                                                                                      Non-Small Cell Lung Cancer
                                                                                                                                                                      definition span
                                                                                                                                                                      end
                                                                                                                                                                      380
                                                                                                                                                                      end exclusive
                                                                                                                                                                      true
                                                                                                                                                                      exact text
                                                                                                                                                                      Non-Small Cell Lung Cancer (NSCLC)
                                                                                                                                                                      label id
                                                                                                                                                                      228e1e3f-d207-481f-8e14-9fdcbd0470e9
                                                                                                                                                                      offset unit
                                                                                                                                                                      unicode_code_points
                                                                                                                                                                      source array index
                                                                                                                                                                      0
                                                                                                                                                                      source field
                                                                                                                                                                      indications_and_usage_exact
                                                                                                                                                                      source text sha256
                                                                                                                                                                      e526ba14c91f10737e6d3331fe23a6219f58c0eca6380bfce9bd78b573fea912
                                                                                                                                                                      start
                                                                                                                                                                      346
                                                                                                                                                                    2. abbreviation
                                                                                                                                                                      CRC
                                                                                                                                                                      definition exact
                                                                                                                                                                      Colorectal Cancer
                                                                                                                                                                      definition span
                                                                                                                                                                      end
                                                                                                                                                                      5042
                                                                                                                                                                      end exclusive
                                                                                                                                                                      true
                                                                                                                                                                      exact text
                                                                                                                                                                      Colorectal Cancer (CRC)
                                                                                                                                                                      label id
                                                                                                                                                                      228e1e3f-d207-481f-8e14-9fdcbd0470e9
                                                                                                                                                                      offset unit
                                                                                                                                                                      unicode_code_points
                                                                                                                                                                      source array index
                                                                                                                                                                      0
                                                                                                                                                                      source field
                                                                                                                                                                      indications_and_usage_exact
                                                                                                                                                                      source text sha256
                                                                                                                                                                      e526ba14c91f10737e6d3331fe23a6219f58c0eca6380bfce9bd78b573fea912
                                                                                                                                                                      start
                                                                                                                                                                      5019
                                                                                                                                                                    source span
                                                                                                                                                                    end
                                                                                                                                                                    10587
                                                                                                                                                                    end exclusive
                                                                                                                                                                    true
                                                                                                                                                                    exact text
                                                                                                                                                                    in combination with sacituzumab govitecan-hziy, for the first-line treatment of adult patients with unresectable locally advanced or metastatic TNBC whose tumors express PD-L1 (CPS ≥10) as determined by an FDA-authorized test.
                                                                                                                                                                    label id
                                                                                                                                                                    228e1e3f-d207-481f-8e14-9fdcbd0470e9
                                                                                                                                                                    offset unit
                                                                                                                                                                    unicode_code_points
                                                                                                                                                                    source array index
                                                                                                                                                                    0
                                                                                                                                                                    source field
                                                                                                                                                                    indications_and_usage_exact
                                                                                                                                                                    source text sha256
                                                                                                                                                                    e526ba14c91f10737e6d3331fe23a6219f58c0eca6380bfce9bd78b573fea912
                                                                                                                                                                    start
                                                                                                                                                                    10361
                                                                                                                                                                    source url
                                                                                                                                                                    https://api.fda.gov/drug/label.json?search=id%3A%22228e1e3f-d207-481f-8e14-9fdcbd0470e9%22
                                                                                                                                                                    spl effective date
                                                                                                                                                                    2026-07-10
                                                                                                                                                                    spl set id
                                                                                                                                                                    9333c79b-d487-4538-a9f0-71b91a02b287
                                                                                                                                                                    spl version
                                                                                                                                                                    228
                                                                                                                                                                    structured fields status
                                                                                                                                                                    not_extracted_no_values_inferred_from_mentions
                                                                                                                                                                    structured indication
                                                                                                                                                                    age
                                                                                                                                                                    Source null
                                                                                                                                                                    approval pathway
                                                                                                                                                                    Source null
                                                                                                                                                                    biomarker and test
                                                                                                                                                                    Source null
                                                                                                                                                                    disease stage
                                                                                                                                                                    Source null
                                                                                                                                                                    limitations
                                                                                                                                                                    Source null
                                                                                                                                                                    line
                                                                                                                                                                    Source null
                                                                                                                                                                    prior therapy
                                                                                                                                                                    Source null
                                                                                                                                                                    regimen
                                                                                                                                                                    Source null
                                                                                                                                                                    tumor histology
                                                                                                                                                                    Source null
                                                                                                                                                                    use intent
                                                                                                                                                                    unclear
                                                                                                                                                                    Passage 62 · unclassified context
                                                                                                                                                                    application numbers
                                                                                                                                                                    1. BLA125514
                                                                                                                                                                    brand names
                                                                                                                                                                    1. KEYTRUDA
                                                                                                                                                                    classification reasons
                                                                                                                                                                    1. no_unambiguous_positive_indication_predicate
                                                                                                                                                                    clinical review status
                                                                                                                                                                    pending
                                                                                                                                                                    content role
                                                                                                                                                                    unclassified_context
                                                                                                                                                                    context span
                                                                                                                                                                    end
                                                                                                                                                                    10999
                                                                                                                                                                    end exclusive
                                                                                                                                                                    true
                                                                                                                                                                    exact text
                                                                                                                                                                    umab govitecan-hziy, for the first-line treatment of adult patients with unresectable locally advanced or metastatic TNBC whose tumors express PD-L1 (CPS ≥10) as determined by an FDA-authorized test. ( 1.20 , 2.1 ) in combination with chemotherapy, for the treatment of patients with locally recurrent unresectable or metastatic TNBC whose tumors express PD-L1 (CPS ≥10) as determined by an FDA-authorized test. ( 1.20 , 2.1 ) Ovarian Cancer in combination with paclitaxel, with or without bevacizumab, for the treatment of adult patients with platinum-resistant epithelial ovarian, fallopian tube, or primary p
                                                                                                                                                                    label id
                                                                                                                                                                    228e1e3f-d207-481f-8e14-9fdcbd0470e9
                                                                                                                                                                    offset unit
                                                                                                                                                                    unicode_code_points
                                                                                                                                                                    source array index
                                                                                                                                                                    0
                                                                                                                                                                    source field
                                                                                                                                                                    indications_and_usage_exact
                                                                                                                                                                    source text sha256
                                                                                                                                                                    e526ba14c91f10737e6d3331fe23a6219f58c0eca6380bfce9bd78b573fea912
                                                                                                                                                                    start
                                                                                                                                                                    10388
                                                                                                                                                                    current approval status
                                                                                                                                                                    not_reconciled
                                                                                                                                                                    duplicate text group
                                                                                                                                                                    dup-8f0439fc090eb67a9682
                                                                                                                                                                    extraction review status
                                                                                                                                                                    automated_candidate_pending_source_review
                                                                                                                                                                    generic names
                                                                                                                                                                    1. PEMBROLIZUMAB
                                                                                                                                                                    id
                                                                                                                                                                    ind-span-5d399c4e7075755eac17
                                                                                                                                                                    label id
                                                                                                                                                                    228e1e3f-d207-481f-8e14-9fdcbd0470e9
                                                                                                                                                                    positive predicate support span
                                                                                                                                                                    Source null
                                                                                                                                                                    qualifier mentions
                                                                                                                                                                    1. context exact
                                                                                                                                                                      reatment of patients with locally recurrent unresectable or metastatic TNBC whose tumors express PD-L1 (CPS ≥10) as determined by an FDA-authorized test.
                                                                                                                                                                      kind
                                                                                                                                                                      biomarker
                                                                                                                                                                      polarity
                                                                                                                                                                      not_inferred
                                                                                                                                                                      span
                                                                                                                                                                      end
                                                                                                                                                                      10749
                                                                                                                                                                      end exclusive
                                                                                                                                                                      true
                                                                                                                                                                      exact text
                                                                                                                                                                      metastatic TNBC whose tumors express PD-L1
                                                                                                                                                                      label id
                                                                                                                                                                      228e1e3f-d207-481f-8e14-9fdcbd0470e9
                                                                                                                                                                      offset unit
                                                                                                                                                                      unicode_code_points
                                                                                                                                                                      source array index
                                                                                                                                                                      0
                                                                                                                                                                      source field
                                                                                                                                                                      indications_and_usage_exact
                                                                                                                                                                      source text sha256
                                                                                                                                                                      e526ba14c91f10737e6d3331fe23a6219f58c0eca6380bfce9bd78b573fea912
                                                                                                                                                                      start
                                                                                                                                                                      10706
                                                                                                                                                                    2. context exact
                                                                                                                                                                      th chemotherapy, for the treatment of patients with locally recurrent unresectable or metastatic TNBC whose tumors express PD-L1 (CPS ≥10) as determined by an FDA-a
                                                                                                                                                                      kind
                                                                                                                                                                      stage_or_setting
                                                                                                                                                                      polarity
                                                                                                                                                                      not_inferred
                                                                                                                                                                      span
                                                                                                                                                                      end
                                                                                                                                                                      10724
                                                                                                                                                                      end exclusive
                                                                                                                                                                      true
                                                                                                                                                                      exact text
                                                                                                                                                                      recurrent unresectable or metastatic TNBC wh
                                                                                                                                                                      label id
                                                                                                                                                                      228e1e3f-d207-481f-8e14-9fdcbd0470e9
                                                                                                                                                                      offset unit
                                                                                                                                                                      unicode_code_points
                                                                                                                                                                      source array index
                                                                                                                                                                      0
                                                                                                                                                                      source field
                                                                                                                                                                      indications_and_usage_exact
                                                                                                                                                                      source text sha256
                                                                                                                                                                      e526ba14c91f10737e6d3331fe23a6219f58c0eca6380bfce9bd78b573fea912
                                                                                                                                                                      start
                                                                                                                                                                      10680
                                                                                                                                                                    3. context exact
                                                                                                                                                                      ( 1.20 , 2.1 ) in combination with chemotherapy, for the treatment of patients with locally recurrent unresectable or metastatic TNBC whose tumors express PD-L1 (CPS ≥10) as determined by an FDA-authorized test.
                                                                                                                                                                      kind
                                                                                                                                                                      regimen
                                                                                                                                                                      polarity
                                                                                                                                                                      not_inferred
                                                                                                                                                                      span
                                                                                                                                                                      end
                                                                                                                                                                      10782
                                                                                                                                                                      end exclusive
                                                                                                                                                                      true
                                                                                                                                                                      exact text
                                                                                                                                                                      in combination with chemotherapy, for the treatment of patients with locally recurrent unresectable or metastatic TNBC whose tumors express PD-L1 (CPS ≥10) as determined by an FDA
                                                                                                                                                                      label id
                                                                                                                                                                      228e1e3f-d207-481f-8e14-9fdcbd0470e9
                                                                                                                                                                      offset unit
                                                                                                                                                                      unicode_code_points
                                                                                                                                                                      source array index
                                                                                                                                                                      0
                                                                                                                                                                      source field
                                                                                                                                                                      indications_and_usage_exact
                                                                                                                                                                      source text sha256
                                                                                                                                                                      e526ba14c91f10737e6d3331fe23a6219f58c0eca6380bfce9bd78b573fea912
                                                                                                                                                                      start
                                                                                                                                                                      10603
                                                                                                                                                                    regulatory links
                                                                                                                                                                      schema version
                                                                                                                                                                      0.1.0
                                                                                                                                                                      source batch sha256
                                                                                                                                                                      fc39a8c5cf96bf95ca20b85578140167b66b2741f7d9217f500d9ba0847ac058
                                                                                                                                                                      source defined aliases
                                                                                                                                                                      1. abbreviation
                                                                                                                                                                        NSCLC
                                                                                                                                                                        definition exact
                                                                                                                                                                        Non-Small Cell Lung Cancer
                                                                                                                                                                        definition span
                                                                                                                                                                        end
                                                                                                                                                                        380
                                                                                                                                                                        end exclusive
                                                                                                                                                                        true
                                                                                                                                                                        exact text
                                                                                                                                                                        Non-Small Cell Lung Cancer (NSCLC)
                                                                                                                                                                        label id
                                                                                                                                                                        228e1e3f-d207-481f-8e14-9fdcbd0470e9
                                                                                                                                                                        offset unit
                                                                                                                                                                        unicode_code_points
                                                                                                                                                                        source array index
                                                                                                                                                                        0
                                                                                                                                                                        source field
                                                                                                                                                                        indications_and_usage_exact
                                                                                                                                                                        source text sha256
                                                                                                                                                                        e526ba14c91f10737e6d3331fe23a6219f58c0eca6380bfce9bd78b573fea912
                                                                                                                                                                        start
                                                                                                                                                                        346
                                                                                                                                                                      2. abbreviation
                                                                                                                                                                        CRC
                                                                                                                                                                        definition exact
                                                                                                                                                                        Colorectal Cancer
                                                                                                                                                                        definition span
                                                                                                                                                                        end
                                                                                                                                                                        5042
                                                                                                                                                                        end exclusive
                                                                                                                                                                        true
                                                                                                                                                                        exact text
                                                                                                                                                                        Colorectal Cancer (CRC)
                                                                                                                                                                        label id
                                                                                                                                                                        228e1e3f-d207-481f-8e14-9fdcbd0470e9
                                                                                                                                                                        offset unit
                                                                                                                                                                        unicode_code_points
                                                                                                                                                                        source array index
                                                                                                                                                                        0
                                                                                                                                                                        source field
                                                                                                                                                                        indications_and_usage_exact
                                                                                                                                                                        source text sha256
                                                                                                                                                                        e526ba14c91f10737e6d3331fe23a6219f58c0eca6380bfce9bd78b573fea912
                                                                                                                                                                        start
                                                                                                                                                                        5019
                                                                                                                                                                      source span
                                                                                                                                                                      end
                                                                                                                                                                      10799
                                                                                                                                                                      end exclusive
                                                                                                                                                                      true
                                                                                                                                                                      exact text
                                                                                                                                                                      ( 1.20 , 2.1 ) in combination with chemotherapy, for the treatment of patients with locally recurrent unresectable or metastatic TNBC whose tumors express PD-L1 (CPS ≥10) as determined by an FDA-authorized test.
                                                                                                                                                                      label id
                                                                                                                                                                      228e1e3f-d207-481f-8e14-9fdcbd0470e9
                                                                                                                                                                      offset unit
                                                                                                                                                                      unicode_code_points
                                                                                                                                                                      source array index
                                                                                                                                                                      0
                                                                                                                                                                      source field
                                                                                                                                                                      indications_and_usage_exact
                                                                                                                                                                      source text sha256
                                                                                                                                                                      e526ba14c91f10737e6d3331fe23a6219f58c0eca6380bfce9bd78b573fea912
                                                                                                                                                                      start
                                                                                                                                                                      10588
                                                                                                                                                                      source url
                                                                                                                                                                      https://api.fda.gov/drug/label.json?search=id%3A%22228e1e3f-d207-481f-8e14-9fdcbd0470e9%22
                                                                                                                                                                      spl effective date
                                                                                                                                                                      2026-07-10
                                                                                                                                                                      spl set id
                                                                                                                                                                      9333c79b-d487-4538-a9f0-71b91a02b287
                                                                                                                                                                      spl version
                                                                                                                                                                      228
                                                                                                                                                                      structured fields status
                                                                                                                                                                      not_extracted_no_values_inferred_from_mentions
                                                                                                                                                                      structured indication
                                                                                                                                                                      age
                                                                                                                                                                      Source null
                                                                                                                                                                      approval pathway
                                                                                                                                                                      Source null
                                                                                                                                                                      biomarker and test
                                                                                                                                                                      Source null
                                                                                                                                                                      disease stage
                                                                                                                                                                      Source null
                                                                                                                                                                      limitations
                                                                                                                                                                      Source null
                                                                                                                                                                      line
                                                                                                                                                                      Source null
                                                                                                                                                                      prior therapy
                                                                                                                                                                      Source null
                                                                                                                                                                      regimen
                                                                                                                                                                      Source null
                                                                                                                                                                      tumor histology
                                                                                                                                                                      Source null
                                                                                                                                                                      use intent
                                                                                                                                                                      unclear
                                                                                                                                                                      Passage 63 · unclassified context
                                                                                                                                                                      application numbers
                                                                                                                                                                      1. BLA125514
                                                                                                                                                                      brand names
                                                                                                                                                                      1. KEYTRUDA
                                                                                                                                                                      classification reasons
                                                                                                                                                                      1. no_unambiguous_positive_indication_predicate
                                                                                                                                                                      clinical review status
                                                                                                                                                                      pending
                                                                                                                                                                      content role
                                                                                                                                                                      unclassified_context
                                                                                                                                                                      context span
                                                                                                                                                                      end
                                                                                                                                                                      11363
                                                                                                                                                                      end exclusive
                                                                                                                                                                      true
                                                                                                                                                                      exact text
                                                                                                                                                                      ) in combination with chemotherapy, for the treatment of patients with locally recurrent unresectable or metastatic TNBC whose tumors express PD-L1 (CPS ≥10) as determined by an FDA-authorized test. ( 1.20 , 2.1 ) Ovarian Cancer in combination with paclitaxel, with or without bevacizumab, for the treatment of adult patients with platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal carcinoma whose tumors express PD-L1 (CPS ≥1) as determined by an FDA-authorized test, and who have received one or two prior systemic treatment regimens. ( 1.21 , 2.1 ) 1 This indication is approved under accelerated approval based on tumor response rate and durability of response. Continued approval for this indication may be contingent upon verifica
                                                                                                                                                                      label id
                                                                                                                                                                      228e1e3f-d207-481f-8e14-9fdcbd0470e9
                                                                                                                                                                      offset unit
                                                                                                                                                                      unicode_code_points
                                                                                                                                                                      source array index
                                                                                                                                                                      0
                                                                                                                                                                      source field
                                                                                                                                                                      indications_and_usage_exact
                                                                                                                                                                      source text sha256
                                                                                                                                                                      e526ba14c91f10737e6d3331fe23a6219f58c0eca6380bfce9bd78b573fea912
                                                                                                                                                                      start
                                                                                                                                                                      10600
                                                                                                                                                                      current approval status
                                                                                                                                                                      not_reconciled
                                                                                                                                                                      duplicate text group
                                                                                                                                                                      dup-b60a51bd3fe0dbb78ece
                                                                                                                                                                      extraction review status
                                                                                                                                                                      automated_candidate_pending_source_review
                                                                                                                                                                      generic names
                                                                                                                                                                      1. PEMBROLIZUMAB
                                                                                                                                                                      id
                                                                                                                                                                      ind-span-4caeaac146ff4e8a5b3d
                                                                                                                                                                      label id
                                                                                                                                                                      228e1e3f-d207-481f-8e14-9fdcbd0470e9
                                                                                                                                                                      positive predicate support span
                                                                                                                                                                      Source null
                                                                                                                                                                      qualifier mentions
                                                                                                                                                                      1. context exact
                                                                                                                                                                        clitaxel, with or without bevacizumab, for the treatment of adult patients with platinum-resistant epithelial ovarian, fallopian tube,
                                                                                                                                                                        kind
                                                                                                                                                                        age
                                                                                                                                                                        polarity
                                                                                                                                                                        not_inferred
                                                                                                                                                                        span
                                                                                                                                                                        end
                                                                                                                                                                        10926
                                                                                                                                                                        end exclusive
                                                                                                                                                                        true
                                                                                                                                                                        exact text
                                                                                                                                                                        adult patients
                                                                                                                                                                        label id
                                                                                                                                                                        228e1e3f-d207-481f-8e14-9fdcbd0470e9
                                                                                                                                                                        offset unit
                                                                                                                                                                        unicode_code_points
                                                                                                                                                                        source array index
                                                                                                                                                                        0
                                                                                                                                                                        source field
                                                                                                                                                                        indications_and_usage_exact
                                                                                                                                                                        source text sha256
                                                                                                                                                                        e526ba14c91f10737e6d3331fe23a6219f58c0eca6380bfce9bd78b573fea912
                                                                                                                                                                        start
                                                                                                                                                                        10912
                                                                                                                                                                      2. context exact
                                                                                                                                                                        tube, or primary peritoneal carcinoma whose tumors express PD-L1 (CPS ≥1) as determined by an FDA-authorized test, and who have received one or two prior systemic t
                                                                                                                                                                        kind
                                                                                                                                                                        biomarker
                                                                                                                                                                        polarity
                                                                                                                                                                        not_inferred
                                                                                                                                                                        span
                                                                                                                                                                        end
                                                                                                                                                                        11085
                                                                                                                                                                        end exclusive
                                                                                                                                                                        true
                                                                                                                                                                        exact text
                                                                                                                                                                        PD-L1 (CPS ≥1) as determined by an FDA-author
                                                                                                                                                                        label id
                                                                                                                                                                        228e1e3f-d207-481f-8e14-9fdcbd0470e9
                                                                                                                                                                        offset unit
                                                                                                                                                                        unicode_code_points
                                                                                                                                                                        source array index
                                                                                                                                                                        0
                                                                                                                                                                        source field
                                                                                                                                                                        indications_and_usage_exact
                                                                                                                                                                        source text sha256
                                                                                                                                                                        e526ba14c91f10737e6d3331fe23a6219f58c0eca6380bfce9bd78b573fea912
                                                                                                                                                                        start
                                                                                                                                                                        11040
                                                                                                                                                                      3. context exact
                                                                                                                                                                        PD-L1 (CPS ≥1) as determined by an FDA-authorized test, and who have received one or two prior systemic treatment regimens.
                                                                                                                                                                        kind
                                                                                                                                                                        prior_therapy_or_line
                                                                                                                                                                        polarity
                                                                                                                                                                        not_inferred
                                                                                                                                                                        span
                                                                                                                                                                        end
                                                                                                                                                                        11162
                                                                                                                                                                        end exclusive
                                                                                                                                                                        true
                                                                                                                                                                        exact text
                                                                                                                                                                        who have received one or two prior systemic treatment regimens
                                                                                                                                                                        label id
                                                                                                                                                                        228e1e3f-d207-481f-8e14-9fdcbd0470e9
                                                                                                                                                                        offset unit
                                                                                                                                                                        unicode_code_points
                                                                                                                                                                        source array index
                                                                                                                                                                        0
                                                                                                                                                                        source field
                                                                                                                                                                        indications_and_usage_exact
                                                                                                                                                                        source text sha256
                                                                                                                                                                        e526ba14c91f10737e6d3331fe23a6219f58c0eca6380bfce9bd78b573fea912
                                                                                                                                                                        start
                                                                                                                                                                        11100
                                                                                                                                                                      4. context exact
                                                                                                                                                                        ( 1.20 , 2.1 ) Ovarian Cancer in combination with paclitaxel, with or without bevacizumab, for the treatment of adult patients with platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal carcinoma whose tumors express PD-L1 (CPS ≥1) as determined
                                                                                                                                                                        kind
                                                                                                                                                                        regimen
                                                                                                                                                                        polarity
                                                                                                                                                                        not_inferred
                                                                                                                                                                        span
                                                                                                                                                                        end
                                                                                                                                                                        11009
                                                                                                                                                                        end exclusive
                                                                                                                                                                        true
                                                                                                                                                                        exact text
                                                                                                                                                                        in combination with paclitaxel, with or without bevacizumab, for the treatment of adult patients with platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal
                                                                                                                                                                        label id
                                                                                                                                                                        228e1e3f-d207-481f-8e14-9fdcbd0470e9
                                                                                                                                                                        offset unit
                                                                                                                                                                        unicode_code_points
                                                                                                                                                                        source array index
                                                                                                                                                                        0
                                                                                                                                                                        source field
                                                                                                                                                                        indications_and_usage_exact
                                                                                                                                                                        source text sha256
                                                                                                                                                                        e526ba14c91f10737e6d3331fe23a6219f58c0eca6380bfce9bd78b573fea912
                                                                                                                                                                        start
                                                                                                                                                                        10830
                                                                                                                                                                      regulatory links
                                                                                                                                                                        schema version
                                                                                                                                                                        0.1.0
                                                                                                                                                                        source batch sha256
                                                                                                                                                                        fc39a8c5cf96bf95ca20b85578140167b66b2741f7d9217f500d9ba0847ac058
                                                                                                                                                                        source defined aliases
                                                                                                                                                                        1. abbreviation
                                                                                                                                                                          NSCLC
                                                                                                                                                                          definition exact
                                                                                                                                                                          Non-Small Cell Lung Cancer
                                                                                                                                                                          definition span
                                                                                                                                                                          end
                                                                                                                                                                          380
                                                                                                                                                                          end exclusive
                                                                                                                                                                          true
                                                                                                                                                                          exact text
                                                                                                                                                                          Non-Small Cell Lung Cancer (NSCLC)
                                                                                                                                                                          label id
                                                                                                                                                                          228e1e3f-d207-481f-8e14-9fdcbd0470e9
                                                                                                                                                                          offset unit
                                                                                                                                                                          unicode_code_points
                                                                                                                                                                          source array index
                                                                                                                                                                          0
                                                                                                                                                                          source field
                                                                                                                                                                          indications_and_usage_exact
                                                                                                                                                                          source text sha256
                                                                                                                                                                          e526ba14c91f10737e6d3331fe23a6219f58c0eca6380bfce9bd78b573fea912
                                                                                                                                                                          start
                                                                                                                                                                          346
                                                                                                                                                                        2. abbreviation
                                                                                                                                                                          CRC
                                                                                                                                                                          definition exact
                                                                                                                                                                          Colorectal Cancer
                                                                                                                                                                          definition span
                                                                                                                                                                          end
                                                                                                                                                                          5042
                                                                                                                                                                          end exclusive
                                                                                                                                                                          true
                                                                                                                                                                          exact text
                                                                                                                                                                          Colorectal Cancer (CRC)
                                                                                                                                                                          label id
                                                                                                                                                                          228e1e3f-d207-481f-8e14-9fdcbd0470e9
                                                                                                                                                                          offset unit
                                                                                                                                                                          unicode_code_points
                                                                                                                                                                          source array index
                                                                                                                                                                          0
                                                                                                                                                                          source field
                                                                                                                                                                          indications_and_usage_exact
                                                                                                                                                                          source text sha256
                                                                                                                                                                          e526ba14c91f10737e6d3331fe23a6219f58c0eca6380bfce9bd78b573fea912
                                                                                                                                                                          start
                                                                                                                                                                          5019
                                                                                                                                                                        source span
                                                                                                                                                                        end
                                                                                                                                                                        11163
                                                                                                                                                                        end exclusive
                                                                                                                                                                        true
                                                                                                                                                                        exact text
                                                                                                                                                                        ( 1.20 , 2.1 ) Ovarian Cancer in combination with paclitaxel, with or without bevacizumab, for the treatment of adult patients with platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal carcinoma whose tumors express PD-L1 (CPS ≥1) as determined by an FDA-authorized test, and who have received one or two prior systemic treatment regimens.
                                                                                                                                                                        label id
                                                                                                                                                                        228e1e3f-d207-481f-8e14-9fdcbd0470e9
                                                                                                                                                                        offset unit
                                                                                                                                                                        unicode_code_points
                                                                                                                                                                        source array index
                                                                                                                                                                        0
                                                                                                                                                                        source field
                                                                                                                                                                        indications_and_usage_exact
                                                                                                                                                                        source text sha256
                                                                                                                                                                        e526ba14c91f10737e6d3331fe23a6219f58c0eca6380bfce9bd78b573fea912
                                                                                                                                                                        start
                                                                                                                                                                        10800
                                                                                                                                                                        source url
                                                                                                                                                                        https://api.fda.gov/drug/label.json?search=id%3A%22228e1e3f-d207-481f-8e14-9fdcbd0470e9%22
                                                                                                                                                                        spl effective date
                                                                                                                                                                        2026-07-10
                                                                                                                                                                        spl set id
                                                                                                                                                                        9333c79b-d487-4538-a9f0-71b91a02b287
                                                                                                                                                                        spl version
                                                                                                                                                                        228
                                                                                                                                                                        structured fields status
                                                                                                                                                                        not_extracted_no_values_inferred_from_mentions
                                                                                                                                                                        structured indication
                                                                                                                                                                        age
                                                                                                                                                                        Source null
                                                                                                                                                                        approval pathway
                                                                                                                                                                        Source null
                                                                                                                                                                        biomarker and test
                                                                                                                                                                        Source null
                                                                                                                                                                        disease stage
                                                                                                                                                                        Source null
                                                                                                                                                                        limitations
                                                                                                                                                                        Source null
                                                                                                                                                                        line
                                                                                                                                                                        Source null
                                                                                                                                                                        prior therapy
                                                                                                                                                                        Source null
                                                                                                                                                                        regimen
                                                                                                                                                                        Source null
                                                                                                                                                                        tumor histology
                                                                                                                                                                        Source null
                                                                                                                                                                        use intent
                                                                                                                                                                        unclear
                                                                                                                                                                        Passage 64 · approval contingency
                                                                                                                                                                        application numbers
                                                                                                                                                                        1. BLA125514
                                                                                                                                                                        brand names
                                                                                                                                                                        1. KEYTRUDA
                                                                                                                                                                        classification reasons
                                                                                                                                                                        1. approval_contingency_words
                                                                                                                                                                        clinical review status
                                                                                                                                                                        pending
                                                                                                                                                                        content role
                                                                                                                                                                        approval_contingency
                                                                                                                                                                        context span
                                                                                                                                                                        end
                                                                                                                                                                        11492
                                                                                                                                                                        end exclusive
                                                                                                                                                                        true
                                                                                                                                                                        exact text
                                                                                                                                                                        arian, fallopian tube, or primary peritoneal carcinoma whose tumors express PD-L1 (CPS ≥1) as determined by an FDA-authorized test, and who have received one or two prior systemic treatment regimens. ( 1.21 , 2.1 ) 1 This indication is approved under accelerated approval based on tumor response rate and durability of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trials. 1.1 Melanoma KEYTRUDA ® is indicated for the treatment of pa
                                                                                                                                                                        label id
                                                                                                                                                                        228e1e3f-d207-481f-8e14-9fdcbd0470e9
                                                                                                                                                                        offset unit
                                                                                                                                                                        unicode_code_points
                                                                                                                                                                        source array index
                                                                                                                                                                        0
                                                                                                                                                                        source field
                                                                                                                                                                        indications_and_usage_exact
                                                                                                                                                                        source text sha256
                                                                                                                                                                        e526ba14c91f10737e6d3331fe23a6219f58c0eca6380bfce9bd78b573fea912
                                                                                                                                                                        start
                                                                                                                                                                        10964
                                                                                                                                                                        current approval status
                                                                                                                                                                        not_reconciled
                                                                                                                                                                        duplicate text group
                                                                                                                                                                        dup-2dd164915328f6a00edd
                                                                                                                                                                        extraction review status
                                                                                                                                                                        automated_candidate_pending_source_review
                                                                                                                                                                        generic names
                                                                                                                                                                        1. PEMBROLIZUMAB
                                                                                                                                                                        id
                                                                                                                                                                        ind-span-e4053d7592879c9eeb09
                                                                                                                                                                        label id
                                                                                                                                                                        228e1e3f-d207-481f-8e14-9fdcbd0470e9
                                                                                                                                                                        positive predicate support span
                                                                                                                                                                        Source null
                                                                                                                                                                        qualifier mentions
                                                                                                                                                                          regulatory links
                                                                                                                                                                            schema version
                                                                                                                                                                            0.1.0
                                                                                                                                                                            source batch sha256
                                                                                                                                                                            fc39a8c5cf96bf95ca20b85578140167b66b2741f7d9217f500d9ba0847ac058
                                                                                                                                                                            source defined aliases
                                                                                                                                                                            1. abbreviation
                                                                                                                                                                              NSCLC
                                                                                                                                                                              definition exact
                                                                                                                                                                              Non-Small Cell Lung Cancer
                                                                                                                                                                              definition span
                                                                                                                                                                              end
                                                                                                                                                                              380
                                                                                                                                                                              end exclusive
                                                                                                                                                                              true
                                                                                                                                                                              exact text
                                                                                                                                                                              Non-Small Cell Lung Cancer (NSCLC)
                                                                                                                                                                              label id
                                                                                                                                                                              228e1e3f-d207-481f-8e14-9fdcbd0470e9
                                                                                                                                                                              offset unit
                                                                                                                                                                              unicode_code_points
                                                                                                                                                                              source array index
                                                                                                                                                                              0
                                                                                                                                                                              source field
                                                                                                                                                                              indications_and_usage_exact
                                                                                                                                                                              source text sha256
                                                                                                                                                                              e526ba14c91f10737e6d3331fe23a6219f58c0eca6380bfce9bd78b573fea912
                                                                                                                                                                              start
                                                                                                                                                                              346
                                                                                                                                                                            2. abbreviation
                                                                                                                                                                              CRC
                                                                                                                                                                              definition exact
                                                                                                                                                                              Colorectal Cancer
                                                                                                                                                                              definition span
                                                                                                                                                                              end
                                                                                                                                                                              5042
                                                                                                                                                                              end exclusive
                                                                                                                                                                              true
                                                                                                                                                                              exact text
                                                                                                                                                                              Colorectal Cancer (CRC)
                                                                                                                                                                              label id
                                                                                                                                                                              228e1e3f-d207-481f-8e14-9fdcbd0470e9
                                                                                                                                                                              offset unit
                                                                                                                                                                              unicode_code_points
                                                                                                                                                                              source array index
                                                                                                                                                                              0
                                                                                                                                                                              source field
                                                                                                                                                                              indications_and_usage_exact
                                                                                                                                                                              source text sha256
                                                                                                                                                                              e526ba14c91f10737e6d3331fe23a6219f58c0eca6380bfce9bd78b573fea912
                                                                                                                                                                              start
                                                                                                                                                                              5019
                                                                                                                                                                            source span
                                                                                                                                                                            end
                                                                                                                                                                            11292
                                                                                                                                                                            end exclusive
                                                                                                                                                                            true
                                                                                                                                                                            exact text
                                                                                                                                                                            ( 1.21 , 2.1 ) 1 This indication is approved under accelerated approval based on tumor response rate and durability of response.
                                                                                                                                                                            label id
                                                                                                                                                                            228e1e3f-d207-481f-8e14-9fdcbd0470e9
                                                                                                                                                                            offset unit
                                                                                                                                                                            unicode_code_points
                                                                                                                                                                            source array index
                                                                                                                                                                            0
                                                                                                                                                                            source field
                                                                                                                                                                            indications_and_usage_exact
                                                                                                                                                                            source text sha256
                                                                                                                                                                            e526ba14c91f10737e6d3331fe23a6219f58c0eca6380bfce9bd78b573fea912
                                                                                                                                                                            start
                                                                                                                                                                            11164
                                                                                                                                                                            source url
                                                                                                                                                                            https://api.fda.gov/drug/label.json?search=id%3A%22228e1e3f-d207-481f-8e14-9fdcbd0470e9%22
                                                                                                                                                                            spl effective date
                                                                                                                                                                            2026-07-10
                                                                                                                                                                            spl set id
                                                                                                                                                                            9333c79b-d487-4538-a9f0-71b91a02b287
                                                                                                                                                                            spl version
                                                                                                                                                                            228
                                                                                                                                                                            structured fields status
                                                                                                                                                                            not_extracted_no_values_inferred_from_mentions
                                                                                                                                                                            structured indication
                                                                                                                                                                            age
                                                                                                                                                                            Source null
                                                                                                                                                                            approval pathway
                                                                                                                                                                            Source null
                                                                                                                                                                            biomarker and test
                                                                                                                                                                            Source null
                                                                                                                                                                            disease stage
                                                                                                                                                                            Source null
                                                                                                                                                                            limitations
                                                                                                                                                                            Source null
                                                                                                                                                                            line
                                                                                                                                                                            Source null
                                                                                                                                                                            prior therapy
                                                                                                                                                                            Source null
                                                                                                                                                                            regimen
                                                                                                                                                                            Source null
                                                                                                                                                                            tumor histology
                                                                                                                                                                            Source null
                                                                                                                                                                            use intent
                                                                                                                                                                            not_applicable
                                                                                                                                                                            Passage 65 · approval contingency
                                                                                                                                                                            application numbers
                                                                                                                                                                            1. BLA125514
                                                                                                                                                                            brand names
                                                                                                                                                                            1. KEYTRUDA
                                                                                                                                                                            classification reasons
                                                                                                                                                                            1. approval_contingency_words
                                                                                                                                                                            clinical review status
                                                                                                                                                                            pending
                                                                                                                                                                            content role
                                                                                                                                                                            approval_contingency
                                                                                                                                                                            context span
                                                                                                                                                                            end
                                                                                                                                                                            11631
                                                                                                                                                                            end exclusive
                                                                                                                                                                            true
                                                                                                                                                                            exact text
                                                                                                                                                                            t, and who have received one or two prior systemic treatment regimens. ( 1.21 , 2.1 ) 1 This indication is approved under accelerated approval based on tumor response rate and durability of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trials. 1.1 Melanoma KEYTRUDA ® is indicated for the treatment of patients with unresectable or metastatic melanoma. KEYTRUDA is indicated for the adjuvant treatment of adult and pediatric (12 years and olde
                                                                                                                                                                            label id
                                                                                                                                                                            228e1e3f-d207-481f-8e14-9fdcbd0470e9
                                                                                                                                                                            offset unit
                                                                                                                                                                            unicode_code_points
                                                                                                                                                                            source array index
                                                                                                                                                                            0
                                                                                                                                                                            source field
                                                                                                                                                                            indications_and_usage_exact
                                                                                                                                                                            source text sha256
                                                                                                                                                                            e526ba14c91f10737e6d3331fe23a6219f58c0eca6380bfce9bd78b573fea912
                                                                                                                                                                            start
                                                                                                                                                                            11093
                                                                                                                                                                            current approval status
                                                                                                                                                                            not_reconciled
                                                                                                                                                                            duplicate text group
                                                                                                                                                                            dup-81b781d538d32f2c330f
                                                                                                                                                                            extraction review status
                                                                                                                                                                            automated_candidate_pending_source_review
                                                                                                                                                                            generic names
                                                                                                                                                                            1. PEMBROLIZUMAB
                                                                                                                                                                            id
                                                                                                                                                                            ind-span-c44c8fdb0da722a2d351
                                                                                                                                                                            label id
                                                                                                                                                                            228e1e3f-d207-481f-8e14-9fdcbd0470e9
                                                                                                                                                                            positive predicate support span
                                                                                                                                                                            Source null
                                                                                                                                                                            qualifier mentions
                                                                                                                                                                              regulatory links
                                                                                                                                                                                schema version
                                                                                                                                                                                0.1.0
                                                                                                                                                                                source batch sha256
                                                                                                                                                                                fc39a8c5cf96bf95ca20b85578140167b66b2741f7d9217f500d9ba0847ac058
                                                                                                                                                                                source defined aliases
                                                                                                                                                                                1. abbreviation
                                                                                                                                                                                  NSCLC
                                                                                                                                                                                  definition exact
                                                                                                                                                                                  Non-Small Cell Lung Cancer
                                                                                                                                                                                  definition span
                                                                                                                                                                                  end
                                                                                                                                                                                  380
                                                                                                                                                                                  end exclusive
                                                                                                                                                                                  true
                                                                                                                                                                                  exact text
                                                                                                                                                                                  Non-Small Cell Lung Cancer (NSCLC)
                                                                                                                                                                                  label id
                                                                                                                                                                                  228e1e3f-d207-481f-8e14-9fdcbd0470e9
                                                                                                                                                                                  offset unit
                                                                                                                                                                                  unicode_code_points
                                                                                                                                                                                  source array index
                                                                                                                                                                                  0
                                                                                                                                                                                  source field
                                                                                                                                                                                  indications_and_usage_exact
                                                                                                                                                                                  source text sha256
                                                                                                                                                                                  e526ba14c91f10737e6d3331fe23a6219f58c0eca6380bfce9bd78b573fea912
                                                                                                                                                                                  start
                                                                                                                                                                                  346
                                                                                                                                                                                2. abbreviation
                                                                                                                                                                                  CRC
                                                                                                                                                                                  definition exact
                                                                                                                                                                                  Colorectal Cancer
                                                                                                                                                                                  definition span
                                                                                                                                                                                  end
                                                                                                                                                                                  5042
                                                                                                                                                                                  end exclusive
                                                                                                                                                                                  true
                                                                                                                                                                                  exact text
                                                                                                                                                                                  Colorectal Cancer (CRC)
                                                                                                                                                                                  label id
                                                                                                                                                                                  228e1e3f-d207-481f-8e14-9fdcbd0470e9
                                                                                                                                                                                  offset unit
                                                                                                                                                                                  unicode_code_points
                                                                                                                                                                                  source array index
                                                                                                                                                                                  0
                                                                                                                                                                                  source field
                                                                                                                                                                                  indications_and_usage_exact
                                                                                                                                                                                  source text sha256
                                                                                                                                                                                  e526ba14c91f10737e6d3331fe23a6219f58c0eca6380bfce9bd78b573fea912
                                                                                                                                                                                  start
                                                                                                                                                                                  5019
                                                                                                                                                                                source span
                                                                                                                                                                                end
                                                                                                                                                                                11431
                                                                                                                                                                                end exclusive
                                                                                                                                                                                true
                                                                                                                                                                                exact text
                                                                                                                                                                                Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trials.
                                                                                                                                                                                label id
                                                                                                                                                                                228e1e3f-d207-481f-8e14-9fdcbd0470e9
                                                                                                                                                                                offset unit
                                                                                                                                                                                unicode_code_points
                                                                                                                                                                                source array index
                                                                                                                                                                                0
                                                                                                                                                                                source field
                                                                                                                                                                                indications_and_usage_exact
                                                                                                                                                                                source text sha256
                                                                                                                                                                                e526ba14c91f10737e6d3331fe23a6219f58c0eca6380bfce9bd78b573fea912
                                                                                                                                                                                start
                                                                                                                                                                                11293
                                                                                                                                                                                source url
                                                                                                                                                                                https://api.fda.gov/drug/label.json?search=id%3A%22228e1e3f-d207-481f-8e14-9fdcbd0470e9%22
                                                                                                                                                                                spl effective date
                                                                                                                                                                                2026-07-10
                                                                                                                                                                                spl set id
                                                                                                                                                                                9333c79b-d487-4538-a9f0-71b91a02b287
                                                                                                                                                                                spl version
                                                                                                                                                                                228
                                                                                                                                                                                structured fields status
                                                                                                                                                                                not_extracted_no_values_inferred_from_mentions
                                                                                                                                                                                structured indication
                                                                                                                                                                                age
                                                                                                                                                                                Source null
                                                                                                                                                                                approval pathway
                                                                                                                                                                                Source null
                                                                                                                                                                                biomarker and test
                                                                                                                                                                                Source null
                                                                                                                                                                                disease stage
                                                                                                                                                                                Source null
                                                                                                                                                                                limitations
                                                                                                                                                                                Source null
                                                                                                                                                                                line
                                                                                                                                                                                Source null
                                                                                                                                                                                prior therapy
                                                                                                                                                                                Source null
                                                                                                                                                                                regimen
                                                                                                                                                                                Source null
                                                                                                                                                                                tumor histology
                                                                                                                                                                                Source null
                                                                                                                                                                                use intent
                                                                                                                                                                                not_applicable
                                                                                                                                                                                Passage 66 · positive indication candidate
                                                                                                                                                                                application numbers
                                                                                                                                                                                1. BLA125514
                                                                                                                                                                                brand names
                                                                                                                                                                                1. KEYTRUDA
                                                                                                                                                                                classification reasons
                                                                                                                                                                                1. explicit_positive_indication_predicate
                                                                                                                                                                                2. tumor_or_malignant_hematology_words_in_positive_statement
                                                                                                                                                                                clinical review status
                                                                                                                                                                                pending
                                                                                                                                                                                content role
                                                                                                                                                                                positive_indication_candidate
                                                                                                                                                                                context span
                                                                                                                                                                                end
                                                                                                                                                                                11740
                                                                                                                                                                                end exclusive
                                                                                                                                                                                true
                                                                                                                                                                                exact text
                                                                                                                                                                                val based on tumor response rate and durability of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trials. 1.1 Melanoma KEYTRUDA ® is indicated for the treatment of patients with unresectable or metastatic melanoma. KEYTRUDA is indicated for the adjuvant treatment of adult and pediatric (12 years and older) patients with Stage IIB, IIC, or III melanoma following complete resection. 1.2 Non-Small Cell Lung Cancer
                                                                                                                                                                                label id
                                                                                                                                                                                228e1e3f-d207-481f-8e14-9fdcbd0470e9
                                                                                                                                                                                offset unit
                                                                                                                                                                                unicode_code_points
                                                                                                                                                                                source array index
                                                                                                                                                                                0
                                                                                                                                                                                source field
                                                                                                                                                                                indications_and_usage_exact
                                                                                                                                                                                source text sha256
                                                                                                                                                                                e526ba14c91f10737e6d3331fe23a6219f58c0eca6380bfce9bd78b573fea912
                                                                                                                                                                                start
                                                                                                                                                                                11232
                                                                                                                                                                                current approval status
                                                                                                                                                                                not_reconciled
                                                                                                                                                                                duplicate text group
                                                                                                                                                                                dup-086463528bff163b24f3
                                                                                                                                                                                extraction review status
                                                                                                                                                                                automated_candidate_pending_source_review
                                                                                                                                                                                generic names
                                                                                                                                                                                1. PEMBROLIZUMAB
                                                                                                                                                                                id
                                                                                                                                                                                ind-span-07ffe10123510628385b
                                                                                                                                                                                label id
                                                                                                                                                                                228e1e3f-d207-481f-8e14-9fdcbd0470e9
                                                                                                                                                                                positive predicate support span
                                                                                                                                                                                end
                                                                                                                                                                                11468
                                                                                                                                                                                end exclusive
                                                                                                                                                                                true
                                                                                                                                                                                exact text
                                                                                                                                                                                is indicated
                                                                                                                                                                                label id
                                                                                                                                                                                228e1e3f-d207-481f-8e14-9fdcbd0470e9
                                                                                                                                                                                offset unit
                                                                                                                                                                                unicode_code_points
                                                                                                                                                                                source array index
                                                                                                                                                                                0
                                                                                                                                                                                source field
                                                                                                                                                                                indications_and_usage_exact
                                                                                                                                                                                source text sha256
                                                                                                                                                                                e526ba14c91f10737e6d3331fe23a6219f58c0eca6380bfce9bd78b573fea912
                                                                                                                                                                                start
                                                                                                                                                                                11456
                                                                                                                                                                                qualifier mentions
                                                                                                                                                                                1. context exact
                                                                                                                                                                                  ndicated for the treatment of patients with unresectable or metastatic melanoma.
                                                                                                                                                                                  kind
                                                                                                                                                                                  biomarker
                                                                                                                                                                                  polarity
                                                                                                                                                                                  not_inferred
                                                                                                                                                                                  span
                                                                                                                                                                                  end
                                                                                                                                                                                  11539
                                                                                                                                                                                  end exclusive
                                                                                                                                                                                  true
                                                                                                                                                                                  exact text
                                                                                                                                                                                  metastatic melanoma
                                                                                                                                                                                  label id
                                                                                                                                                                                  228e1e3f-d207-481f-8e14-9fdcbd0470e9
                                                                                                                                                                                  offset unit
                                                                                                                                                                                  unicode_code_points
                                                                                                                                                                                  source array index
                                                                                                                                                                                  0
                                                                                                                                                                                  source field
                                                                                                                                                                                  indications_and_usage_exact
                                                                                                                                                                                  source text sha256
                                                                                                                                                                                  e526ba14c91f10737e6d3331fe23a6219f58c0eca6380bfce9bd78b573fea912
                                                                                                                                                                                  start
                                                                                                                                                                                  11520
                                                                                                                                                                                2. context exact
                                                                                                                                                                                  KEYTRUDA ® is indicated for the treatment of patients with unresectable or metastatic melanoma.
                                                                                                                                                                                  kind
                                                                                                                                                                                  stage_or_setting
                                                                                                                                                                                  polarity
                                                                                                                                                                                  not_inferred
                                                                                                                                                                                  span
                                                                                                                                                                                  end
                                                                                                                                                                                  11539
                                                                                                                                                                                  end exclusive
                                                                                                                                                                                  true
                                                                                                                                                                                  exact text
                                                                                                                                                                                  unresectable or metastatic melanoma
                                                                                                                                                                                  label id
                                                                                                                                                                                  228e1e3f-d207-481f-8e14-9fdcbd0470e9
                                                                                                                                                                                  offset unit
                                                                                                                                                                                  unicode_code_points
                                                                                                                                                                                  source array index
                                                                                                                                                                                  0
                                                                                                                                                                                  source field
                                                                                                                                                                                  indications_and_usage_exact
                                                                                                                                                                                  source text sha256
                                                                                                                                                                                  e526ba14c91f10737e6d3331fe23a6219f58c0eca6380bfce9bd78b573fea912
                                                                                                                                                                                  start
                                                                                                                                                                                  11504
                                                                                                                                                                                regulatory links
                                                                                                                                                                                  schema version
                                                                                                                                                                                  0.1.0
                                                                                                                                                                                  source batch sha256
                                                                                                                                                                                  fc39a8c5cf96bf95ca20b85578140167b66b2741f7d9217f500d9ba0847ac058
                                                                                                                                                                                  source defined aliases
                                                                                                                                                                                  1. abbreviation
                                                                                                                                                                                    NSCLC
                                                                                                                                                                                    definition exact
                                                                                                                                                                                    Non-Small Cell Lung Cancer
                                                                                                                                                                                    definition span
                                                                                                                                                                                    end
                                                                                                                                                                                    380
                                                                                                                                                                                    end exclusive
                                                                                                                                                                                    true
                                                                                                                                                                                    exact text
                                                                                                                                                                                    Non-Small Cell Lung Cancer (NSCLC)
                                                                                                                                                                                    label id
                                                                                                                                                                                    228e1e3f-d207-481f-8e14-9fdcbd0470e9
                                                                                                                                                                                    offset unit
                                                                                                                                                                                    unicode_code_points
                                                                                                                                                                                    source array index
                                                                                                                                                                                    0
                                                                                                                                                                                    source field
                                                                                                                                                                                    indications_and_usage_exact
                                                                                                                                                                                    source text sha256
                                                                                                                                                                                    e526ba14c91f10737e6d3331fe23a6219f58c0eca6380bfce9bd78b573fea912
                                                                                                                                                                                    start
                                                                                                                                                                                    346
                                                                                                                                                                                  2. abbreviation
                                                                                                                                                                                    CRC
                                                                                                                                                                                    definition exact
                                                                                                                                                                                    Colorectal Cancer
                                                                                                                                                                                    definition span
                                                                                                                                                                                    end
                                                                                                                                                                                    5042
                                                                                                                                                                                    end exclusive
                                                                                                                                                                                    true
                                                                                                                                                                                    exact text
                                                                                                                                                                                    Colorectal Cancer (CRC)
                                                                                                                                                                                    label id
                                                                                                                                                                                    228e1e3f-d207-481f-8e14-9fdcbd0470e9
                                                                                                                                                                                    offset unit
                                                                                                                                                                                    unicode_code_points
                                                                                                                                                                                    source array index
                                                                                                                                                                                    0
                                                                                                                                                                                    source field
                                                                                                                                                                                    indications_and_usage_exact
                                                                                                                                                                                    source text sha256
                                                                                                                                                                                    e526ba14c91f10737e6d3331fe23a6219f58c0eca6380bfce9bd78b573fea912
                                                                                                                                                                                    start
                                                                                                                                                                                    5019
                                                                                                                                                                                  source span
                                                                                                                                                                                  end
                                                                                                                                                                                  11540
                                                                                                                                                                                  end exclusive
                                                                                                                                                                                  true
                                                                                                                                                                                  exact text
                                                                                                                                                                                  1.1 Melanoma KEYTRUDA ® is indicated for the treatment of patients with unresectable or metastatic melanoma.
                                                                                                                                                                                  label id
                                                                                                                                                                                  228e1e3f-d207-481f-8e14-9fdcbd0470e9
                                                                                                                                                                                  offset unit
                                                                                                                                                                                  unicode_code_points
                                                                                                                                                                                  source array index
                                                                                                                                                                                  0
                                                                                                                                                                                  source field
                                                                                                                                                                                  indications_and_usage_exact
                                                                                                                                                                                  source text sha256
                                                                                                                                                                                  e526ba14c91f10737e6d3331fe23a6219f58c0eca6380bfce9bd78b573fea912
                                                                                                                                                                                  start
                                                                                                                                                                                  11432
                                                                                                                                                                                  source url
                                                                                                                                                                                  https://api.fda.gov/drug/label.json?search=id%3A%22228e1e3f-d207-481f-8e14-9fdcbd0470e9%22
                                                                                                                                                                                  spl effective date
                                                                                                                                                                                  2026-07-10
                                                                                                                                                                                  spl set id
                                                                                                                                                                                  9333c79b-d487-4538-a9f0-71b91a02b287
                                                                                                                                                                                  spl version
                                                                                                                                                                                  228
                                                                                                                                                                                  structured fields status
                                                                                                                                                                                  not_extracted_no_values_inferred_from_mentions
                                                                                                                                                                                  structured indication
                                                                                                                                                                                  age
                                                                                                                                                                                  Source null
                                                                                                                                                                                  approval pathway
                                                                                                                                                                                  Source null
                                                                                                                                                                                  biomarker and test
                                                                                                                                                                                  Source null
                                                                                                                                                                                  disease stage
                                                                                                                                                                                  Source null
                                                                                                                                                                                  limitations
                                                                                                                                                                                  Source null
                                                                                                                                                                                  line
                                                                                                                                                                                  Source null
                                                                                                                                                                                  prior therapy
                                                                                                                                                                                  Source null
                                                                                                                                                                                  regimen
                                                                                                                                                                                  Source null
                                                                                                                                                                                  tumor histology
                                                                                                                                                                                  Source null
                                                                                                                                                                                  use intent
                                                                                                                                                                                  tumor_directed_candidate
                                                                                                                                                                                  Passage 67 · positive indication candidate
                                                                                                                                                                                  application numbers
                                                                                                                                                                                  1. BLA125514
                                                                                                                                                                                  brand names
                                                                                                                                                                                  1. KEYTRUDA
                                                                                                                                                                                  classification reasons
                                                                                                                                                                                  1. explicit_positive_indication_predicate
                                                                                                                                                                                  2. tumor_or_malignant_hematology_words_in_positive_statement
                                                                                                                                                                                  clinical review status
                                                                                                                                                                                  pending
                                                                                                                                                                                  content role
                                                                                                                                                                                  positive_indication_candidate
                                                                                                                                                                                  context span
                                                                                                                                                                                  end
                                                                                                                                                                                  11909
                                                                                                                                                                                  end exclusive
                                                                                                                                                                                  true
                                                                                                                                                                                  exact text
                                                                                                                                                                                  ntingent upon verification and description of clinical benefit in the confirmatory trials. 1.1 Melanoma KEYTRUDA ® is indicated for the treatment of patients with unresectable or metastatic melanoma. KEYTRUDA is indicated for the adjuvant treatment of adult and pediatric (12 years and older) patients with Stage IIB, IIC, or III melanoma following complete resection. 1.2 Non-Small Cell Lung Cancer KEYTRUDA, in combination with pemetrexed and platinum chemotherapy, is indicated for the first-line treatment of patients with metastatic nonsquamous non-small cell lun
                                                                                                                                                                                  label id
                                                                                                                                                                                  228e1e3f-d207-481f-8e14-9fdcbd0470e9
                                                                                                                                                                                  offset unit
                                                                                                                                                                                  unicode_code_points
                                                                                                                                                                                  source array index
                                                                                                                                                                                  0
                                                                                                                                                                                  source field
                                                                                                                                                                                  indications_and_usage_exact
                                                                                                                                                                                  source text sha256
                                                                                                                                                                                  e526ba14c91f10737e6d3331fe23a6219f58c0eca6380bfce9bd78b573fea912
                                                                                                                                                                                  start
                                                                                                                                                                                  11341
                                                                                                                                                                                  current approval status
                                                                                                                                                                                  not_reconciled
                                                                                                                                                                                  duplicate text group
                                                                                                                                                                                  dup-1062df79a7876a102d72
                                                                                                                                                                                  extraction review status
                                                                                                                                                                                  automated_candidate_pending_source_review
                                                                                                                                                                                  generic names
                                                                                                                                                                                  1. PEMBROLIZUMAB
                                                                                                                                                                                  id
                                                                                                                                                                                  ind-span-9562f075c65b61f03886
                                                                                                                                                                                  label id
                                                                                                                                                                                  228e1e3f-d207-481f-8e14-9fdcbd0470e9
                                                                                                                                                                                  positive predicate support span
                                                                                                                                                                                  end
                                                                                                                                                                                  11562
                                                                                                                                                                                  end exclusive
                                                                                                                                                                                  true
                                                                                                                                                                                  exact text
                                                                                                                                                                                  is indicated
                                                                                                                                                                                  label id
                                                                                                                                                                                  228e1e3f-d207-481f-8e14-9fdcbd0470e9
                                                                                                                                                                                  offset unit
                                                                                                                                                                                  unicode_code_points
                                                                                                                                                                                  source array index
                                                                                                                                                                                  0
                                                                                                                                                                                  source field
                                                                                                                                                                                  indications_and_usage_exact
                                                                                                                                                                                  source text sha256
                                                                                                                                                                                  e526ba14c91f10737e6d3331fe23a6219f58c0eca6380bfce9bd78b573fea912
                                                                                                                                                                                  start
                                                                                                                                                                                  11550
                                                                                                                                                                                  qualifier mentions
                                                                                                                                                                                  1. context exact
                                                                                                                                                                                    KEYTRUDA is indicated for the adjuvant treatment of adult and pediatric (12 years and older) patients with Stage IIB,
                                                                                                                                                                                    kind
                                                                                                                                                                                    age
                                                                                                                                                                                    polarity
                                                                                                                                                                                    not_inferred
                                                                                                                                                                                    span
                                                                                                                                                                                    end
                                                                                                                                                                                    11598
                                                                                                                                                                                    end exclusive
                                                                                                                                                                                    true
                                                                                                                                                                                    exact text
                                                                                                                                                                                    adult
                                                                                                                                                                                    label id
                                                                                                                                                                                    228e1e3f-d207-481f-8e14-9fdcbd0470e9
                                                                                                                                                                                    offset unit
                                                                                                                                                                                    unicode_code_points
                                                                                                                                                                                    source array index
                                                                                                                                                                                    0
                                                                                                                                                                                    source field
                                                                                                                                                                                    indications_and_usage_exact
                                                                                                                                                                                    source text sha256
                                                                                                                                                                                    e526ba14c91f10737e6d3331fe23a6219f58c0eca6380bfce9bd78b573fea912
                                                                                                                                                                                    start
                                                                                                                                                                                    11593
                                                                                                                                                                                  2. context exact
                                                                                                                                                                                    YTRUDA is indicated for the adjuvant treatment of adult and pediatric (12 years and older) patients with Stage IIB, IIC, or III m
                                                                                                                                                                                    kind
                                                                                                                                                                                    age
                                                                                                                                                                                    polarity
                                                                                                                                                                                    not_inferred
                                                                                                                                                                                    span
                                                                                                                                                                                    end
                                                                                                                                                                                    11612
                                                                                                                                                                                    end exclusive
                                                                                                                                                                                    true
                                                                                                                                                                                    exact text
                                                                                                                                                                                    pediatric
                                                                                                                                                                                    label id
                                                                                                                                                                                    228e1e3f-d207-481f-8e14-9fdcbd0470e9
                                                                                                                                                                                    offset unit
                                                                                                                                                                                    unicode_code_points
                                                                                                                                                                                    source array index
                                                                                                                                                                                    0
                                                                                                                                                                                    source field
                                                                                                                                                                                    indications_and_usage_exact
                                                                                                                                                                                    source text sha256
                                                                                                                                                                                    e526ba14c91f10737e6d3331fe23a6219f58c0eca6380bfce9bd78b573fea912
                                                                                                                                                                                    start
                                                                                                                                                                                    11603
                                                                                                                                                                                  3. context exact
                                                                                                                                                                                    ndicated for the adjuvant treatment of adult and pediatric (12 years and older) patients with Stage IIB, IIC, or III melanoma following co
                                                                                                                                                                                    kind
                                                                                                                                                                                    age
                                                                                                                                                                                    polarity
                                                                                                                                                                                    not_inferred
                                                                                                                                                                                    span
                                                                                                                                                                                    end
                                                                                                                                                                                    11632
                                                                                                                                                                                    end exclusive
                                                                                                                                                                                    true
                                                                                                                                                                                    exact text
                                                                                                                                                                                    12 years and older
                                                                                                                                                                                    label id
                                                                                                                                                                                    228e1e3f-d207-481f-8e14-9fdcbd0470e9
                                                                                                                                                                                    offset unit
                                                                                                                                                                                    unicode_code_points
                                                                                                                                                                                    source array index
                                                                                                                                                                                    0
                                                                                                                                                                                    source field
                                                                                                                                                                                    indications_and_usage_exact
                                                                                                                                                                                    source text sha256
                                                                                                                                                                                    e526ba14c91f10737e6d3331fe23a6219f58c0eca6380bfce9bd78b573fea912
                                                                                                                                                                                    start
                                                                                                                                                                                    11614
                                                                                                                                                                                  4. context exact
                                                                                                                                                                                    KEYTRUDA is indicated for the adjuvant treatment of adult and pediatric (12 years and older) patients with Stage IIB, IIC, or III mel
                                                                                                                                                                                    kind
                                                                                                                                                                                    stage_or_setting
                                                                                                                                                                                    polarity
                                                                                                                                                                                    not_inferred
                                                                                                                                                                                    span
                                                                                                                                                                                    end
                                                                                                                                                                                    11614
                                                                                                                                                                                    end exclusive
                                                                                                                                                                                    true
                                                                                                                                                                                    exact text
                                                                                                                                                                                    adjuvant treatment of adult and pediatric (
                                                                                                                                                                                    label id
                                                                                                                                                                                    228e1e3f-d207-481f-8e14-9fdcbd0470e9
                                                                                                                                                                                    offset unit
                                                                                                                                                                                    unicode_code_points
                                                                                                                                                                                    source array index
                                                                                                                                                                                    0
                                                                                                                                                                                    source field
                                                                                                                                                                                    indications_and_usage_exact
                                                                                                                                                                                    source text sha256
                                                                                                                                                                                    e526ba14c91f10737e6d3331fe23a6219f58c0eca6380bfce9bd78b573fea912
                                                                                                                                                                                    start
                                                                                                                                                                                    11571
                                                                                                                                                                                  regulatory links
                                                                                                                                                                                    schema version
                                                                                                                                                                                    0.1.0
                                                                                                                                                                                    source batch sha256
                                                                                                                                                                                    fc39a8c5cf96bf95ca20b85578140167b66b2741f7d9217f500d9ba0847ac058
                                                                                                                                                                                    source defined aliases
                                                                                                                                                                                    1. abbreviation
                                                                                                                                                                                      NSCLC
                                                                                                                                                                                      definition exact
                                                                                                                                                                                      Non-Small Cell Lung Cancer
                                                                                                                                                                                      definition span
                                                                                                                                                                                      end
                                                                                                                                                                                      380
                                                                                                                                                                                      end exclusive
                                                                                                                                                                                      true
                                                                                                                                                                                      exact text
                                                                                                                                                                                      Non-Small Cell Lung Cancer (NSCLC)
                                                                                                                                                                                      label id
                                                                                                                                                                                      228e1e3f-d207-481f-8e14-9fdcbd0470e9
                                                                                                                                                                                      offset unit
                                                                                                                                                                                      unicode_code_points
                                                                                                                                                                                      source array index
                                                                                                                                                                                      0
                                                                                                                                                                                      source field
                                                                                                                                                                                      indications_and_usage_exact
                                                                                                                                                                                      source text sha256
                                                                                                                                                                                      e526ba14c91f10737e6d3331fe23a6219f58c0eca6380bfce9bd78b573fea912
                                                                                                                                                                                      start
                                                                                                                                                                                      346
                                                                                                                                                                                    2. abbreviation
                                                                                                                                                                                      CRC
                                                                                                                                                                                      definition exact
                                                                                                                                                                                      Colorectal Cancer
                                                                                                                                                                                      definition span
                                                                                                                                                                                      end
                                                                                                                                                                                      5042
                                                                                                                                                                                      end exclusive
                                                                                                                                                                                      true
                                                                                                                                                                                      exact text
                                                                                                                                                                                      Colorectal Cancer (CRC)
                                                                                                                                                                                      label id
                                                                                                                                                                                      228e1e3f-d207-481f-8e14-9fdcbd0470e9
                                                                                                                                                                                      offset unit
                                                                                                                                                                                      unicode_code_points
                                                                                                                                                                                      source array index
                                                                                                                                                                                      0
                                                                                                                                                                                      source field
                                                                                                                                                                                      indications_and_usage_exact
                                                                                                                                                                                      source text sha256
                                                                                                                                                                                      e526ba14c91f10737e6d3331fe23a6219f58c0eca6380bfce9bd78b573fea912
                                                                                                                                                                                      start
                                                                                                                                                                                      5019
                                                                                                                                                                                    source span
                                                                                                                                                                                    end
                                                                                                                                                                                    11709
                                                                                                                                                                                    end exclusive
                                                                                                                                                                                    true
                                                                                                                                                                                    exact text
                                                                                                                                                                                    KEYTRUDA is indicated for the adjuvant treatment of adult and pediatric (12 years and older) patients with Stage IIB, IIC, or III melanoma following complete resection.
                                                                                                                                                                                    label id
                                                                                                                                                                                    228e1e3f-d207-481f-8e14-9fdcbd0470e9
                                                                                                                                                                                    offset unit
                                                                                                                                                                                    unicode_code_points
                                                                                                                                                                                    source array index
                                                                                                                                                                                    0
                                                                                                                                                                                    source field
                                                                                                                                                                                    indications_and_usage_exact
                                                                                                                                                                                    source text sha256
                                                                                                                                                                                    e526ba14c91f10737e6d3331fe23a6219f58c0eca6380bfce9bd78b573fea912
                                                                                                                                                                                    start
                                                                                                                                                                                    11541
                                                                                                                                                                                    source url
                                                                                                                                                                                    https://api.fda.gov/drug/label.json?search=id%3A%22228e1e3f-d207-481f-8e14-9fdcbd0470e9%22
                                                                                                                                                                                    spl effective date
                                                                                                                                                                                    2026-07-10
                                                                                                                                                                                    spl set id
                                                                                                                                                                                    9333c79b-d487-4538-a9f0-71b91a02b287
                                                                                                                                                                                    spl version
                                                                                                                                                                                    228
                                                                                                                                                                                    structured fields status
                                                                                                                                                                                    not_extracted_no_values_inferred_from_mentions
                                                                                                                                                                                    structured indication
                                                                                                                                                                                    age
                                                                                                                                                                                    Source null
                                                                                                                                                                                    approval pathway
                                                                                                                                                                                    Source null
                                                                                                                                                                                    biomarker and test
                                                                                                                                                                                    Source null
                                                                                                                                                                                    disease stage
                                                                                                                                                                                    Source null
                                                                                                                                                                                    limitations
                                                                                                                                                                                    Source null
                                                                                                                                                                                    line
                                                                                                                                                                                    Source null
                                                                                                                                                                                    prior therapy
                                                                                                                                                                                    Source null
                                                                                                                                                                                    regimen
                                                                                                                                                                                    Source null
                                                                                                                                                                                    tumor histology
                                                                                                                                                                                    Source null
                                                                                                                                                                                    use intent
                                                                                                                                                                                    tumor_directed_candidate
                                                                                                                                                                                    Passage 68 · positive indication candidate
                                                                                                                                                                                    application numbers
                                                                                                                                                                                    1. BLA125514
                                                                                                                                                                                    brand names
                                                                                                                                                                                    1. KEYTRUDA
                                                                                                                                                                                    classification reasons
                                                                                                                                                                                    1. explicit_positive_indication_predicate
                                                                                                                                                                                    2. tumor_or_malignant_hematology_words_in_positive_statement
                                                                                                                                                                                    clinical review status
                                                                                                                                                                                    pending
                                                                                                                                                                                    content role
                                                                                                                                                                                    positive_indication_candidate
                                                                                                                                                                                    context span
                                                                                                                                                                                    end
                                                                                                                                                                                    12173
                                                                                                                                                                                    end exclusive
                                                                                                                                                                                    true
                                                                                                                                                                                    exact text
                                                                                                                                                                                    ctable or metastatic melanoma. KEYTRUDA is indicated for the adjuvant treatment of adult and pediatric (12 years and older) patients with Stage IIB, IIC, or III melanoma following complete resection. 1.2 Non-Small Cell Lung Cancer KEYTRUDA, in combination with pemetrexed and platinum chemotherapy, is indicated for the first-line treatment of patients with metastatic nonsquamous non-small cell lung cancer (NSCLC), with no EGFR or ALK genomic tumor aberrations. KEYTRUDA, in combination with carboplatin and either paclitaxel or paclitaxel protein-bound, is indicated for the first-line treatment of patients with metastatic squamous NSCLC. KEYTRUDA, as a singl
                                                                                                                                                                                    label id
                                                                                                                                                                                    228e1e3f-d207-481f-8e14-9fdcbd0470e9
                                                                                                                                                                                    offset unit
                                                                                                                                                                                    unicode_code_points
                                                                                                                                                                                    source array index
                                                                                                                                                                                    0
                                                                                                                                                                                    source field
                                                                                                                                                                                    indications_and_usage_exact
                                                                                                                                                                                    source text sha256
                                                                                                                                                                                    e526ba14c91f10737e6d3331fe23a6219f58c0eca6380bfce9bd78b573fea912
                                                                                                                                                                                    start
                                                                                                                                                                                    11510
                                                                                                                                                                                    current approval status
                                                                                                                                                                                    not_reconciled
                                                                                                                                                                                    duplicate text group
                                                                                                                                                                                    dup-379c01d641c24962e45b
                                                                                                                                                                                    extraction review status
                                                                                                                                                                                    automated_candidate_pending_source_review
                                                                                                                                                                                    generic names
                                                                                                                                                                                    1. PEMBROLIZUMAB
                                                                                                                                                                                    id
                                                                                                                                                                                    ind-span-ae6c41ac7f301a1bc8af
                                                                                                                                                                                    label id
                                                                                                                                                                                    228e1e3f-d207-481f-8e14-9fdcbd0470e9
                                                                                                                                                                                    positive predicate support span
                                                                                                                                                                                    end
                                                                                                                                                                                    11821
                                                                                                                                                                                    end exclusive
                                                                                                                                                                                    true
                                                                                                                                                                                    exact text
                                                                                                                                                                                    is indicated
                                                                                                                                                                                    label id
                                                                                                                                                                                    228e1e3f-d207-481f-8e14-9fdcbd0470e9
                                                                                                                                                                                    offset unit
                                                                                                                                                                                    unicode_code_points
                                                                                                                                                                                    source array index
                                                                                                                                                                                    0
                                                                                                                                                                                    source field
                                                                                                                                                                                    indications_and_usage_exact
                                                                                                                                                                                    source text sha256
                                                                                                                                                                                    e526ba14c91f10737e6d3331fe23a6219f58c0eca6380bfce9bd78b573fea912
                                                                                                                                                                                    start
                                                                                                                                                                                    11809
                                                                                                                                                                                    qualifier mentions
                                                                                                                                                                                    1. context exact
                                                                                                                                                                                      is indicated for the first-line treatment of patients with metastatic nonsquamous non-small cell lung cancer (NSCLC), with no EGFR or ALK genomic tumor aberration
                                                                                                                                                                                      kind
                                                                                                                                                                                      biomarker
                                                                                                                                                                                      polarity
                                                                                                                                                                                      not_inferred
                                                                                                                                                                                      span
                                                                                                                                                                                      end
                                                                                                                                                                                      11911
                                                                                                                                                                                      end exclusive
                                                                                                                                                                                      true
                                                                                                                                                                                      exact text
                                                                                                                                                                                      metastatic nonsquamous non-small cell lung
                                                                                                                                                                                      label id
                                                                                                                                                                                      228e1e3f-d207-481f-8e14-9fdcbd0470e9
                                                                                                                                                                                      offset unit
                                                                                                                                                                                      unicode_code_points
                                                                                                                                                                                      source array index
                                                                                                                                                                                      0
                                                                                                                                                                                      source field
                                                                                                                                                                                      indications_and_usage_exact
                                                                                                                                                                                      source text sha256
                                                                                                                                                                                      e526ba14c91f10737e6d3331fe23a6219f58c0eca6380bfce9bd78b573fea912
                                                                                                                                                                                      start
                                                                                                                                                                                      11868
                                                                                                                                                                                    2. context exact
                                                                                                                                                                                      tic nonsquamous non-small cell lung cancer (NSCLC), with no EGFR or ALK genomic tumor aberrations.
                                                                                                                                                                                      kind
                                                                                                                                                                                      biomarker
                                                                                                                                                                                      polarity
                                                                                                                                                                                      not_inferred
                                                                                                                                                                                      span
                                                                                                                                                                                      end
                                                                                                                                                                                      11972
                                                                                                                                                                                      end exclusive
                                                                                                                                                                                      true
                                                                                                                                                                                      exact text
                                                                                                                                                                                      EGFR or ALK genomic tumor aberrations
                                                                                                                                                                                      label id
                                                                                                                                                                                      228e1e3f-d207-481f-8e14-9fdcbd0470e9
                                                                                                                                                                                      offset unit
                                                                                                                                                                                      unicode_code_points
                                                                                                                                                                                      source array index
                                                                                                                                                                                      0
                                                                                                                                                                                      source field
                                                                                                                                                                                      indications_and_usage_exact
                                                                                                                                                                                      source text sha256
                                                                                                                                                                                      e526ba14c91f10737e6d3331fe23a6219f58c0eca6380bfce9bd78b573fea912
                                                                                                                                                                                      start
                                                                                                                                                                                      11935
                                                                                                                                                                                    3. context exact
                                                                                                                                                                                      is indicated for the first-line treatment of patients with metastatic nonsquamous non-small cell lung cancer (NSCLC), with no EGFR or ALK genomic tumor aberrations.
                                                                                                                                                                                      kind
                                                                                                                                                                                      stage_or_setting
                                                                                                                                                                                      polarity
                                                                                                                                                                                      not_inferred
                                                                                                                                                                                      span
                                                                                                                                                                                      end
                                                                                                                                                                                      11913
                                                                                                                                                                                      end exclusive
                                                                                                                                                                                      true
                                                                                                                                                                                      exact text
                                                                                                                                                                                      metastatic nonsquamous non-small cell lung ca
                                                                                                                                                                                      label id
                                                                                                                                                                                      228e1e3f-d207-481f-8e14-9fdcbd0470e9
                                                                                                                                                                                      offset unit
                                                                                                                                                                                      unicode_code_points
                                                                                                                                                                                      source array index
                                                                                                                                                                                      0
                                                                                                                                                                                      source field
                                                                                                                                                                                      indications_and_usage_exact
                                                                                                                                                                                      source text sha256
                                                                                                                                                                                      e526ba14c91f10737e6d3331fe23a6219f58c0eca6380bfce9bd78b573fea912
                                                                                                                                                                                      start
                                                                                                                                                                                      11868
                                                                                                                                                                                    4. context exact
                                                                                                                                                                                      pemetrexed and platinum chemotherapy, is indicated for the first-line treatment of patients with metastatic nonsquamous non-small cell lung cancer (NSCLC), with no EGFR or ALK genomic tumor aberrations.
                                                                                                                                                                                      kind
                                                                                                                                                                                      prior_therapy_or_line
                                                                                                                                                                                      polarity
                                                                                                                                                                                      not_inferred
                                                                                                                                                                                      span
                                                                                                                                                                                      end
                                                                                                                                                                                      11972
                                                                                                                                                                                      end exclusive
                                                                                                                                                                                      true
                                                                                                                                                                                      exact text
                                                                                                                                                                                      first-line treatment of patients with metastatic nonsquamous non-small cell lung cancer (NSCLC), with no EGFR or ALK genomic tumor aberrations
                                                                                                                                                                                      label id
                                                                                                                                                                                      228e1e3f-d207-481f-8e14-9fdcbd0470e9
                                                                                                                                                                                      offset unit
                                                                                                                                                                                      unicode_code_points
                                                                                                                                                                                      source array index
                                                                                                                                                                                      0
                                                                                                                                                                                      source field
                                                                                                                                                                                      indications_and_usage_exact
                                                                                                                                                                                      source text sha256
                                                                                                                                                                                      e526ba14c91f10737e6d3331fe23a6219f58c0eca6380bfce9bd78b573fea912
                                                                                                                                                                                      start
                                                                                                                                                                                      11830
                                                                                                                                                                                    5. context exact
                                                                                                                                                                                      1.2 Non-Small Cell Lung Cancer KEYTRUDA, in combination with pemetrexed and platinum chemotherapy, is indicated for the first-line treatment of patients with metastatic nonsquamous non-small cell lung cancer (NSCLC), with no EGFR or ALK genomic tumor aberrations.
                                                                                                                                                                                      kind
                                                                                                                                                                                      regimen
                                                                                                                                                                                      polarity
                                                                                                                                                                                      not_inferred
                                                                                                                                                                                      span
                                                                                                                                                                                      end
                                                                                                                                                                                      11930
                                                                                                                                                                                      end exclusive
                                                                                                                                                                                      true
                                                                                                                                                                                      exact text
                                                                                                                                                                                      in combination with pemetrexed and platinum chemotherapy, is indicated for the first-line treatment of patients with metastatic nonsquamous non-small cell lung cancer (NSCLC), wit
                                                                                                                                                                                      label id
                                                                                                                                                                                      228e1e3f-d207-481f-8e14-9fdcbd0470e9
                                                                                                                                                                                      offset unit
                                                                                                                                                                                      unicode_code_points
                                                                                                                                                                                      source array index
                                                                                                                                                                                      0
                                                                                                                                                                                      source field
                                                                                                                                                                                      indications_and_usage_exact
                                                                                                                                                                                      source text sha256
                                                                                                                                                                                      e526ba14c91f10737e6d3331fe23a6219f58c0eca6380bfce9bd78b573fea912
                                                                                                                                                                                      start
                                                                                                                                                                                      11751
                                                                                                                                                                                    regulatory links
                                                                                                                                                                                      schema version
                                                                                                                                                                                      0.1.0
                                                                                                                                                                                      source batch sha256
                                                                                                                                                                                      fc39a8c5cf96bf95ca20b85578140167b66b2741f7d9217f500d9ba0847ac058
                                                                                                                                                                                      source defined aliases
                                                                                                                                                                                      1. abbreviation
                                                                                                                                                                                        NSCLC
                                                                                                                                                                                        definition exact
                                                                                                                                                                                        Non-Small Cell Lung Cancer
                                                                                                                                                                                        definition span
                                                                                                                                                                                        end
                                                                                                                                                                                        380
                                                                                                                                                                                        end exclusive
                                                                                                                                                                                        true
                                                                                                                                                                                        exact text
                                                                                                                                                                                        Non-Small Cell Lung Cancer (NSCLC)
                                                                                                                                                                                        label id
                                                                                                                                                                                        228e1e3f-d207-481f-8e14-9fdcbd0470e9
                                                                                                                                                                                        offset unit
                                                                                                                                                                                        unicode_code_points
                                                                                                                                                                                        source array index
                                                                                                                                                                                        0
                                                                                                                                                                                        source field
                                                                                                                                                                                        indications_and_usage_exact
                                                                                                                                                                                        source text sha256
                                                                                                                                                                                        e526ba14c91f10737e6d3331fe23a6219f58c0eca6380bfce9bd78b573fea912
                                                                                                                                                                                        start
                                                                                                                                                                                        346
                                                                                                                                                                                      2. abbreviation
                                                                                                                                                                                        CRC
                                                                                                                                                                                        definition exact
                                                                                                                                                                                        Colorectal Cancer
                                                                                                                                                                                        definition span
                                                                                                                                                                                        end
                                                                                                                                                                                        5042
                                                                                                                                                                                        end exclusive
                                                                                                                                                                                        true
                                                                                                                                                                                        exact text
                                                                                                                                                                                        Colorectal Cancer (CRC)
                                                                                                                                                                                        label id
                                                                                                                                                                                        228e1e3f-d207-481f-8e14-9fdcbd0470e9
                                                                                                                                                                                        offset unit
                                                                                                                                                                                        unicode_code_points
                                                                                                                                                                                        source array index
                                                                                                                                                                                        0
                                                                                                                                                                                        source field
                                                                                                                                                                                        indications_and_usage_exact
                                                                                                                                                                                        source text sha256
                                                                                                                                                                                        e526ba14c91f10737e6d3331fe23a6219f58c0eca6380bfce9bd78b573fea912
                                                                                                                                                                                        start
                                                                                                                                                                                        5019
                                                                                                                                                                                      source span
                                                                                                                                                                                      end
                                                                                                                                                                                      11973
                                                                                                                                                                                      end exclusive
                                                                                                                                                                                      true
                                                                                                                                                                                      exact text
                                                                                                                                                                                      1.2 Non-Small Cell Lung Cancer KEYTRUDA, in combination with pemetrexed and platinum chemotherapy, is indicated for the first-line treatment of patients with metastatic nonsquamous non-small cell lung cancer (NSCLC), with no EGFR or ALK genomic tumor aberrations.
                                                                                                                                                                                      label id
                                                                                                                                                                                      228e1e3f-d207-481f-8e14-9fdcbd0470e9
                                                                                                                                                                                      offset unit
                                                                                                                                                                                      unicode_code_points
                                                                                                                                                                                      source array index
                                                                                                                                                                                      0
                                                                                                                                                                                      source field
                                                                                                                                                                                      indications_and_usage_exact
                                                                                                                                                                                      source text sha256
                                                                                                                                                                                      e526ba14c91f10737e6d3331fe23a6219f58c0eca6380bfce9bd78b573fea912
                                                                                                                                                                                      start
                                                                                                                                                                                      11710
                                                                                                                                                                                      source url
                                                                                                                                                                                      https://api.fda.gov/drug/label.json?search=id%3A%22228e1e3f-d207-481f-8e14-9fdcbd0470e9%22
                                                                                                                                                                                      spl effective date
                                                                                                                                                                                      2026-07-10
                                                                                                                                                                                      spl set id
                                                                                                                                                                                      9333c79b-d487-4538-a9f0-71b91a02b287
                                                                                                                                                                                      spl version
                                                                                                                                                                                      228
                                                                                                                                                                                      structured fields status
                                                                                                                                                                                      not_extracted_no_values_inferred_from_mentions
                                                                                                                                                                                      structured indication
                                                                                                                                                                                      age
                                                                                                                                                                                      Source null
                                                                                                                                                                                      approval pathway
                                                                                                                                                                                      Source null
                                                                                                                                                                                      biomarker and test
                                                                                                                                                                                      Source null
                                                                                                                                                                                      disease stage
                                                                                                                                                                                      Source null
                                                                                                                                                                                      limitations
                                                                                                                                                                                      Source null
                                                                                                                                                                                      line
                                                                                                                                                                                      Source null
                                                                                                                                                                                      prior therapy
                                                                                                                                                                                      Source null
                                                                                                                                                                                      regimen
                                                                                                                                                                                      Source null
                                                                                                                                                                                      tumor histology
                                                                                                                                                                                      Source null
                                                                                                                                                                                      use intent
                                                                                                                                                                                      tumor_directed_candidate
                                                                                                                                                                                      Passage 69 · positive indication candidate
                                                                                                                                                                                      application numbers
                                                                                                                                                                                      1. BLA125514
                                                                                                                                                                                      brand names
                                                                                                                                                                                      1. KEYTRUDA
                                                                                                                                                                                      classification reasons
                                                                                                                                                                                      1. explicit_positive_indication_predicate
                                                                                                                                                                                      2. tumor_or_malignant_hematology_words_in_positive_statement
                                                                                                                                                                                      clinical review status
                                                                                                                                                                                      pending
                                                                                                                                                                                      content role
                                                                                                                                                                                      positive_indication_candidate
                                                                                                                                                                                      context span
                                                                                                                                                                                      end
                                                                                                                                                                                      12352
                                                                                                                                                                                      end exclusive
                                                                                                                                                                                      true
                                                                                                                                                                                      exact text
                                                                                                                                                                                      etrexed and platinum chemotherapy, is indicated for the first-line treatment of patients with metastatic nonsquamous non-small cell lung cancer (NSCLC), with no EGFR or ALK genomic tumor aberrations. KEYTRUDA, in combination with carboplatin and either paclitaxel or paclitaxel protein-bound, is indicated for the first-line treatment of patients with metastatic squamous NSCLC. KEYTRUDA, as a single agent, is indicated for the first-line treatment of patients with NSCLC expressing PD-L1 [Tumor Proportion Score (TPS) ≥1%] as determined by an FDA-authorized test [see Dosage a
                                                                                                                                                                                      label id
                                                                                                                                                                                      228e1e3f-d207-481f-8e14-9fdcbd0470e9
                                                                                                                                                                                      offset unit
                                                                                                                                                                                      unicode_code_points
                                                                                                                                                                                      source array index
                                                                                                                                                                                      0
                                                                                                                                                                                      source field
                                                                                                                                                                                      indications_and_usage_exact
                                                                                                                                                                                      source text sha256
                                                                                                                                                                                      e526ba14c91f10737e6d3331fe23a6219f58c0eca6380bfce9bd78b573fea912
                                                                                                                                                                                      start
                                                                                                                                                                                      11774
                                                                                                                                                                                      current approval status
                                                                                                                                                                                      not_reconciled
                                                                                                                                                                                      duplicate text group
                                                                                                                                                                                      dup-eb7effe8ada52f4db230
                                                                                                                                                                                      extraction review status
                                                                                                                                                                                      automated_candidate_pending_source_review
                                                                                                                                                                                      generic names
                                                                                                                                                                                      1. PEMBROLIZUMAB
                                                                                                                                                                                      id
                                                                                                                                                                                      ind-span-a7bd697f47f8f0e8177e
                                                                                                                                                                                      label id
                                                                                                                                                                                      228e1e3f-d207-481f-8e14-9fdcbd0470e9
                                                                                                                                                                                      positive predicate support span
                                                                                                                                                                                      end
                                                                                                                                                                                      12079
                                                                                                                                                                                      end exclusive
                                                                                                                                                                                      true
                                                                                                                                                                                      exact text
                                                                                                                                                                                      is indicated
                                                                                                                                                                                      label id
                                                                                                                                                                                      228e1e3f-d207-481f-8e14-9fdcbd0470e9
                                                                                                                                                                                      offset unit
                                                                                                                                                                                      unicode_code_points
                                                                                                                                                                                      source array index
                                                                                                                                                                                      0
                                                                                                                                                                                      source field
                                                                                                                                                                                      indications_and_usage_exact
                                                                                                                                                                                      source text sha256
                                                                                                                                                                                      e526ba14c91f10737e6d3331fe23a6219f58c0eca6380bfce9bd78b573fea912
                                                                                                                                                                                      start
                                                                                                                                                                                      12067
                                                                                                                                                                                      qualifier mentions
                                                                                                                                                                                      1. context exact
                                                                                                                                                                                        is indicated for the first-line treatment of patients with metastatic squamous NSCLC.
                                                                                                                                                                                        kind
                                                                                                                                                                                        biomarker
                                                                                                                                                                                        polarity
                                                                                                                                                                                        not_inferred
                                                                                                                                                                                        span
                                                                                                                                                                                        end
                                                                                                                                                                                        12151
                                                                                                                                                                                        end exclusive
                                                                                                                                                                                        true
                                                                                                                                                                                        exact text
                                                                                                                                                                                        metastatic squamous NSCLC
                                                                                                                                                                                        label id
                                                                                                                                                                                        228e1e3f-d207-481f-8e14-9fdcbd0470e9
                                                                                                                                                                                        offset unit
                                                                                                                                                                                        unicode_code_points
                                                                                                                                                                                        source array index
                                                                                                                                                                                        0
                                                                                                                                                                                        source field
                                                                                                                                                                                        indications_and_usage_exact
                                                                                                                                                                                        source text sha256
                                                                                                                                                                                        e526ba14c91f10737e6d3331fe23a6219f58c0eca6380bfce9bd78b573fea912
                                                                                                                                                                                        start
                                                                                                                                                                                        12126
                                                                                                                                                                                      2. context exact
                                                                                                                                                                                        is indicated for the first-line treatment of patients with metastatic squamous NSCLC.
                                                                                                                                                                                        kind
                                                                                                                                                                                        stage_or_setting
                                                                                                                                                                                        polarity
                                                                                                                                                                                        not_inferred
                                                                                                                                                                                        span
                                                                                                                                                                                        end
                                                                                                                                                                                        12151
                                                                                                                                                                                        end exclusive
                                                                                                                                                                                        true
                                                                                                                                                                                        exact text
                                                                                                                                                                                        metastatic squamous NSCLC
                                                                                                                                                                                        label id
                                                                                                                                                                                        228e1e3f-d207-481f-8e14-9fdcbd0470e9
                                                                                                                                                                                        offset unit
                                                                                                                                                                                        unicode_code_points
                                                                                                                                                                                        source array index
                                                                                                                                                                                        0
                                                                                                                                                                                        source field
                                                                                                                                                                                        indications_and_usage_exact
                                                                                                                                                                                        source text sha256
                                                                                                                                                                                        e526ba14c91f10737e6d3331fe23a6219f58c0eca6380bfce9bd78b573fea912
                                                                                                                                                                                        start
                                                                                                                                                                                        12126
                                                                                                                                                                                      3. context exact
                                                                                                                                                                                        aclitaxel or paclitaxel protein-bound, is indicated for the first-line treatment of patients with metastatic squamous NSCLC.
                                                                                                                                                                                        kind
                                                                                                                                                                                        prior_therapy_or_line
                                                                                                                                                                                        polarity
                                                                                                                                                                                        not_inferred
                                                                                                                                                                                        span
                                                                                                                                                                                        end
                                                                                                                                                                                        12151
                                                                                                                                                                                        end exclusive
                                                                                                                                                                                        true
                                                                                                                                                                                        exact text
                                                                                                                                                                                        first-line treatment of patients with metastatic squamous NSCLC
                                                                                                                                                                                        label id
                                                                                                                                                                                        228e1e3f-d207-481f-8e14-9fdcbd0470e9
                                                                                                                                                                                        offset unit
                                                                                                                                                                                        unicode_code_points
                                                                                                                                                                                        source array index
                                                                                                                                                                                        0
                                                                                                                                                                                        source field
                                                                                                                                                                                        indications_and_usage_exact
                                                                                                                                                                                        source text sha256
                                                                                                                                                                                        e526ba14c91f10737e6d3331fe23a6219f58c0eca6380bfce9bd78b573fea912
                                                                                                                                                                                        start
                                                                                                                                                                                        12088
                                                                                                                                                                                      4. context exact
                                                                                                                                                                                        KEYTRUDA, in combination with carboplatin and either paclitaxel or paclitaxel protein-bound, is indicated for the first-line treatment of patients with metastatic squamous NSCLC.
                                                                                                                                                                                        kind
                                                                                                                                                                                        regimen
                                                                                                                                                                                        polarity
                                                                                                                                                                                        not_inferred
                                                                                                                                                                                        span
                                                                                                                                                                                        end
                                                                                                                                                                                        12151
                                                                                                                                                                                        end exclusive
                                                                                                                                                                                        true
                                                                                                                                                                                        exact text
                                                                                                                                                                                        in combination with carboplatin and either paclitaxel or paclitaxel protein-bound, is indicated for the first-line treatment of patients with metastatic squamous NSCLC
                                                                                                                                                                                        label id
                                                                                                                                                                                        228e1e3f-d207-481f-8e14-9fdcbd0470e9
                                                                                                                                                                                        offset unit
                                                                                                                                                                                        unicode_code_points
                                                                                                                                                                                        source array index
                                                                                                                                                                                        0
                                                                                                                                                                                        source field
                                                                                                                                                                                        indications_and_usage_exact
                                                                                                                                                                                        source text sha256
                                                                                                                                                                                        e526ba14c91f10737e6d3331fe23a6219f58c0eca6380bfce9bd78b573fea912
                                                                                                                                                                                        start
                                                                                                                                                                                        11984
                                                                                                                                                                                      regulatory links
                                                                                                                                                                                        schema version
                                                                                                                                                                                        0.1.0
                                                                                                                                                                                        source batch sha256
                                                                                                                                                                                        fc39a8c5cf96bf95ca20b85578140167b66b2741f7d9217f500d9ba0847ac058
                                                                                                                                                                                        source defined aliases
                                                                                                                                                                                        1. abbreviation
                                                                                                                                                                                          NSCLC
                                                                                                                                                                                          definition exact
                                                                                                                                                                                          Non-Small Cell Lung Cancer
                                                                                                                                                                                          definition span
                                                                                                                                                                                          end
                                                                                                                                                                                          380
                                                                                                                                                                                          end exclusive
                                                                                                                                                                                          true
                                                                                                                                                                                          exact text
                                                                                                                                                                                          Non-Small Cell Lung Cancer (NSCLC)
                                                                                                                                                                                          label id
                                                                                                                                                                                          228e1e3f-d207-481f-8e14-9fdcbd0470e9
                                                                                                                                                                                          offset unit
                                                                                                                                                                                          unicode_code_points
                                                                                                                                                                                          source array index
                                                                                                                                                                                          0
                                                                                                                                                                                          source field
                                                                                                                                                                                          indications_and_usage_exact
                                                                                                                                                                                          source text sha256
                                                                                                                                                                                          e526ba14c91f10737e6d3331fe23a6219f58c0eca6380bfce9bd78b573fea912
                                                                                                                                                                                          start
                                                                                                                                                                                          346
                                                                                                                                                                                        2. abbreviation
                                                                                                                                                                                          CRC
                                                                                                                                                                                          definition exact
                                                                                                                                                                                          Colorectal Cancer
                                                                                                                                                                                          definition span
                                                                                                                                                                                          end
                                                                                                                                                                                          5042
                                                                                                                                                                                          end exclusive
                                                                                                                                                                                          true
                                                                                                                                                                                          exact text
                                                                                                                                                                                          Colorectal Cancer (CRC)
                                                                                                                                                                                          label id
                                                                                                                                                                                          228e1e3f-d207-481f-8e14-9fdcbd0470e9
                                                                                                                                                                                          offset unit
                                                                                                                                                                                          unicode_code_points
                                                                                                                                                                                          source array index
                                                                                                                                                                                          0
                                                                                                                                                                                          source field
                                                                                                                                                                                          indications_and_usage_exact
                                                                                                                                                                                          source text sha256
                                                                                                                                                                                          e526ba14c91f10737e6d3331fe23a6219f58c0eca6380bfce9bd78b573fea912
                                                                                                                                                                                          start
                                                                                                                                                                                          5019
                                                                                                                                                                                        source span
                                                                                                                                                                                        end
                                                                                                                                                                                        12152
                                                                                                                                                                                        end exclusive
                                                                                                                                                                                        true
                                                                                                                                                                                        exact text
                                                                                                                                                                                        KEYTRUDA, in combination with carboplatin and either paclitaxel or paclitaxel protein-bound, is indicated for the first-line treatment of patients with metastatic squamous NSCLC.
                                                                                                                                                                                        label id
                                                                                                                                                                                        228e1e3f-d207-481f-8e14-9fdcbd0470e9
                                                                                                                                                                                        offset unit
                                                                                                                                                                                        unicode_code_points
                                                                                                                                                                                        source array index
                                                                                                                                                                                        0
                                                                                                                                                                                        source field
                                                                                                                                                                                        indications_and_usage_exact
                                                                                                                                                                                        source text sha256
                                                                                                                                                                                        e526ba14c91f10737e6d3331fe23a6219f58c0eca6380bfce9bd78b573fea912
                                                                                                                                                                                        start
                                                                                                                                                                                        11974
                                                                                                                                                                                        source url
                                                                                                                                                                                        https://api.fda.gov/drug/label.json?search=id%3A%22228e1e3f-d207-481f-8e14-9fdcbd0470e9%22
                                                                                                                                                                                        spl effective date
                                                                                                                                                                                        2026-07-10
                                                                                                                                                                                        spl set id
                                                                                                                                                                                        9333c79b-d487-4538-a9f0-71b91a02b287
                                                                                                                                                                                        spl version
                                                                                                                                                                                        228
                                                                                                                                                                                        structured fields status
                                                                                                                                                                                        not_extracted_no_values_inferred_from_mentions
                                                                                                                                                                                        structured indication
                                                                                                                                                                                        age
                                                                                                                                                                                        Source null
                                                                                                                                                                                        approval pathway
                                                                                                                                                                                        Source null
                                                                                                                                                                                        biomarker and test
                                                                                                                                                                                        Source null
                                                                                                                                                                                        disease stage
                                                                                                                                                                                        Source null
                                                                                                                                                                                        limitations
                                                                                                                                                                                        Source null
                                                                                                                                                                                        line
                                                                                                                                                                                        Source null
                                                                                                                                                                                        prior therapy
                                                                                                                                                                                        Source null
                                                                                                                                                                                        regimen
                                                                                                                                                                                        Source null
                                                                                                                                                                                        tumor histology
                                                                                                                                                                                        Source null
                                                                                                                                                                                        use intent
                                                                                                                                                                                        tumor_directed_candidate
                                                                                                                                                                                        Passage 70 · positive indication candidate
                                                                                                                                                                                        application numbers
                                                                                                                                                                                        1. BLA125514
                                                                                                                                                                                        brand names
                                                                                                                                                                                        1. KEYTRUDA
                                                                                                                                                                                        classification reasons
                                                                                                                                                                                        1. explicit_positive_indication_predicate
                                                                                                                                                                                        2. tumor_or_malignant_hematology_words_in_positive_statement
                                                                                                                                                                                        clinical review status
                                                                                                                                                                                        pending
                                                                                                                                                                                        content role
                                                                                                                                                                                        positive_indication_candidate
                                                                                                                                                                                        context span
                                                                                                                                                                                        end
                                                                                                                                                                                        12746
                                                                                                                                                                                        end exclusive
                                                                                                                                                                                        true
                                                                                                                                                                                        exact text
                                                                                                                                                                                        c tumor aberrations. KEYTRUDA, in combination with carboplatin and either paclitaxel or paclitaxel protein-bound, is indicated for the first-line treatment of patients with metastatic squamous NSCLC. KEYTRUDA, as a single agent, is indicated for the first-line treatment of patients with NSCLC expressing PD-L1 [Tumor Proportion Score (TPS) ≥1%] as determined by an FDA-authorized test [see Dosage and Administration (2.1) ] , with no EGFR or ALK genomic tumor aberrations, and is: Stage III where patients are not candidates for surgical resection or definitive chemoradiation, or metastatic. KEYTRUDA, as a single agent, is indicated for the treatment of patients with metastatic NSCLC whose tumors express PD-L1 (TPS ≥1%) as determined by an FDA-authorized test [see Dosage and Administrati
                                                                                                                                                                                        label id
                                                                                                                                                                                        228e1e3f-d207-481f-8e14-9fdcbd0470e9
                                                                                                                                                                                        offset unit
                                                                                                                                                                                        unicode_code_points
                                                                                                                                                                                        source array index
                                                                                                                                                                                        0
                                                                                                                                                                                        source field
                                                                                                                                                                                        indications_and_usage_exact
                                                                                                                                                                                        source text sha256
                                                                                                                                                                                        e526ba14c91f10737e6d3331fe23a6219f58c0eca6380bfce9bd78b573fea912
                                                                                                                                                                                        start
                                                                                                                                                                                        11953
                                                                                                                                                                                        current approval status
                                                                                                                                                                                        not_reconciled
                                                                                                                                                                                        duplicate text group
                                                                                                                                                                                        dup-ac8f23bb914e82996f9b
                                                                                                                                                                                        extraction review status
                                                                                                                                                                                        automated_candidate_pending_source_review
                                                                                                                                                                                        generic names
                                                                                                                                                                                        1. PEMBROLIZUMAB
                                                                                                                                                                                        id
                                                                                                                                                                                        ind-span-ee562146fcdd308ef2f9
                                                                                                                                                                                        label id
                                                                                                                                                                                        228e1e3f-d207-481f-8e14-9fdcbd0470e9
                                                                                                                                                                                        positive predicate support span
                                                                                                                                                                                        end
                                                                                                                                                                                        12194
                                                                                                                                                                                        end exclusive
                                                                                                                                                                                        true
                                                                                                                                                                                        exact text
                                                                                                                                                                                        is indicated
                                                                                                                                                                                        label id
                                                                                                                                                                                        228e1e3f-d207-481f-8e14-9fdcbd0470e9
                                                                                                                                                                                        offset unit
                                                                                                                                                                                        unicode_code_points
                                                                                                                                                                                        source array index
                                                                                                                                                                                        0
                                                                                                                                                                                        source field
                                                                                                                                                                                        indications_and_usage_exact
                                                                                                                                                                                        source text sha256
                                                                                                                                                                                        e526ba14c91f10737e6d3331fe23a6219f58c0eca6380bfce9bd78b573fea912
                                                                                                                                                                                        start
                                                                                                                                                                                        12182
                                                                                                                                                                                        qualifier mentions
                                                                                                                                                                                        1. context exact
                                                                                                                                                                                          the first-line treatment of patients with NSCLC expressing PD-L1 [Tumor Proportion Score (TPS) ≥1%] as determined by an FDA-authorized test [see Dosage and Administ
                                                                                                                                                                                          kind
                                                                                                                                                                                          biomarker
                                                                                                                                                                                          polarity
                                                                                                                                                                                          not_inferred
                                                                                                                                                                                          span
                                                                                                                                                                                          end
                                                                                                                                                                                          12303
                                                                                                                                                                                          end exclusive
                                                                                                                                                                                          true
                                                                                                                                                                                          exact text
                                                                                                                                                                                          PD-L1 [Tumor Proportion Score (TPS) ≥1%] as d
                                                                                                                                                                                          label id
                                                                                                                                                                                          228e1e3f-d207-481f-8e14-9fdcbd0470e9
                                                                                                                                                                                          offset unit
                                                                                                                                                                                          unicode_code_points
                                                                                                                                                                                          source array index
                                                                                                                                                                                          0
                                                                                                                                                                                          source field
                                                                                                                                                                                          indications_and_usage_exact
                                                                                                                                                                                          source text sha256
                                                                                                                                                                                          e526ba14c91f10737e6d3331fe23a6219f58c0eca6380bfce9bd78b573fea912
                                                                                                                                                                                          start
                                                                                                                                                                                          12258
                                                                                                                                                                                        2. context exact
                                                                                                                                                                                          rized test [see Dosage and Administration (2.1) ] , with no EGFR or ALK genomic tumor aberrations, and is: Stage III where patients are not candidates for su
                                                                                                                                                                                          kind
                                                                                                                                                                                          biomarker
                                                                                                                                                                                          polarity
                                                                                                                                                                                          not_inferred
                                                                                                                                                                                          span
                                                                                                                                                                                          end
                                                                                                                                                                                          12425
                                                                                                                                                                                          end exclusive
                                                                                                                                                                                          true
                                                                                                                                                                                          exact text
                                                                                                                                                                                          EGFR or ALK genomic tumor aberrations
                                                                                                                                                                                          label id
                                                                                                                                                                                          228e1e3f-d207-481f-8e14-9fdcbd0470e9
                                                                                                                                                                                          offset unit
                                                                                                                                                                                          unicode_code_points
                                                                                                                                                                                          source array index
                                                                                                                                                                                          0
                                                                                                                                                                                          source field
                                                                                                                                                                                          indications_and_usage_exact
                                                                                                                                                                                          source text sha256
                                                                                                                                                                                          e526ba14c91f10737e6d3331fe23a6219f58c0eca6380bfce9bd78b573fea912
                                                                                                                                                                                          start
                                                                                                                                                                                          12388
                                                                                                                                                                                        3. context exact
                                                                                                                                                                                          tes for surgical resection or definitive chemoradiation, or metastatic.
                                                                                                                                                                                          kind
                                                                                                                                                                                          biomarker
                                                                                                                                                                                          polarity
                                                                                                                                                                                          not_inferred
                                                                                                                                                                                          span
                                                                                                                                                                                          end
                                                                                                                                                                                          12545
                                                                                                                                                                                          end exclusive
                                                                                                                                                                                          true
                                                                                                                                                                                          exact text
                                                                                                                                                                                          metastatic
                                                                                                                                                                                          label id
                                                                                                                                                                                          228e1e3f-d207-481f-8e14-9fdcbd0470e9
                                                                                                                                                                                          offset unit
                                                                                                                                                                                          unicode_code_points
                                                                                                                                                                                          source array index
                                                                                                                                                                                          0
                                                                                                                                                                                          source field
                                                                                                                                                                                          indications_and_usage_exact
                                                                                                                                                                                          source text sha256
                                                                                                                                                                                          e526ba14c91f10737e6d3331fe23a6219f58c0eca6380bfce9bd78b573fea912
                                                                                                                                                                                          start
                                                                                                                                                                                          12535
                                                                                                                                                                                        4. context exact
                                                                                                                                                                                          tes for surgical resection or definitive chemoradiation, or metastatic.
                                                                                                                                                                                          kind
                                                                                                                                                                                          stage_or_setting
                                                                                                                                                                                          polarity
                                                                                                                                                                                          not_inferred
                                                                                                                                                                                          span
                                                                                                                                                                                          end
                                                                                                                                                                                          12545
                                                                                                                                                                                          end exclusive
                                                                                                                                                                                          true
                                                                                                                                                                                          exact text
                                                                                                                                                                                          metastatic
                                                                                                                                                                                          label id
                                                                                                                                                                                          228e1e3f-d207-481f-8e14-9fdcbd0470e9
                                                                                                                                                                                          offset unit
                                                                                                                                                                                          unicode_code_points
                                                                                                                                                                                          source array index
                                                                                                                                                                                          0
                                                                                                                                                                                          source field
                                                                                                                                                                                          indications_and_usage_exact
                                                                                                                                                                                          source text sha256
                                                                                                                                                                                          e526ba14c91f10737e6d3331fe23a6219f58c0eca6380bfce9bd78b573fea912
                                                                                                                                                                                          start
                                                                                                                                                                                          12535
                                                                                                                                                                                        5. context exact
                                                                                                                                                                                          KEYTRUDA, as a single agent, is indicated for the first-line treatment of patients with NSCLC expressing PD-L1 [Tumor Proportion Score (TPS) ≥1%] as determined by an FDA-authorized test [see Dosage and Administration (2.1) ] , with no EGFR or ALK genomic tumor aberrations, and i
                                                                                                                                                                                          kind
                                                                                                                                                                                          prior_therapy_or_line
                                                                                                                                                                                          polarity
                                                                                                                                                                                          not_inferred
                                                                                                                                                                                          span
                                                                                                                                                                                          end
                                                                                                                                                                                          12372
                                                                                                                                                                                          end exclusive
                                                                                                                                                                                          true
                                                                                                                                                                                          exact text
                                                                                                                                                                                          first-line treatment of patients with NSCLC expressing PD-L1 [Tumor Proportion Score (TPS) ≥1%] as determined by an FDA-authorized test [see Dosage and Administration (2
                                                                                                                                                                                          label id
                                                                                                                                                                                          228e1e3f-d207-481f-8e14-9fdcbd0470e9
                                                                                                                                                                                          offset unit
                                                                                                                                                                                          unicode_code_points
                                                                                                                                                                                          source array index
                                                                                                                                                                                          0
                                                                                                                                                                                          source field
                                                                                                                                                                                          indications_and_usage_exact
                                                                                                                                                                                          source text sha256
                                                                                                                                                                                          e526ba14c91f10737e6d3331fe23a6219f58c0eca6380bfce9bd78b573fea912
                                                                                                                                                                                          start
                                                                                                                                                                                          12203
                                                                                                                                                                                        6. context exact
                                                                                                                                                                                          KEYTRUDA, as a single agent, is indicated for the first-line treatment of patients with NSCLC expressing PD-L1 [Tumor Proportion Score (TPS) ≥1%] as determined by an FDA-authorized test [see Dosage and Administration (2.1) ] , with no EGFR or ALK
                                                                                                                                                                                          kind
                                                                                                                                                                                          regimen
                                                                                                                                                                                          polarity
                                                                                                                                                                                          not_inferred
                                                                                                                                                                                          span
                                                                                                                                                                                          end
                                                                                                                                                                                          12340
                                                                                                                                                                                          end exclusive
                                                                                                                                                                                          true
                                                                                                                                                                                          exact text
                                                                                                                                                                                          as a single agent, is indicated for the first-line treatment of patients with NSCLC expressing PD-L1 [Tumor Proportion Score (TPS) ≥1%] as determined by an FDA-authorized test [
                                                                                                                                                                                          label id
                                                                                                                                                                                          228e1e3f-d207-481f-8e14-9fdcbd0470e9
                                                                                                                                                                                          offset unit
                                                                                                                                                                                          unicode_code_points
                                                                                                                                                                                          source array index
                                                                                                                                                                                          0
                                                                                                                                                                                          source field
                                                                                                                                                                                          indications_and_usage_exact
                                                                                                                                                                                          source text sha256
                                                                                                                                                                                          e526ba14c91f10737e6d3331fe23a6219f58c0eca6380bfce9bd78b573fea912
                                                                                                                                                                                          start
                                                                                                                                                                                          12163
                                                                                                                                                                                        regulatory links
                                                                                                                                                                                          schema version
                                                                                                                                                                                          0.1.0
                                                                                                                                                                                          source batch sha256
                                                                                                                                                                                          fc39a8c5cf96bf95ca20b85578140167b66b2741f7d9217f500d9ba0847ac058
                                                                                                                                                                                          source defined aliases
                                                                                                                                                                                          1. abbreviation
                                                                                                                                                                                            NSCLC
                                                                                                                                                                                            definition exact
                                                                                                                                                                                            Non-Small Cell Lung Cancer
                                                                                                                                                                                            definition span
                                                                                                                                                                                            end
                                                                                                                                                                                            380
                                                                                                                                                                                            end exclusive
                                                                                                                                                                                            true
                                                                                                                                                                                            exact text
                                                                                                                                                                                            Non-Small Cell Lung Cancer (NSCLC)
                                                                                                                                                                                            label id
                                                                                                                                                                                            228e1e3f-d207-481f-8e14-9fdcbd0470e9
                                                                                                                                                                                            offset unit
                                                                                                                                                                                            unicode_code_points
                                                                                                                                                                                            source array index
                                                                                                                                                                                            0
                                                                                                                                                                                            source field
                                                                                                                                                                                            indications_and_usage_exact
                                                                                                                                                                                            source text sha256
                                                                                                                                                                                            e526ba14c91f10737e6d3331fe23a6219f58c0eca6380bfce9bd78b573fea912
                                                                                                                                                                                            start
                                                                                                                                                                                            346
                                                                                                                                                                                          2. abbreviation
                                                                                                                                                                                            CRC
                                                                                                                                                                                            definition exact
                                                                                                                                                                                            Colorectal Cancer
                                                                                                                                                                                            definition span
                                                                                                                                                                                            end
                                                                                                                                                                                            5042
                                                                                                                                                                                            end exclusive
                                                                                                                                                                                            true
                                                                                                                                                                                            exact text
                                                                                                                                                                                            Colorectal Cancer (CRC)
                                                                                                                                                                                            label id
                                                                                                                                                                                            228e1e3f-d207-481f-8e14-9fdcbd0470e9
                                                                                                                                                                                            offset unit
                                                                                                                                                                                            unicode_code_points
                                                                                                                                                                                            source array index
                                                                                                                                                                                            0
                                                                                                                                                                                            source field
                                                                                                                                                                                            indications_and_usage_exact
                                                                                                                                                                                            source text sha256
                                                                                                                                                                                            e526ba14c91f10737e6d3331fe23a6219f58c0eca6380bfce9bd78b573fea912
                                                                                                                                                                                            start
                                                                                                                                                                                            5019
                                                                                                                                                                                          source span
                                                                                                                                                                                          end
                                                                                                                                                                                          12546
                                                                                                                                                                                          end exclusive
                                                                                                                                                                                          true
                                                                                                                                                                                          exact text
                                                                                                                                                                                          KEYTRUDA, as a single agent, is indicated for the first-line treatment of patients with NSCLC expressing PD-L1 [Tumor Proportion Score (TPS) ≥1%] as determined by an FDA-authorized test [see Dosage and Administration (2.1) ] , with no EGFR or ALK genomic tumor aberrations, and is: Stage III where patients are not candidates for surgical resection or definitive chemoradiation, or metastatic.
                                                                                                                                                                                          label id
                                                                                                                                                                                          228e1e3f-d207-481f-8e14-9fdcbd0470e9
                                                                                                                                                                                          offset unit
                                                                                                                                                                                          unicode_code_points
                                                                                                                                                                                          source array index
                                                                                                                                                                                          0
                                                                                                                                                                                          source field
                                                                                                                                                                                          indications_and_usage_exact
                                                                                                                                                                                          source text sha256
                                                                                                                                                                                          e526ba14c91f10737e6d3331fe23a6219f58c0eca6380bfce9bd78b573fea912
                                                                                                                                                                                          start
                                                                                                                                                                                          12153
                                                                                                                                                                                          source url
                                                                                                                                                                                          https://api.fda.gov/drug/label.json?search=id%3A%22228e1e3f-d207-481f-8e14-9fdcbd0470e9%22
                                                                                                                                                                                          spl effective date
                                                                                                                                                                                          2026-07-10
                                                                                                                                                                                          spl set id
                                                                                                                                                                                          9333c79b-d487-4538-a9f0-71b91a02b287
                                                                                                                                                                                          spl version
                                                                                                                                                                                          228
                                                                                                                                                                                          structured fields status
                                                                                                                                                                                          not_extracted_no_values_inferred_from_mentions
                                                                                                                                                                                          structured indication
                                                                                                                                                                                          age
                                                                                                                                                                                          Source null
                                                                                                                                                                                          approval pathway
                                                                                                                                                                                          Source null
                                                                                                                                                                                          biomarker and test
                                                                                                                                                                                          Source null
                                                                                                                                                                                          disease stage
                                                                                                                                                                                          Source null
                                                                                                                                                                                          limitations
                                                                                                                                                                                          Source null
                                                                                                                                                                                          line
                                                                                                                                                                                          Source null
                                                                                                                                                                                          prior therapy
                                                                                                                                                                                          Source null
                                                                                                                                                                                          regimen
                                                                                                                                                                                          Source null
                                                                                                                                                                                          tumor histology
                                                                                                                                                                                          Source null
                                                                                                                                                                                          use intent
                                                                                                                                                                                          tumor_directed_candidate
                                                                                                                                                                                          Passage 71 · positive indication candidate
                                                                                                                                                                                          application numbers
                                                                                                                                                                                          1. BLA125514
                                                                                                                                                                                          brand names
                                                                                                                                                                                          1. KEYTRUDA
                                                                                                                                                                                          classification reasons
                                                                                                                                                                                          1. explicit_positive_indication_predicate
                                                                                                                                                                                          2. tumor_or_malignant_hematology_words_in_positive_statement
                                                                                                                                                                                          clinical review status
                                                                                                                                                                                          pending
                                                                                                                                                                                          content role
                                                                                                                                                                                          positive_indication_candidate
                                                                                                                                                                                          context span
                                                                                                                                                                                          end
                                                                                                                                                                                          13029
                                                                                                                                                                                          end exclusive
                                                                                                                                                                                          true
                                                                                                                                                                                          exact text
                                                                                                                                                                                          age and Administration (2.1) ] , with no EGFR or ALK genomic tumor aberrations, and is: Stage III where patients are not candidates for surgical resection or definitive chemoradiation, or metastatic. KEYTRUDA, as a single agent, is indicated for the treatment of patients with metastatic NSCLC whose tumors express PD-L1 (TPS ≥1%) as determined by an FDA-authorized test [see Dosage and Administration (2.1) ] , with disease progression on or after platinum-containing chemotherapy. Patients with EGFR or ALK genomic tumor aberrations should have disease progression on FDA-approved therapy for these aberrations prior to receiving KEYTRUDA. KEYTRUDA is indicated for the treatment
                                                                                                                                                                                          label id
                                                                                                                                                                                          228e1e3f-d207-481f-8e14-9fdcbd0470e9
                                                                                                                                                                                          offset unit
                                                                                                                                                                                          unicode_code_points
                                                                                                                                                                                          source array index
                                                                                                                                                                                          0
                                                                                                                                                                                          source field
                                                                                                                                                                                          indications_and_usage_exact
                                                                                                                                                                                          source text sha256
                                                                                                                                                                                          e526ba14c91f10737e6d3331fe23a6219f58c0eca6380bfce9bd78b573fea912
                                                                                                                                                                                          start
                                                                                                                                                                                          12347
                                                                                                                                                                                          current approval status
                                                                                                                                                                                          not_reconciled
                                                                                                                                                                                          duplicate text group
                                                                                                                                                                                          dup-e01902a4c659d9ae07e5
                                                                                                                                                                                          extraction review status
                                                                                                                                                                                          automated_candidate_pending_source_review
                                                                                                                                                                                          generic names
                                                                                                                                                                                          1. PEMBROLIZUMAB
                                                                                                                                                                                          id
                                                                                                                                                                                          ind-span-8376e43f3467d450dcdf
                                                                                                                                                                                          label id
                                                                                                                                                                                          228e1e3f-d207-481f-8e14-9fdcbd0470e9
                                                                                                                                                                                          positive predicate support span
                                                                                                                                                                                          end
                                                                                                                                                                                          12588
                                                                                                                                                                                          end exclusive
                                                                                                                                                                                          true
                                                                                                                                                                                          exact text
                                                                                                                                                                                          is indicated
                                                                                                                                                                                          label id
                                                                                                                                                                                          228e1e3f-d207-481f-8e14-9fdcbd0470e9
                                                                                                                                                                                          offset unit
                                                                                                                                                                                          unicode_code_points
                                                                                                                                                                                          source array index
                                                                                                                                                                                          0
                                                                                                                                                                                          source field
                                                                                                                                                                                          indications_and_usage_exact
                                                                                                                                                                                          source text sha256
                                                                                                                                                                                          e526ba14c91f10737e6d3331fe23a6219f58c0eca6380bfce9bd78b573fea912
                                                                                                                                                                                          start
                                                                                                                                                                                          12576
                                                                                                                                                                                          qualifier mentions
                                                                                                                                                                                          1. context exact
                                                                                                                                                                                            ngle agent, is indicated for the treatment of patients with metastatic NSCLC whose tumors express PD-L1 (TPS ≥1%) as determined by an FDA-authorized test [see Dosa
                                                                                                                                                                                            kind
                                                                                                                                                                                            biomarker
                                                                                                                                                                                            polarity
                                                                                                                                                                                            not_inferred
                                                                                                                                                                                            span
                                                                                                                                                                                            end
                                                                                                                                                                                            12667
                                                                                                                                                                                            end exclusive
                                                                                                                                                                                            true
                                                                                                                                                                                            exact text
                                                                                                                                                                                            metastatic NSCLC whose tumors express PD-L1
                                                                                                                                                                                            label id
                                                                                                                                                                                            228e1e3f-d207-481f-8e14-9fdcbd0470e9
                                                                                                                                                                                            offset unit
                                                                                                                                                                                            unicode_code_points
                                                                                                                                                                                            source array index
                                                                                                                                                                                            0
                                                                                                                                                                                            source field
                                                                                                                                                                                            indications_and_usage_exact
                                                                                                                                                                                            source text sha256
                                                                                                                                                                                            e526ba14c91f10737e6d3331fe23a6219f58c0eca6380bfce9bd78b573fea912
                                                                                                                                                                                            start
                                                                                                                                                                                            12624
                                                                                                                                                                                          2. context exact
                                                                                                                                                                                            ngle agent, is indicated for the treatment of patients with metastatic NSCLC whose tumors express PD-L1 (TPS ≥1%) as determined by an FDA-authorized test [see Dosage
                                                                                                                                                                                            kind
                                                                                                                                                                                            stage_or_setting
                                                                                                                                                                                            polarity
                                                                                                                                                                                            not_inferred
                                                                                                                                                                                            span
                                                                                                                                                                                            end
                                                                                                                                                                                            12669
                                                                                                                                                                                            end exclusive
                                                                                                                                                                                            true
                                                                                                                                                                                            exact text
                                                                                                                                                                                            metastatic NSCLC whose tumors express PD-L1 (
                                                                                                                                                                                            label id
                                                                                                                                                                                            228e1e3f-d207-481f-8e14-9fdcbd0470e9
                                                                                                                                                                                            offset unit
                                                                                                                                                                                            unicode_code_points
                                                                                                                                                                                            source array index
                                                                                                                                                                                            0
                                                                                                                                                                                            source field
                                                                                                                                                                                            indications_and_usage_exact
                                                                                                                                                                                            source text sha256
                                                                                                                                                                                            e526ba14c91f10737e6d3331fe23a6219f58c0eca6380bfce9bd78b573fea912
                                                                                                                                                                                            start
                                                                                                                                                                                            12624
                                                                                                                                                                                          3. context exact
                                                                                                                                                                                            KEYTRUDA, as a single agent, is indicated for the treatment of patients with metastatic NSCLC whose tumors express PD-L1 (TPS ≥1%) as determined by an FDA-authorized test [see Dosage and Administration (2.1) ] , with disease progression on or afte
                                                                                                                                                                                            kind
                                                                                                                                                                                            regimen
                                                                                                                                                                                            polarity
                                                                                                                                                                                            not_inferred
                                                                                                                                                                                            span
                                                                                                                                                                                            end
                                                                                                                                                                                            12734
                                                                                                                                                                                            end exclusive
                                                                                                                                                                                            true
                                                                                                                                                                                            exact text
                                                                                                                                                                                            as a single agent, is indicated for the treatment of patients with metastatic NSCLC whose tumors express PD-L1 (TPS ≥1%) as determined by an FDA-authorized test [see Dosage and
                                                                                                                                                                                            label id
                                                                                                                                                                                            228e1e3f-d207-481f-8e14-9fdcbd0470e9
                                                                                                                                                                                            offset unit
                                                                                                                                                                                            unicode_code_points
                                                                                                                                                                                            source array index
                                                                                                                                                                                            0
                                                                                                                                                                                            source field
                                                                                                                                                                                            indications_and_usage_exact
                                                                                                                                                                                            source text sha256
                                                                                                                                                                                            e526ba14c91f10737e6d3331fe23a6219f58c0eca6380bfce9bd78b573fea912
                                                                                                                                                                                            start
                                                                                                                                                                                            12557
                                                                                                                                                                                          regulatory links
                                                                                                                                                                                            schema version
                                                                                                                                                                                            0.1.0
                                                                                                                                                                                            source batch sha256
                                                                                                                                                                                            fc39a8c5cf96bf95ca20b85578140167b66b2741f7d9217f500d9ba0847ac058
                                                                                                                                                                                            source defined aliases
                                                                                                                                                                                            1. abbreviation
                                                                                                                                                                                              NSCLC
                                                                                                                                                                                              definition exact
                                                                                                                                                                                              Non-Small Cell Lung Cancer
                                                                                                                                                                                              definition span
                                                                                                                                                                                              end
                                                                                                                                                                                              380
                                                                                                                                                                                              end exclusive
                                                                                                                                                                                              true
                                                                                                                                                                                              exact text
                                                                                                                                                                                              Non-Small Cell Lung Cancer (NSCLC)
                                                                                                                                                                                              label id
                                                                                                                                                                                              228e1e3f-d207-481f-8e14-9fdcbd0470e9
                                                                                                                                                                                              offset unit
                                                                                                                                                                                              unicode_code_points
                                                                                                                                                                                              source array index
                                                                                                                                                                                              0
                                                                                                                                                                                              source field
                                                                                                                                                                                              indications_and_usage_exact
                                                                                                                                                                                              source text sha256
                                                                                                                                                                                              e526ba14c91f10737e6d3331fe23a6219f58c0eca6380bfce9bd78b573fea912
                                                                                                                                                                                              start
                                                                                                                                                                                              346
                                                                                                                                                                                            2. abbreviation
                                                                                                                                                                                              CRC
                                                                                                                                                                                              definition exact
                                                                                                                                                                                              Colorectal Cancer
                                                                                                                                                                                              definition span
                                                                                                                                                                                              end
                                                                                                                                                                                              5042
                                                                                                                                                                                              end exclusive
                                                                                                                                                                                              true
                                                                                                                                                                                              exact text
                                                                                                                                                                                              Colorectal Cancer (CRC)
                                                                                                                                                                                              label id
                                                                                                                                                                                              228e1e3f-d207-481f-8e14-9fdcbd0470e9
                                                                                                                                                                                              offset unit
                                                                                                                                                                                              unicode_code_points
                                                                                                                                                                                              source array index
                                                                                                                                                                                              0
                                                                                                                                                                                              source field
                                                                                                                                                                                              indications_and_usage_exact
                                                                                                                                                                                              source text sha256
                                                                                                                                                                                              e526ba14c91f10737e6d3331fe23a6219f58c0eca6380bfce9bd78b573fea912
                                                                                                                                                                                              start
                                                                                                                                                                                              5019
                                                                                                                                                                                            source span
                                                                                                                                                                                            end
                                                                                                                                                                                            12829
                                                                                                                                                                                            end exclusive
                                                                                                                                                                                            true
                                                                                                                                                                                            exact text
                                                                                                                                                                                            KEYTRUDA, as a single agent, is indicated for the treatment of patients with metastatic NSCLC whose tumors express PD-L1 (TPS ≥1%) as determined by an FDA-authorized test [see Dosage and Administration (2.1) ] , with disease progression on or after platinum-containing chemotherapy.
                                                                                                                                                                                            label id
                                                                                                                                                                                            228e1e3f-d207-481f-8e14-9fdcbd0470e9
                                                                                                                                                                                            offset unit
                                                                                                                                                                                            unicode_code_points
                                                                                                                                                                                            source array index
                                                                                                                                                                                            0
                                                                                                                                                                                            source field
                                                                                                                                                                                            indications_and_usage_exact
                                                                                                                                                                                            source text sha256
                                                                                                                                                                                            e526ba14c91f10737e6d3331fe23a6219f58c0eca6380bfce9bd78b573fea912
                                                                                                                                                                                            start
                                                                                                                                                                                            12547
                                                                                                                                                                                            source url
                                                                                                                                                                                            https://api.fda.gov/drug/label.json?search=id%3A%22228e1e3f-d207-481f-8e14-9fdcbd0470e9%22
                                                                                                                                                                                            spl effective date
                                                                                                                                                                                            2026-07-10
                                                                                                                                                                                            spl set id
                                                                                                                                                                                            9333c79b-d487-4538-a9f0-71b91a02b287
                                                                                                                                                                                            spl version
                                                                                                                                                                                            228
                                                                                                                                                                                            structured fields status
                                                                                                                                                                                            not_extracted_no_values_inferred_from_mentions
                                                                                                                                                                                            structured indication
                                                                                                                                                                                            age
                                                                                                                                                                                            Source null
                                                                                                                                                                                            approval pathway
                                                                                                                                                                                            Source null
                                                                                                                                                                                            biomarker and test
                                                                                                                                                                                            Source null
                                                                                                                                                                                            disease stage
                                                                                                                                                                                            Source null
                                                                                                                                                                                            limitations
                                                                                                                                                                                            Source null
                                                                                                                                                                                            line
                                                                                                                                                                                            Source null
                                                                                                                                                                                            prior therapy
                                                                                                                                                                                            Source null
                                                                                                                                                                                            regimen
                                                                                                                                                                                            Source null
                                                                                                                                                                                            tumor histology
                                                                                                                                                                                            Source null
                                                                                                                                                                                            use intent
                                                                                                                                                                                            tumor_directed_candidate
                                                                                                                                                                                            Passage 72 · positive indication candidate
                                                                                                                                                                                            application numbers
                                                                                                                                                                                            1. BLA125514
                                                                                                                                                                                            brand names
                                                                                                                                                                                            1. KEYTRUDA
                                                                                                                                                                                            classification reasons
                                                                                                                                                                                            1. inherited_predicate_from_same_label_section_requires_review
                                                                                                                                                                                            2. tumor_or_malignant_hematology_words_in_positive_statement
                                                                                                                                                                                            clinical review status
                                                                                                                                                                                            pending
                                                                                                                                                                                            content role
                                                                                                                                                                                            positive_indication_candidate
                                                                                                                                                                                            context span
                                                                                                                                                                                            end
                                                                                                                                                                                            13188
                                                                                                                                                                                            end exclusive
                                                                                                                                                                                            true
                                                                                                                                                                                            exact text
                                                                                                                                                                                            atic NSCLC whose tumors express PD-L1 (TPS ≥1%) as determined by an FDA-authorized test [see Dosage and Administration (2.1) ] , with disease progression on or after platinum-containing chemotherapy. Patients with EGFR or ALK genomic tumor aberrations should have disease progression on FDA-approved therapy for these aberrations prior to receiving KEYTRUDA. KEYTRUDA is indicated for the treatment of patients with resectable (tumors ≥4 cm or node positive) NSCLC in combination with platinum-containing chemotherapy as neoadjuvant treatment, and then conti
                                                                                                                                                                                            label id
                                                                                                                                                                                            228e1e3f-d207-481f-8e14-9fdcbd0470e9
                                                                                                                                                                                            offset unit
                                                                                                                                                                                            unicode_code_points
                                                                                                                                                                                            source array index
                                                                                                                                                                                            0
                                                                                                                                                                                            source field
                                                                                                                                                                                            indications_and_usage_exact
                                                                                                                                                                                            source text sha256
                                                                                                                                                                                            e526ba14c91f10737e6d3331fe23a6219f58c0eca6380bfce9bd78b573fea912
                                                                                                                                                                                            start
                                                                                                                                                                                            12630
                                                                                                                                                                                            current approval status
                                                                                                                                                                                            not_reconciled
                                                                                                                                                                                            duplicate text group
                                                                                                                                                                                            dup-06445d0b116646587e17
                                                                                                                                                                                            extraction review status
                                                                                                                                                                                            automated_candidate_pending_source_review
                                                                                                                                                                                            generic names
                                                                                                                                                                                            1. PEMBROLIZUMAB
                                                                                                                                                                                            id
                                                                                                                                                                                            ind-span-cf1c104350cd89c17632
                                                                                                                                                                                            label id
                                                                                                                                                                                            228e1e3f-d207-481f-8e14-9fdcbd0470e9
                                                                                                                                                                                            positive predicate support span
                                                                                                                                                                                            end
                                                                                                                                                                                            12194
                                                                                                                                                                                            end exclusive
                                                                                                                                                                                            true
                                                                                                                                                                                            exact text
                                                                                                                                                                                            is indicated
                                                                                                                                                                                            label id
                                                                                                                                                                                            228e1e3f-d207-481f-8e14-9fdcbd0470e9
                                                                                                                                                                                            offset unit
                                                                                                                                                                                            unicode_code_points
                                                                                                                                                                                            source array index
                                                                                                                                                                                            0
                                                                                                                                                                                            source field
                                                                                                                                                                                            indications_and_usage_exact
                                                                                                                                                                                            source text sha256
                                                                                                                                                                                            e526ba14c91f10737e6d3331fe23a6219f58c0eca6380bfce9bd78b573fea912
                                                                                                                                                                                            start
                                                                                                                                                                                            12182
                                                                                                                                                                                            qualifier mentions
                                                                                                                                                                                            1. context exact
                                                                                                                                                                                              Patients with EGFR or ALK genomic tumor aberrations should have disease progression on FDA-approved therapy for these
                                                                                                                                                                                              kind
                                                                                                                                                                                              biomarker
                                                                                                                                                                                              polarity
                                                                                                                                                                                              not_inferred
                                                                                                                                                                                              span
                                                                                                                                                                                              end
                                                                                                                                                                                              12888
                                                                                                                                                                                              end exclusive
                                                                                                                                                                                              true
                                                                                                                                                                                              exact text
                                                                                                                                                                                              EGFR or ALK genomic tumor aberrations should
                                                                                                                                                                                              label id
                                                                                                                                                                                              228e1e3f-d207-481f-8e14-9fdcbd0470e9
                                                                                                                                                                                              offset unit
                                                                                                                                                                                              unicode_code_points
                                                                                                                                                                                              source array index
                                                                                                                                                                                              0
                                                                                                                                                                                              source field
                                                                                                                                                                                              indications_and_usage_exact
                                                                                                                                                                                              source text sha256
                                                                                                                                                                                              e526ba14c91f10737e6d3331fe23a6219f58c0eca6380bfce9bd78b573fea912
                                                                                                                                                                                              start
                                                                                                                                                                                              12844
                                                                                                                                                                                            regulatory links
                                                                                                                                                                                              schema version
                                                                                                                                                                                              0.1.0
                                                                                                                                                                                              source batch sha256
                                                                                                                                                                                              fc39a8c5cf96bf95ca20b85578140167b66b2741f7d9217f500d9ba0847ac058
                                                                                                                                                                                              source defined aliases
                                                                                                                                                                                              1. abbreviation
                                                                                                                                                                                                NSCLC
                                                                                                                                                                                                definition exact
                                                                                                                                                                                                Non-Small Cell Lung Cancer
                                                                                                                                                                                                definition span
                                                                                                                                                                                                end
                                                                                                                                                                                                380
                                                                                                                                                                                                end exclusive
                                                                                                                                                                                                true
                                                                                                                                                                                                exact text
                                                                                                                                                                                                Non-Small Cell Lung Cancer (NSCLC)
                                                                                                                                                                                                label id
                                                                                                                                                                                                228e1e3f-d207-481f-8e14-9fdcbd0470e9
                                                                                                                                                                                                offset unit
                                                                                                                                                                                                unicode_code_points
                                                                                                                                                                                                source array index
                                                                                                                                                                                                0
                                                                                                                                                                                                source field
                                                                                                                                                                                                indications_and_usage_exact
                                                                                                                                                                                                source text sha256
                                                                                                                                                                                                e526ba14c91f10737e6d3331fe23a6219f58c0eca6380bfce9bd78b573fea912
                                                                                                                                                                                                start
                                                                                                                                                                                                346
                                                                                                                                                                                              2. abbreviation
                                                                                                                                                                                                CRC
                                                                                                                                                                                                definition exact
                                                                                                                                                                                                Colorectal Cancer
                                                                                                                                                                                                definition span
                                                                                                                                                                                                end
                                                                                                                                                                                                5042
                                                                                                                                                                                                end exclusive
                                                                                                                                                                                                true
                                                                                                                                                                                                exact text
                                                                                                                                                                                                Colorectal Cancer (CRC)
                                                                                                                                                                                                label id
                                                                                                                                                                                                228e1e3f-d207-481f-8e14-9fdcbd0470e9
                                                                                                                                                                                                offset unit
                                                                                                                                                                                                unicode_code_points
                                                                                                                                                                                                source array index
                                                                                                                                                                                                0
                                                                                                                                                                                                source field
                                                                                                                                                                                                indications_and_usage_exact
                                                                                                                                                                                                source text sha256
                                                                                                                                                                                                e526ba14c91f10737e6d3331fe23a6219f58c0eca6380bfce9bd78b573fea912
                                                                                                                                                                                                start
                                                                                                                                                                                                5019
                                                                                                                                                                                              source span
                                                                                                                                                                                              end
                                                                                                                                                                                              12988
                                                                                                                                                                                              end exclusive
                                                                                                                                                                                              true
                                                                                                                                                                                              exact text
                                                                                                                                                                                              Patients with EGFR or ALK genomic tumor aberrations should have disease progression on FDA-approved therapy for these aberrations prior to receiving KEYTRUDA.
                                                                                                                                                                                              label id
                                                                                                                                                                                              228e1e3f-d207-481f-8e14-9fdcbd0470e9
                                                                                                                                                                                              offset unit
                                                                                                                                                                                              unicode_code_points
                                                                                                                                                                                              source array index
                                                                                                                                                                                              0
                                                                                                                                                                                              source field
                                                                                                                                                                                              indications_and_usage_exact
                                                                                                                                                                                              source text sha256
                                                                                                                                                                                              e526ba14c91f10737e6d3331fe23a6219f58c0eca6380bfce9bd78b573fea912
                                                                                                                                                                                              start
                                                                                                                                                                                              12830
                                                                                                                                                                                              source url
                                                                                                                                                                                              https://api.fda.gov/drug/label.json?search=id%3A%22228e1e3f-d207-481f-8e14-9fdcbd0470e9%22
                                                                                                                                                                                              spl effective date
                                                                                                                                                                                              2026-07-10
                                                                                                                                                                                              spl set id
                                                                                                                                                                                              9333c79b-d487-4538-a9f0-71b91a02b287
                                                                                                                                                                                              spl version
                                                                                                                                                                                              228
                                                                                                                                                                                              structured fields status
                                                                                                                                                                                              not_extracted_no_values_inferred_from_mentions
                                                                                                                                                                                              structured indication
                                                                                                                                                                                              age
                                                                                                                                                                                              Source null
                                                                                                                                                                                              approval pathway
                                                                                                                                                                                              Source null
                                                                                                                                                                                              biomarker and test
                                                                                                                                                                                              Source null
                                                                                                                                                                                              disease stage
                                                                                                                                                                                              Source null
                                                                                                                                                                                              limitations
                                                                                                                                                                                              Source null
                                                                                                                                                                                              line
                                                                                                                                                                                              Source null
                                                                                                                                                                                              prior therapy
                                                                                                                                                                                              Source null
                                                                                                                                                                                              regimen
                                                                                                                                                                                              Source null
                                                                                                                                                                                              tumor histology
                                                                                                                                                                                              Source null
                                                                                                                                                                                              use intent
                                                                                                                                                                                              tumor_directed_candidate
                                                                                                                                                                                              Passage 73 · positive indication candidate
                                                                                                                                                                                              application numbers
                                                                                                                                                                                              1. BLA125514
                                                                                                                                                                                              brand names
                                                                                                                                                                                              1. KEYTRUDA
                                                                                                                                                                                              classification reasons
                                                                                                                                                                                              1. explicit_positive_indication_predicate
                                                                                                                                                                                              2. tumor_or_malignant_hematology_words_in_positive_statement
                                                                                                                                                                                              clinical review status
                                                                                                                                                                                              pending
                                                                                                                                                                                              content role
                                                                                                                                                                                              positive_indication_candidate
                                                                                                                                                                                              context span
                                                                                                                                                                                              end
                                                                                                                                                                                              13447
                                                                                                                                                                                              end exclusive
                                                                                                                                                                                              true
                                                                                                                                                                                              exact text
                                                                                                                                                                                              after platinum-containing chemotherapy. Patients with EGFR or ALK genomic tumor aberrations should have disease progression on FDA-approved therapy for these aberrations prior to receiving KEYTRUDA. KEYTRUDA is indicated for the treatment of patients with resectable (tumors ≥4 cm or node positive) NSCLC in combination with platinum-containing chemotherapy as neoadjuvant treatment, and then continued as a single agent as adjuvant treatment after surgery. KEYTRUDA, as a single agent, is indicated as adjuvant treatment following resection and platinum-based chemotherapy for adult patients with Stage IB (T2a ≥4 cm), II, or IIIA NSCLC. 1.3 Malignant Pleu
                                                                                                                                                                                              label id
                                                                                                                                                                                              228e1e3f-d207-481f-8e14-9fdcbd0470e9
                                                                                                                                                                                              offset unit
                                                                                                                                                                                              unicode_code_points
                                                                                                                                                                                              source array index
                                                                                                                                                                                              0
                                                                                                                                                                                              source field
                                                                                                                                                                                              indications_and_usage_exact
                                                                                                                                                                                              source text sha256
                                                                                                                                                                                              e526ba14c91f10737e6d3331fe23a6219f58c0eca6380bfce9bd78b573fea912
                                                                                                                                                                                              start
                                                                                                                                                                                              12789
                                                                                                                                                                                              current approval status
                                                                                                                                                                                              not_reconciled
                                                                                                                                                                                              duplicate text group
                                                                                                                                                                                              dup-ec8618ca6b52a671be45
                                                                                                                                                                                              extraction review status
                                                                                                                                                                                              automated_candidate_pending_source_review
                                                                                                                                                                                              generic names
                                                                                                                                                                                              1. PEMBROLIZUMAB
                                                                                                                                                                                              id
                                                                                                                                                                                              ind-span-e07a580c30b7b3be41c8
                                                                                                                                                                                              label id
                                                                                                                                                                                              228e1e3f-d207-481f-8e14-9fdcbd0470e9
                                                                                                                                                                                              positive predicate support span
                                                                                                                                                                                              end
                                                                                                                                                                                              13010
                                                                                                                                                                                              end exclusive
                                                                                                                                                                                              true
                                                                                                                                                                                              exact text
                                                                                                                                                                                              is indicated
                                                                                                                                                                                              label id
                                                                                                                                                                                              228e1e3f-d207-481f-8e14-9fdcbd0470e9
                                                                                                                                                                                              offset unit
                                                                                                                                                                                              unicode_code_points
                                                                                                                                                                                              source array index
                                                                                                                                                                                              0
                                                                                                                                                                                              source field
                                                                                                                                                                                              indications_and_usage_exact
                                                                                                                                                                                              source text sha256
                                                                                                                                                                                              e526ba14c91f10737e6d3331fe23a6219f58c0eca6380bfce9bd78b573fea912
                                                                                                                                                                                              start
                                                                                                                                                                                              12998
                                                                                                                                                                                              qualifier mentions
                                                                                                                                                                                              1. context exact
                                                                                                                                                                                                KEYTRUDA is indicated for the treatment of patients with resectable (tumors ≥4 cm or node positive) NSCLC in combination with platinum-containing chemotherapy as
                                                                                                                                                                                                kind
                                                                                                                                                                                                stage_or_setting
                                                                                                                                                                                                polarity
                                                                                                                                                                                                not_inferred
                                                                                                                                                                                                span
                                                                                                                                                                                                end
                                                                                                                                                                                                13091
                                                                                                                                                                                                end exclusive
                                                                                                                                                                                                true
                                                                                                                                                                                                exact text
                                                                                                                                                                                                resectable (tumors ≥4 cm or node positive) NS
                                                                                                                                                                                                label id
                                                                                                                                                                                                228e1e3f-d207-481f-8e14-9fdcbd0470e9
                                                                                                                                                                                                offset unit
                                                                                                                                                                                                unicode_code_points
                                                                                                                                                                                                source array index
                                                                                                                                                                                                0
                                                                                                                                                                                                source field
                                                                                                                                                                                                indications_and_usage_exact
                                                                                                                                                                                                source text sha256
                                                                                                                                                                                                e526ba14c91f10737e6d3331fe23a6219f58c0eca6380bfce9bd78b573fea912
                                                                                                                                                                                                start
                                                                                                                                                                                                13046
                                                                                                                                                                                              2. context exact
                                                                                                                                                                                                CLC in combination with platinum-containing chemotherapy as neoadjuvant treatment, and then continued as a single agent as adjuvant treatment
                                                                                                                                                                                                kind
                                                                                                                                                                                                stage_or_setting
                                                                                                                                                                                                polarity
                                                                                                                                                                                                not_inferred
                                                                                                                                                                                                span
                                                                                                                                                                                                end
                                                                                                                                                                                                13172
                                                                                                                                                                                                end exclusive
                                                                                                                                                                                                true
                                                                                                                                                                                                exact text
                                                                                                                                                                                                neoadjuvant treatment
                                                                                                                                                                                                label id
                                                                                                                                                                                                228e1e3f-d207-481f-8e14-9fdcbd0470e9
                                                                                                                                                                                                offset unit
                                                                                                                                                                                                unicode_code_points
                                                                                                                                                                                                source array index
                                                                                                                                                                                                0
                                                                                                                                                                                                source field
                                                                                                                                                                                                indications_and_usage_exact
                                                                                                                                                                                                source text sha256
                                                                                                                                                                                                e526ba14c91f10737e6d3331fe23a6219f58c0eca6380bfce9bd78b573fea912
                                                                                                                                                                                                start
                                                                                                                                                                                                13151
                                                                                                                                                                                              3. context exact
                                                                                                                                                                                                adjuvant treatment, and then continued as a single agent as adjuvant treatment after surgery.
                                                                                                                                                                                                kind
                                                                                                                                                                                                stage_or_setting
                                                                                                                                                                                                polarity
                                                                                                                                                                                                not_inferred
                                                                                                                                                                                                span
                                                                                                                                                                                                end
                                                                                                                                                                                                13246
                                                                                                                                                                                                end exclusive
                                                                                                                                                                                                true
                                                                                                                                                                                                exact text
                                                                                                                                                                                                adjuvant treatment after surgery
                                                                                                                                                                                                label id
                                                                                                                                                                                                228e1e3f-d207-481f-8e14-9fdcbd0470e9
                                                                                                                                                                                                offset unit
                                                                                                                                                                                                unicode_code_points
                                                                                                                                                                                                source array index
                                                                                                                                                                                                0
                                                                                                                                                                                                source field
                                                                                                                                                                                                indications_and_usage_exact
                                                                                                                                                                                                source text sha256
                                                                                                                                                                                                e526ba14c91f10737e6d3331fe23a6219f58c0eca6380bfce9bd78b573fea912
                                                                                                                                                                                                start
                                                                                                                                                                                                13214
                                                                                                                                                                                              4. context exact
                                                                                                                                                                                                ients with resectable (tumors ≥4 cm or node positive) NSCLC in combination with platinum-containing chemotherapy as neoadjuvant treatment, and then continued as a single agent as adjuvant treatment after surgery.
                                                                                                                                                                                                kind
                                                                                                                                                                                                regimen
                                                                                                                                                                                                polarity
                                                                                                                                                                                                not_inferred
                                                                                                                                                                                                span
                                                                                                                                                                                                end
                                                                                                                                                                                                13246
                                                                                                                                                                                                end exclusive
                                                                                                                                                                                                true
                                                                                                                                                                                                exact text
                                                                                                                                                                                                in combination with platinum-containing chemotherapy as neoadjuvant treatment, and then continued as a single agent as adjuvant treatment after surgery
                                                                                                                                                                                                label id
                                                                                                                                                                                                228e1e3f-d207-481f-8e14-9fdcbd0470e9
                                                                                                                                                                                                offset unit
                                                                                                                                                                                                unicode_code_points
                                                                                                                                                                                                source array index
                                                                                                                                                                                                0
                                                                                                                                                                                                source field
                                                                                                                                                                                                indications_and_usage_exact
                                                                                                                                                                                                source text sha256
                                                                                                                                                                                                e526ba14c91f10737e6d3331fe23a6219f58c0eca6380bfce9bd78b573fea912
                                                                                                                                                                                                start
                                                                                                                                                                                                13095
                                                                                                                                                                                              regulatory links
                                                                                                                                                                                                schema version
                                                                                                                                                                                                0.1.0
                                                                                                                                                                                                source batch sha256
                                                                                                                                                                                                fc39a8c5cf96bf95ca20b85578140167b66b2741f7d9217f500d9ba0847ac058
                                                                                                                                                                                                source defined aliases
                                                                                                                                                                                                1. abbreviation
                                                                                                                                                                                                  NSCLC
                                                                                                                                                                                                  definition exact
                                                                                                                                                                                                  Non-Small Cell Lung Cancer
                                                                                                                                                                                                  definition span
                                                                                                                                                                                                  end
                                                                                                                                                                                                  380
                                                                                                                                                                                                  end exclusive
                                                                                                                                                                                                  true
                                                                                                                                                                                                  exact text
                                                                                                                                                                                                  Non-Small Cell Lung Cancer (NSCLC)
                                                                                                                                                                                                  label id
                                                                                                                                                                                                  228e1e3f-d207-481f-8e14-9fdcbd0470e9
                                                                                                                                                                                                  offset unit
                                                                                                                                                                                                  unicode_code_points
                                                                                                                                                                                                  source array index
                                                                                                                                                                                                  0
                                                                                                                                                                                                  source field
                                                                                                                                                                                                  indications_and_usage_exact
                                                                                                                                                                                                  source text sha256
                                                                                                                                                                                                  e526ba14c91f10737e6d3331fe23a6219f58c0eca6380bfce9bd78b573fea912
                                                                                                                                                                                                  start
                                                                                                                                                                                                  346
                                                                                                                                                                                                2. abbreviation
                                                                                                                                                                                                  CRC
                                                                                                                                                                                                  definition exact
                                                                                                                                                                                                  Colorectal Cancer
                                                                                                                                                                                                  definition span
                                                                                                                                                                                                  end
                                                                                                                                                                                                  5042
                                                                                                                                                                                                  end exclusive
                                                                                                                                                                                                  true
                                                                                                                                                                                                  exact text
                                                                                                                                                                                                  Colorectal Cancer (CRC)
                                                                                                                                                                                                  label id
                                                                                                                                                                                                  228e1e3f-d207-481f-8e14-9fdcbd0470e9
                                                                                                                                                                                                  offset unit
                                                                                                                                                                                                  unicode_code_points
                                                                                                                                                                                                  source array index
                                                                                                                                                                                                  0
                                                                                                                                                                                                  source field
                                                                                                                                                                                                  indications_and_usage_exact
                                                                                                                                                                                                  source text sha256
                                                                                                                                                                                                  e526ba14c91f10737e6d3331fe23a6219f58c0eca6380bfce9bd78b573fea912
                                                                                                                                                                                                  start
                                                                                                                                                                                                  5019
                                                                                                                                                                                                source span
                                                                                                                                                                                                end
                                                                                                                                                                                                13247
                                                                                                                                                                                                end exclusive
                                                                                                                                                                                                true
                                                                                                                                                                                                exact text
                                                                                                                                                                                                KEYTRUDA is indicated for the treatment of patients with resectable (tumors ≥4 cm or node positive) NSCLC in combination with platinum-containing chemotherapy as neoadjuvant treatment, and then continued as a single agent as adjuvant treatment after surgery.
                                                                                                                                                                                                label id
                                                                                                                                                                                                228e1e3f-d207-481f-8e14-9fdcbd0470e9
                                                                                                                                                                                                offset unit
                                                                                                                                                                                                unicode_code_points
                                                                                                                                                                                                source array index
                                                                                                                                                                                                0
                                                                                                                                                                                                source field
                                                                                                                                                                                                indications_and_usage_exact
                                                                                                                                                                                                source text sha256
                                                                                                                                                                                                e526ba14c91f10737e6d3331fe23a6219f58c0eca6380bfce9bd78b573fea912
                                                                                                                                                                                                start
                                                                                                                                                                                                12989
                                                                                                                                                                                                source url
                                                                                                                                                                                                https://api.fda.gov/drug/label.json?search=id%3A%22228e1e3f-d207-481f-8e14-9fdcbd0470e9%22
                                                                                                                                                                                                spl effective date
                                                                                                                                                                                                2026-07-10
                                                                                                                                                                                                spl set id
                                                                                                                                                                                                9333c79b-d487-4538-a9f0-71b91a02b287
                                                                                                                                                                                                spl version
                                                                                                                                                                                                228
                                                                                                                                                                                                structured fields status
                                                                                                                                                                                                not_extracted_no_values_inferred_from_mentions
                                                                                                                                                                                                structured indication
                                                                                                                                                                                                age
                                                                                                                                                                                                Source null
                                                                                                                                                                                                approval pathway
                                                                                                                                                                                                Source null
                                                                                                                                                                                                biomarker and test
                                                                                                                                                                                                Source null
                                                                                                                                                                                                disease stage
                                                                                                                                                                                                Source null
                                                                                                                                                                                                limitations
                                                                                                                                                                                                Source null
                                                                                                                                                                                                line
                                                                                                                                                                                                Source null
                                                                                                                                                                                                prior therapy
                                                                                                                                                                                                Source null
                                                                                                                                                                                                regimen
                                                                                                                                                                                                Source null
                                                                                                                                                                                                tumor histology
                                                                                                                                                                                                Source null
                                                                                                                                                                                                use intent
                                                                                                                                                                                                tumor_directed_candidate
                                                                                                                                                                                                Passage 74 · positive indication candidate
                                                                                                                                                                                                application numbers
                                                                                                                                                                                                1. BLA125514
                                                                                                                                                                                                brand names
                                                                                                                                                                                                1. KEYTRUDA
                                                                                                                                                                                                classification reasons
                                                                                                                                                                                                1. explicit_positive_indication_predicate
                                                                                                                                                                                                2. tumor_or_malignant_hematology_words_in_positive_statement
                                                                                                                                                                                                clinical review status
                                                                                                                                                                                                pending
                                                                                                                                                                                                content role
                                                                                                                                                                                                positive_indication_candidate
                                                                                                                                                                                                context span
                                                                                                                                                                                                end
                                                                                                                                                                                                13628
                                                                                                                                                                                                end exclusive
                                                                                                                                                                                                true
                                                                                                                                                                                                exact text
                                                                                                                                                                                                sectable (tumors ≥4 cm or node positive) NSCLC in combination with platinum-containing chemotherapy as neoadjuvant treatment, and then continued as a single agent as adjuvant treatment after surgery. KEYTRUDA, as a single agent, is indicated as adjuvant treatment following resection and platinum-based chemotherapy for adult patients with Stage IB (T2a ≥4 cm), II, or IIIA NSCLC. 1.3 Malignant Pleural Mesothelioma KEYTRUDA, in combination with pemetrexed and platinum chemotherapy, is indicated for the first-line treatment of adult patients with unresectable advanced or metast
                                                                                                                                                                                                label id
                                                                                                                                                                                                228e1e3f-d207-481f-8e14-9fdcbd0470e9
                                                                                                                                                                                                offset unit
                                                                                                                                                                                                unicode_code_points
                                                                                                                                                                                                source array index
                                                                                                                                                                                                0
                                                                                                                                                                                                source field
                                                                                                                                                                                                indications_and_usage_exact
                                                                                                                                                                                                source text sha256
                                                                                                                                                                                                e526ba14c91f10737e6d3331fe23a6219f58c0eca6380bfce9bd78b573fea912
                                                                                                                                                                                                start
                                                                                                                                                                                                13048
                                                                                                                                                                                                current approval status
                                                                                                                                                                                                not_reconciled
                                                                                                                                                                                                duplicate text group
                                                                                                                                                                                                dup-b15f1ecce66d5a8c4d76
                                                                                                                                                                                                extraction review status
                                                                                                                                                                                                automated_candidate_pending_source_review
                                                                                                                                                                                                generic names
                                                                                                                                                                                                1. PEMBROLIZUMAB
                                                                                                                                                                                                id
                                                                                                                                                                                                ind-span-af0319963e42e328b715
                                                                                                                                                                                                label id
                                                                                                                                                                                                228e1e3f-d207-481f-8e14-9fdcbd0470e9
                                                                                                                                                                                                positive predicate support span
                                                                                                                                                                                                end
                                                                                                                                                                                                13289
                                                                                                                                                                                                end exclusive
                                                                                                                                                                                                true
                                                                                                                                                                                                exact text
                                                                                                                                                                                                is indicated
                                                                                                                                                                                                label id
                                                                                                                                                                                                228e1e3f-d207-481f-8e14-9fdcbd0470e9
                                                                                                                                                                                                offset unit
                                                                                                                                                                                                unicode_code_points
                                                                                                                                                                                                source array index
                                                                                                                                                                                                0
                                                                                                                                                                                                source field
                                                                                                                                                                                                indications_and_usage_exact
                                                                                                                                                                                                source text sha256
                                                                                                                                                                                                e526ba14c91f10737e6d3331fe23a6219f58c0eca6380bfce9bd78b573fea912
                                                                                                                                                                                                start
                                                                                                                                                                                                13277
                                                                                                                                                                                                qualifier mentions
                                                                                                                                                                                                1. context exact
                                                                                                                                                                                                  ent following resection and platinum-based chemotherapy for adult patients with Stage IB (T2a ≥4 cm), II, or IIIA NSCLC.
                                                                                                                                                                                                  kind
                                                                                                                                                                                                  age
                                                                                                                                                                                                  polarity
                                                                                                                                                                                                  not_inferred
                                                                                                                                                                                                  span
                                                                                                                                                                                                  end
                                                                                                                                                                                                  13382
                                                                                                                                                                                                  end exclusive
                                                                                                                                                                                                  true
                                                                                                                                                                                                  exact text
                                                                                                                                                                                                  adult patients
                                                                                                                                                                                                  label id
                                                                                                                                                                                                  228e1e3f-d207-481f-8e14-9fdcbd0470e9
                                                                                                                                                                                                  offset unit
                                                                                                                                                                                                  unicode_code_points
                                                                                                                                                                                                  source array index
                                                                                                                                                                                                  0
                                                                                                                                                                                                  source field
                                                                                                                                                                                                  indications_and_usage_exact
                                                                                                                                                                                                  source text sha256
                                                                                                                                                                                                  e526ba14c91f10737e6d3331fe23a6219f58c0eca6380bfce9bd78b573fea912
                                                                                                                                                                                                  start
                                                                                                                                                                                                  13368
                                                                                                                                                                                                2. context exact
                                                                                                                                                                                                  KEYTRUDA, as a single agent, is indicated as adjuvant treatment following resection and platinum-based chemotherapy for adult patients with Stage IB
                                                                                                                                                                                                  kind
                                                                                                                                                                                                  stage_or_setting
                                                                                                                                                                                                  polarity
                                                                                                                                                                                                  not_inferred
                                                                                                                                                                                                  span
                                                                                                                                                                                                  end
                                                                                                                                                                                                  13336
                                                                                                                                                                                                  end exclusive
                                                                                                                                                                                                  true
                                                                                                                                                                                                  exact text
                                                                                                                                                                                                  adjuvant treatment following resection and
                                                                                                                                                                                                  label id
                                                                                                                                                                                                  228e1e3f-d207-481f-8e14-9fdcbd0470e9
                                                                                                                                                                                                  offset unit
                                                                                                                                                                                                  unicode_code_points
                                                                                                                                                                                                  source array index
                                                                                                                                                                                                  0
                                                                                                                                                                                                  source field
                                                                                                                                                                                                  indications_and_usage_exact
                                                                                                                                                                                                  source text sha256
                                                                                                                                                                                                  e526ba14c91f10737e6d3331fe23a6219f58c0eca6380bfce9bd78b573fea912
                                                                                                                                                                                                  start
                                                                                                                                                                                                  13293
                                                                                                                                                                                                3. context exact
                                                                                                                                                                                                  KEYTRUDA, as a single agent, is indicated as adjuvant treatment following resection and platinum-based chemotherapy for adult patients with Stage IB (T2a ≥4 cm), II, or IIIA NSCLC.
                                                                                                                                                                                                  kind
                                                                                                                                                                                                  regimen
                                                                                                                                                                                                  polarity
                                                                                                                                                                                                  not_inferred
                                                                                                                                                                                                  span
                                                                                                                                                                                                  end
                                                                                                                                                                                                  13427
                                                                                                                                                                                                  end exclusive
                                                                                                                                                                                                  true
                                                                                                                                                                                                  exact text
                                                                                                                                                                                                  as a single agent, is indicated as adjuvant treatment following resection and platinum-based chemotherapy for adult patients with Stage IB (T2a ≥4 cm), II, or IIIA NSCLC
                                                                                                                                                                                                  label id
                                                                                                                                                                                                  228e1e3f-d207-481f-8e14-9fdcbd0470e9
                                                                                                                                                                                                  offset unit
                                                                                                                                                                                                  unicode_code_points
                                                                                                                                                                                                  source array index
                                                                                                                                                                                                  0
                                                                                                                                                                                                  source field
                                                                                                                                                                                                  indications_and_usage_exact
                                                                                                                                                                                                  source text sha256
                                                                                                                                                                                                  e526ba14c91f10737e6d3331fe23a6219f58c0eca6380bfce9bd78b573fea912
                                                                                                                                                                                                  start
                                                                                                                                                                                                  13258
                                                                                                                                                                                                regulatory links
                                                                                                                                                                                                  schema version
                                                                                                                                                                                                  0.1.0
                                                                                                                                                                                                  source batch sha256
                                                                                                                                                                                                  fc39a8c5cf96bf95ca20b85578140167b66b2741f7d9217f500d9ba0847ac058
                                                                                                                                                                                                  source defined aliases
                                                                                                                                                                                                  1. abbreviation
                                                                                                                                                                                                    NSCLC
                                                                                                                                                                                                    definition exact
                                                                                                                                                                                                    Non-Small Cell Lung Cancer
                                                                                                                                                                                                    definition span
                                                                                                                                                                                                    end
                                                                                                                                                                                                    380
                                                                                                                                                                                                    end exclusive
                                                                                                                                                                                                    true
                                                                                                                                                                                                    exact text
                                                                                                                                                                                                    Non-Small Cell Lung Cancer (NSCLC)
                                                                                                                                                                                                    label id
                                                                                                                                                                                                    228e1e3f-d207-481f-8e14-9fdcbd0470e9
                                                                                                                                                                                                    offset unit
                                                                                                                                                                                                    unicode_code_points
                                                                                                                                                                                                    source array index
                                                                                                                                                                                                    0
                                                                                                                                                                                                    source field
                                                                                                                                                                                                    indications_and_usage_exact
                                                                                                                                                                                                    source text sha256
                                                                                                                                                                                                    e526ba14c91f10737e6d3331fe23a6219f58c0eca6380bfce9bd78b573fea912
                                                                                                                                                                                                    start
                                                                                                                                                                                                    346
                                                                                                                                                                                                  2. abbreviation
                                                                                                                                                                                                    CRC
                                                                                                                                                                                                    definition exact
                                                                                                                                                                                                    Colorectal Cancer
                                                                                                                                                                                                    definition span
                                                                                                                                                                                                    end
                                                                                                                                                                                                    5042
                                                                                                                                                                                                    end exclusive
                                                                                                                                                                                                    true
                                                                                                                                                                                                    exact text
                                                                                                                                                                                                    Colorectal Cancer (CRC)
                                                                                                                                                                                                    label id
                                                                                                                                                                                                    228e1e3f-d207-481f-8e14-9fdcbd0470e9
                                                                                                                                                                                                    offset unit
                                                                                                                                                                                                    unicode_code_points
                                                                                                                                                                                                    source array index
                                                                                                                                                                                                    0
                                                                                                                                                                                                    source field
                                                                                                                                                                                                    indications_and_usage_exact
                                                                                                                                                                                                    source text sha256
                                                                                                                                                                                                    e526ba14c91f10737e6d3331fe23a6219f58c0eca6380bfce9bd78b573fea912
                                                                                                                                                                                                    start
                                                                                                                                                                                                    5019
                                                                                                                                                                                                  source span
                                                                                                                                                                                                  end
                                                                                                                                                                                                  13428
                                                                                                                                                                                                  end exclusive
                                                                                                                                                                                                  true
                                                                                                                                                                                                  exact text
                                                                                                                                                                                                  KEYTRUDA, as a single agent, is indicated as adjuvant treatment following resection and platinum-based chemotherapy for adult patients with Stage IB (T2a ≥4 cm), II, or IIIA NSCLC.
                                                                                                                                                                                                  label id
                                                                                                                                                                                                  228e1e3f-d207-481f-8e14-9fdcbd0470e9
                                                                                                                                                                                                  offset unit
                                                                                                                                                                                                  unicode_code_points
                                                                                                                                                                                                  source array index
                                                                                                                                                                                                  0
                                                                                                                                                                                                  source field
                                                                                                                                                                                                  indications_and_usage_exact
                                                                                                                                                                                                  source text sha256
                                                                                                                                                                                                  e526ba14c91f10737e6d3331fe23a6219f58c0eca6380bfce9bd78b573fea912
                                                                                                                                                                                                  start
                                                                                                                                                                                                  13248
                                                                                                                                                                                                  source url
                                                                                                                                                                                                  https://api.fda.gov/drug/label.json?search=id%3A%22228e1e3f-d207-481f-8e14-9fdcbd0470e9%22
                                                                                                                                                                                                  spl effective date
                                                                                                                                                                                                  2026-07-10
                                                                                                                                                                                                  spl set id
                                                                                                                                                                                                  9333c79b-d487-4538-a9f0-71b91a02b287
                                                                                                                                                                                                  spl version
                                                                                                                                                                                                  228
                                                                                                                                                                                                  structured fields status
                                                                                                                                                                                                  not_extracted_no_values_inferred_from_mentions
                                                                                                                                                                                                  structured indication
                                                                                                                                                                                                  age
                                                                                                                                                                                                  Source null
                                                                                                                                                                                                  approval pathway
                                                                                                                                                                                                  Source null
                                                                                                                                                                                                  biomarker and test
                                                                                                                                                                                                  Source null
                                                                                                                                                                                                  disease stage
                                                                                                                                                                                                  Source null
                                                                                                                                                                                                  limitations
                                                                                                                                                                                                  Source null
                                                                                                                                                                                                  line
                                                                                                                                                                                                  Source null
                                                                                                                                                                                                  prior therapy
                                                                                                                                                                                                  Source null
                                                                                                                                                                                                  regimen
                                                                                                                                                                                                  Source null
                                                                                                                                                                                                  tumor histology
                                                                                                                                                                                                  Source null
                                                                                                                                                                                                  use intent
                                                                                                                                                                                                  tumor_directed_candidate
                                                                                                                                                                                                  Passage 75 · positive indication candidate
                                                                                                                                                                                                  application numbers
                                                                                                                                                                                                  1. BLA125514
                                                                                                                                                                                                  brand names
                                                                                                                                                                                                  1. KEYTRUDA
                                                                                                                                                                                                  classification reasons
                                                                                                                                                                                                  1. explicit_positive_indication_predicate
                                                                                                                                                                                                  2. no_tumor_directed_keyword_in_positive_statement
                                                                                                                                                                                                  clinical review status
                                                                                                                                                                                                  pending
                                                                                                                                                                                                  content role
                                                                                                                                                                                                  positive_indication_candidate
                                                                                                                                                                                                  context span
                                                                                                                                                                                                  end
                                                                                                                                                                                                  13870
                                                                                                                                                                                                  end exclusive
                                                                                                                                                                                                  true
                                                                                                                                                                                                  exact text
                                                                                                                                                                                                  ent after surgery. KEYTRUDA, as a single agent, is indicated as adjuvant treatment following resection and platinum-based chemotherapy for adult patients with Stage IB (T2a ≥4 cm), II, or IIIA NSCLC. 1.3 Malignant Pleural Mesothelioma KEYTRUDA, in combination with pemetrexed and platinum chemotherapy, is indicated for the first-line treatment of adult patients with unresectable advanced or metastatic malignant pleural mesothelioma (MPM). 1.4 Head and Neck Squamous Cell Cancer KEYTRUDA is indicated for the treatment of adult patients with resectable locally advanced HNSCC whose tumors express PD-L1 [Combined Positive Score (CPS) ≥1] a
                                                                                                                                                                                                  label id
                                                                                                                                                                                                  228e1e3f-d207-481f-8e14-9fdcbd0470e9
                                                                                                                                                                                                  offset unit
                                                                                                                                                                                                  unicode_code_points
                                                                                                                                                                                                  source array index
                                                                                                                                                                                                  0
                                                                                                                                                                                                  source field
                                                                                                                                                                                                  indications_and_usage_exact
                                                                                                                                                                                                  source text sha256
                                                                                                                                                                                                  e526ba14c91f10737e6d3331fe23a6219f58c0eca6380bfce9bd78b573fea912
                                                                                                                                                                                                  start
                                                                                                                                                                                                  13229
                                                                                                                                                                                                  current approval status
                                                                                                                                                                                                  not_reconciled
                                                                                                                                                                                                  duplicate text group
                                                                                                                                                                                                  dup-b46d454fa268c1f7727e
                                                                                                                                                                                                  extraction review status
                                                                                                                                                                                                  automated_candidate_pending_source_review
                                                                                                                                                                                                  generic names
                                                                                                                                                                                                  1. PEMBROLIZUMAB
                                                                                                                                                                                                  id
                                                                                                                                                                                                  ind-span-e71904cf9b03ca820eb2
                                                                                                                                                                                                  label id
                                                                                                                                                                                                  228e1e3f-d207-481f-8e14-9fdcbd0470e9
                                                                                                                                                                                                  positive predicate support span
                                                                                                                                                                                                  end
                                                                                                                                                                                                  13544
                                                                                                                                                                                                  end exclusive
                                                                                                                                                                                                  true
                                                                                                                                                                                                  exact text
                                                                                                                                                                                                  is indicated
                                                                                                                                                                                                  label id
                                                                                                                                                                                                  228e1e3f-d207-481f-8e14-9fdcbd0470e9
                                                                                                                                                                                                  offset unit
                                                                                                                                                                                                  unicode_code_points
                                                                                                                                                                                                  source array index
                                                                                                                                                                                                  0
                                                                                                                                                                                                  source field
                                                                                                                                                                                                  indications_and_usage_exact
                                                                                                                                                                                                  source text sha256
                                                                                                                                                                                                  e526ba14c91f10737e6d3331fe23a6219f58c0eca6380bfce9bd78b573fea912
                                                                                                                                                                                                  start
                                                                                                                                                                                                  13532
                                                                                                                                                                                                  qualifier mentions
                                                                                                                                                                                                  1. context exact
                                                                                                                                                                                                    chemotherapy, is indicated for the first-line treatment of adult patients with unresectable advanced or metastatic malignant pleural
                                                                                                                                                                                                    kind
                                                                                                                                                                                                    age
                                                                                                                                                                                                    polarity
                                                                                                                                                                                                    not_inferred
                                                                                                                                                                                                    span
                                                                                                                                                                                                    end
                                                                                                                                                                                                    13591
                                                                                                                                                                                                    end exclusive
                                                                                                                                                                                                    true
                                                                                                                                                                                                    exact text
                                                                                                                                                                                                    adult patients
                                                                                                                                                                                                    label id
                                                                                                                                                                                                    228e1e3f-d207-481f-8e14-9fdcbd0470e9
                                                                                                                                                                                                    offset unit
                                                                                                                                                                                                    unicode_code_points
                                                                                                                                                                                                    source array index
                                                                                                                                                                                                    0
                                                                                                                                                                                                    source field
                                                                                                                                                                                                    indications_and_usage_exact
                                                                                                                                                                                                    source text sha256
                                                                                                                                                                                                    e526ba14c91f10737e6d3331fe23a6219f58c0eca6380bfce9bd78b573fea912
                                                                                                                                                                                                    start
                                                                                                                                                                                                    13577
                                                                                                                                                                                                  2. context exact
                                                                                                                                                                                                    e treatment of adult patients with unresectable advanced or metastatic malignant pleural mesothelioma (MPM).
                                                                                                                                                                                                    kind
                                                                                                                                                                                                    biomarker
                                                                                                                                                                                                    polarity
                                                                                                                                                                                                    not_inferred
                                                                                                                                                                                                    span
                                                                                                                                                                                                    end
                                                                                                                                                                                                    13665
                                                                                                                                                                                                    end exclusive
                                                                                                                                                                                                    true
                                                                                                                                                                                                    exact text
                                                                                                                                                                                                    metastatic malignant pleural mesothelioma (
                                                                                                                                                                                                    label id
                                                                                                                                                                                                    228e1e3f-d207-481f-8e14-9fdcbd0470e9
                                                                                                                                                                                                    offset unit
                                                                                                                                                                                                    unicode_code_points
                                                                                                                                                                                                    source array index
                                                                                                                                                                                                    0
                                                                                                                                                                                                    source field
                                                                                                                                                                                                    indications_and_usage_exact
                                                                                                                                                                                                    source text sha256
                                                                                                                                                                                                    e526ba14c91f10737e6d3331fe23a6219f58c0eca6380bfce9bd78b573fea912
                                                                                                                                                                                                    start
                                                                                                                                                                                                    13622
                                                                                                                                                                                                  3. context exact
                                                                                                                                                                                                    dicated for the first-line treatment of adult patients with unresectable advanced or metastatic malignant pleural mesothelioma (MPM).
                                                                                                                                                                                                    kind
                                                                                                                                                                                                    stage_or_setting
                                                                                                                                                                                                    polarity
                                                                                                                                                                                                    not_inferred
                                                                                                                                                                                                    span
                                                                                                                                                                                                    end
                                                                                                                                                                                                    13644
                                                                                                                                                                                                    end exclusive
                                                                                                                                                                                                    true
                                                                                                                                                                                                    exact text
                                                                                                                                                                                                    unresectable advanced or metastatic malignant p
                                                                                                                                                                                                    label id
                                                                                                                                                                                                    228e1e3f-d207-481f-8e14-9fdcbd0470e9
                                                                                                                                                                                                    offset unit
                                                                                                                                                                                                    unicode_code_points
                                                                                                                                                                                                    source array index
                                                                                                                                                                                                    0
                                                                                                                                                                                                    source field
                                                                                                                                                                                                    indications_and_usage_exact
                                                                                                                                                                                                    source text sha256
                                                                                                                                                                                                    e526ba14c91f10737e6d3331fe23a6219f58c0eca6380bfce9bd78b573fea912
                                                                                                                                                                                                    start
                                                                                                                                                                                                    13597
                                                                                                                                                                                                  4. context exact
                                                                                                                                                                                                    pemetrexed and platinum chemotherapy, is indicated for the first-line treatment of adult patients with unresectable advanced or metastatic malignant pleural mesothelioma (MPM).
                                                                                                                                                                                                    kind
                                                                                                                                                                                                    prior_therapy_or_line
                                                                                                                                                                                                    polarity
                                                                                                                                                                                                    not_inferred
                                                                                                                                                                                                    span
                                                                                                                                                                                                    end
                                                                                                                                                                                                    13669
                                                                                                                                                                                                    end exclusive
                                                                                                                                                                                                    true
                                                                                                                                                                                                    exact text
                                                                                                                                                                                                    first-line treatment of adult patients with unresectable advanced or metastatic malignant pleural mesothelioma (MPM)
                                                                                                                                                                                                    label id
                                                                                                                                                                                                    228e1e3f-d207-481f-8e14-9fdcbd0470e9
                                                                                                                                                                                                    offset unit
                                                                                                                                                                                                    unicode_code_points
                                                                                                                                                                                                    source array index
                                                                                                                                                                                                    0
                                                                                                                                                                                                    source field
                                                                                                                                                                                                    indications_and_usage_exact
                                                                                                                                                                                                    source text sha256
                                                                                                                                                                                                    e526ba14c91f10737e6d3331fe23a6219f58c0eca6380bfce9bd78b573fea912
                                                                                                                                                                                                    start
                                                                                                                                                                                                    13553
                                                                                                                                                                                                  5. context exact
                                                                                                                                                                                                    1.3 Malignant Pleural Mesothelioma KEYTRUDA, in combination with pemetrexed and platinum chemotherapy, is indicated for the first-line treatment of adult patients with unresectable advanced or metastatic malignant pleural mesothelioma (MPM).
                                                                                                                                                                                                    kind
                                                                                                                                                                                                    regimen
                                                                                                                                                                                                    polarity
                                                                                                                                                                                                    not_inferred
                                                                                                                                                                                                    span
                                                                                                                                                                                                    end
                                                                                                                                                                                                    13653
                                                                                                                                                                                                    end exclusive
                                                                                                                                                                                                    true
                                                                                                                                                                                                    exact text
                                                                                                                                                                                                    in combination with pemetrexed and platinum chemotherapy, is indicated for the first-line treatment of adult patients with unresectable advanced or metastatic malignant pleural me
                                                                                                                                                                                                    label id
                                                                                                                                                                                                    228e1e3f-d207-481f-8e14-9fdcbd0470e9
                                                                                                                                                                                                    offset unit
                                                                                                                                                                                                    unicode_code_points
                                                                                                                                                                                                    source array index
                                                                                                                                                                                                    0
                                                                                                                                                                                                    source field
                                                                                                                                                                                                    indications_and_usage_exact
                                                                                                                                                                                                    source text sha256
                                                                                                                                                                                                    e526ba14c91f10737e6d3331fe23a6219f58c0eca6380bfce9bd78b573fea912
                                                                                                                                                                                                    start
                                                                                                                                                                                                    13474
                                                                                                                                                                                                  regulatory links
                                                                                                                                                                                                    schema version
                                                                                                                                                                                                    0.1.0
                                                                                                                                                                                                    source batch sha256
                                                                                                                                                                                                    fc39a8c5cf96bf95ca20b85578140167b66b2741f7d9217f500d9ba0847ac058
                                                                                                                                                                                                    source defined aliases
                                                                                                                                                                                                    1. abbreviation
                                                                                                                                                                                                      NSCLC
                                                                                                                                                                                                      definition exact
                                                                                                                                                                                                      Non-Small Cell Lung Cancer
                                                                                                                                                                                                      definition span
                                                                                                                                                                                                      end
                                                                                                                                                                                                      380
                                                                                                                                                                                                      end exclusive
                                                                                                                                                                                                      true
                                                                                                                                                                                                      exact text
                                                                                                                                                                                                      Non-Small Cell Lung Cancer (NSCLC)
                                                                                                                                                                                                      label id
                                                                                                                                                                                                      228e1e3f-d207-481f-8e14-9fdcbd0470e9
                                                                                                                                                                                                      offset unit
                                                                                                                                                                                                      unicode_code_points
                                                                                                                                                                                                      source array index
                                                                                                                                                                                                      0
                                                                                                                                                                                                      source field
                                                                                                                                                                                                      indications_and_usage_exact
                                                                                                                                                                                                      source text sha256
                                                                                                                                                                                                      e526ba14c91f10737e6d3331fe23a6219f58c0eca6380bfce9bd78b573fea912
                                                                                                                                                                                                      start
                                                                                                                                                                                                      346
                                                                                                                                                                                                    2. abbreviation
                                                                                                                                                                                                      CRC
                                                                                                                                                                                                      definition exact
                                                                                                                                                                                                      Colorectal Cancer
                                                                                                                                                                                                      definition span
                                                                                                                                                                                                      end
                                                                                                                                                                                                      5042
                                                                                                                                                                                                      end exclusive
                                                                                                                                                                                                      true
                                                                                                                                                                                                      exact text
                                                                                                                                                                                                      Colorectal Cancer (CRC)
                                                                                                                                                                                                      label id
                                                                                                                                                                                                      228e1e3f-d207-481f-8e14-9fdcbd0470e9
                                                                                                                                                                                                      offset unit
                                                                                                                                                                                                      unicode_code_points
                                                                                                                                                                                                      source array index
                                                                                                                                                                                                      0
                                                                                                                                                                                                      source field
                                                                                                                                                                                                      indications_and_usage_exact
                                                                                                                                                                                                      source text sha256
                                                                                                                                                                                                      e526ba14c91f10737e6d3331fe23a6219f58c0eca6380bfce9bd78b573fea912
                                                                                                                                                                                                      start
                                                                                                                                                                                                      5019
                                                                                                                                                                                                    source span
                                                                                                                                                                                                    end
                                                                                                                                                                                                    13670
                                                                                                                                                                                                    end exclusive
                                                                                                                                                                                                    true
                                                                                                                                                                                                    exact text
                                                                                                                                                                                                    1.3 Malignant Pleural Mesothelioma KEYTRUDA, in combination with pemetrexed and platinum chemotherapy, is indicated for the first-line treatment of adult patients with unresectable advanced or metastatic malignant pleural mesothelioma (MPM).
                                                                                                                                                                                                    label id
                                                                                                                                                                                                    228e1e3f-d207-481f-8e14-9fdcbd0470e9
                                                                                                                                                                                                    offset unit
                                                                                                                                                                                                    unicode_code_points
                                                                                                                                                                                                    source array index
                                                                                                                                                                                                    0
                                                                                                                                                                                                    source field
                                                                                                                                                                                                    indications_and_usage_exact
                                                                                                                                                                                                    source text sha256
                                                                                                                                                                                                    e526ba14c91f10737e6d3331fe23a6219f58c0eca6380bfce9bd78b573fea912
                                                                                                                                                                                                    start
                                                                                                                                                                                                    13429
                                                                                                                                                                                                    source url
                                                                                                                                                                                                    https://api.fda.gov/drug/label.json?search=id%3A%22228e1e3f-d207-481f-8e14-9fdcbd0470e9%22
                                                                                                                                                                                                    spl effective date
                                                                                                                                                                                                    2026-07-10
                                                                                                                                                                                                    spl set id
                                                                                                                                                                                                    9333c79b-d487-4538-a9f0-71b91a02b287
                                                                                                                                                                                                    spl version
                                                                                                                                                                                                    228
                                                                                                                                                                                                    structured fields status
                                                                                                                                                                                                    not_extracted_no_values_inferred_from_mentions
                                                                                                                                                                                                    structured indication
                                                                                                                                                                                                    age
                                                                                                                                                                                                    Source null
                                                                                                                                                                                                    approval pathway
                                                                                                                                                                                                    Source null
                                                                                                                                                                                                    biomarker and test
                                                                                                                                                                                                    Source null
                                                                                                                                                                                                    disease stage
                                                                                                                                                                                                    Source null
                                                                                                                                                                                                    limitations
                                                                                                                                                                                                    Source null
                                                                                                                                                                                                    line
                                                                                                                                                                                                    Source null
                                                                                                                                                                                                    prior therapy
                                                                                                                                                                                                    Source null
                                                                                                                                                                                                    regimen
                                                                                                                                                                                                    Source null
                                                                                                                                                                                                    tumor histology
                                                                                                                                                                                                    Source null
                                                                                                                                                                                                    use intent
                                                                                                                                                                                                    non_oncology_or_unclear_candidate
                                                                                                                                                                                                    Passage 76 · positive indication candidate
                                                                                                                                                                                                    application numbers
                                                                                                                                                                                                    1. BLA125514
                                                                                                                                                                                                    brand names
                                                                                                                                                                                                    1. KEYTRUDA
                                                                                                                                                                                                    classification reasons
                                                                                                                                                                                                    1. explicit_positive_indication_predicate
                                                                                                                                                                                                    2. tumor_or_malignant_hematology_words_in_positive_statement
                                                                                                                                                                                                    clinical review status
                                                                                                                                                                                                    pending
                                                                                                                                                                                                    content role
                                                                                                                                                                                                    positive_indication_candidate
                                                                                                                                                                                                    context span
                                                                                                                                                                                                    end
                                                                                                                                                                                                    14317
                                                                                                                                                                                                    end exclusive
                                                                                                                                                                                                    true
                                                                                                                                                                                                    exact text
                                                                                                                                                                                                    A, in combination with pemetrexed and platinum chemotherapy, is indicated for the first-line treatment of adult patients with unresectable advanced or metastatic malignant pleural mesothelioma (MPM). 1.4 Head and Neck Squamous Cell Cancer KEYTRUDA is indicated for the treatment of adult patients with resectable locally advanced HNSCC whose tumors express PD-L1 [Combined Positive Score (CPS) ≥1] as determined by an FDA-authorized test [see Dosage and Administration (2.1) ] , as a single agent as neoadjuvant treatment, continued as adjuvant treatment in combination with radiotherapy (RT) with or without cisplatin and then as a single agent. KEYTRUDA, in combination with platinum and fluorouracil (FU), is indicated for the first-line treatment of patients with metastatic or with unresectable, recurrent head and neck squamous cell carcino
                                                                                                                                                                                                    label id
                                                                                                                                                                                                    228e1e3f-d207-481f-8e14-9fdcbd0470e9
                                                                                                                                                                                                    offset unit
                                                                                                                                                                                                    unicode_code_points
                                                                                                                                                                                                    source array index
                                                                                                                                                                                                    0
                                                                                                                                                                                                    source field
                                                                                                                                                                                                    indications_and_usage_exact
                                                                                                                                                                                                    source text sha256
                                                                                                                                                                                                    e526ba14c91f10737e6d3331fe23a6219f58c0eca6380bfce9bd78b573fea912
                                                                                                                                                                                                    start
                                                                                                                                                                                                    13471
                                                                                                                                                                                                    current approval status
                                                                                                                                                                                                    not_reconciled
                                                                                                                                                                                                    duplicate text group
                                                                                                                                                                                                    dup-fcf31227be02b4f70f11
                                                                                                                                                                                                    extraction review status
                                                                                                                                                                                                    automated_candidate_pending_source_review
                                                                                                                                                                                                    generic names
                                                                                                                                                                                                    1. PEMBROLIZUMAB
                                                                                                                                                                                                    id
                                                                                                                                                                                                    ind-span-069ff596d2b12319b662
                                                                                                                                                                                                    label id
                                                                                                                                                                                                    228e1e3f-d207-481f-8e14-9fdcbd0470e9
                                                                                                                                                                                                    positive predicate support span
                                                                                                                                                                                                    end
                                                                                                                                                                                                    13731
                                                                                                                                                                                                    end exclusive
                                                                                                                                                                                                    true
                                                                                                                                                                                                    exact text
                                                                                                                                                                                                    is indicated
                                                                                                                                                                                                    label id
                                                                                                                                                                                                    228e1e3f-d207-481f-8e14-9fdcbd0470e9
                                                                                                                                                                                                    offset unit
                                                                                                                                                                                                    unicode_code_points
                                                                                                                                                                                                    source array index
                                                                                                                                                                                                    0
                                                                                                                                                                                                    source field
                                                                                                                                                                                                    indications_and_usage_exact
                                                                                                                                                                                                    source text sha256
                                                                                                                                                                                                    e526ba14c91f10737e6d3331fe23a6219f58c0eca6380bfce9bd78b573fea912
                                                                                                                                                                                                    start
                                                                                                                                                                                                    13719
                                                                                                                                                                                                    qualifier mentions
                                                                                                                                                                                                    1. context exact
                                                                                                                                                                                                      mous Cell Cancer KEYTRUDA is indicated for the treatment of adult patients with resectable locally advanced HNSCC whose tumors express
                                                                                                                                                                                                      kind
                                                                                                                                                                                                      age
                                                                                                                                                                                                      polarity
                                                                                                                                                                                                      not_inferred
                                                                                                                                                                                                      span
                                                                                                                                                                                                      end
                                                                                                                                                                                                      13767
                                                                                                                                                                                                      end exclusive
                                                                                                                                                                                                      true
                                                                                                                                                                                                      exact text
                                                                                                                                                                                                      adult patients
                                                                                                                                                                                                      label id
                                                                                                                                                                                                      228e1e3f-d207-481f-8e14-9fdcbd0470e9
                                                                                                                                                                                                      offset unit
                                                                                                                                                                                                      unicode_code_points
                                                                                                                                                                                                      source array index
                                                                                                                                                                                                      0
                                                                                                                                                                                                      source field
                                                                                                                                                                                                      indications_and_usage_exact
                                                                                                                                                                                                      source text sha256
                                                                                                                                                                                                      e526ba14c91f10737e6d3331fe23a6219f58c0eca6380bfce9bd78b573fea912
                                                                                                                                                                                                      start
                                                                                                                                                                                                      13753
                                                                                                                                                                                                    2. context exact
                                                                                                                                                                                                      with resectable locally advanced HNSCC whose tumors express PD-L1 [Combined Positive Score (CPS) ≥1] as determined by an FDA-authorized test [see Dosage and Administ
                                                                                                                                                                                                      kind
                                                                                                                                                                                                      biomarker
                                                                                                                                                                                                      polarity
                                                                                                                                                                                                      not_inferred
                                                                                                                                                                                                      span
                                                                                                                                                                                                      end
                                                                                                                                                                                                      13873
                                                                                                                                                                                                      end exclusive
                                                                                                                                                                                                      true
                                                                                                                                                                                                      exact text
                                                                                                                                                                                                      PD-L1 [Combined Positive Score (CPS) ≥1] as d
                                                                                                                                                                                                      label id
                                                                                                                                                                                                      228e1e3f-d207-481f-8e14-9fdcbd0470e9
                                                                                                                                                                                                      offset unit
                                                                                                                                                                                                      unicode_code_points
                                                                                                                                                                                                      source array index
                                                                                                                                                                                                      0
                                                                                                                                                                                                      source field
                                                                                                                                                                                                      indications_and_usage_exact
                                                                                                                                                                                                      source text sha256
                                                                                                                                                                                                      e526ba14c91f10737e6d3331fe23a6219f58c0eca6380bfce9bd78b573fea912
                                                                                                                                                                                                      start
                                                                                                                                                                                                      13828
                                                                                                                                                                                                    3. context exact
                                                                                                                                                                                                      TRUDA is indicated for the treatment of adult patients with resectable locally advanced HNSCC whose tumors express PD-L1 [Combined Positive Score (CPS) ≥1] as determ
                                                                                                                                                                                                      kind
                                                                                                                                                                                                      stage_or_setting
                                                                                                                                                                                                      polarity
                                                                                                                                                                                                      not_inferred
                                                                                                                                                                                                      span
                                                                                                                                                                                                      end
                                                                                                                                                                                                      13818
                                                                                                                                                                                                      end exclusive
                                                                                                                                                                                                      true
                                                                                                                                                                                                      exact text
                                                                                                                                                                                                      resectable locally advanced HNSCC whose tumor
                                                                                                                                                                                                      label id
                                                                                                                                                                                                      228e1e3f-d207-481f-8e14-9fdcbd0470e9
                                                                                                                                                                                                      offset unit
                                                                                                                                                                                                      unicode_code_points
                                                                                                                                                                                                      source array index
                                                                                                                                                                                                      0
                                                                                                                                                                                                      source field
                                                                                                                                                                                                      indications_and_usage_exact
                                                                                                                                                                                                      source text sha256
                                                                                                                                                                                                      e526ba14c91f10737e6d3331fe23a6219f58c0eca6380bfce9bd78b573fea912
                                                                                                                                                                                                      start
                                                                                                                                                                                                      13773
                                                                                                                                                                                                    4. context exact
                                                                                                                                                                                                      ee Dosage and Administration (2.1) ] , as a single agent as neoadjuvant treatment, continued as adjuvant treatment in combination with radiot
                                                                                                                                                                                                      kind
                                                                                                                                                                                                      stage_or_setting
                                                                                                                                                                                                      polarity
                                                                                                                                                                                                      not_inferred
                                                                                                                                                                                                      span
                                                                                                                                                                                                      end
                                                                                                                                                                                                      13992
                                                                                                                                                                                                      end exclusive
                                                                                                                                                                                                      true
                                                                                                                                                                                                      exact text
                                                                                                                                                                                                      neoadjuvant treatment
                                                                                                                                                                                                      label id
                                                                                                                                                                                                      228e1e3f-d207-481f-8e14-9fdcbd0470e9
                                                                                                                                                                                                      offset unit
                                                                                                                                                                                                      unicode_code_points
                                                                                                                                                                                                      source array index
                                                                                                                                                                                                      0
                                                                                                                                                                                                      source field
                                                                                                                                                                                                      indications_and_usage_exact
                                                                                                                                                                                                      source text sha256
                                                                                                                                                                                                      e526ba14c91f10737e6d3331fe23a6219f58c0eca6380bfce9bd78b573fea912
                                                                                                                                                                                                      start
                                                                                                                                                                                                      13971
                                                                                                                                                                                                    5. context exact
                                                                                                                                                                                                      , as a single agent as neoadjuvant treatment, continued as adjuvant treatment in combination with radiotherapy (RT) with or without cisplatin and then as a single
                                                                                                                                                                                                      kind
                                                                                                                                                                                                      stage_or_setting
                                                                                                                                                                                                      polarity
                                                                                                                                                                                                      not_inferred
                                                                                                                                                                                                      span
                                                                                                                                                                                                      end
                                                                                                                                                                                                      14050
                                                                                                                                                                                                      end exclusive
                                                                                                                                                                                                      true
                                                                                                                                                                                                      exact text
                                                                                                                                                                                                      adjuvant treatment in combination with radi
                                                                                                                                                                                                      label id
                                                                                                                                                                                                      228e1e3f-d207-481f-8e14-9fdcbd0470e9
                                                                                                                                                                                                      offset unit
                                                                                                                                                                                                      unicode_code_points
                                                                                                                                                                                                      source array index
                                                                                                                                                                                                      0
                                                                                                                                                                                                      source field
                                                                                                                                                                                                      indications_and_usage_exact
                                                                                                                                                                                                      source text sha256
                                                                                                                                                                                                      e526ba14c91f10737e6d3331fe23a6219f58c0eca6380bfce9bd78b573fea912
                                                                                                                                                                                                      start
                                                                                                                                                                                                      14007
                                                                                                                                                                                                    6. context exact
                                                                                                                                                                                                      DA-authorized test [see Dosage and Administration (2.1) ] , as a single agent as neoadjuvant treatment, continued as adjuvant treatment in combination with radiotherapy (RT) with or without cisplatin and then as a single agent.
                                                                                                                                                                                                      kind
                                                                                                                                                                                                      regimen
                                                                                                                                                                                                      polarity
                                                                                                                                                                                                      not_inferred
                                                                                                                                                                                                      span
                                                                                                                                                                                                      end
                                                                                                                                                                                                      14116
                                                                                                                                                                                                      end exclusive
                                                                                                                                                                                                      true
                                                                                                                                                                                                      exact text
                                                                                                                                                                                                      as a single agent as neoadjuvant treatment, continued as adjuvant treatment in combination with radiotherapy (RT) with or without cisplatin and then as a single agent
                                                                                                                                                                                                      label id
                                                                                                                                                                                                      228e1e3f-d207-481f-8e14-9fdcbd0470e9
                                                                                                                                                                                                      offset unit
                                                                                                                                                                                                      unicode_code_points
                                                                                                                                                                                                      source array index
                                                                                                                                                                                                      0
                                                                                                                                                                                                      source field
                                                                                                                                                                                                      indications_and_usage_exact
                                                                                                                                                                                                      source text sha256
                                                                                                                                                                                                      e526ba14c91f10737e6d3331fe23a6219f58c0eca6380bfce9bd78b573fea912
                                                                                                                                                                                                      start
                                                                                                                                                                                                      13950
                                                                                                                                                                                                    regulatory links
                                                                                                                                                                                                      schema version
                                                                                                                                                                                                      0.1.0
                                                                                                                                                                                                      source batch sha256
                                                                                                                                                                                                      fc39a8c5cf96bf95ca20b85578140167b66b2741f7d9217f500d9ba0847ac058
                                                                                                                                                                                                      source defined aliases
                                                                                                                                                                                                      1. abbreviation
                                                                                                                                                                                                        NSCLC
                                                                                                                                                                                                        definition exact
                                                                                                                                                                                                        Non-Small Cell Lung Cancer
                                                                                                                                                                                                        definition span
                                                                                                                                                                                                        end
                                                                                                                                                                                                        380
                                                                                                                                                                                                        end exclusive
                                                                                                                                                                                                        true
                                                                                                                                                                                                        exact text
                                                                                                                                                                                                        Non-Small Cell Lung Cancer (NSCLC)
                                                                                                                                                                                                        label id
                                                                                                                                                                                                        228e1e3f-d207-481f-8e14-9fdcbd0470e9
                                                                                                                                                                                                        offset unit
                                                                                                                                                                                                        unicode_code_points
                                                                                                                                                                                                        source array index
                                                                                                                                                                                                        0
                                                                                                                                                                                                        source field
                                                                                                                                                                                                        indications_and_usage_exact
                                                                                                                                                                                                        source text sha256
                                                                                                                                                                                                        e526ba14c91f10737e6d3331fe23a6219f58c0eca6380bfce9bd78b573fea912
                                                                                                                                                                                                        start
                                                                                                                                                                                                        346
                                                                                                                                                                                                      2. abbreviation
                                                                                                                                                                                                        CRC
                                                                                                                                                                                                        definition exact
                                                                                                                                                                                                        Colorectal Cancer
                                                                                                                                                                                                        definition span
                                                                                                                                                                                                        end
                                                                                                                                                                                                        5042
                                                                                                                                                                                                        end exclusive
                                                                                                                                                                                                        true
                                                                                                                                                                                                        exact text
                                                                                                                                                                                                        Colorectal Cancer (CRC)
                                                                                                                                                                                                        label id
                                                                                                                                                                                                        228e1e3f-d207-481f-8e14-9fdcbd0470e9
                                                                                                                                                                                                        offset unit
                                                                                                                                                                                                        unicode_code_points
                                                                                                                                                                                                        source array index
                                                                                                                                                                                                        0
                                                                                                                                                                                                        source field
                                                                                                                                                                                                        indications_and_usage_exact
                                                                                                                                                                                                        source text sha256
                                                                                                                                                                                                        e526ba14c91f10737e6d3331fe23a6219f58c0eca6380bfce9bd78b573fea912
                                                                                                                                                                                                        start
                                                                                                                                                                                                        5019
                                                                                                                                                                                                      source span
                                                                                                                                                                                                      end
                                                                                                                                                                                                      14117
                                                                                                                                                                                                      end exclusive
                                                                                                                                                                                                      true
                                                                                                                                                                                                      exact text
                                                                                                                                                                                                      1.4 Head and Neck Squamous Cell Cancer KEYTRUDA is indicated for the treatment of adult patients with resectable locally advanced HNSCC whose tumors express PD-L1 [Combined Positive Score (CPS) ≥1] as determined by an FDA-authorized test [see Dosage and Administration (2.1) ] , as a single agent as neoadjuvant treatment, continued as adjuvant treatment in combination with radiotherapy (RT) with or without cisplatin and then as a single agent.
                                                                                                                                                                                                      label id
                                                                                                                                                                                                      228e1e3f-d207-481f-8e14-9fdcbd0470e9
                                                                                                                                                                                                      offset unit
                                                                                                                                                                                                      unicode_code_points
                                                                                                                                                                                                      source array index
                                                                                                                                                                                                      0
                                                                                                                                                                                                      source field
                                                                                                                                                                                                      indications_and_usage_exact
                                                                                                                                                                                                      source text sha256
                                                                                                                                                                                                      e526ba14c91f10737e6d3331fe23a6219f58c0eca6380bfce9bd78b573fea912
                                                                                                                                                                                                      start
                                                                                                                                                                                                      13671
                                                                                                                                                                                                      source url
                                                                                                                                                                                                      https://api.fda.gov/drug/label.json?search=id%3A%22228e1e3f-d207-481f-8e14-9fdcbd0470e9%22
                                                                                                                                                                                                      spl effective date
                                                                                                                                                                                                      2026-07-10
                                                                                                                                                                                                      spl set id
                                                                                                                                                                                                      9333c79b-d487-4538-a9f0-71b91a02b287
                                                                                                                                                                                                      spl version
                                                                                                                                                                                                      228
                                                                                                                                                                                                      structured fields status
                                                                                                                                                                                                      not_extracted_no_values_inferred_from_mentions
                                                                                                                                                                                                      structured indication
                                                                                                                                                                                                      age
                                                                                                                                                                                                      Source null
                                                                                                                                                                                                      approval pathway
                                                                                                                                                                                                      Source null
                                                                                                                                                                                                      biomarker and test
                                                                                                                                                                                                      Source null
                                                                                                                                                                                                      disease stage
                                                                                                                                                                                                      Source null
                                                                                                                                                                                                      limitations
                                                                                                                                                                                                      Source null
                                                                                                                                                                                                      line
                                                                                                                                                                                                      Source null
                                                                                                                                                                                                      prior therapy
                                                                                                                                                                                                      Source null
                                                                                                                                                                                                      regimen
                                                                                                                                                                                                      Source null
                                                                                                                                                                                                      tumor histology
                                                                                                                                                                                                      Source null
                                                                                                                                                                                                      use intent
                                                                                                                                                                                                      tumor_directed_candidate
                                                                                                                                                                                                      Passage 77 · positive indication candidate
                                                                                                                                                                                                      application numbers
                                                                                                                                                                                                      1. BLA125514
                                                                                                                                                                                                      brand names
                                                                                                                                                                                                      1. KEYTRUDA
                                                                                                                                                                                                      classification reasons
                                                                                                                                                                                                      1. explicit_positive_indication_predicate
                                                                                                                                                                                                      2. tumor_or_malignant_hematology_words_in_positive_statement
                                                                                                                                                                                                      clinical review status
                                                                                                                                                                                                      pending
                                                                                                                                                                                                      content role
                                                                                                                                                                                                      positive_indication_candidate
                                                                                                                                                                                                      context span
                                                                                                                                                                                                      end
                                                                                                                                                                                                      14528
                                                                                                                                                                                                      end exclusive
                                                                                                                                                                                                      true
                                                                                                                                                                                                      exact text
                                                                                                                                                                                                      ge and Administration (2.1) ] , as a single agent as neoadjuvant treatment, continued as adjuvant treatment in combination with radiotherapy (RT) with or without cisplatin and then as a single agent. KEYTRUDA, in combination with platinum and fluorouracil (FU), is indicated for the first-line treatment of patients with metastatic or with unresectable, recurrent head and neck squamous cell carcinoma (HNSCC). KEYTRUDA, as a single agent, is indicated for the first-line treatment of patients with metastatic or with unresectable, recurrent HNSCC whose tumors express PD-L1 [Combined Positive Score (CPS) ≥1]
                                                                                                                                                                                                      label id
                                                                                                                                                                                                      228e1e3f-d207-481f-8e14-9fdcbd0470e9
                                                                                                                                                                                                      offset unit
                                                                                                                                                                                                      unicode_code_points
                                                                                                                                                                                                      source array index
                                                                                                                                                                                                      0
                                                                                                                                                                                                      source field
                                                                                                                                                                                                      indications_and_usage_exact
                                                                                                                                                                                                      source text sha256
                                                                                                                                                                                                      e526ba14c91f10737e6d3331fe23a6219f58c0eca6380bfce9bd78b573fea912
                                                                                                                                                                                                      start
                                                                                                                                                                                                      13918
                                                                                                                                                                                                      current approval status
                                                                                                                                                                                                      not_reconciled
                                                                                                                                                                                                      duplicate text group
                                                                                                                                                                                                      dup-67123fae2f72272002ab
                                                                                                                                                                                                      extraction review status
                                                                                                                                                                                                      automated_candidate_pending_source_review
                                                                                                                                                                                                      generic names
                                                                                                                                                                                                      1. PEMBROLIZUMAB
                                                                                                                                                                                                      id
                                                                                                                                                                                                      ind-span-59d7c0dbddf8ca194e9a
                                                                                                                                                                                                      label id
                                                                                                                                                                                                      228e1e3f-d207-481f-8e14-9fdcbd0470e9
                                                                                                                                                                                                      positive predicate support span
                                                                                                                                                                                                      end
                                                                                                                                                                                                      14192
                                                                                                                                                                                                      end exclusive
                                                                                                                                                                                                      true
                                                                                                                                                                                                      exact text
                                                                                                                                                                                                      is indicated
                                                                                                                                                                                                      label id
                                                                                                                                                                                                      228e1e3f-d207-481f-8e14-9fdcbd0470e9
                                                                                                                                                                                                      offset unit
                                                                                                                                                                                                      unicode_code_points
                                                                                                                                                                                                      source array index
                                                                                                                                                                                                      0
                                                                                                                                                                                                      source field
                                                                                                                                                                                                      indications_and_usage_exact
                                                                                                                                                                                                      source text sha256
                                                                                                                                                                                                      e526ba14c91f10737e6d3331fe23a6219f58c0eca6380bfce9bd78b573fea912
                                                                                                                                                                                                      start
                                                                                                                                                                                                      14180
                                                                                                                                                                                                      qualifier mentions
                                                                                                                                                                                                      1. context exact
                                                                                                                                                                                                        is indicated for the first-line treatment of patients with metastatic or with unresectable, recurrent head and neck squamous cell carcinoma (HNSCC).
                                                                                                                                                                                                        kind
                                                                                                                                                                                                        biomarker
                                                                                                                                                                                                        polarity
                                                                                                                                                                                                        not_inferred
                                                                                                                                                                                                        span
                                                                                                                                                                                                        end
                                                                                                                                                                                                        14270
                                                                                                                                                                                                        end exclusive
                                                                                                                                                                                                        true
                                                                                                                                                                                                        exact text
                                                                                                                                                                                                        metastatic or with unresectable
                                                                                                                                                                                                        label id
                                                                                                                                                                                                        228e1e3f-d207-481f-8e14-9fdcbd0470e9
                                                                                                                                                                                                        offset unit
                                                                                                                                                                                                        unicode_code_points
                                                                                                                                                                                                        source array index
                                                                                                                                                                                                        0
                                                                                                                                                                                                        source field
                                                                                                                                                                                                        indications_and_usage_exact
                                                                                                                                                                                                        source text sha256
                                                                                                                                                                                                        e526ba14c91f10737e6d3331fe23a6219f58c0eca6380bfce9bd78b573fea912
                                                                                                                                                                                                        start
                                                                                                                                                                                                        14239
                                                                                                                                                                                                      2. context exact
                                                                                                                                                                                                        is indicated for the first-line treatment of patients with metastatic or with unresectable, recurrent head and neck squamous cell carcinoma (HNSCC).
                                                                                                                                                                                                        kind
                                                                                                                                                                                                        stage_or_setting
                                                                                                                                                                                                        polarity
                                                                                                                                                                                                        not_inferred
                                                                                                                                                                                                        span
                                                                                                                                                                                                        end
                                                                                                                                                                                                        14270
                                                                                                                                                                                                        end exclusive
                                                                                                                                                                                                        true
                                                                                                                                                                                                        exact text
                                                                                                                                                                                                        metastatic or with unresectable
                                                                                                                                                                                                        label id
                                                                                                                                                                                                        228e1e3f-d207-481f-8e14-9fdcbd0470e9
                                                                                                                                                                                                        offset unit
                                                                                                                                                                                                        unicode_code_points
                                                                                                                                                                                                        source array index
                                                                                                                                                                                                        0
                                                                                                                                                                                                        source field
                                                                                                                                                                                                        indications_and_usage_exact
                                                                                                                                                                                                        source text sha256
                                                                                                                                                                                                        e526ba14c91f10737e6d3331fe23a6219f58c0eca6380bfce9bd78b573fea912
                                                                                                                                                                                                        start
                                                                                                                                                                                                        14239
                                                                                                                                                                                                      3. context exact
                                                                                                                                                                                                        treatment of patients with metastatic or with unresectable, recurrent head and neck squamous cell carcinoma (HNSCC).
                                                                                                                                                                                                        kind
                                                                                                                                                                                                        stage_or_setting
                                                                                                                                                                                                        polarity
                                                                                                                                                                                                        not_inferred
                                                                                                                                                                                                        span
                                                                                                                                                                                                        end
                                                                                                                                                                                                        14316
                                                                                                                                                                                                        end exclusive
                                                                                                                                                                                                        true
                                                                                                                                                                                                        exact text
                                                                                                                                                                                                        recurrent head and neck squamous cell carcin
                                                                                                                                                                                                        label id
                                                                                                                                                                                                        228e1e3f-d207-481f-8e14-9fdcbd0470e9
                                                                                                                                                                                                        offset unit
                                                                                                                                                                                                        unicode_code_points
                                                                                                                                                                                                        source array index
                                                                                                                                                                                                        0
                                                                                                                                                                                                        source field
                                                                                                                                                                                                        indications_and_usage_exact
                                                                                                                                                                                                        source text sha256
                                                                                                                                                                                                        e526ba14c91f10737e6d3331fe23a6219f58c0eca6380bfce9bd78b573fea912
                                                                                                                                                                                                        start
                                                                                                                                                                                                        14272
                                                                                                                                                                                                      4. context exact
                                                                                                                                                                                                        n with platinum and fluorouracil (FU), is indicated for the first-line treatment of patients with metastatic or with unresectable, recurrent head and neck squamous cell carcinoma (HNSCC).
                                                                                                                                                                                                        kind
                                                                                                                                                                                                        prior_therapy_or_line
                                                                                                                                                                                                        polarity
                                                                                                                                                                                                        not_inferred
                                                                                                                                                                                                        span
                                                                                                                                                                                                        end
                                                                                                                                                                                                        14327
                                                                                                                                                                                                        end exclusive
                                                                                                                                                                                                        true
                                                                                                                                                                                                        exact text
                                                                                                                                                                                                        first-line treatment of patients with metastatic or with unresectable, recurrent head and neck squamous cell carcinoma (HNSCC)
                                                                                                                                                                                                        label id
                                                                                                                                                                                                        228e1e3f-d207-481f-8e14-9fdcbd0470e9
                                                                                                                                                                                                        offset unit
                                                                                                                                                                                                        unicode_code_points
                                                                                                                                                                                                        source array index
                                                                                                                                                                                                        0
                                                                                                                                                                                                        source field
                                                                                                                                                                                                        indications_and_usage_exact
                                                                                                                                                                                                        source text sha256
                                                                                                                                                                                                        e526ba14c91f10737e6d3331fe23a6219f58c0eca6380bfce9bd78b573fea912
                                                                                                                                                                                                        start
                                                                                                                                                                                                        14201
                                                                                                                                                                                                      5. context exact
                                                                                                                                                                                                        KEYTRUDA, in combination with platinum and fluorouracil (FU), is indicated for the first-line treatment of patients with metastatic or with unresectable, recurrent head and neck squamous cell carcinoma (HNSCC).
                                                                                                                                                                                                        kind
                                                                                                                                                                                                        regimen
                                                                                                                                                                                                        polarity
                                                                                                                                                                                                        not_inferred
                                                                                                                                                                                                        span
                                                                                                                                                                                                        end
                                                                                                                                                                                                        14307
                                                                                                                                                                                                        end exclusive
                                                                                                                                                                                                        true
                                                                                                                                                                                                        exact text
                                                                                                                                                                                                        in combination with platinum and fluorouracil (FU), is indicated for the first-line treatment of patients with metastatic or with unresectable, recurrent head and neck squamous ce
                                                                                                                                                                                                        label id
                                                                                                                                                                                                        228e1e3f-d207-481f-8e14-9fdcbd0470e9
                                                                                                                                                                                                        offset unit
                                                                                                                                                                                                        unicode_code_points
                                                                                                                                                                                                        source array index
                                                                                                                                                                                                        0
                                                                                                                                                                                                        source field
                                                                                                                                                                                                        indications_and_usage_exact
                                                                                                                                                                                                        source text sha256
                                                                                                                                                                                                        e526ba14c91f10737e6d3331fe23a6219f58c0eca6380bfce9bd78b573fea912
                                                                                                                                                                                                        start
                                                                                                                                                                                                        14128
                                                                                                                                                                                                      regulatory links
                                                                                                                                                                                                        schema version
                                                                                                                                                                                                        0.1.0
                                                                                                                                                                                                        source batch sha256
                                                                                                                                                                                                        fc39a8c5cf96bf95ca20b85578140167b66b2741f7d9217f500d9ba0847ac058
                                                                                                                                                                                                        source defined aliases
                                                                                                                                                                                                        1. abbreviation
                                                                                                                                                                                                          NSCLC
                                                                                                                                                                                                          definition exact
                                                                                                                                                                                                          Non-Small Cell Lung Cancer
                                                                                                                                                                                                          definition span
                                                                                                                                                                                                          end
                                                                                                                                                                                                          380
                                                                                                                                                                                                          end exclusive
                                                                                                                                                                                                          true
                                                                                                                                                                                                          exact text
                                                                                                                                                                                                          Non-Small Cell Lung Cancer (NSCLC)
                                                                                                                                                                                                          label id
                                                                                                                                                                                                          228e1e3f-d207-481f-8e14-9fdcbd0470e9
                                                                                                                                                                                                          offset unit
                                                                                                                                                                                                          unicode_code_points
                                                                                                                                                                                                          source array index
                                                                                                                                                                                                          0
                                                                                                                                                                                                          source field
                                                                                                                                                                                                          indications_and_usage_exact
                                                                                                                                                                                                          source text sha256
                                                                                                                                                                                                          e526ba14c91f10737e6d3331fe23a6219f58c0eca6380bfce9bd78b573fea912
                                                                                                                                                                                                          start
                                                                                                                                                                                                          346
                                                                                                                                                                                                        2. abbreviation
                                                                                                                                                                                                          CRC
                                                                                                                                                                                                          definition exact
                                                                                                                                                                                                          Colorectal Cancer
                                                                                                                                                                                                          definition span
                                                                                                                                                                                                          end
                                                                                                                                                                                                          5042
                                                                                                                                                                                                          end exclusive
                                                                                                                                                                                                          true
                                                                                                                                                                                                          exact text
                                                                                                                                                                                                          Colorectal Cancer (CRC)
                                                                                                                                                                                                          label id
                                                                                                                                                                                                          228e1e3f-d207-481f-8e14-9fdcbd0470e9
                                                                                                                                                                                                          offset unit
                                                                                                                                                                                                          unicode_code_points
                                                                                                                                                                                                          source array index
                                                                                                                                                                                                          0
                                                                                                                                                                                                          source field
                                                                                                                                                                                                          indications_and_usage_exact
                                                                                                                                                                                                          source text sha256
                                                                                                                                                                                                          e526ba14c91f10737e6d3331fe23a6219f58c0eca6380bfce9bd78b573fea912
                                                                                                                                                                                                          start
                                                                                                                                                                                                          5019
                                                                                                                                                                                                        source span
                                                                                                                                                                                                        end
                                                                                                                                                                                                        14328
                                                                                                                                                                                                        end exclusive
                                                                                                                                                                                                        true
                                                                                                                                                                                                        exact text
                                                                                                                                                                                                        KEYTRUDA, in combination with platinum and fluorouracil (FU), is indicated for the first-line treatment of patients with metastatic or with unresectable, recurrent head and neck squamous cell carcinoma (HNSCC).
                                                                                                                                                                                                        label id
                                                                                                                                                                                                        228e1e3f-d207-481f-8e14-9fdcbd0470e9
                                                                                                                                                                                                        offset unit
                                                                                                                                                                                                        unicode_code_points
                                                                                                                                                                                                        source array index
                                                                                                                                                                                                        0
                                                                                                                                                                                                        source field
                                                                                                                                                                                                        indications_and_usage_exact
                                                                                                                                                                                                        source text sha256
                                                                                                                                                                                                        e526ba14c91f10737e6d3331fe23a6219f58c0eca6380bfce9bd78b573fea912
                                                                                                                                                                                                        start
                                                                                                                                                                                                        14118
                                                                                                                                                                                                        source url
                                                                                                                                                                                                        https://api.fda.gov/drug/label.json?search=id%3A%22228e1e3f-d207-481f-8e14-9fdcbd0470e9%22
                                                                                                                                                                                                        spl effective date
                                                                                                                                                                                                        2026-07-10
                                                                                                                                                                                                        spl set id
                                                                                                                                                                                                        9333c79b-d487-4538-a9f0-71b91a02b287
                                                                                                                                                                                                        spl version
                                                                                                                                                                                                        228
                                                                                                                                                                                                        structured fields status
                                                                                                                                                                                                        not_extracted_no_values_inferred_from_mentions
                                                                                                                                                                                                        structured indication
                                                                                                                                                                                                        age
                                                                                                                                                                                                        Source null
                                                                                                                                                                                                        approval pathway
                                                                                                                                                                                                        Source null
                                                                                                                                                                                                        biomarker and test
                                                                                                                                                                                                        Source null
                                                                                                                                                                                                        disease stage
                                                                                                                                                                                                        Source null
                                                                                                                                                                                                        limitations
                                                                                                                                                                                                        Source null
                                                                                                                                                                                                        line
                                                                                                                                                                                                        Source null
                                                                                                                                                                                                        prior therapy
                                                                                                                                                                                                        Source null
                                                                                                                                                                                                        regimen
                                                                                                                                                                                                        Source null
                                                                                                                                                                                                        tumor histology
                                                                                                                                                                                                        Source null
                                                                                                                                                                                                        use intent
                                                                                                                                                                                                        tumor_directed_candidate
                                                                                                                                                                                                        Passage 78 · positive indication candidate
                                                                                                                                                                                                        application numbers
                                                                                                                                                                                                        1. BLA125514
                                                                                                                                                                                                        brand names
                                                                                                                                                                                                        1. KEYTRUDA
                                                                                                                                                                                                        classification reasons
                                                                                                                                                                                                        1. explicit_positive_indication_predicate
                                                                                                                                                                                                        2. tumor_or_malignant_hematology_words_in_positive_statement
                                                                                                                                                                                                        clinical review status
                                                                                                                                                                                                        pending
                                                                                                                                                                                                        content role
                                                                                                                                                                                                        positive_indication_candidate
                                                                                                                                                                                                        context span
                                                                                                                                                                                                        end
                                                                                                                                                                                                        14808
                                                                                                                                                                                                        end exclusive
                                                                                                                                                                                                        true
                                                                                                                                                                                                        exact text
                                                                                                                                                                                                        n combination with platinum and fluorouracil (FU), is indicated for the first-line treatment of patients with metastatic or with unresectable, recurrent head and neck squamous cell carcinoma (HNSCC). KEYTRUDA, as a single agent, is indicated for the first-line treatment of patients with metastatic or with unresectable, recurrent HNSCC whose tumors express PD-L1 [Combined Positive Score (CPS) ≥1] as determined by an FDA-authorized test [see Dosage and Administration (2.1) ] . KEYTRUDA, as a single agent, is indicated for the treatment of patients with recurrent or metastatic HNSCC with disease progression on or after platinum-containing chemotherapy. 1.5 Classical Hodgkin
                                                                                                                                                                                                        label id
                                                                                                                                                                                                        228e1e3f-d207-481f-8e14-9fdcbd0470e9
                                                                                                                                                                                                        offset unit
                                                                                                                                                                                                        unicode_code_points
                                                                                                                                                                                                        source array index
                                                                                                                                                                                                        0
                                                                                                                                                                                                        source field
                                                                                                                                                                                                        indications_and_usage_exact
                                                                                                                                                                                                        source text sha256
                                                                                                                                                                                                        e526ba14c91f10737e6d3331fe23a6219f58c0eca6380bfce9bd78b573fea912
                                                                                                                                                                                                        start
                                                                                                                                                                                                        14129
                                                                                                                                                                                                        current approval status
                                                                                                                                                                                                        not_reconciled
                                                                                                                                                                                                        duplicate text group
                                                                                                                                                                                                        dup-b1c0adbb640f777a5c79
                                                                                                                                                                                                        extraction review status
                                                                                                                                                                                                        automated_candidate_pending_source_review
                                                                                                                                                                                                        generic names
                                                                                                                                                                                                        1. PEMBROLIZUMAB
                                                                                                                                                                                                        id
                                                                                                                                                                                                        ind-span-21c0cda6ef42b606d888
                                                                                                                                                                                                        label id
                                                                                                                                                                                                        228e1e3f-d207-481f-8e14-9fdcbd0470e9
                                                                                                                                                                                                        positive predicate support span
                                                                                                                                                                                                        end
                                                                                                                                                                                                        14370
                                                                                                                                                                                                        end exclusive
                                                                                                                                                                                                        true
                                                                                                                                                                                                        exact text
                                                                                                                                                                                                        is indicated
                                                                                                                                                                                                        label id
                                                                                                                                                                                                        228e1e3f-d207-481f-8e14-9fdcbd0470e9
                                                                                                                                                                                                        offset unit
                                                                                                                                                                                                        unicode_code_points
                                                                                                                                                                                                        source array index
                                                                                                                                                                                                        0
                                                                                                                                                                                                        source field
                                                                                                                                                                                                        indications_and_usage_exact
                                                                                                                                                                                                        source text sha256
                                                                                                                                                                                                        e526ba14c91f10737e6d3331fe23a6219f58c0eca6380bfce9bd78b573fea912
                                                                                                                                                                                                        start
                                                                                                                                                                                                        14358
                                                                                                                                                                                                        qualifier mentions
                                                                                                                                                                                                        1. context exact
                                                                                                                                                                                                          is indicated for the first-line treatment of patients with metastatic or with unresectable, recurrent HNSCC whose tumors express PD-L1 [Combined Posit
                                                                                                                                                                                                          kind
                                                                                                                                                                                                          biomarker
                                                                                                                                                                                                          polarity
                                                                                                                                                                                                          not_inferred
                                                                                                                                                                                                          span
                                                                                                                                                                                                          end
                                                                                                                                                                                                          14448
                                                                                                                                                                                                          end exclusive
                                                                                                                                                                                                          true
                                                                                                                                                                                                          exact text
                                                                                                                                                                                                          metastatic or with unresectable
                                                                                                                                                                                                          label id
                                                                                                                                                                                                          228e1e3f-d207-481f-8e14-9fdcbd0470e9
                                                                                                                                                                                                          offset unit
                                                                                                                                                                                                          unicode_code_points
                                                                                                                                                                                                          source array index
                                                                                                                                                                                                          0
                                                                                                                                                                                                          source field
                                                                                                                                                                                                          indications_and_usage_exact
                                                                                                                                                                                                          source text sha256
                                                                                                                                                                                                          e526ba14c91f10737e6d3331fe23a6219f58c0eca6380bfce9bd78b573fea912
                                                                                                                                                                                                          start
                                                                                                                                                                                                          14417
                                                                                                                                                                                                        2. context exact
                                                                                                                                                                                                          or with unresectable, recurrent HNSCC whose tumors express PD-L1 [Combined Positive Score (CPS) ≥1] as determined by an FDA-authorized test [see Dosage and Administ
                                                                                                                                                                                                          kind
                                                                                                                                                                                                          biomarker
                                                                                                                                                                                                          polarity
                                                                                                                                                                                                          not_inferred
                                                                                                                                                                                                          span
                                                                                                                                                                                                          end
                                                                                                                                                                                                          14532
                                                                                                                                                                                                          end exclusive
                                                                                                                                                                                                          true
                                                                                                                                                                                                          exact text
                                                                                                                                                                                                          PD-L1 [Combined Positive Score (CPS) ≥1] as d
                                                                                                                                                                                                          label id
                                                                                                                                                                                                          228e1e3f-d207-481f-8e14-9fdcbd0470e9
                                                                                                                                                                                                          offset unit
                                                                                                                                                                                                          unicode_code_points
                                                                                                                                                                                                          source array index
                                                                                                                                                                                                          0
                                                                                                                                                                                                          source field
                                                                                                                                                                                                          indications_and_usage_exact
                                                                                                                                                                                                          source text sha256
                                                                                                                                                                                                          e526ba14c91f10737e6d3331fe23a6219f58c0eca6380bfce9bd78b573fea912
                                                                                                                                                                                                          start
                                                                                                                                                                                                          14487
                                                                                                                                                                                                        3. context exact
                                                                                                                                                                                                          is indicated for the first-line treatment of patients with metastatic or with unresectable, recurrent HNSCC whose tumors express PD-L1 [Combined Posit
                                                                                                                                                                                                          kind
                                                                                                                                                                                                          stage_or_setting
                                                                                                                                                                                                          polarity
                                                                                                                                                                                                          not_inferred
                                                                                                                                                                                                          span
                                                                                                                                                                                                          end
                                                                                                                                                                                                          14448
                                                                                                                                                                                                          end exclusive
                                                                                                                                                                                                          true
                                                                                                                                                                                                          exact text
                                                                                                                                                                                                          metastatic or with unresectable
                                                                                                                                                                                                          label id
                                                                                                                                                                                                          228e1e3f-d207-481f-8e14-9fdcbd0470e9
                                                                                                                                                                                                          offset unit
                                                                                                                                                                                                          unicode_code_points
                                                                                                                                                                                                          source array index
                                                                                                                                                                                                          0
                                                                                                                                                                                                          source field
                                                                                                                                                                                                          indications_and_usage_exact
                                                                                                                                                                                                          source text sha256
                                                                                                                                                                                                          e526ba14c91f10737e6d3331fe23a6219f58c0eca6380bfce9bd78b573fea912
                                                                                                                                                                                                          start
                                                                                                                                                                                                          14417
                                                                                                                                                                                                        4. context exact
                                                                                                                                                                                                          treatment of patients with metastatic or with unresectable, recurrent HNSCC whose tumors express PD-L1 [Combined Positive Score (CPS) ≥1] as determined by an FDA-au
                                                                                                                                                                                                          kind
                                                                                                                                                                                                          stage_or_setting
                                                                                                                                                                                                          polarity
                                                                                                                                                                                                          not_inferred
                                                                                                                                                                                                          span
                                                                                                                                                                                                          end
                                                                                                                                                                                                          14494
                                                                                                                                                                                                          end exclusive
                                                                                                                                                                                                          true
                                                                                                                                                                                                          exact text
                                                                                                                                                                                                          recurrent HNSCC whose tumors express PD-L1 [
                                                                                                                                                                                                          label id
                                                                                                                                                                                                          228e1e3f-d207-481f-8e14-9fdcbd0470e9
                                                                                                                                                                                                          offset unit
                                                                                                                                                                                                          unicode_code_points
                                                                                                                                                                                                          source array index
                                                                                                                                                                                                          0
                                                                                                                                                                                                          source field
                                                                                                                                                                                                          indications_and_usage_exact
                                                                                                                                                                                                          source text sha256
                                                                                                                                                                                                          e526ba14c91f10737e6d3331fe23a6219f58c0eca6380bfce9bd78b573fea912
                                                                                                                                                                                                          start
                                                                                                                                                                                                          14450
                                                                                                                                                                                                        5. context exact
                                                                                                                                                                                                          KEYTRUDA, as a single agent, is indicated for the first-line treatment of patients with metastatic or with unresectable, recurrent HNSCC whose tumors express PD-L1 [Combined Positive Score (CPS) ≥1] as determined by an FDA-authorized test [see Dosage and Administration (2.1) ] .
                                                                                                                                                                                                          kind
                                                                                                                                                                                                          prior_therapy_or_line
                                                                                                                                                                                                          polarity
                                                                                                                                                                                                          not_inferred
                                                                                                                                                                                                          span
                                                                                                                                                                                                          end
                                                                                                                                                                                                          14549
                                                                                                                                                                                                          end exclusive
                                                                                                                                                                                                          true
                                                                                                                                                                                                          exact text
                                                                                                                                                                                                          first-line treatment of patients with metastatic or with unresectable, recurrent HNSCC whose tumors express PD-L1 [Combined Positive Score (CPS) ≥1] as determined by an F
                                                                                                                                                                                                          label id
                                                                                                                                                                                                          228e1e3f-d207-481f-8e14-9fdcbd0470e9
                                                                                                                                                                                                          offset unit
                                                                                                                                                                                                          unicode_code_points
                                                                                                                                                                                                          source array index
                                                                                                                                                                                                          0
                                                                                                                                                                                                          source field
                                                                                                                                                                                                          indications_and_usage_exact
                                                                                                                                                                                                          source text sha256
                                                                                                                                                                                                          e526ba14c91f10737e6d3331fe23a6219f58c0eca6380bfce9bd78b573fea912
                                                                                                                                                                                                          start
                                                                                                                                                                                                          14379
                                                                                                                                                                                                        6. context exact
                                                                                                                                                                                                          KEYTRUDA, as a single agent, is indicated for the first-line treatment of patients with metastatic or with unresectable, recurrent HNSCC whose tumors express PD-L1 [Combined Positive Score (CPS) ≥1] as determined by an FDA-authorized test [see Dos
                                                                                                                                                                                                          kind
                                                                                                                                                                                                          regimen
                                                                                                                                                                                                          polarity
                                                                                                                                                                                                          not_inferred
                                                                                                                                                                                                          span
                                                                                                                                                                                                          end
                                                                                                                                                                                                          14516
                                                                                                                                                                                                          end exclusive
                                                                                                                                                                                                          true
                                                                                                                                                                                                          exact text
                                                                                                                                                                                                          as a single agent, is indicated for the first-line treatment of patients with metastatic or with unresectable, recurrent HNSCC whose tumors express PD-L1 [Combined Positive Scor
                                                                                                                                                                                                          label id
                                                                                                                                                                                                          228e1e3f-d207-481f-8e14-9fdcbd0470e9
                                                                                                                                                                                                          offset unit
                                                                                                                                                                                                          unicode_code_points
                                                                                                                                                                                                          source array index
                                                                                                                                                                                                          0
                                                                                                                                                                                                          source field
                                                                                                                                                                                                          indications_and_usage_exact
                                                                                                                                                                                                          source text sha256
                                                                                                                                                                                                          e526ba14c91f10737e6d3331fe23a6219f58c0eca6380bfce9bd78b573fea912
                                                                                                                                                                                                          start
                                                                                                                                                                                                          14339
                                                                                                                                                                                                        regulatory links
                                                                                                                                                                                                          schema version
                                                                                                                                                                                                          0.1.0
                                                                                                                                                                                                          source batch sha256
                                                                                                                                                                                                          fc39a8c5cf96bf95ca20b85578140167b66b2741f7d9217f500d9ba0847ac058
                                                                                                                                                                                                          source defined aliases
                                                                                                                                                                                                          1. abbreviation
                                                                                                                                                                                                            NSCLC
                                                                                                                                                                                                            definition exact
                                                                                                                                                                                                            Non-Small Cell Lung Cancer
                                                                                                                                                                                                            definition span
                                                                                                                                                                                                            end
                                                                                                                                                                                                            380
                                                                                                                                                                                                            end exclusive
                                                                                                                                                                                                            true
                                                                                                                                                                                                            exact text
                                                                                                                                                                                                            Non-Small Cell Lung Cancer (NSCLC)
                                                                                                                                                                                                            label id
                                                                                                                                                                                                            228e1e3f-d207-481f-8e14-9fdcbd0470e9
                                                                                                                                                                                                            offset unit
                                                                                                                                                                                                            unicode_code_points
                                                                                                                                                                                                            source array index
                                                                                                                                                                                                            0
                                                                                                                                                                                                            source field
                                                                                                                                                                                                            indications_and_usage_exact
                                                                                                                                                                                                            source text sha256
                                                                                                                                                                                                            e526ba14c91f10737e6d3331fe23a6219f58c0eca6380bfce9bd78b573fea912
                                                                                                                                                                                                            start
                                                                                                                                                                                                            346
                                                                                                                                                                                                          2. abbreviation
                                                                                                                                                                                                            CRC
                                                                                                                                                                                                            definition exact
                                                                                                                                                                                                            Colorectal Cancer
                                                                                                                                                                                                            definition span
                                                                                                                                                                                                            end
                                                                                                                                                                                                            5042
                                                                                                                                                                                                            end exclusive
                                                                                                                                                                                                            true
                                                                                                                                                                                                            exact text
                                                                                                                                                                                                            Colorectal Cancer (CRC)
                                                                                                                                                                                                            label id
                                                                                                                                                                                                            228e1e3f-d207-481f-8e14-9fdcbd0470e9
                                                                                                                                                                                                            offset unit
                                                                                                                                                                                                            unicode_code_points
                                                                                                                                                                                                            source array index
                                                                                                                                                                                                            0
                                                                                                                                                                                                            source field
                                                                                                                                                                                                            indications_and_usage_exact
                                                                                                                                                                                                            source text sha256
                                                                                                                                                                                                            e526ba14c91f10737e6d3331fe23a6219f58c0eca6380bfce9bd78b573fea912
                                                                                                                                                                                                            start
                                                                                                                                                                                                            5019
                                                                                                                                                                                                          source span
                                                                                                                                                                                                          end
                                                                                                                                                                                                          14608
                                                                                                                                                                                                          end exclusive
                                                                                                                                                                                                          true
                                                                                                                                                                                                          exact text
                                                                                                                                                                                                          KEYTRUDA, as a single agent, is indicated for the first-line treatment of patients with metastatic or with unresectable, recurrent HNSCC whose tumors express PD-L1 [Combined Positive Score (CPS) ≥1] as determined by an FDA-authorized test [see Dosage and Administration (2.1) ] .
                                                                                                                                                                                                          label id
                                                                                                                                                                                                          228e1e3f-d207-481f-8e14-9fdcbd0470e9
                                                                                                                                                                                                          offset unit
                                                                                                                                                                                                          unicode_code_points
                                                                                                                                                                                                          source array index
                                                                                                                                                                                                          0
                                                                                                                                                                                                          source field
                                                                                                                                                                                                          indications_and_usage_exact
                                                                                                                                                                                                          source text sha256
                                                                                                                                                                                                          e526ba14c91f10737e6d3331fe23a6219f58c0eca6380bfce9bd78b573fea912
                                                                                                                                                                                                          start
                                                                                                                                                                                                          14329
                                                                                                                                                                                                          source url
                                                                                                                                                                                                          https://api.fda.gov/drug/label.json?search=id%3A%22228e1e3f-d207-481f-8e14-9fdcbd0470e9%22
                                                                                                                                                                                                          spl effective date
                                                                                                                                                                                                          2026-07-10
                                                                                                                                                                                                          spl set id
                                                                                                                                                                                                          9333c79b-d487-4538-a9f0-71b91a02b287
                                                                                                                                                                                                          spl version
                                                                                                                                                                                                          228
                                                                                                                                                                                                          structured fields status
                                                                                                                                                                                                          not_extracted_no_values_inferred_from_mentions
                                                                                                                                                                                                          structured indication
                                                                                                                                                                                                          age
                                                                                                                                                                                                          Source null
                                                                                                                                                                                                          approval pathway
                                                                                                                                                                                                          Source null
                                                                                                                                                                                                          biomarker and test
                                                                                                                                                                                                          Source null
                                                                                                                                                                                                          disease stage
                                                                                                                                                                                                          Source null
                                                                                                                                                                                                          limitations
                                                                                                                                                                                                          Source null
                                                                                                                                                                                                          line
                                                                                                                                                                                                          Source null
                                                                                                                                                                                                          prior therapy
                                                                                                                                                                                                          Source null
                                                                                                                                                                                                          regimen
                                                                                                                                                                                                          Source null
                                                                                                                                                                                                          tumor histology
                                                                                                                                                                                                          Source null
                                                                                                                                                                                                          use intent
                                                                                                                                                                                                          tumor_directed_candidate
                                                                                                                                                                                                          Passage 79 · positive indication candidate
                                                                                                                                                                                                          application numbers
                                                                                                                                                                                                          1. BLA125514
                                                                                                                                                                                                          brand names
                                                                                                                                                                                                          1. KEYTRUDA
                                                                                                                                                                                                          classification reasons
                                                                                                                                                                                                          1. explicit_positive_indication_predicate
                                                                                                                                                                                                          2. no_tumor_directed_keyword_in_positive_statement
                                                                                                                                                                                                          clinical review status
                                                                                                                                                                                                          pending
                                                                                                                                                                                                          content role
                                                                                                                                                                                                          positive_indication_candidate
                                                                                                                                                                                                          context span
                                                                                                                                                                                                          end
                                                                                                                                                                                                          14986
                                                                                                                                                                                                          end exclusive
                                                                                                                                                                                                          true
                                                                                                                                                                                                          exact text
                                                                                                                                                                                                          ts with metastatic or with unresectable, recurrent HNSCC whose tumors express PD-L1 [Combined Positive Score (CPS) ≥1] as determined by an FDA-authorized test [see Dosage and Administration (2.1) ] . KEYTRUDA, as a single agent, is indicated for the treatment of patients with recurrent or metastatic HNSCC with disease progression on or after platinum-containing chemotherapy. 1.5 Classical Hodgkin Lymphoma KEYTRUDA is indicated for the treatment of adult patients with relapsed or refractory classical Hodgkin lymphoma (cHL). KEYTRUDA is indicated for the treatment of pedia
                                                                                                                                                                                                          label id
                                                                                                                                                                                                          228e1e3f-d207-481f-8e14-9fdcbd0470e9
                                                                                                                                                                                                          offset unit
                                                                                                                                                                                                          unicode_code_points
                                                                                                                                                                                                          source array index
                                                                                                                                                                                                          0
                                                                                                                                                                                                          source field
                                                                                                                                                                                                          indications_and_usage_exact
                                                                                                                                                                                                          source text sha256
                                                                                                                                                                                                          e526ba14c91f10737e6d3331fe23a6219f58c0eca6380bfce9bd78b573fea912
                                                                                                                                                                                                          start
                                                                                                                                                                                                          14409
                                                                                                                                                                                                          current approval status
                                                                                                                                                                                                          not_reconciled
                                                                                                                                                                                                          duplicate text group
                                                                                                                                                                                                          dup-12e1a0ec5c6fbb920426
                                                                                                                                                                                                          extraction review status
                                                                                                                                                                                                          automated_candidate_pending_source_review
                                                                                                                                                                                                          generic names
                                                                                                                                                                                                          1. PEMBROLIZUMAB
                                                                                                                                                                                                          id
                                                                                                                                                                                                          ind-span-c1bd61f85a8d805bccb6
                                                                                                                                                                                                          label id
                                                                                                                                                                                                          228e1e3f-d207-481f-8e14-9fdcbd0470e9
                                                                                                                                                                                                          positive predicate support span
                                                                                                                                                                                                          end
                                                                                                                                                                                                          14650
                                                                                                                                                                                                          end exclusive
                                                                                                                                                                                                          true
                                                                                                                                                                                                          exact text
                                                                                                                                                                                                          is indicated
                                                                                                                                                                                                          label id
                                                                                                                                                                                                          228e1e3f-d207-481f-8e14-9fdcbd0470e9
                                                                                                                                                                                                          offset unit
                                                                                                                                                                                                          unicode_code_points
                                                                                                                                                                                                          source array index
                                                                                                                                                                                                          0
                                                                                                                                                                                                          source field
                                                                                                                                                                                                          indications_and_usage_exact
                                                                                                                                                                                                          source text sha256
                                                                                                                                                                                                          e526ba14c91f10737e6d3331fe23a6219f58c0eca6380bfce9bd78b573fea912
                                                                                                                                                                                                          start
                                                                                                                                                                                                          14638
                                                                                                                                                                                                          qualifier mentions
                                                                                                                                                                                                          1. context exact
                                                                                                                                                                                                            s indicated for the treatment of patients with recurrent or metastatic HNSCC with disease progression on or after platinum-containing chemotherapy.
                                                                                                                                                                                                            kind
                                                                                                                                                                                                            biomarker
                                                                                                                                                                                                            polarity
                                                                                                                                                                                                            not_inferred
                                                                                                                                                                                                            span
                                                                                                                                                                                                            end
                                                                                                                                                                                                            14742
                                                                                                                                                                                                            end exclusive
                                                                                                                                                                                                            true
                                                                                                                                                                                                            exact text
                                                                                                                                                                                                            metastatic HNSCC with disease progression o
                                                                                                                                                                                                            label id
                                                                                                                                                                                                            228e1e3f-d207-481f-8e14-9fdcbd0470e9
                                                                                                                                                                                                            offset unit
                                                                                                                                                                                                            unicode_code_points
                                                                                                                                                                                                            source array index
                                                                                                                                                                                                            0
                                                                                                                                                                                                            source field
                                                                                                                                                                                                            indications_and_usage_exact
                                                                                                                                                                                                            source text sha256
                                                                                                                                                                                                            e526ba14c91f10737e6d3331fe23a6219f58c0eca6380bfce9bd78b573fea912
                                                                                                                                                                                                            start
                                                                                                                                                                                                            14699
                                                                                                                                                                                                          2. context exact
                                                                                                                                                                                                            ngle agent, is indicated for the treatment of patients with recurrent or metastatic HNSCC with disease progression on or after platinum-containing chemotherapy.
                                                                                                                                                                                                            kind
                                                                                                                                                                                                            stage_or_setting
                                                                                                                                                                                                            polarity
                                                                                                                                                                                                            not_inferred
                                                                                                                                                                                                            span
                                                                                                                                                                                                            end
                                                                                                                                                                                                            14730
                                                                                                                                                                                                            end exclusive
                                                                                                                                                                                                            true
                                                                                                                                                                                                            exact text
                                                                                                                                                                                                            recurrent or metastatic HNSCC with disease p
                                                                                                                                                                                                            label id
                                                                                                                                                                                                            228e1e3f-d207-481f-8e14-9fdcbd0470e9
                                                                                                                                                                                                            offset unit
                                                                                                                                                                                                            unicode_code_points
                                                                                                                                                                                                            source array index
                                                                                                                                                                                                            0
                                                                                                                                                                                                            source field
                                                                                                                                                                                                            indications_and_usage_exact
                                                                                                                                                                                                            source text sha256
                                                                                                                                                                                                            e526ba14c91f10737e6d3331fe23a6219f58c0eca6380bfce9bd78b573fea912
                                                                                                                                                                                                            start
                                                                                                                                                                                                            14686
                                                                                                                                                                                                          3. context exact
                                                                                                                                                                                                            KEYTRUDA, as a single agent, is indicated for the treatment of patients with recurrent or metastatic HNSCC with disease progression on or after platinum-containing chemotherapy.
                                                                                                                                                                                                            kind
                                                                                                                                                                                                            regimen
                                                                                                                                                                                                            polarity
                                                                                                                                                                                                            not_inferred
                                                                                                                                                                                                            span
                                                                                                                                                                                                            end
                                                                                                                                                                                                            14785
                                                                                                                                                                                                            end exclusive
                                                                                                                                                                                                            true
                                                                                                                                                                                                            exact text
                                                                                                                                                                                                            as a single agent, is indicated for the treatment of patients with recurrent or metastatic HNSCC with disease progression on or after platinum-containing chemotherapy
                                                                                                                                                                                                            label id
                                                                                                                                                                                                            228e1e3f-d207-481f-8e14-9fdcbd0470e9
                                                                                                                                                                                                            offset unit
                                                                                                                                                                                                            unicode_code_points
                                                                                                                                                                                                            source array index
                                                                                                                                                                                                            0
                                                                                                                                                                                                            source field
                                                                                                                                                                                                            indications_and_usage_exact
                                                                                                                                                                                                            source text sha256
                                                                                                                                                                                                            e526ba14c91f10737e6d3331fe23a6219f58c0eca6380bfce9bd78b573fea912
                                                                                                                                                                                                            start
                                                                                                                                                                                                            14619
                                                                                                                                                                                                          regulatory links
                                                                                                                                                                                                            schema version
                                                                                                                                                                                                            0.1.0
                                                                                                                                                                                                            source batch sha256
                                                                                                                                                                                                            fc39a8c5cf96bf95ca20b85578140167b66b2741f7d9217f500d9ba0847ac058
                                                                                                                                                                                                            source defined aliases
                                                                                                                                                                                                            1. abbreviation
                                                                                                                                                                                                              NSCLC
                                                                                                                                                                                                              definition exact
                                                                                                                                                                                                              Non-Small Cell Lung Cancer
                                                                                                                                                                                                              definition span
                                                                                                                                                                                                              end
                                                                                                                                                                                                              380
                                                                                                                                                                                                              end exclusive
                                                                                                                                                                                                              true
                                                                                                                                                                                                              exact text
                                                                                                                                                                                                              Non-Small Cell Lung Cancer (NSCLC)
                                                                                                                                                                                                              label id
                                                                                                                                                                                                              228e1e3f-d207-481f-8e14-9fdcbd0470e9
                                                                                                                                                                                                              offset unit
                                                                                                                                                                                                              unicode_code_points
                                                                                                                                                                                                              source array index
                                                                                                                                                                                                              0
                                                                                                                                                                                                              source field
                                                                                                                                                                                                              indications_and_usage_exact
                                                                                                                                                                                                              source text sha256
                                                                                                                                                                                                              e526ba14c91f10737e6d3331fe23a6219f58c0eca6380bfce9bd78b573fea912
                                                                                                                                                                                                              start
                                                                                                                                                                                                              346
                                                                                                                                                                                                            2. abbreviation
                                                                                                                                                                                                              CRC
                                                                                                                                                                                                              definition exact
                                                                                                                                                                                                              Colorectal Cancer
                                                                                                                                                                                                              definition span
                                                                                                                                                                                                              end
                                                                                                                                                                                                              5042
                                                                                                                                                                                                              end exclusive
                                                                                                                                                                                                              true
                                                                                                                                                                                                              exact text
                                                                                                                                                                                                              Colorectal Cancer (CRC)
                                                                                                                                                                                                              label id
                                                                                                                                                                                                              228e1e3f-d207-481f-8e14-9fdcbd0470e9
                                                                                                                                                                                                              offset unit
                                                                                                                                                                                                              unicode_code_points
                                                                                                                                                                                                              source array index
                                                                                                                                                                                                              0
                                                                                                                                                                                                              source field
                                                                                                                                                                                                              indications_and_usage_exact
                                                                                                                                                                                                              source text sha256
                                                                                                                                                                                                              e526ba14c91f10737e6d3331fe23a6219f58c0eca6380bfce9bd78b573fea912
                                                                                                                                                                                                              start
                                                                                                                                                                                                              5019
                                                                                                                                                                                                            source span
                                                                                                                                                                                                            end
                                                                                                                                                                                                            14786
                                                                                                                                                                                                            end exclusive
                                                                                                                                                                                                            true
                                                                                                                                                                                                            exact text
                                                                                                                                                                                                            KEYTRUDA, as a single agent, is indicated for the treatment of patients with recurrent or metastatic HNSCC with disease progression on or after platinum-containing chemotherapy.
                                                                                                                                                                                                            label id
                                                                                                                                                                                                            228e1e3f-d207-481f-8e14-9fdcbd0470e9
                                                                                                                                                                                                            offset unit
                                                                                                                                                                                                            unicode_code_points
                                                                                                                                                                                                            source array index
                                                                                                                                                                                                            0
                                                                                                                                                                                                            source field
                                                                                                                                                                                                            indications_and_usage_exact
                                                                                                                                                                                                            source text sha256
                                                                                                                                                                                                            e526ba14c91f10737e6d3331fe23a6219f58c0eca6380bfce9bd78b573fea912
                                                                                                                                                                                                            start
                                                                                                                                                                                                            14609
                                                                                                                                                                                                            source url
                                                                                                                                                                                                            https://api.fda.gov/drug/label.json?search=id%3A%22228e1e3f-d207-481f-8e14-9fdcbd0470e9%22
                                                                                                                                                                                                            spl effective date
                                                                                                                                                                                                            2026-07-10
                                                                                                                                                                                                            spl set id
                                                                                                                                                                                                            9333c79b-d487-4538-a9f0-71b91a02b287
                                                                                                                                                                                                            spl version
                                                                                                                                                                                                            228
                                                                                                                                                                                                            structured fields status
                                                                                                                                                                                                            not_extracted_no_values_inferred_from_mentions
                                                                                                                                                                                                            structured indication
                                                                                                                                                                                                            age
                                                                                                                                                                                                            Source null
                                                                                                                                                                                                            approval pathway
                                                                                                                                                                                                            Source null
                                                                                                                                                                                                            biomarker and test
                                                                                                                                                                                                            Source null
                                                                                                                                                                                                            disease stage
                                                                                                                                                                                                            Source null
                                                                                                                                                                                                            limitations
                                                                                                                                                                                                            Source null
                                                                                                                                                                                                            line
                                                                                                                                                                                                            Source null
                                                                                                                                                                                                            prior therapy
                                                                                                                                                                                                            Source null
                                                                                                                                                                                                            regimen
                                                                                                                                                                                                            Source null
                                                                                                                                                                                                            tumor histology
                                                                                                                                                                                                            Source null
                                                                                                                                                                                                            use intent
                                                                                                                                                                                                            non_oncology_or_unclear_candidate
                                                                                                                                                                                                            Passage 80 · positive indication candidate
                                                                                                                                                                                                            application numbers
                                                                                                                                                                                                            1. BLA125514
                                                                                                                                                                                                            brand names
                                                                                                                                                                                                            1. KEYTRUDA
                                                                                                                                                                                                            classification reasons
                                                                                                                                                                                                            1. explicit_positive_indication_predicate
                                                                                                                                                                                                            2. tumor_or_malignant_hematology_words_in_positive_statement
                                                                                                                                                                                                            clinical review status
                                                                                                                                                                                                            pending
                                                                                                                                                                                                            content role
                                                                                                                                                                                                            positive_indication_candidate
                                                                                                                                                                                                            context span
                                                                                                                                                                                                            end
                                                                                                                                                                                                            15137
                                                                                                                                                                                                            end exclusive
                                                                                                                                                                                                            true
                                                                                                                                                                                                            exact text
                                                                                                                                                                                                            inistration (2.1) ] . KEYTRUDA, as a single agent, is indicated for the treatment of patients with recurrent or metastatic HNSCC with disease progression on or after platinum-containing chemotherapy. 1.5 Classical Hodgkin Lymphoma KEYTRUDA is indicated for the treatment of adult patients with relapsed or refractory classical Hodgkin lymphoma (cHL). KEYTRUDA is indicated for the treatment of pediatric patients with refractory cHL, or cHL that has relapsed after 2 or more lines of therapy. 1.6 Primary Mediastinal Large B-Cell Lymphoma KEYTRUDA is
                                                                                                                                                                                                            label id
                                                                                                                                                                                                            228e1e3f-d207-481f-8e14-9fdcbd0470e9
                                                                                                                                                                                                            offset unit
                                                                                                                                                                                                            unicode_code_points
                                                                                                                                                                                                            source array index
                                                                                                                                                                                                            0
                                                                                                                                                                                                            source field
                                                                                                                                                                                                            indications_and_usage_exact
                                                                                                                                                                                                            source text sha256
                                                                                                                                                                                                            e526ba14c91f10737e6d3331fe23a6219f58c0eca6380bfce9bd78b573fea912
                                                                                                                                                                                                            start
                                                                                                                                                                                                            14587
                                                                                                                                                                                                            current approval status
                                                                                                                                                                                                            not_reconciled
                                                                                                                                                                                                            duplicate text group
                                                                                                                                                                                                            dup-8063c20fbe9309818a9b
                                                                                                                                                                                                            extraction review status
                                                                                                                                                                                                            automated_candidate_pending_source_review
                                                                                                                                                                                                            generic names
                                                                                                                                                                                                            1. PEMBROLIZUMAB
                                                                                                                                                                                                            id
                                                                                                                                                                                                            ind-span-50da7388488700919c86
                                                                                                                                                                                                            label id
                                                                                                                                                                                                            228e1e3f-d207-481f-8e14-9fdcbd0470e9
                                                                                                                                                                                                            positive predicate support span
                                                                                                                                                                                                            end
                                                                                                                                                                                                            14839
                                                                                                                                                                                                            end exclusive
                                                                                                                                                                                                            true
                                                                                                                                                                                                            exact text
                                                                                                                                                                                                            is indicated
                                                                                                                                                                                                            label id
                                                                                                                                                                                                            228e1e3f-d207-481f-8e14-9fdcbd0470e9
                                                                                                                                                                                                            offset unit
                                                                                                                                                                                                            unicode_code_points
                                                                                                                                                                                                            source array index
                                                                                                                                                                                                            0
                                                                                                                                                                                                            source field
                                                                                                                                                                                                            indications_and_usage_exact
                                                                                                                                                                                                            source text sha256
                                                                                                                                                                                                            e526ba14c91f10737e6d3331fe23a6219f58c0eca6380bfce9bd78b573fea912
                                                                                                                                                                                                            start
                                                                                                                                                                                                            14827
                                                                                                                                                                                                            qualifier mentions
                                                                                                                                                                                                            1. context exact
                                                                                                                                                                                                              Hodgkin Lymphoma KEYTRUDA is indicated for the treatment of adult patients with relapsed or refractory classical Hodgkin lymphoma (cHL
                                                                                                                                                                                                              kind
                                                                                                                                                                                                              age
                                                                                                                                                                                                              polarity
                                                                                                                                                                                                              not_inferred
                                                                                                                                                                                                              span
                                                                                                                                                                                                              end
                                                                                                                                                                                                              14875
                                                                                                                                                                                                              end exclusive
                                                                                                                                                                                                              true
                                                                                                                                                                                                              exact text
                                                                                                                                                                                                              adult patients
                                                                                                                                                                                                              label id
                                                                                                                                                                                                              228e1e3f-d207-481f-8e14-9fdcbd0470e9
                                                                                                                                                                                                              offset unit
                                                                                                                                                                                                              unicode_code_points
                                                                                                                                                                                                              source array index
                                                                                                                                                                                                              0
                                                                                                                                                                                                              source field
                                                                                                                                                                                                              indications_and_usage_exact
                                                                                                                                                                                                              source text sha256
                                                                                                                                                                                                              e526ba14c91f10737e6d3331fe23a6219f58c0eca6380bfce9bd78b573fea912
                                                                                                                                                                                                              start
                                                                                                                                                                                                              14861
                                                                                                                                                                                                            2. context exact
                                                                                                                                                                                                              TRUDA is indicated for the treatment of adult patients with relapsed or refractory classical Hodgkin lymphoma (cHL).
                                                                                                                                                                                                              kind
                                                                                                                                                                                                              stage_or_setting
                                                                                                                                                                                                              polarity
                                                                                                                                                                                                              not_inferred
                                                                                                                                                                                                              span
                                                                                                                                                                                                              end
                                                                                                                                                                                                              14924
                                                                                                                                                                                                              end exclusive
                                                                                                                                                                                                              true
                                                                                                                                                                                                              exact text
                                                                                                                                                                                                              relapsed or refractory classical Hodgkin ly
                                                                                                                                                                                                              label id
                                                                                                                                                                                                              228e1e3f-d207-481f-8e14-9fdcbd0470e9
                                                                                                                                                                                                              offset unit
                                                                                                                                                                                                              unicode_code_points
                                                                                                                                                                                                              source array index
                                                                                                                                                                                                              0
                                                                                                                                                                                                              source field
                                                                                                                                                                                                              indications_and_usage_exact
                                                                                                                                                                                                              source text sha256
                                                                                                                                                                                                              e526ba14c91f10737e6d3331fe23a6219f58c0eca6380bfce9bd78b573fea912
                                                                                                                                                                                                              start
                                                                                                                                                                                                              14881
                                                                                                                                                                                                            regulatory links
                                                                                                                                                                                                              schema version
                                                                                                                                                                                                              0.1.0
                                                                                                                                                                                                              source batch sha256
                                                                                                                                                                                                              fc39a8c5cf96bf95ca20b85578140167b66b2741f7d9217f500d9ba0847ac058
                                                                                                                                                                                                              source defined aliases
                                                                                                                                                                                                              1. abbreviation
                                                                                                                                                                                                                NSCLC
                                                                                                                                                                                                                definition exact
                                                                                                                                                                                                                Non-Small Cell Lung Cancer
                                                                                                                                                                                                                definition span
                                                                                                                                                                                                                end
                                                                                                                                                                                                                380
                                                                                                                                                                                                                end exclusive
                                                                                                                                                                                                                true
                                                                                                                                                                                                                exact text
                                                                                                                                                                                                                Non-Small Cell Lung Cancer (NSCLC)
                                                                                                                                                                                                                label id
                                                                                                                                                                                                                228e1e3f-d207-481f-8e14-9fdcbd0470e9
                                                                                                                                                                                                                offset unit
                                                                                                                                                                                                                unicode_code_points
                                                                                                                                                                                                                source array index
                                                                                                                                                                                                                0
                                                                                                                                                                                                                source field
                                                                                                                                                                                                                indications_and_usage_exact
                                                                                                                                                                                                                source text sha256
                                                                                                                                                                                                                e526ba14c91f10737e6d3331fe23a6219f58c0eca6380bfce9bd78b573fea912
                                                                                                                                                                                                                start
                                                                                                                                                                                                                346
                                                                                                                                                                                                              2. abbreviation
                                                                                                                                                                                                                CRC
                                                                                                                                                                                                                definition exact
                                                                                                                                                                                                                Colorectal Cancer
                                                                                                                                                                                                                definition span
                                                                                                                                                                                                                end
                                                                                                                                                                                                                5042
                                                                                                                                                                                                                end exclusive
                                                                                                                                                                                                                true
                                                                                                                                                                                                                exact text
                                                                                                                                                                                                                Colorectal Cancer (CRC)
                                                                                                                                                                                                                label id
                                                                                                                                                                                                                228e1e3f-d207-481f-8e14-9fdcbd0470e9
                                                                                                                                                                                                                offset unit
                                                                                                                                                                                                                unicode_code_points
                                                                                                                                                                                                                source array index
                                                                                                                                                                                                                0
                                                                                                                                                                                                                source field
                                                                                                                                                                                                                indications_and_usage_exact
                                                                                                                                                                                                                source text sha256
                                                                                                                                                                                                                e526ba14c91f10737e6d3331fe23a6219f58c0eca6380bfce9bd78b573fea912
                                                                                                                                                                                                                start
                                                                                                                                                                                                                5019
                                                                                                                                                                                                              source span
                                                                                                                                                                                                              end
                                                                                                                                                                                                              14937
                                                                                                                                                                                                              end exclusive
                                                                                                                                                                                                              true
                                                                                                                                                                                                              exact text
                                                                                                                                                                                                              1.5 Classical Hodgkin Lymphoma KEYTRUDA is indicated for the treatment of adult patients with relapsed or refractory classical Hodgkin lymphoma (cHL).
                                                                                                                                                                                                              label id
                                                                                                                                                                                                              228e1e3f-d207-481f-8e14-9fdcbd0470e9
                                                                                                                                                                                                              offset unit
                                                                                                                                                                                                              unicode_code_points
                                                                                                                                                                                                              source array index
                                                                                                                                                                                                              0
                                                                                                                                                                                                              source field
                                                                                                                                                                                                              indications_and_usage_exact
                                                                                                                                                                                                              source text sha256
                                                                                                                                                                                                              e526ba14c91f10737e6d3331fe23a6219f58c0eca6380bfce9bd78b573fea912
                                                                                                                                                                                                              start
                                                                                                                                                                                                              14787
                                                                                                                                                                                                              source url
                                                                                                                                                                                                              https://api.fda.gov/drug/label.json?search=id%3A%22228e1e3f-d207-481f-8e14-9fdcbd0470e9%22
                                                                                                                                                                                                              spl effective date
                                                                                                                                                                                                              2026-07-10
                                                                                                                                                                                                              spl set id
                                                                                                                                                                                                              9333c79b-d487-4538-a9f0-71b91a02b287
                                                                                                                                                                                                              spl version
                                                                                                                                                                                                              228
                                                                                                                                                                                                              structured fields status
                                                                                                                                                                                                              not_extracted_no_values_inferred_from_mentions
                                                                                                                                                                                                              structured indication
                                                                                                                                                                                                              age
                                                                                                                                                                                                              Source null
                                                                                                                                                                                                              approval pathway
                                                                                                                                                                                                              Source null
                                                                                                                                                                                                              biomarker and test
                                                                                                                                                                                                              Source null
                                                                                                                                                                                                              disease stage
                                                                                                                                                                                                              Source null
                                                                                                                                                                                                              limitations
                                                                                                                                                                                                              Source null
                                                                                                                                                                                                              line
                                                                                                                                                                                                              Source null
                                                                                                                                                                                                              prior therapy
                                                                                                                                                                                                              Source null
                                                                                                                                                                                                              regimen
                                                                                                                                                                                                              Source null
                                                                                                                                                                                                              tumor histology
                                                                                                                                                                                                              Source null
                                                                                                                                                                                                              use intent
                                                                                                                                                                                                              tumor_directed_candidate
                                                                                                                                                                                                              Passage 81 · positive indication candidate
                                                                                                                                                                                                              application numbers
                                                                                                                                                                                                              1. BLA125514
                                                                                                                                                                                                              brand names
                                                                                                                                                                                                              1. KEYTRUDA
                                                                                                                                                                                                              classification reasons
                                                                                                                                                                                                              1. explicit_positive_indication_predicate
                                                                                                                                                                                                              2. no_tumor_directed_keyword_in_positive_statement
                                                                                                                                                                                                              clinical review status
                                                                                                                                                                                                              pending
                                                                                                                                                                                                              content role
                                                                                                                                                                                                              positive_indication_candidate
                                                                                                                                                                                                              context span
                                                                                                                                                                                                              end
                                                                                                                                                                                                              15279
                                                                                                                                                                                                              end exclusive
                                                                                                                                                                                                              true
                                                                                                                                                                                                              exact text
                                                                                                                                                                                                              on on or after platinum-containing chemotherapy. 1.5 Classical Hodgkin Lymphoma KEYTRUDA is indicated for the treatment of adult patients with relapsed or refractory classical Hodgkin lymphoma (cHL). KEYTRUDA is indicated for the treatment of pediatric patients with refractory cHL, or cHL that has relapsed after 2 or more lines of therapy. 1.6 Primary Mediastinal Large B-Cell Lymphoma KEYTRUDA is indicated for the treatment of adult and pediatric patients with refractory primary mediastinal large B-cell lymphoma (PMBCL), or who have re
                                                                                                                                                                                                              label id
                                                                                                                                                                                                              228e1e3f-d207-481f-8e14-9fdcbd0470e9
                                                                                                                                                                                                              offset unit
                                                                                                                                                                                                              unicode_code_points
                                                                                                                                                                                                              source array index
                                                                                                                                                                                                              0
                                                                                                                                                                                                              source field
                                                                                                                                                                                                              indications_and_usage_exact
                                                                                                                                                                                                              source text sha256
                                                                                                                                                                                                              e526ba14c91f10737e6d3331fe23a6219f58c0eca6380bfce9bd78b573fea912
                                                                                                                                                                                                              start
                                                                                                                                                                                                              14738
                                                                                                                                                                                                              current approval status
                                                                                                                                                                                                              not_reconciled
                                                                                                                                                                                                              duplicate text group
                                                                                                                                                                                                              dup-b641cfe1cfd7067b2d33
                                                                                                                                                                                                              extraction review status
                                                                                                                                                                                                              automated_candidate_pending_source_review
                                                                                                                                                                                                              generic names
                                                                                                                                                                                                              1. PEMBROLIZUMAB
                                                                                                                                                                                                              id
                                                                                                                                                                                                              ind-span-7e73091612db1cb199a1
                                                                                                                                                                                                              label id
                                                                                                                                                                                                              228e1e3f-d207-481f-8e14-9fdcbd0470e9
                                                                                                                                                                                                              positive predicate support span
                                                                                                                                                                                                              end
                                                                                                                                                                                                              14959
                                                                                                                                                                                                              end exclusive
                                                                                                                                                                                                              true
                                                                                                                                                                                                              exact text
                                                                                                                                                                                                              is indicated
                                                                                                                                                                                                              label id
                                                                                                                                                                                                              228e1e3f-d207-481f-8e14-9fdcbd0470e9
                                                                                                                                                                                                              offset unit
                                                                                                                                                                                                              unicode_code_points
                                                                                                                                                                                                              source array index
                                                                                                                                                                                                              0
                                                                                                                                                                                                              source field
                                                                                                                                                                                                              indications_and_usage_exact
                                                                                                                                                                                                              source text sha256
                                                                                                                                                                                                              e526ba14c91f10737e6d3331fe23a6219f58c0eca6380bfce9bd78b573fea912
                                                                                                                                                                                                              start
                                                                                                                                                                                                              14947
                                                                                                                                                                                                              qualifier mentions
                                                                                                                                                                                                              1. context exact
                                                                                                                                                                                                                KEYTRUDA is indicated for the treatment of pediatric patients with refractory cHL, or cHL that has relapsed after 2 or mo
                                                                                                                                                                                                                kind
                                                                                                                                                                                                                age
                                                                                                                                                                                                                polarity
                                                                                                                                                                                                                not_inferred
                                                                                                                                                                                                                span
                                                                                                                                                                                                                end
                                                                                                                                                                                                                14999
                                                                                                                                                                                                                end exclusive
                                                                                                                                                                                                                true
                                                                                                                                                                                                                exact text
                                                                                                                                                                                                                pediatric patients
                                                                                                                                                                                                                label id
                                                                                                                                                                                                                228e1e3f-d207-481f-8e14-9fdcbd0470e9
                                                                                                                                                                                                                offset unit
                                                                                                                                                                                                                unicode_code_points
                                                                                                                                                                                                                source array index
                                                                                                                                                                                                                0
                                                                                                                                                                                                                source field
                                                                                                                                                                                                                indications_and_usage_exact
                                                                                                                                                                                                                source text sha256
                                                                                                                                                                                                                e526ba14c91f10737e6d3331fe23a6219f58c0eca6380bfce9bd78b573fea912
                                                                                                                                                                                                                start
                                                                                                                                                                                                                14981
                                                                                                                                                                                                              2. context exact
                                                                                                                                                                                                                A is indicated for the treatment of pediatric patients with refractory cHL, or cHL that has relapsed after 2 or more lines of therapy.
                                                                                                                                                                                                                kind
                                                                                                                                                                                                                stage_or_setting
                                                                                                                                                                                                                polarity
                                                                                                                                                                                                                not_inferred
                                                                                                                                                                                                                span
                                                                                                                                                                                                                end
                                                                                                                                                                                                                15019
                                                                                                                                                                                                                end exclusive
                                                                                                                                                                                                                true
                                                                                                                                                                                                                exact text
                                                                                                                                                                                                                refractory cHL
                                                                                                                                                                                                                label id
                                                                                                                                                                                                                228e1e3f-d207-481f-8e14-9fdcbd0470e9
                                                                                                                                                                                                                offset unit
                                                                                                                                                                                                                unicode_code_points
                                                                                                                                                                                                                source array index
                                                                                                                                                                                                                0
                                                                                                                                                                                                                source field
                                                                                                                                                                                                                indications_and_usage_exact
                                                                                                                                                                                                                source text sha256
                                                                                                                                                                                                                e526ba14c91f10737e6d3331fe23a6219f58c0eca6380bfce9bd78b573fea912
                                                                                                                                                                                                                start
                                                                                                                                                                                                                15005
                                                                                                                                                                                                              3. context exact
                                                                                                                                                                                                                of pediatric patients with refractory cHL, or cHL that has relapsed after 2 or more lines of therapy.
                                                                                                                                                                                                                kind
                                                                                                                                                                                                                stage_or_setting
                                                                                                                                                                                                                polarity
                                                                                                                                                                                                                not_inferred
                                                                                                                                                                                                                span
                                                                                                                                                                                                                end
                                                                                                                                                                                                                15078
                                                                                                                                                                                                                end exclusive
                                                                                                                                                                                                                true
                                                                                                                                                                                                                exact text
                                                                                                                                                                                                                relapsed after 2 or more lines of therapy
                                                                                                                                                                                                                label id
                                                                                                                                                                                                                228e1e3f-d207-481f-8e14-9fdcbd0470e9
                                                                                                                                                                                                                offset unit
                                                                                                                                                                                                                unicode_code_points
                                                                                                                                                                                                                source array index
                                                                                                                                                                                                                0
                                                                                                                                                                                                                source field
                                                                                                                                                                                                                indications_and_usage_exact
                                                                                                                                                                                                                source text sha256
                                                                                                                                                                                                                e526ba14c91f10737e6d3331fe23a6219f58c0eca6380bfce9bd78b573fea912
                                                                                                                                                                                                                start
                                                                                                                                                                                                                15037
                                                                                                                                                                                                              regulatory links
                                                                                                                                                                                                                schema version
                                                                                                                                                                                                                0.1.0
                                                                                                                                                                                                                source batch sha256
                                                                                                                                                                                                                fc39a8c5cf96bf95ca20b85578140167b66b2741f7d9217f500d9ba0847ac058
                                                                                                                                                                                                                source defined aliases
                                                                                                                                                                                                                1. abbreviation
                                                                                                                                                                                                                  NSCLC
                                                                                                                                                                                                                  definition exact
                                                                                                                                                                                                                  Non-Small Cell Lung Cancer
                                                                                                                                                                                                                  definition span
                                                                                                                                                                                                                  end
                                                                                                                                                                                                                  380
                                                                                                                                                                                                                  end exclusive
                                                                                                                                                                                                                  true
                                                                                                                                                                                                                  exact text
                                                                                                                                                                                                                  Non-Small Cell Lung Cancer (NSCLC)
                                                                                                                                                                                                                  label id
                                                                                                                                                                                                                  228e1e3f-d207-481f-8e14-9fdcbd0470e9
                                                                                                                                                                                                                  offset unit
                                                                                                                                                                                                                  unicode_code_points
                                                                                                                                                                                                                  source array index
                                                                                                                                                                                                                  0
                                                                                                                                                                                                                  source field
                                                                                                                                                                                                                  indications_and_usage_exact
                                                                                                                                                                                                                  source text sha256
                                                                                                                                                                                                                  e526ba14c91f10737e6d3331fe23a6219f58c0eca6380bfce9bd78b573fea912
                                                                                                                                                                                                                  start
                                                                                                                                                                                                                  346
                                                                                                                                                                                                                2. abbreviation
                                                                                                                                                                                                                  CRC
                                                                                                                                                                                                                  definition exact
                                                                                                                                                                                                                  Colorectal Cancer
                                                                                                                                                                                                                  definition span
                                                                                                                                                                                                                  end
                                                                                                                                                                                                                  5042
                                                                                                                                                                                                                  end exclusive
                                                                                                                                                                                                                  true
                                                                                                                                                                                                                  exact text
                                                                                                                                                                                                                  Colorectal Cancer (CRC)
                                                                                                                                                                                                                  label id
                                                                                                                                                                                                                  228e1e3f-d207-481f-8e14-9fdcbd0470e9
                                                                                                                                                                                                                  offset unit
                                                                                                                                                                                                                  unicode_code_points
                                                                                                                                                                                                                  source array index
                                                                                                                                                                                                                  0
                                                                                                                                                                                                                  source field
                                                                                                                                                                                                                  indications_and_usage_exact
                                                                                                                                                                                                                  source text sha256
                                                                                                                                                                                                                  e526ba14c91f10737e6d3331fe23a6219f58c0eca6380bfce9bd78b573fea912
                                                                                                                                                                                                                  start
                                                                                                                                                                                                                  5019
                                                                                                                                                                                                                source span
                                                                                                                                                                                                                end
                                                                                                                                                                                                                15079
                                                                                                                                                                                                                end exclusive
                                                                                                                                                                                                                true
                                                                                                                                                                                                                exact text
                                                                                                                                                                                                                KEYTRUDA is indicated for the treatment of pediatric patients with refractory cHL, or cHL that has relapsed after 2 or more lines of therapy.
                                                                                                                                                                                                                label id
                                                                                                                                                                                                                228e1e3f-d207-481f-8e14-9fdcbd0470e9
                                                                                                                                                                                                                offset unit
                                                                                                                                                                                                                unicode_code_points
                                                                                                                                                                                                                source array index
                                                                                                                                                                                                                0
                                                                                                                                                                                                                source field
                                                                                                                                                                                                                indications_and_usage_exact
                                                                                                                                                                                                                source text sha256
                                                                                                                                                                                                                e526ba14c91f10737e6d3331fe23a6219f58c0eca6380bfce9bd78b573fea912
                                                                                                                                                                                                                start
                                                                                                                                                                                                                14938
                                                                                                                                                                                                                source url
                                                                                                                                                                                                                https://api.fda.gov/drug/label.json?search=id%3A%22228e1e3f-d207-481f-8e14-9fdcbd0470e9%22
                                                                                                                                                                                                                spl effective date
                                                                                                                                                                                                                2026-07-10
                                                                                                                                                                                                                spl set id
                                                                                                                                                                                                                9333c79b-d487-4538-a9f0-71b91a02b287
                                                                                                                                                                                                                spl version
                                                                                                                                                                                                                228
                                                                                                                                                                                                                structured fields status
                                                                                                                                                                                                                not_extracted_no_values_inferred_from_mentions
                                                                                                                                                                                                                structured indication
                                                                                                                                                                                                                age
                                                                                                                                                                                                                Source null
                                                                                                                                                                                                                approval pathway
                                                                                                                                                                                                                Source null
                                                                                                                                                                                                                biomarker and test
                                                                                                                                                                                                                Source null
                                                                                                                                                                                                                disease stage
                                                                                                                                                                                                                Source null
                                                                                                                                                                                                                limitations
                                                                                                                                                                                                                Source null
                                                                                                                                                                                                                line
                                                                                                                                                                                                                Source null
                                                                                                                                                                                                                prior therapy
                                                                                                                                                                                                                Source null
                                                                                                                                                                                                                regimen
                                                                                                                                                                                                                Source null
                                                                                                                                                                                                                tumor histology
                                                                                                                                                                                                                Source null
                                                                                                                                                                                                                use intent
                                                                                                                                                                                                                non_oncology_or_unclear_candidate
                                                                                                                                                                                                                Passage 82 · positive indication candidate
                                                                                                                                                                                                                application numbers
                                                                                                                                                                                                                1. BLA125514
                                                                                                                                                                                                                brand names
                                                                                                                                                                                                                1. KEYTRUDA
                                                                                                                                                                                                                classification reasons
                                                                                                                                                                                                                1. explicit_positive_indication_predicate
                                                                                                                                                                                                                2. tumor_or_malignant_hematology_words_in_positive_statement
                                                                                                                                                                                                                clinical review status
                                                                                                                                                                                                                pending
                                                                                                                                                                                                                content role
                                                                                                                                                                                                                positive_indication_candidate
                                                                                                                                                                                                                context span
                                                                                                                                                                                                                end
                                                                                                                                                                                                                15525
                                                                                                                                                                                                                end exclusive
                                                                                                                                                                                                                true
                                                                                                                                                                                                                exact text
                                                                                                                                                                                                                relapsed or refractory classical Hodgkin lymphoma (cHL). KEYTRUDA is indicated for the treatment of pediatric patients with refractory cHL, or cHL that has relapsed after 2 or more lines of therapy. 1.6 Primary Mediastinal Large B-Cell Lymphoma KEYTRUDA is indicated for the treatment of adult and pediatric patients with refractory primary mediastinal large B-cell lymphoma (PMBCL), or who have relapsed after 2 or more prior lines of therapy. Limitations of Use : KEYTRUDA is not recommended for treatment of patients with PMBCL who require urgent cytoreductive therapy. 1.7 Urothelial Cancer KEYTRUDA, in combination with enfortumab vedotin-
                                                                                                                                                                                                                label id
                                                                                                                                                                                                                228e1e3f-d207-481f-8e14-9fdcbd0470e9
                                                                                                                                                                                                                offset unit
                                                                                                                                                                                                                unicode_code_points
                                                                                                                                                                                                                source array index
                                                                                                                                                                                                                0
                                                                                                                                                                                                                source field
                                                                                                                                                                                                                indications_and_usage_exact
                                                                                                                                                                                                                source text sha256
                                                                                                                                                                                                                e526ba14c91f10737e6d3331fe23a6219f58c0eca6380bfce9bd78b573fea912
                                                                                                                                                                                                                start
                                                                                                                                                                                                                14880
                                                                                                                                                                                                                current approval status
                                                                                                                                                                                                                not_reconciled
                                                                                                                                                                                                                duplicate text group
                                                                                                                                                                                                                dup-4f9bbb686dfed694694c
                                                                                                                                                                                                                extraction review status
                                                                                                                                                                                                                automated_candidate_pending_source_review
                                                                                                                                                                                                                generic names
                                                                                                                                                                                                                1. PEMBROLIZUMAB
                                                                                                                                                                                                                id
                                                                                                                                                                                                                ind-span-c998e80aff4ef6cbc810
                                                                                                                                                                                                                label id
                                                                                                                                                                                                                228e1e3f-d207-481f-8e14-9fdcbd0470e9
                                                                                                                                                                                                                positive predicate support span
                                                                                                                                                                                                                end
                                                                                                                                                                                                                15147
                                                                                                                                                                                                                end exclusive
                                                                                                                                                                                                                true
                                                                                                                                                                                                                exact text
                                                                                                                                                                                                                is indicated
                                                                                                                                                                                                                label id
                                                                                                                                                                                                                228e1e3f-d207-481f-8e14-9fdcbd0470e9
                                                                                                                                                                                                                offset unit
                                                                                                                                                                                                                unicode_code_points
                                                                                                                                                                                                                source array index
                                                                                                                                                                                                                0
                                                                                                                                                                                                                source field
                                                                                                                                                                                                                indications_and_usage_exact
                                                                                                                                                                                                                source text sha256
                                                                                                                                                                                                                e526ba14c91f10737e6d3331fe23a6219f58c0eca6380bfce9bd78b573fea912
                                                                                                                                                                                                                start
                                                                                                                                                                                                                15135
                                                                                                                                                                                                                qualifier mentions
                                                                                                                                                                                                                1. context exact
                                                                                                                                                                                                                  B-Cell Lymphoma KEYTRUDA is indicated for the treatment of adult and pediatric patients with refractory primary mediastinal
                                                                                                                                                                                                                  kind
                                                                                                                                                                                                                  age
                                                                                                                                                                                                                  polarity
                                                                                                                                                                                                                  not_inferred
                                                                                                                                                                                                                  span
                                                                                                                                                                                                                  end
                                                                                                                                                                                                                  15174
                                                                                                                                                                                                                  end exclusive
                                                                                                                                                                                                                  true
                                                                                                                                                                                                                  exact text
                                                                                                                                                                                                                  adult
                                                                                                                                                                                                                  label id
                                                                                                                                                                                                                  228e1e3f-d207-481f-8e14-9fdcbd0470e9
                                                                                                                                                                                                                  offset unit
                                                                                                                                                                                                                  unicode_code_points
                                                                                                                                                                                                                  source array index
                                                                                                                                                                                                                  0
                                                                                                                                                                                                                  source field
                                                                                                                                                                                                                  indications_and_usage_exact
                                                                                                                                                                                                                  source text sha256
                                                                                                                                                                                                                  e526ba14c91f10737e6d3331fe23a6219f58c0eca6380bfce9bd78b573fea912
                                                                                                                                                                                                                  start
                                                                                                                                                                                                                  15169
                                                                                                                                                                                                                2. context exact
                                                                                                                                                                                                                  mphoma KEYTRUDA is indicated for the treatment of adult and pediatric patients with refractory primary mediastinal large B-cell lymphoma (
                                                                                                                                                                                                                  kind
                                                                                                                                                                                                                  age
                                                                                                                                                                                                                  polarity
                                                                                                                                                                                                                  not_inferred
                                                                                                                                                                                                                  span
                                                                                                                                                                                                                  end
                                                                                                                                                                                                                  15197
                                                                                                                                                                                                                  end exclusive
                                                                                                                                                                                                                  true
                                                                                                                                                                                                                  exact text
                                                                                                                                                                                                                  pediatric patients
                                                                                                                                                                                                                  label id
                                                                                                                                                                                                                  228e1e3f-d207-481f-8e14-9fdcbd0470e9
                                                                                                                                                                                                                  offset unit
                                                                                                                                                                                                                  unicode_code_points
                                                                                                                                                                                                                  source array index
                                                                                                                                                                                                                  0
                                                                                                                                                                                                                  source field
                                                                                                                                                                                                                  indications_and_usage_exact
                                                                                                                                                                                                                  source text sha256
                                                                                                                                                                                                                  e526ba14c91f10737e6d3331fe23a6219f58c0eca6380bfce9bd78b573fea912
                                                                                                                                                                                                                  start
                                                                                                                                                                                                                  15179
                                                                                                                                                                                                                3. context exact
                                                                                                                                                                                                                  ated for the treatment of adult and pediatric patients with refractory primary mediastinal large B-cell lymphoma (PMBCL), or who have relapsed after 2 or more prior
                                                                                                                                                                                                                  kind
                                                                                                                                                                                                                  stage_or_setting
                                                                                                                                                                                                                  polarity
                                                                                                                                                                                                                  not_inferred
                                                                                                                                                                                                                  span
                                                                                                                                                                                                                  end
                                                                                                                                                                                                                  15248
                                                                                                                                                                                                                  end exclusive
                                                                                                                                                                                                                  true
                                                                                                                                                                                                                  exact text
                                                                                                                                                                                                                  refractory primary mediastinal large B-cell l
                                                                                                                                                                                                                  label id
                                                                                                                                                                                                                  228e1e3f-d207-481f-8e14-9fdcbd0470e9
                                                                                                                                                                                                                  offset unit
                                                                                                                                                                                                                  unicode_code_points
                                                                                                                                                                                                                  source array index
                                                                                                                                                                                                                  0
                                                                                                                                                                                                                  source field
                                                                                                                                                                                                                  indications_and_usage_exact
                                                                                                                                                                                                                  source text sha256
                                                                                                                                                                                                                  e526ba14c91f10737e6d3331fe23a6219f58c0eca6380bfce9bd78b573fea912
                                                                                                                                                                                                                  start
                                                                                                                                                                                                                  15203
                                                                                                                                                                                                                4. context exact
                                                                                                                                                                                                                  mary mediastinal large B-cell lymphoma (PMBCL), or who have relapsed after 2 or more prior lines of therapy.
                                                                                                                                                                                                                  kind
                                                                                                                                                                                                                  stage_or_setting
                                                                                                                                                                                                                  polarity
                                                                                                                                                                                                                  not_inferred
                                                                                                                                                                                                                  span
                                                                                                                                                                                                                  end
                                                                                                                                                                                                                  15320
                                                                                                                                                                                                                  end exclusive
                                                                                                                                                                                                                  true
                                                                                                                                                                                                                  exact text
                                                                                                                                                                                                                  relapsed after 2 or more prior lines of the
                                                                                                                                                                                                                  label id
                                                                                                                                                                                                                  228e1e3f-d207-481f-8e14-9fdcbd0470e9
                                                                                                                                                                                                                  offset unit
                                                                                                                                                                                                                  unicode_code_points
                                                                                                                                                                                                                  source array index
                                                                                                                                                                                                                  0
                                                                                                                                                                                                                  source field
                                                                                                                                                                                                                  indications_and_usage_exact
                                                                                                                                                                                                                  source text sha256
                                                                                                                                                                                                                  e526ba14c91f10737e6d3331fe23a6219f58c0eca6380bfce9bd78b573fea912
                                                                                                                                                                                                                  start
                                                                                                                                                                                                                  15277
                                                                                                                                                                                                                regulatory links
                                                                                                                                                                                                                  schema version
                                                                                                                                                                                                                  0.1.0
                                                                                                                                                                                                                  source batch sha256
                                                                                                                                                                                                                  fc39a8c5cf96bf95ca20b85578140167b66b2741f7d9217f500d9ba0847ac058
                                                                                                                                                                                                                  source defined aliases
                                                                                                                                                                                                                  1. abbreviation
                                                                                                                                                                                                                    NSCLC
                                                                                                                                                                                                                    definition exact
                                                                                                                                                                                                                    Non-Small Cell Lung Cancer
                                                                                                                                                                                                                    definition span
                                                                                                                                                                                                                    end
                                                                                                                                                                                                                    380
                                                                                                                                                                                                                    end exclusive
                                                                                                                                                                                                                    true
                                                                                                                                                                                                                    exact text
                                                                                                                                                                                                                    Non-Small Cell Lung Cancer (NSCLC)
                                                                                                                                                                                                                    label id
                                                                                                                                                                                                                    228e1e3f-d207-481f-8e14-9fdcbd0470e9
                                                                                                                                                                                                                    offset unit
                                                                                                                                                                                                                    unicode_code_points
                                                                                                                                                                                                                    source array index
                                                                                                                                                                                                                    0
                                                                                                                                                                                                                    source field
                                                                                                                                                                                                                    indications_and_usage_exact
                                                                                                                                                                                                                    source text sha256
                                                                                                                                                                                                                    e526ba14c91f10737e6d3331fe23a6219f58c0eca6380bfce9bd78b573fea912
                                                                                                                                                                                                                    start
                                                                                                                                                                                                                    346
                                                                                                                                                                                                                  2. abbreviation
                                                                                                                                                                                                                    CRC
                                                                                                                                                                                                                    definition exact
                                                                                                                                                                                                                    Colorectal Cancer
                                                                                                                                                                                                                    definition span
                                                                                                                                                                                                                    end
                                                                                                                                                                                                                    5042
                                                                                                                                                                                                                    end exclusive
                                                                                                                                                                                                                    true
                                                                                                                                                                                                                    exact text
                                                                                                                                                                                                                    Colorectal Cancer (CRC)
                                                                                                                                                                                                                    label id
                                                                                                                                                                                                                    228e1e3f-d207-481f-8e14-9fdcbd0470e9
                                                                                                                                                                                                                    offset unit
                                                                                                                                                                                                                    unicode_code_points
                                                                                                                                                                                                                    source array index
                                                                                                                                                                                                                    0
                                                                                                                                                                                                                    source field
                                                                                                                                                                                                                    indications_and_usage_exact
                                                                                                                                                                                                                    source text sha256
                                                                                                                                                                                                                    e526ba14c91f10737e6d3331fe23a6219f58c0eca6380bfce9bd78b573fea912
                                                                                                                                                                                                                    start
                                                                                                                                                                                                                    5019
                                                                                                                                                                                                                  source span
                                                                                                                                                                                                                  end
                                                                                                                                                                                                                  15325
                                                                                                                                                                                                                  end exclusive
                                                                                                                                                                                                                  true
                                                                                                                                                                                                                  exact text
                                                                                                                                                                                                                  1.6 Primary Mediastinal Large B-Cell Lymphoma KEYTRUDA is indicated for the treatment of adult and pediatric patients with refractory primary mediastinal large B-cell lymphoma (PMBCL), or who have relapsed after 2 or more prior lines of therapy.
                                                                                                                                                                                                                  label id
                                                                                                                                                                                                                  228e1e3f-d207-481f-8e14-9fdcbd0470e9
                                                                                                                                                                                                                  offset unit
                                                                                                                                                                                                                  unicode_code_points
                                                                                                                                                                                                                  source array index
                                                                                                                                                                                                                  0
                                                                                                                                                                                                                  source field
                                                                                                                                                                                                                  indications_and_usage_exact
                                                                                                                                                                                                                  source text sha256
                                                                                                                                                                                                                  e526ba14c91f10737e6d3331fe23a6219f58c0eca6380bfce9bd78b573fea912
                                                                                                                                                                                                                  start
                                                                                                                                                                                                                  15080
                                                                                                                                                                                                                  source url
                                                                                                                                                                                                                  https://api.fda.gov/drug/label.json?search=id%3A%22228e1e3f-d207-481f-8e14-9fdcbd0470e9%22
                                                                                                                                                                                                                  spl effective date
                                                                                                                                                                                                                  2026-07-10
                                                                                                                                                                                                                  spl set id
                                                                                                                                                                                                                  9333c79b-d487-4538-a9f0-71b91a02b287
                                                                                                                                                                                                                  spl version
                                                                                                                                                                                                                  228
                                                                                                                                                                                                                  structured fields status
                                                                                                                                                                                                                  not_extracted_no_values_inferred_from_mentions
                                                                                                                                                                                                                  structured indication
                                                                                                                                                                                                                  age
                                                                                                                                                                                                                  Source null
                                                                                                                                                                                                                  approval pathway
                                                                                                                                                                                                                  Source null
                                                                                                                                                                                                                  biomarker and test
                                                                                                                                                                                                                  Source null
                                                                                                                                                                                                                  disease stage
                                                                                                                                                                                                                  Source null
                                                                                                                                                                                                                  limitations
                                                                                                                                                                                                                  Source null
                                                                                                                                                                                                                  line
                                                                                                                                                                                                                  Source null
                                                                                                                                                                                                                  prior therapy
                                                                                                                                                                                                                  Source null
                                                                                                                                                                                                                  regimen
                                                                                                                                                                                                                  Source null
                                                                                                                                                                                                                  tumor histology
                                                                                                                                                                                                                  Source null
                                                                                                                                                                                                                  use intent
                                                                                                                                                                                                                  tumor_directed_candidate
                                                                                                                                                                                                                  Passage 83 · limitation of use
                                                                                                                                                                                                                  application numbers
                                                                                                                                                                                                                  1. BLA125514
                                                                                                                                                                                                                  brand names
                                                                                                                                                                                                                  1. KEYTRUDA
                                                                                                                                                                                                                  classification reasons
                                                                                                                                                                                                                  1. negative_or_not_established_clause
                                                                                                                                                                                                                  clinical review status
                                                                                                                                                                                                                  pending
                                                                                                                                                                                                                  content role
                                                                                                                                                                                                                  limitation_of_use
                                                                                                                                                                                                                  context span
                                                                                                                                                                                                                  end
                                                                                                                                                                                                                  15653
                                                                                                                                                                                                                  end exclusive
                                                                                                                                                                                                                  true
                                                                                                                                                                                                                  exact text
                                                                                                                                                                                                                  KEYTRUDA is indicated for the treatment of adult and pediatric patients with refractory primary mediastinal large B-cell lymphoma (PMBCL), or who have relapsed after 2 or more prior lines of therapy. Limitations of Use : KEYTRUDA is not recommended for treatment of patients with PMBCL who require urgent cytoreductive therapy. 1.7 Urothelial Cancer KEYTRUDA, in combination with enfortumab vedotin-ejfv, is indicated for the treatment of adult patients with locally advanced or metastatic urothelial cancer. KEYTRUDA, as a sin
                                                                                                                                                                                                                  label id
                                                                                                                                                                                                                  228e1e3f-d207-481f-8e14-9fdcbd0470e9
                                                                                                                                                                                                                  offset unit
                                                                                                                                                                                                                  unicode_code_points
                                                                                                                                                                                                                  source array index
                                                                                                                                                                                                                  0
                                                                                                                                                                                                                  source field
                                                                                                                                                                                                                  indications_and_usage_exact
                                                                                                                                                                                                                  source text sha256
                                                                                                                                                                                                                  e526ba14c91f10737e6d3331fe23a6219f58c0eca6380bfce9bd78b573fea912
                                                                                                                                                                                                                  start
                                                                                                                                                                                                                  15126
                                                                                                                                                                                                                  current approval status
                                                                                                                                                                                                                  not_reconciled
                                                                                                                                                                                                                  duplicate text group
                                                                                                                                                                                                                  dup-eeb6dd697ca1d69d38f9
                                                                                                                                                                                                                  extraction review status
                                                                                                                                                                                                                  automated_candidate_pending_source_review
                                                                                                                                                                                                                  generic names
                                                                                                                                                                                                                  1. PEMBROLIZUMAB
                                                                                                                                                                                                                  id
                                                                                                                                                                                                                  ind-span-97664570d0025865c703
                                                                                                                                                                                                                  label id
                                                                                                                                                                                                                  228e1e3f-d207-481f-8e14-9fdcbd0470e9
                                                                                                                                                                                                                  positive predicate support span
                                                                                                                                                                                                                  Source null
                                                                                                                                                                                                                  qualifier mentions
                                                                                                                                                                                                                    regulatory links
                                                                                                                                                                                                                      schema version
                                                                                                                                                                                                                      0.1.0
                                                                                                                                                                                                                      source batch sha256
                                                                                                                                                                                                                      fc39a8c5cf96bf95ca20b85578140167b66b2741f7d9217f500d9ba0847ac058
                                                                                                                                                                                                                      source defined aliases
                                                                                                                                                                                                                      1. abbreviation
                                                                                                                                                                                                                        NSCLC
                                                                                                                                                                                                                        definition exact
                                                                                                                                                                                                                        Non-Small Cell Lung Cancer
                                                                                                                                                                                                                        definition span
                                                                                                                                                                                                                        end
                                                                                                                                                                                                                        380
                                                                                                                                                                                                                        end exclusive
                                                                                                                                                                                                                        true
                                                                                                                                                                                                                        exact text
                                                                                                                                                                                                                        Non-Small Cell Lung Cancer (NSCLC)
                                                                                                                                                                                                                        label id
                                                                                                                                                                                                                        228e1e3f-d207-481f-8e14-9fdcbd0470e9
                                                                                                                                                                                                                        offset unit
                                                                                                                                                                                                                        unicode_code_points
                                                                                                                                                                                                                        source array index
                                                                                                                                                                                                                        0
                                                                                                                                                                                                                        source field
                                                                                                                                                                                                                        indications_and_usage_exact
                                                                                                                                                                                                                        source text sha256
                                                                                                                                                                                                                        e526ba14c91f10737e6d3331fe23a6219f58c0eca6380bfce9bd78b573fea912
                                                                                                                                                                                                                        start
                                                                                                                                                                                                                        346
                                                                                                                                                                                                                      2. abbreviation
                                                                                                                                                                                                                        CRC
                                                                                                                                                                                                                        definition exact
                                                                                                                                                                                                                        Colorectal Cancer
                                                                                                                                                                                                                        definition span
                                                                                                                                                                                                                        end
                                                                                                                                                                                                                        5042
                                                                                                                                                                                                                        end exclusive
                                                                                                                                                                                                                        true
                                                                                                                                                                                                                        exact text
                                                                                                                                                                                                                        Colorectal Cancer (CRC)
                                                                                                                                                                                                                        label id
                                                                                                                                                                                                                        228e1e3f-d207-481f-8e14-9fdcbd0470e9
                                                                                                                                                                                                                        offset unit
                                                                                                                                                                                                                        unicode_code_points
                                                                                                                                                                                                                        source array index
                                                                                                                                                                                                                        0
                                                                                                                                                                                                                        source field
                                                                                                                                                                                                                        indications_and_usage_exact
                                                                                                                                                                                                                        source text sha256
                                                                                                                                                                                                                        e526ba14c91f10737e6d3331fe23a6219f58c0eca6380bfce9bd78b573fea912
                                                                                                                                                                                                                        start
                                                                                                                                                                                                                        5019
                                                                                                                                                                                                                      source span
                                                                                                                                                                                                                      end
                                                                                                                                                                                                                      15453
                                                                                                                                                                                                                      end exclusive
                                                                                                                                                                                                                      true
                                                                                                                                                                                                                      exact text
                                                                                                                                                                                                                      Limitations of Use : KEYTRUDA is not recommended for treatment of patients with PMBCL who require urgent cytoreductive therapy.
                                                                                                                                                                                                                      label id
                                                                                                                                                                                                                      228e1e3f-d207-481f-8e14-9fdcbd0470e9
                                                                                                                                                                                                                      offset unit
                                                                                                                                                                                                                      unicode_code_points
                                                                                                                                                                                                                      source array index
                                                                                                                                                                                                                      0
                                                                                                                                                                                                                      source field
                                                                                                                                                                                                                      indications_and_usage_exact
                                                                                                                                                                                                                      source text sha256
                                                                                                                                                                                                                      e526ba14c91f10737e6d3331fe23a6219f58c0eca6380bfce9bd78b573fea912
                                                                                                                                                                                                                      start
                                                                                                                                                                                                                      15326
                                                                                                                                                                                                                      source url
                                                                                                                                                                                                                      https://api.fda.gov/drug/label.json?search=id%3A%22228e1e3f-d207-481f-8e14-9fdcbd0470e9%22
                                                                                                                                                                                                                      spl effective date
                                                                                                                                                                                                                      2026-07-10
                                                                                                                                                                                                                      spl set id
                                                                                                                                                                                                                      9333c79b-d487-4538-a9f0-71b91a02b287
                                                                                                                                                                                                                      spl version
                                                                                                                                                                                                                      228
                                                                                                                                                                                                                      structured fields status
                                                                                                                                                                                                                      not_extracted_no_values_inferred_from_mentions
                                                                                                                                                                                                                      structured indication
                                                                                                                                                                                                                      age
                                                                                                                                                                                                                      Source null
                                                                                                                                                                                                                      approval pathway
                                                                                                                                                                                                                      Source null
                                                                                                                                                                                                                      biomarker and test
                                                                                                                                                                                                                      Source null
                                                                                                                                                                                                                      disease stage
                                                                                                                                                                                                                      Source null
                                                                                                                                                                                                                      limitations
                                                                                                                                                                                                                      Source null
                                                                                                                                                                                                                      line
                                                                                                                                                                                                                      Source null
                                                                                                                                                                                                                      prior therapy
                                                                                                                                                                                                                      Source null
                                                                                                                                                                                                                      regimen
                                                                                                                                                                                                                      Source null
                                                                                                                                                                                                                      tumor histology
                                                                                                                                                                                                                      Source null
                                                                                                                                                                                                                      use intent
                                                                                                                                                                                                                      not_applicable
                                                                                                                                                                                                                      Passage 84 · positive indication candidate
                                                                                                                                                                                                                      application numbers
                                                                                                                                                                                                                      1. BLA125514
                                                                                                                                                                                                                      brand names
                                                                                                                                                                                                                      1. KEYTRUDA
                                                                                                                                                                                                                      classification reasons
                                                                                                                                                                                                                      1. explicit_positive_indication_predicate
                                                                                                                                                                                                                      2. tumor_or_malignant_hematology_words_in_positive_statement
                                                                                                                                                                                                                      clinical review status
                                                                                                                                                                                                                      pending
                                                                                                                                                                                                                      content role
                                                                                                                                                                                                                      positive_indication_candidate
                                                                                                                                                                                                                      context span
                                                                                                                                                                                                                      end
                                                                                                                                                                                                                      15834
                                                                                                                                                                                                                      end exclusive
                                                                                                                                                                                                                      true
                                                                                                                                                                                                                      exact text
                                                                                                                                                                                                                      a (PMBCL), or who have relapsed after 2 or more prior lines of therapy. Limitations of Use : KEYTRUDA is not recommended for treatment of patients with PMBCL who require urgent cytoreductive therapy. 1.7 Urothelial Cancer KEYTRUDA, in combination with enfortumab vedotin-ejfv, is indicated for the treatment of adult patients with locally advanced or metastatic urothelial cancer. KEYTRUDA, as a single agent, is indicated for the treatment of patients with locally advanced or metastatic urothelial carcinoma: who are not eligible for any platinum-containing chemotherapy, or who
                                                                                                                                                                                                                      label id
                                                                                                                                                                                                                      228e1e3f-d207-481f-8e14-9fdcbd0470e9
                                                                                                                                                                                                                      offset unit
                                                                                                                                                                                                                      unicode_code_points
                                                                                                                                                                                                                      source array index
                                                                                                                                                                                                                      0
                                                                                                                                                                                                                      source field
                                                                                                                                                                                                                      indications_and_usage_exact
                                                                                                                                                                                                                      source text sha256
                                                                                                                                                                                                                      e526ba14c91f10737e6d3331fe23a6219f58c0eca6380bfce9bd78b573fea912
                                                                                                                                                                                                                      start
                                                                                                                                                                                                                      15254
                                                                                                                                                                                                                      current approval status
                                                                                                                                                                                                                      not_reconciled
                                                                                                                                                                                                                      duplicate text group
                                                                                                                                                                                                                      dup-f72067a80e770edca56a
                                                                                                                                                                                                                      extraction review status
                                                                                                                                                                                                                      automated_candidate_pending_source_review
                                                                                                                                                                                                                      generic names
                                                                                                                                                                                                                      1. PEMBROLIZUMAB
                                                                                                                                                                                                                      id
                                                                                                                                                                                                                      ind-span-0b47f113090a39534283
                                                                                                                                                                                                                      label id
                                                                                                                                                                                                                      228e1e3f-d207-481f-8e14-9fdcbd0470e9
                                                                                                                                                                                                                      positive predicate support span
                                                                                                                                                                                                                      end
                                                                                                                                                                                                                      15543
                                                                                                                                                                                                                      end exclusive
                                                                                                                                                                                                                      true
                                                                                                                                                                                                                      exact text
                                                                                                                                                                                                                      is indicated
                                                                                                                                                                                                                      label id
                                                                                                                                                                                                                      228e1e3f-d207-481f-8e14-9fdcbd0470e9
                                                                                                                                                                                                                      offset unit
                                                                                                                                                                                                                      unicode_code_points
                                                                                                                                                                                                                      source array index
                                                                                                                                                                                                                      0
                                                                                                                                                                                                                      source field
                                                                                                                                                                                                                      indications_and_usage_exact
                                                                                                                                                                                                                      source text sha256
                                                                                                                                                                                                                      e526ba14c91f10737e6d3331fe23a6219f58c0eca6380bfce9bd78b573fea912
                                                                                                                                                                                                                      start
                                                                                                                                                                                                                      15531
                                                                                                                                                                                                                      qualifier mentions
                                                                                                                                                                                                                      1. context exact
                                                                                                                                                                                                                        enfortumab vedotin-ejfv, is indicated for the treatment of adult patients with locally advanced or metastatic urothelial cancer.
                                                                                                                                                                                                                        kind
                                                                                                                                                                                                                        age
                                                                                                                                                                                                                        polarity
                                                                                                                                                                                                                        not_inferred
                                                                                                                                                                                                                        span
                                                                                                                                                                                                                        end
                                                                                                                                                                                                                        15579
                                                                                                                                                                                                                        end exclusive
                                                                                                                                                                                                                        true
                                                                                                                                                                                                                        exact text
                                                                                                                                                                                                                        adult patients
                                                                                                                                                                                                                        label id
                                                                                                                                                                                                                        228e1e3f-d207-481f-8e14-9fdcbd0470e9
                                                                                                                                                                                                                        offset unit
                                                                                                                                                                                                                        unicode_code_points
                                                                                                                                                                                                                        source array index
                                                                                                                                                                                                                        0
                                                                                                                                                                                                                        source field
                                                                                                                                                                                                                        indications_and_usage_exact
                                                                                                                                                                                                                        source text sha256
                                                                                                                                                                                                                        e526ba14c91f10737e6d3331fe23a6219f58c0eca6380bfce9bd78b573fea912
                                                                                                                                                                                                                        start
                                                                                                                                                                                                                        15565
                                                                                                                                                                                                                      2. context exact
                                                                                                                                                                                                                        or the treatment of adult patients with locally advanced or metastatic urothelial cancer.
                                                                                                                                                                                                                        kind
                                                                                                                                                                                                                        biomarker
                                                                                                                                                                                                                        polarity
                                                                                                                                                                                                                        not_inferred
                                                                                                                                                                                                                        span
                                                                                                                                                                                                                        end
                                                                                                                                                                                                                        15633
                                                                                                                                                                                                                        end exclusive
                                                                                                                                                                                                                        true
                                                                                                                                                                                                                        exact text
                                                                                                                                                                                                                        metastatic urothelial cancer
                                                                                                                                                                                                                        label id
                                                                                                                                                                                                                        228e1e3f-d207-481f-8e14-9fdcbd0470e9
                                                                                                                                                                                                                        offset unit
                                                                                                                                                                                                                        unicode_code_points
                                                                                                                                                                                                                        source array index
                                                                                                                                                                                                                        0
                                                                                                                                                                                                                        source field
                                                                                                                                                                                                                        indications_and_usage_exact
                                                                                                                                                                                                                        source text sha256
                                                                                                                                                                                                                        e526ba14c91f10737e6d3331fe23a6219f58c0eca6380bfce9bd78b573fea912
                                                                                                                                                                                                                        start
                                                                                                                                                                                                                        15605
                                                                                                                                                                                                                      3. context exact
                                                                                                                                                                                                                        ejfv, is indicated for the treatment of adult patients with locally advanced or metastatic urothelial cancer.
                                                                                                                                                                                                                        kind
                                                                                                                                                                                                                        stage_or_setting
                                                                                                                                                                                                                        polarity
                                                                                                                                                                                                                        not_inferred
                                                                                                                                                                                                                        span
                                                                                                                                                                                                                        end
                                                                                                                                                                                                                        15633
                                                                                                                                                                                                                        end exclusive
                                                                                                                                                                                                                        true
                                                                                                                                                                                                                        exact text
                                                                                                                                                                                                                        locally advanced or metastatic urothelial cancer
                                                                                                                                                                                                                        label id
                                                                                                                                                                                                                        228e1e3f-d207-481f-8e14-9fdcbd0470e9
                                                                                                                                                                                                                        offset unit
                                                                                                                                                                                                                        unicode_code_points
                                                                                                                                                                                                                        source array index
                                                                                                                                                                                                                        0
                                                                                                                                                                                                                        source field
                                                                                                                                                                                                                        indications_and_usage_exact
                                                                                                                                                                                                                        source text sha256
                                                                                                                                                                                                                        e526ba14c91f10737e6d3331fe23a6219f58c0eca6380bfce9bd78b573fea912
                                                                                                                                                                                                                        start
                                                                                                                                                                                                                        15585
                                                                                                                                                                                                                      4. context exact
                                                                                                                                                                                                                        1.7 Urothelial Cancer KEYTRUDA, in combination with enfortumab vedotin-ejfv, is indicated for the treatment of adult patients with locally advanced or metastatic urothelial cancer.
                                                                                                                                                                                                                        kind
                                                                                                                                                                                                                        regimen
                                                                                                                                                                                                                        polarity
                                                                                                                                                                                                                        not_inferred
                                                                                                                                                                                                                        span
                                                                                                                                                                                                                        end
                                                                                                                                                                                                                        15633
                                                                                                                                                                                                                        end exclusive
                                                                                                                                                                                                                        true
                                                                                                                                                                                                                        exact text
                                                                                                                                                                                                                        in combination with enfortumab vedotin-ejfv, is indicated for the treatment of adult patients with locally advanced or metastatic urothelial cancer
                                                                                                                                                                                                                        label id
                                                                                                                                                                                                                        228e1e3f-d207-481f-8e14-9fdcbd0470e9
                                                                                                                                                                                                                        offset unit
                                                                                                                                                                                                                        unicode_code_points
                                                                                                                                                                                                                        source array index
                                                                                                                                                                                                                        0
                                                                                                                                                                                                                        source field
                                                                                                                                                                                                                        indications_and_usage_exact
                                                                                                                                                                                                                        source text sha256
                                                                                                                                                                                                                        e526ba14c91f10737e6d3331fe23a6219f58c0eca6380bfce9bd78b573fea912
                                                                                                                                                                                                                        start
                                                                                                                                                                                                                        15486
                                                                                                                                                                                                                      regulatory links
                                                                                                                                                                                                                        schema version
                                                                                                                                                                                                                        0.1.0
                                                                                                                                                                                                                        source batch sha256
                                                                                                                                                                                                                        fc39a8c5cf96bf95ca20b85578140167b66b2741f7d9217f500d9ba0847ac058
                                                                                                                                                                                                                        source defined aliases
                                                                                                                                                                                                                        1. abbreviation
                                                                                                                                                                                                                          NSCLC
                                                                                                                                                                                                                          definition exact
                                                                                                                                                                                                                          Non-Small Cell Lung Cancer
                                                                                                                                                                                                                          definition span
                                                                                                                                                                                                                          end
                                                                                                                                                                                                                          380
                                                                                                                                                                                                                          end exclusive
                                                                                                                                                                                                                          true
                                                                                                                                                                                                                          exact text
                                                                                                                                                                                                                          Non-Small Cell Lung Cancer (NSCLC)
                                                                                                                                                                                                                          label id
                                                                                                                                                                                                                          228e1e3f-d207-481f-8e14-9fdcbd0470e9
                                                                                                                                                                                                                          offset unit
                                                                                                                                                                                                                          unicode_code_points
                                                                                                                                                                                                                          source array index
                                                                                                                                                                                                                          0
                                                                                                                                                                                                                          source field
                                                                                                                                                                                                                          indications_and_usage_exact
                                                                                                                                                                                                                          source text sha256
                                                                                                                                                                                                                          e526ba14c91f10737e6d3331fe23a6219f58c0eca6380bfce9bd78b573fea912
                                                                                                                                                                                                                          start
                                                                                                                                                                                                                          346
                                                                                                                                                                                                                        2. abbreviation
                                                                                                                                                                                                                          CRC
                                                                                                                                                                                                                          definition exact
                                                                                                                                                                                                                          Colorectal Cancer
                                                                                                                                                                                                                          definition span
                                                                                                                                                                                                                          end
                                                                                                                                                                                                                          5042
                                                                                                                                                                                                                          end exclusive
                                                                                                                                                                                                                          true
                                                                                                                                                                                                                          exact text
                                                                                                                                                                                                                          Colorectal Cancer (CRC)
                                                                                                                                                                                                                          label id
                                                                                                                                                                                                                          228e1e3f-d207-481f-8e14-9fdcbd0470e9
                                                                                                                                                                                                                          offset unit
                                                                                                                                                                                                                          unicode_code_points
                                                                                                                                                                                                                          source array index
                                                                                                                                                                                                                          0
                                                                                                                                                                                                                          source field
                                                                                                                                                                                                                          indications_and_usage_exact
                                                                                                                                                                                                                          source text sha256
                                                                                                                                                                                                                          e526ba14c91f10737e6d3331fe23a6219f58c0eca6380bfce9bd78b573fea912
                                                                                                                                                                                                                          start
                                                                                                                                                                                                                          5019
                                                                                                                                                                                                                        source span
                                                                                                                                                                                                                        end
                                                                                                                                                                                                                        15634
                                                                                                                                                                                                                        end exclusive
                                                                                                                                                                                                                        true
                                                                                                                                                                                                                        exact text
                                                                                                                                                                                                                        1.7 Urothelial Cancer KEYTRUDA, in combination with enfortumab vedotin-ejfv, is indicated for the treatment of adult patients with locally advanced or metastatic urothelial cancer.
                                                                                                                                                                                                                        label id
                                                                                                                                                                                                                        228e1e3f-d207-481f-8e14-9fdcbd0470e9
                                                                                                                                                                                                                        offset unit
                                                                                                                                                                                                                        unicode_code_points
                                                                                                                                                                                                                        source array index
                                                                                                                                                                                                                        0
                                                                                                                                                                                                                        source field
                                                                                                                                                                                                                        indications_and_usage_exact
                                                                                                                                                                                                                        source text sha256
                                                                                                                                                                                                                        e526ba14c91f10737e6d3331fe23a6219f58c0eca6380bfce9bd78b573fea912
                                                                                                                                                                                                                        start
                                                                                                                                                                                                                        15454
                                                                                                                                                                                                                        source url
                                                                                                                                                                                                                        https://api.fda.gov/drug/label.json?search=id%3A%22228e1e3f-d207-481f-8e14-9fdcbd0470e9%22
                                                                                                                                                                                                                        spl effective date
                                                                                                                                                                                                                        2026-07-10
                                                                                                                                                                                                                        spl set id
                                                                                                                                                                                                                        9333c79b-d487-4538-a9f0-71b91a02b287
                                                                                                                                                                                                                        spl version
                                                                                                                                                                                                                        228
                                                                                                                                                                                                                        structured fields status
                                                                                                                                                                                                                        not_extracted_no_values_inferred_from_mentions
                                                                                                                                                                                                                        structured indication
                                                                                                                                                                                                                        age
                                                                                                                                                                                                                        Source null
                                                                                                                                                                                                                        approval pathway
                                                                                                                                                                                                                        Source null
                                                                                                                                                                                                                        biomarker and test
                                                                                                                                                                                                                        Source null
                                                                                                                                                                                                                        disease stage
                                                                                                                                                                                                                        Source null
                                                                                                                                                                                                                        limitations
                                                                                                                                                                                                                        Source null
                                                                                                                                                                                                                        line
                                                                                                                                                                                                                        Source null
                                                                                                                                                                                                                        prior therapy
                                                                                                                                                                                                                        Source null
                                                                                                                                                                                                                        regimen
                                                                                                                                                                                                                        Source null
                                                                                                                                                                                                                        tumor histology
                                                                                                                                                                                                                        Source null
                                                                                                                                                                                                                        use intent
                                                                                                                                                                                                                        tumor_directed_candidate
                                                                                                                                                                                                                        Passage 85 · positive indication candidate
                                                                                                                                                                                                                        application numbers
                                                                                                                                                                                                                        1. BLA125514
                                                                                                                                                                                                                        brand names
                                                                                                                                                                                                                        1. KEYTRUDA
                                                                                                                                                                                                                        classification reasons
                                                                                                                                                                                                                        1. explicit_positive_indication_predicate
                                                                                                                                                                                                                        2. tumor_or_malignant_hematology_words_in_positive_statement
                                                                                                                                                                                                                        clinical review status
                                                                                                                                                                                                                        pending
                                                                                                                                                                                                                        content role
                                                                                                                                                                                                                        positive_indication_candidate
                                                                                                                                                                                                                        context span
                                                                                                                                                                                                                        end
                                                                                                                                                                                                                        16208
                                                                                                                                                                                                                        end exclusive
                                                                                                                                                                                                                        true
                                                                                                                                                                                                                        exact text
                                                                                                                                                                                                                        reductive therapy. 1.7 Urothelial Cancer KEYTRUDA, in combination with enfortumab vedotin-ejfv, is indicated for the treatment of adult patients with locally advanced or metastatic urothelial cancer. KEYTRUDA, as a single agent, is indicated for the treatment of patients with locally advanced or metastatic urothelial carcinoma: who are not eligible for any platinum-containing chemotherapy, or who have disease progression during or following platinum-containing chemotherapy or within 12 months of neoadjuvant or adjuvant treatment with platinum-containing chemotherapy. KEYTRUDA, in combination with enfortumab vedotin-ejfv, as neoadjuvant treatment and then continued after cystectomy as adjuvant treatment, is indicated for the treatment of adult patients with muscle
                                                                                                                                                                                                                        label id
                                                                                                                                                                                                                        228e1e3f-d207-481f-8e14-9fdcbd0470e9
                                                                                                                                                                                                                        offset unit
                                                                                                                                                                                                                        unicode_code_points
                                                                                                                                                                                                                        source array index
                                                                                                                                                                                                                        0
                                                                                                                                                                                                                        source field
                                                                                                                                                                                                                        indications_and_usage_exact
                                                                                                                                                                                                                        source text sha256
                                                                                                                                                                                                                        e526ba14c91f10737e6d3331fe23a6219f58c0eca6380bfce9bd78b573fea912
                                                                                                                                                                                                                        start
                                                                                                                                                                                                                        15435
                                                                                                                                                                                                                        current approval status
                                                                                                                                                                                                                        not_reconciled
                                                                                                                                                                                                                        duplicate text group
                                                                                                                                                                                                                        dup-2c8b9ddb229ae46fe051
                                                                                                                                                                                                                        extraction review status
                                                                                                                                                                                                                        automated_candidate_pending_source_review
                                                                                                                                                                                                                        generic names
                                                                                                                                                                                                                        1. PEMBROLIZUMAB
                                                                                                                                                                                                                        id
                                                                                                                                                                                                                        ind-span-68aa15a3b57213f8eeef
                                                                                                                                                                                                                        label id
                                                                                                                                                                                                                        228e1e3f-d207-481f-8e14-9fdcbd0470e9
                                                                                                                                                                                                                        positive predicate support span
                                                                                                                                                                                                                        end
                                                                                                                                                                                                                        15676
                                                                                                                                                                                                                        end exclusive
                                                                                                                                                                                                                        true
                                                                                                                                                                                                                        exact text
                                                                                                                                                                                                                        is indicated
                                                                                                                                                                                                                        label id
                                                                                                                                                                                                                        228e1e3f-d207-481f-8e14-9fdcbd0470e9
                                                                                                                                                                                                                        offset unit
                                                                                                                                                                                                                        unicode_code_points
                                                                                                                                                                                                                        source array index
                                                                                                                                                                                                                        0
                                                                                                                                                                                                                        source field
                                                                                                                                                                                                                        indications_and_usage_exact
                                                                                                                                                                                                                        source text sha256
                                                                                                                                                                                                                        e526ba14c91f10737e6d3331fe23a6219f58c0eca6380bfce9bd78b573fea912
                                                                                                                                                                                                                        start
                                                                                                                                                                                                                        15664
                                                                                                                                                                                                                        qualifier mentions
                                                                                                                                                                                                                        1. context exact
                                                                                                                                                                                                                          ated for the treatment of patients with locally advanced or metastatic urothelial carcinoma: who are not eligible for any platinum-containing chemotherapy, or who
                                                                                                                                                                                                                          kind
                                                                                                                                                                                                                          biomarker
                                                                                                                                                                                                                          polarity
                                                                                                                                                                                                                          not_inferred
                                                                                                                                                                                                                          span
                                                                                                                                                                                                                          end
                                                                                                                                                                                                                          15775
                                                                                                                                                                                                                          end exclusive
                                                                                                                                                                                                                          true
                                                                                                                                                                                                                          exact text
                                                                                                                                                                                                                          metastatic urothelial carcinoma: who are no
                                                                                                                                                                                                                          label id
                                                                                                                                                                                                                          228e1e3f-d207-481f-8e14-9fdcbd0470e9
                                                                                                                                                                                                                          offset unit
                                                                                                                                                                                                                          unicode_code_points
                                                                                                                                                                                                                          source array index
                                                                                                                                                                                                                          0
                                                                                                                                                                                                                          source field
                                                                                                                                                                                                                          indications_and_usage_exact
                                                                                                                                                                                                                          source text sha256
                                                                                                                                                                                                                          e526ba14c91f10737e6d3331fe23a6219f58c0eca6380bfce9bd78b573fea912
                                                                                                                                                                                                                          start
                                                                                                                                                                                                                          15732
                                                                                                                                                                                                                        2. context exact
                                                                                                                                                                                                                          ngle agent, is indicated for the treatment of patients with locally advanced or metastatic urothelial carcinoma: who are not eligible for any platinum-containing chemother
                                                                                                                                                                                                                          kind
                                                                                                                                                                                                                          stage_or_setting
                                                                                                                                                                                                                          polarity
                                                                                                                                                                                                                          not_inferred
                                                                                                                                                                                                                          span
                                                                                                                                                                                                                          end
                                                                                                                                                                                                                          15763
                                                                                                                                                                                                                          end exclusive
                                                                                                                                                                                                                          true
                                                                                                                                                                                                                          exact text
                                                                                                                                                                                                                          locally advanced or metastatic urothelial carcinoma
                                                                                                                                                                                                                          label id
                                                                                                                                                                                                                          228e1e3f-d207-481f-8e14-9fdcbd0470e9
                                                                                                                                                                                                                          offset unit
                                                                                                                                                                                                                          unicode_code_points
                                                                                                                                                                                                                          source array index
                                                                                                                                                                                                                          0
                                                                                                                                                                                                                          source field
                                                                                                                                                                                                                          indications_and_usage_exact
                                                                                                                                                                                                                          source text sha256
                                                                                                                                                                                                                          e526ba14c91f10737e6d3331fe23a6219f58c0eca6380bfce9bd78b573fea912
                                                                                                                                                                                                                          start
                                                                                                                                                                                                                          15712
                                                                                                                                                                                                                        3. context exact
                                                                                                                                                                                                                          ing platinum-containing chemotherapy or within 12 months of neoadjuvant or adjuvant treatment with platinum-containing chemotherapy.
                                                                                                                                                                                                                          kind
                                                                                                                                                                                                                          stage_or_setting
                                                                                                                                                                                                                          polarity
                                                                                                                                                                                                                          not_inferred
                                                                                                                                                                                                                          span
                                                                                                                                                                                                                          end
                                                                                                                                                                                                                          15982
                                                                                                                                                                                                                          end exclusive
                                                                                                                                                                                                                          true
                                                                                                                                                                                                                          exact text
                                                                                                                                                                                                                          neoadjuvant or adjuvant treatment with platinu
                                                                                                                                                                                                                          label id
                                                                                                                                                                                                                          228e1e3f-d207-481f-8e14-9fdcbd0470e9
                                                                                                                                                                                                                          offset unit
                                                                                                                                                                                                                          unicode_code_points
                                                                                                                                                                                                                          source array index
                                                                                                                                                                                                                          0
                                                                                                                                                                                                                          source field
                                                                                                                                                                                                                          indications_and_usage_exact
                                                                                                                                                                                                                          source text sha256
                                                                                                                                                                                                                          e526ba14c91f10737e6d3331fe23a6219f58c0eca6380bfce9bd78b573fea912
                                                                                                                                                                                                                          start
                                                                                                                                                                                                                          15936
                                                                                                                                                                                                                        4. context exact
                                                                                                                                                                                                                          KEYTRUDA, as a single agent, is indicated for the treatment of patients with locally advanced or metastatic urothelial carcinoma: who are not eligible for any platinum-containing chemotherapy, or who have disease progression during or following pl
                                                                                                                                                                                                                          kind
                                                                                                                                                                                                                          regimen
                                                                                                                                                                                                                          polarity
                                                                                                                                                                                                                          not_inferred
                                                                                                                                                                                                                          span
                                                                                                                                                                                                                          end
                                                                                                                                                                                                                          15822
                                                                                                                                                                                                                          end exclusive
                                                                                                                                                                                                                          true
                                                                                                                                                                                                                          exact text
                                                                                                                                                                                                                          as a single agent, is indicated for the treatment of patients with locally advanced or metastatic urothelial carcinoma: who are not eligible for any platinum-containing chemothe
                                                                                                                                                                                                                          label id
                                                                                                                                                                                                                          228e1e3f-d207-481f-8e14-9fdcbd0470e9
                                                                                                                                                                                                                          offset unit
                                                                                                                                                                                                                          unicode_code_points
                                                                                                                                                                                                                          source array index
                                                                                                                                                                                                                          0
                                                                                                                                                                                                                          source field
                                                                                                                                                                                                                          indications_and_usage_exact
                                                                                                                                                                                                                          source text sha256
                                                                                                                                                                                                                          e526ba14c91f10737e6d3331fe23a6219f58c0eca6380bfce9bd78b573fea912
                                                                                                                                                                                                                          start
                                                                                                                                                                                                                          15645
                                                                                                                                                                                                                        regulatory links
                                                                                                                                                                                                                          schema version
                                                                                                                                                                                                                          0.1.0
                                                                                                                                                                                                                          source batch sha256
                                                                                                                                                                                                                          fc39a8c5cf96bf95ca20b85578140167b66b2741f7d9217f500d9ba0847ac058
                                                                                                                                                                                                                          source defined aliases
                                                                                                                                                                                                                          1. abbreviation
                                                                                                                                                                                                                            NSCLC
                                                                                                                                                                                                                            definition exact
                                                                                                                                                                                                                            Non-Small Cell Lung Cancer
                                                                                                                                                                                                                            definition span
                                                                                                                                                                                                                            end
                                                                                                                                                                                                                            380
                                                                                                                                                                                                                            end exclusive
                                                                                                                                                                                                                            true
                                                                                                                                                                                                                            exact text
                                                                                                                                                                                                                            Non-Small Cell Lung Cancer (NSCLC)
                                                                                                                                                                                                                            label id
                                                                                                                                                                                                                            228e1e3f-d207-481f-8e14-9fdcbd0470e9
                                                                                                                                                                                                                            offset unit
                                                                                                                                                                                                                            unicode_code_points
                                                                                                                                                                                                                            source array index
                                                                                                                                                                                                                            0
                                                                                                                                                                                                                            source field
                                                                                                                                                                                                                            indications_and_usage_exact
                                                                                                                                                                                                                            source text sha256
                                                                                                                                                                                                                            e526ba14c91f10737e6d3331fe23a6219f58c0eca6380bfce9bd78b573fea912
                                                                                                                                                                                                                            start
                                                                                                                                                                                                                            346
                                                                                                                                                                                                                          2. abbreviation
                                                                                                                                                                                                                            CRC
                                                                                                                                                                                                                            definition exact
                                                                                                                                                                                                                            Colorectal Cancer
                                                                                                                                                                                                                            definition span
                                                                                                                                                                                                                            end
                                                                                                                                                                                                                            5042
                                                                                                                                                                                                                            end exclusive
                                                                                                                                                                                                                            true
                                                                                                                                                                                                                            exact text
                                                                                                                                                                                                                            Colorectal Cancer (CRC)
                                                                                                                                                                                                                            label id
                                                                                                                                                                                                                            228e1e3f-d207-481f-8e14-9fdcbd0470e9
                                                                                                                                                                                                                            offset unit
                                                                                                                                                                                                                            unicode_code_points
                                                                                                                                                                                                                            source array index
                                                                                                                                                                                                                            0
                                                                                                                                                                                                                            source field
                                                                                                                                                                                                                            indications_and_usage_exact
                                                                                                                                                                                                                            source text sha256
                                                                                                                                                                                                                            e526ba14c91f10737e6d3331fe23a6219f58c0eca6380bfce9bd78b573fea912
                                                                                                                                                                                                                            start
                                                                                                                                                                                                                            5019
                                                                                                                                                                                                                          source span
                                                                                                                                                                                                                          end
                                                                                                                                                                                                                          16008
                                                                                                                                                                                                                          end exclusive
                                                                                                                                                                                                                          true
                                                                                                                                                                                                                          exact text
                                                                                                                                                                                                                          KEYTRUDA, as a single agent, is indicated for the treatment of patients with locally advanced or metastatic urothelial carcinoma: who are not eligible for any platinum-containing chemotherapy, or who have disease progression during or following platinum-containing chemotherapy or within 12 months of neoadjuvant or adjuvant treatment with platinum-containing chemotherapy.
                                                                                                                                                                                                                          label id
                                                                                                                                                                                                                          228e1e3f-d207-481f-8e14-9fdcbd0470e9
                                                                                                                                                                                                                          offset unit
                                                                                                                                                                                                                          unicode_code_points
                                                                                                                                                                                                                          source array index
                                                                                                                                                                                                                          0
                                                                                                                                                                                                                          source field
                                                                                                                                                                                                                          indications_and_usage_exact
                                                                                                                                                                                                                          source text sha256
                                                                                                                                                                                                                          e526ba14c91f10737e6d3331fe23a6219f58c0eca6380bfce9bd78b573fea912
                                                                                                                                                                                                                          start
                                                                                                                                                                                                                          15635
                                                                                                                                                                                                                          source url
                                                                                                                                                                                                                          https://api.fda.gov/drug/label.json?search=id%3A%22228e1e3f-d207-481f-8e14-9fdcbd0470e9%22
                                                                                                                                                                                                                          spl effective date
                                                                                                                                                                                                                          2026-07-10
                                                                                                                                                                                                                          spl set id
                                                                                                                                                                                                                          9333c79b-d487-4538-a9f0-71b91a02b287
                                                                                                                                                                                                                          spl version
                                                                                                                                                                                                                          228
                                                                                                                                                                                                                          structured fields status
                                                                                                                                                                                                                          not_extracted_no_values_inferred_from_mentions
                                                                                                                                                                                                                          structured indication
                                                                                                                                                                                                                          age
                                                                                                                                                                                                                          Source null
                                                                                                                                                                                                                          approval pathway
                                                                                                                                                                                                                          Source null
                                                                                                                                                                                                                          biomarker and test
                                                                                                                                                                                                                          Source null
                                                                                                                                                                                                                          disease stage
                                                                                                                                                                                                                          Source null
                                                                                                                                                                                                                          limitations
                                                                                                                                                                                                                          Source null
                                                                                                                                                                                                                          line
                                                                                                                                                                                                                          Source null
                                                                                                                                                                                                                          prior therapy
                                                                                                                                                                                                                          Source null
                                                                                                                                                                                                                          regimen
                                                                                                                                                                                                                          Source null
                                                                                                                                                                                                                          tumor histology
                                                                                                                                                                                                                          Source null
                                                                                                                                                                                                                          use intent
                                                                                                                                                                                                                          tumor_directed_candidate
                                                                                                                                                                                                                          Passage 86 · positive indication candidate
                                                                                                                                                                                                                          application numbers
                                                                                                                                                                                                                          1. BLA125514
                                                                                                                                                                                                                          brand names
                                                                                                                                                                                                                          1. KEYTRUDA
                                                                                                                                                                                                                          classification reasons
                                                                                                                                                                                                                          1. explicit_positive_indication_predicate
                                                                                                                                                                                                                          2. tumor_or_malignant_hematology_words_in_positive_statement
                                                                                                                                                                                                                          clinical review status
                                                                                                                                                                                                                          pending
                                                                                                                                                                                                                          content role
                                                                                                                                                                                                                          positive_indication_candidate
                                                                                                                                                                                                                          context span
                                                                                                                                                                                                                          end
                                                                                                                                                                                                                          16440
                                                                                                                                                                                                                          end exclusive
                                                                                                                                                                                                                          true
                                                                                                                                                                                                                          exact text
                                                                                                                                                                                                                          ning chemotherapy, or who have disease progression during or following platinum-containing chemotherapy or within 12 months of neoadjuvant or adjuvant treatment with platinum-containing chemotherapy. KEYTRUDA, in combination with enfortumab vedotin-ejfv, as neoadjuvant treatment and then continued after cystectomy as adjuvant treatment, is indicated for the treatment of adult patients with muscle invasive bladder cancer (MIBC). KEYTRUDA, as a single agent, is indicated for the treatment of patients with Bacillus Calmette-Guerin (BCG)-unresponsive, high-risk, non-muscle invasive bladder cancer (NMIBC) with carcinoma in situ
                                                                                                                                                                                                                          label id
                                                                                                                                                                                                                          228e1e3f-d207-481f-8e14-9fdcbd0470e9
                                                                                                                                                                                                                          offset unit
                                                                                                                                                                                                                          unicode_code_points
                                                                                                                                                                                                                          source array index
                                                                                                                                                                                                                          0
                                                                                                                                                                                                                          source field
                                                                                                                                                                                                                          indications_and_usage_exact
                                                                                                                                                                                                                          source text sha256
                                                                                                                                                                                                                          e526ba14c91f10737e6d3331fe23a6219f58c0eca6380bfce9bd78b573fea912
                                                                                                                                                                                                                          start
                                                                                                                                                                                                                          15809
                                                                                                                                                                                                                          current approval status
                                                                                                                                                                                                                          not_reconciled
                                                                                                                                                                                                                          duplicate text group
                                                                                                                                                                                                                          dup-c4b6ae6bcf3eae5501dc
                                                                                                                                                                                                                          extraction review status
                                                                                                                                                                                                                          automated_candidate_pending_source_review
                                                                                                                                                                                                                          generic names
                                                                                                                                                                                                                          1. PEMBROLIZUMAB
                                                                                                                                                                                                                          id
                                                                                                                                                                                                                          ind-span-1be478d1c3035336cddb
                                                                                                                                                                                                                          label id
                                                                                                                                                                                                                          228e1e3f-d207-481f-8e14-9fdcbd0470e9
                                                                                                                                                                                                                          positive predicate support span
                                                                                                                                                                                                                          end
                                                                                                                                                                                                                          16160
                                                                                                                                                                                                                          end exclusive
                                                                                                                                                                                                                          true
                                                                                                                                                                                                                          exact text
                                                                                                                                                                                                                          is indicated
                                                                                                                                                                                                                          label id
                                                                                                                                                                                                                          228e1e3f-d207-481f-8e14-9fdcbd0470e9
                                                                                                                                                                                                                          offset unit
                                                                                                                                                                                                                          unicode_code_points
                                                                                                                                                                                                                          source array index
                                                                                                                                                                                                                          0
                                                                                                                                                                                                                          source field
                                                                                                                                                                                                                          indications_and_usage_exact
                                                                                                                                                                                                                          source text sha256
                                                                                                                                                                                                                          e526ba14c91f10737e6d3331fe23a6219f58c0eca6380bfce9bd78b573fea912
                                                                                                                                                                                                                          start
                                                                                                                                                                                                                          16148
                                                                                                                                                                                                                          qualifier mentions
                                                                                                                                                                                                                          1. context exact
                                                                                                                                                                                                                            my as adjuvant treatment, is indicated for the treatment of adult patients with muscle invasive bladder cancer (MIBC).
                                                                                                                                                                                                                            kind
                                                                                                                                                                                                                            age
                                                                                                                                                                                                                            polarity
                                                                                                                                                                                                                            not_inferred
                                                                                                                                                                                                                            span
                                                                                                                                                                                                                            end
                                                                                                                                                                                                                            16196
                                                                                                                                                                                                                            end exclusive
                                                                                                                                                                                                                            true
                                                                                                                                                                                                                            exact text
                                                                                                                                                                                                                            adult patients
                                                                                                                                                                                                                            label id
                                                                                                                                                                                                                            228e1e3f-d207-481f-8e14-9fdcbd0470e9
                                                                                                                                                                                                                            offset unit
                                                                                                                                                                                                                            unicode_code_points
                                                                                                                                                                                                                            source array index
                                                                                                                                                                                                                            0
                                                                                                                                                                                                                            source field
                                                                                                                                                                                                                            indications_and_usage_exact
                                                                                                                                                                                                                            source text sha256
                                                                                                                                                                                                                            e526ba14c91f10737e6d3331fe23a6219f58c0eca6380bfce9bd78b573fea912
                                                                                                                                                                                                                            start
                                                                                                                                                                                                                            16182
                                                                                                                                                                                                                          2. context exact
                                                                                                                                                                                                                            KEYTRUDA, in combination with enfortumab vedotin-ejfv, as neoadjuvant treatment and then continued after cystectomy as adjuvant treatment, is indicated for the trea
                                                                                                                                                                                                                            kind
                                                                                                                                                                                                                            stage_or_setting
                                                                                                                                                                                                                            polarity
                                                                                                                                                                                                                            not_inferred
                                                                                                                                                                                                                            span
                                                                                                                                                                                                                            end
                                                                                                                                                                                                                            16113
                                                                                                                                                                                                                            end exclusive
                                                                                                                                                                                                                            true
                                                                                                                                                                                                                            exact text
                                                                                                                                                                                                                            neoadjuvant treatment and then continued after
                                                                                                                                                                                                                            label id
                                                                                                                                                                                                                            228e1e3f-d207-481f-8e14-9fdcbd0470e9
                                                                                                                                                                                                                            offset unit
                                                                                                                                                                                                                            unicode_code_points
                                                                                                                                                                                                                            source array index
                                                                                                                                                                                                                            0
                                                                                                                                                                                                                            source field
                                                                                                                                                                                                                            indications_and_usage_exact
                                                                                                                                                                                                                            source text sha256
                                                                                                                                                                                                                            e526ba14c91f10737e6d3331fe23a6219f58c0eca6380bfce9bd78b573fea912
                                                                                                                                                                                                                            start
                                                                                                                                                                                                                            16067
                                                                                                                                                                                                                          3. context exact
                                                                                                                                                                                                                            eoadjuvant treatment and then continued after cystectomy as adjuvant treatment, is indicated for the treatment of adult patients with musc
                                                                                                                                                                                                                            kind
                                                                                                                                                                                                                            stage_or_setting
                                                                                                                                                                                                                            polarity
                                                                                                                                                                                                                            not_inferred
                                                                                                                                                                                                                            span
                                                                                                                                                                                                                            end
                                                                                                                                                                                                                            16146
                                                                                                                                                                                                                            end exclusive
                                                                                                                                                                                                                            true
                                                                                                                                                                                                                            exact text
                                                                                                                                                                                                                            adjuvant treatment
                                                                                                                                                                                                                            label id
                                                                                                                                                                                                                            228e1e3f-d207-481f-8e14-9fdcbd0470e9
                                                                                                                                                                                                                            offset unit
                                                                                                                                                                                                                            unicode_code_points
                                                                                                                                                                                                                            source array index
                                                                                                                                                                                                                            0
                                                                                                                                                                                                                            source field
                                                                                                                                                                                                                            indications_and_usage_exact
                                                                                                                                                                                                                            source text sha256
                                                                                                                                                                                                                            e526ba14c91f10737e6d3331fe23a6219f58c0eca6380bfce9bd78b573fea912
                                                                                                                                                                                                                            start
                                                                                                                                                                                                                            16128
                                                                                                                                                                                                                          4. context exact
                                                                                                                                                                                                                            KEYTRUDA, in combination with enfortumab vedotin-ejfv, as neoadjuvant treatment and then continued after cystectomy as adjuvant treatment, is indicated for the treatment of adult patients with muscle invasive bladder cancer (MIBC).
                                                                                                                                                                                                                            kind
                                                                                                                                                                                                                            regimen
                                                                                                                                                                                                                            polarity
                                                                                                                                                                                                                            not_inferred
                                                                                                                                                                                                                            span
                                                                                                                                                                                                                            end
                                                                                                                                                                                                                            16198
                                                                                                                                                                                                                            end exclusive
                                                                                                                                                                                                                            true
                                                                                                                                                                                                                            exact text
                                                                                                                                                                                                                            in combination with enfortumab vedotin-ejfv, as neoadjuvant treatment and then continued after cystectomy as adjuvant treatment, is indicated for the treatment of adult patients w
                                                                                                                                                                                                                            label id
                                                                                                                                                                                                                            228e1e3f-d207-481f-8e14-9fdcbd0470e9
                                                                                                                                                                                                                            offset unit
                                                                                                                                                                                                                            unicode_code_points
                                                                                                                                                                                                                            source array index
                                                                                                                                                                                                                            0
                                                                                                                                                                                                                            source field
                                                                                                                                                                                                                            indications_and_usage_exact
                                                                                                                                                                                                                            source text sha256
                                                                                                                                                                                                                            e526ba14c91f10737e6d3331fe23a6219f58c0eca6380bfce9bd78b573fea912
                                                                                                                                                                                                                            start
                                                                                                                                                                                                                            16019
                                                                                                                                                                                                                          regulatory links
                                                                                                                                                                                                                            schema version
                                                                                                                                                                                                                            0.1.0
                                                                                                                                                                                                                            source batch sha256
                                                                                                                                                                                                                            fc39a8c5cf96bf95ca20b85578140167b66b2741f7d9217f500d9ba0847ac058
                                                                                                                                                                                                                            source defined aliases
                                                                                                                                                                                                                            1. abbreviation
                                                                                                                                                                                                                              NSCLC
                                                                                                                                                                                                                              definition exact
                                                                                                                                                                                                                              Non-Small Cell Lung Cancer
                                                                                                                                                                                                                              definition span
                                                                                                                                                                                                                              end
                                                                                                                                                                                                                              380
                                                                                                                                                                                                                              end exclusive
                                                                                                                                                                                                                              true
                                                                                                                                                                                                                              exact text
                                                                                                                                                                                                                              Non-Small Cell Lung Cancer (NSCLC)
                                                                                                                                                                                                                              label id
                                                                                                                                                                                                                              228e1e3f-d207-481f-8e14-9fdcbd0470e9
                                                                                                                                                                                                                              offset unit
                                                                                                                                                                                                                              unicode_code_points
                                                                                                                                                                                                                              source array index
                                                                                                                                                                                                                              0
                                                                                                                                                                                                                              source field
                                                                                                                                                                                                                              indications_and_usage_exact
                                                                                                                                                                                                                              source text sha256
                                                                                                                                                                                                                              e526ba14c91f10737e6d3331fe23a6219f58c0eca6380bfce9bd78b573fea912
                                                                                                                                                                                                                              start
                                                                                                                                                                                                                              346
                                                                                                                                                                                                                            2. abbreviation
                                                                                                                                                                                                                              CRC
                                                                                                                                                                                                                              definition exact
                                                                                                                                                                                                                              Colorectal Cancer
                                                                                                                                                                                                                              definition span
                                                                                                                                                                                                                              end
                                                                                                                                                                                                                              5042
                                                                                                                                                                                                                              end exclusive
                                                                                                                                                                                                                              true
                                                                                                                                                                                                                              exact text
                                                                                                                                                                                                                              Colorectal Cancer (CRC)
                                                                                                                                                                                                                              label id
                                                                                                                                                                                                                              228e1e3f-d207-481f-8e14-9fdcbd0470e9
                                                                                                                                                                                                                              offset unit
                                                                                                                                                                                                                              unicode_code_points
                                                                                                                                                                                                                              source array index
                                                                                                                                                                                                                              0
                                                                                                                                                                                                                              source field
                                                                                                                                                                                                                              indications_and_usage_exact
                                                                                                                                                                                                                              source text sha256
                                                                                                                                                                                                                              e526ba14c91f10737e6d3331fe23a6219f58c0eca6380bfce9bd78b573fea912
                                                                                                                                                                                                                              start
                                                                                                                                                                                                                              5019
                                                                                                                                                                                                                            source span
                                                                                                                                                                                                                            end
                                                                                                                                                                                                                            16240
                                                                                                                                                                                                                            end exclusive
                                                                                                                                                                                                                            true
                                                                                                                                                                                                                            exact text
                                                                                                                                                                                                                            KEYTRUDA, in combination with enfortumab vedotin-ejfv, as neoadjuvant treatment and then continued after cystectomy as adjuvant treatment, is indicated for the treatment of adult patients with muscle invasive bladder cancer (MIBC).
                                                                                                                                                                                                                            label id
                                                                                                                                                                                                                            228e1e3f-d207-481f-8e14-9fdcbd0470e9
                                                                                                                                                                                                                            offset unit
                                                                                                                                                                                                                            unicode_code_points
                                                                                                                                                                                                                            source array index
                                                                                                                                                                                                                            0
                                                                                                                                                                                                                            source field
                                                                                                                                                                                                                            indications_and_usage_exact
                                                                                                                                                                                                                            source text sha256
                                                                                                                                                                                                                            e526ba14c91f10737e6d3331fe23a6219f58c0eca6380bfce9bd78b573fea912
                                                                                                                                                                                                                            start
                                                                                                                                                                                                                            16009
                                                                                                                                                                                                                            source url
                                                                                                                                                                                                                            https://api.fda.gov/drug/label.json?search=id%3A%22228e1e3f-d207-481f-8e14-9fdcbd0470e9%22
                                                                                                                                                                                                                            spl effective date
                                                                                                                                                                                                                            2026-07-10
                                                                                                                                                                                                                            spl set id
                                                                                                                                                                                                                            9333c79b-d487-4538-a9f0-71b91a02b287
                                                                                                                                                                                                                            spl version
                                                                                                                                                                                                                            228
                                                                                                                                                                                                                            structured fields status
                                                                                                                                                                                                                            not_extracted_no_values_inferred_from_mentions
                                                                                                                                                                                                                            structured indication
                                                                                                                                                                                                                            age
                                                                                                                                                                                                                            Source null
                                                                                                                                                                                                                            approval pathway
                                                                                                                                                                                                                            Source null
                                                                                                                                                                                                                            biomarker and test
                                                                                                                                                                                                                            Source null
                                                                                                                                                                                                                            disease stage
                                                                                                                                                                                                                            Source null
                                                                                                                                                                                                                            limitations
                                                                                                                                                                                                                            Source null
                                                                                                                                                                                                                            line
                                                                                                                                                                                                                            Source null
                                                                                                                                                                                                                            prior therapy
                                                                                                                                                                                                                            Source null
                                                                                                                                                                                                                            regimen
                                                                                                                                                                                                                            Source null
                                                                                                                                                                                                                            tumor histology
                                                                                                                                                                                                                            Source null
                                                                                                                                                                                                                            use intent
                                                                                                                                                                                                                            tumor_directed_candidate
                                                                                                                                                                                                                            Passage 87 · positive indication candidate
                                                                                                                                                                                                                            application numbers
                                                                                                                                                                                                                            1. BLA125514
                                                                                                                                                                                                                            brand names
                                                                                                                                                                                                                            1. KEYTRUDA
                                                                                                                                                                                                                            classification reasons
                                                                                                                                                                                                                            1. explicit_positive_indication_predicate
                                                                                                                                                                                                                            2. tumor_or_malignant_hematology_words_in_positive_statement
                                                                                                                                                                                                                            clinical review status
                                                                                                                                                                                                                            pending
                                                                                                                                                                                                                            content role
                                                                                                                                                                                                                            positive_indication_candidate
                                                                                                                                                                                                                            context span
                                                                                                                                                                                                                            end
                                                                                                                                                                                                                            16744
                                                                                                                                                                                                                            end exclusive
                                                                                                                                                                                                                            true
                                                                                                                                                                                                                            exact text
                                                                                                                                                                                                                            fortumab vedotin-ejfv, as neoadjuvant treatment and then continued after cystectomy as adjuvant treatment, is indicated for the treatment of adult patients with muscle invasive bladder cancer (MIBC). KEYTRUDA, as a single agent, is indicated for the treatment of patients with Bacillus Calmette-Guerin (BCG)-unresponsive, high-risk, non-muscle invasive bladder cancer (NMIBC) with carcinoma in situ (CIS) with or without papillary tumors who are ineligible for or have elected not to undergo cystectomy. 1.8 Microsatellite Instability-High or Mismatch Repair Deficient Cancer KEYTRUDA is indicated for the treatment of adult and pediatric patients with unresectable or metastatic microsatellite instabil
                                                                                                                                                                                                                            label id
                                                                                                                                                                                                                            228e1e3f-d207-481f-8e14-9fdcbd0470e9
                                                                                                                                                                                                                            offset unit
                                                                                                                                                                                                                            unicode_code_points
                                                                                                                                                                                                                            source array index
                                                                                                                                                                                                                            0
                                                                                                                                                                                                                            source field
                                                                                                                                                                                                                            indications_and_usage_exact
                                                                                                                                                                                                                            source text sha256
                                                                                                                                                                                                                            e526ba14c91f10737e6d3331fe23a6219f58c0eca6380bfce9bd78b573fea912
                                                                                                                                                                                                                            start
                                                                                                                                                                                                                            16041
                                                                                                                                                                                                                            current approval status
                                                                                                                                                                                                                            not_reconciled
                                                                                                                                                                                                                            duplicate text group
                                                                                                                                                                                                                            dup-12e3539f38edf3ed4b75
                                                                                                                                                                                                                            extraction review status
                                                                                                                                                                                                                            automated_candidate_pending_source_review
                                                                                                                                                                                                                            generic names
                                                                                                                                                                                                                            1. PEMBROLIZUMAB
                                                                                                                                                                                                                            id
                                                                                                                                                                                                                            ind-span-9a899f65487a4ee1b57b
                                                                                                                                                                                                                            label id
                                                                                                                                                                                                                            228e1e3f-d207-481f-8e14-9fdcbd0470e9
                                                                                                                                                                                                                            positive predicate support span
                                                                                                                                                                                                                            end
                                                                                                                                                                                                                            16282
                                                                                                                                                                                                                            end exclusive
                                                                                                                                                                                                                            true
                                                                                                                                                                                                                            exact text
                                                                                                                                                                                                                            is indicated
                                                                                                                                                                                                                            label id
                                                                                                                                                                                                                            228e1e3f-d207-481f-8e14-9fdcbd0470e9
                                                                                                                                                                                                                            offset unit
                                                                                                                                                                                                                            unicode_code_points
                                                                                                                                                                                                                            source array index
                                                                                                                                                                                                                            0
                                                                                                                                                                                                                            source field
                                                                                                                                                                                                                            indications_and_usage_exact
                                                                                                                                                                                                                            source text sha256
                                                                                                                                                                                                                            e526ba14c91f10737e6d3331fe23a6219f58c0eca6380bfce9bd78b573fea912
                                                                                                                                                                                                                            start
                                                                                                                                                                                                                            16270
                                                                                                                                                                                                                            qualifier mentions
                                                                                                                                                                                                                            1. context exact
                                                                                                                                                                                                                              KEYTRUDA, as a single agent, is indicated for the treatment of patients with Bacillus Calmette-Guerin (BCG)-unresponsive, high-risk, non-muscle invasive bladder cancer (NMIBC) with carcinoma in situ (CIS) with or without papillary tumors who are i
                                                                                                                                                                                                                              kind
                                                                                                                                                                                                                              regimen
                                                                                                                                                                                                                              polarity
                                                                                                                                                                                                                              not_inferred
                                                                                                                                                                                                                              span
                                                                                                                                                                                                                              end
                                                                                                                                                                                                                              16428
                                                                                                                                                                                                                              end exclusive
                                                                                                                                                                                                                              true
                                                                                                                                                                                                                              exact text
                                                                                                                                                                                                                              as a single agent, is indicated for the treatment of patients with Bacillus Calmette-Guerin (BCG)-unresponsive, high-risk, non-muscle invasive bladder cancer (NMIBC) with carcin
                                                                                                                                                                                                                              label id
                                                                                                                                                                                                                              228e1e3f-d207-481f-8e14-9fdcbd0470e9
                                                                                                                                                                                                                              offset unit
                                                                                                                                                                                                                              unicode_code_points
                                                                                                                                                                                                                              source array index
                                                                                                                                                                                                                              0
                                                                                                                                                                                                                              source field
                                                                                                                                                                                                                              indications_and_usage_exact
                                                                                                                                                                                                                              source text sha256
                                                                                                                                                                                                                              e526ba14c91f10737e6d3331fe23a6219f58c0eca6380bfce9bd78b573fea912
                                                                                                                                                                                                                              start
                                                                                                                                                                                                                              16251
                                                                                                                                                                                                                            2. context exact
                                                                                                                                                                                                                              nvasive bladder cancer (NMIBC) with carcinoma in situ (CIS) with or without papillary tumors who are ineligible for or have elected not to undergo cystectomy.
                                                                                                                                                                                                                              kind
                                                                                                                                                                                                                              regimen
                                                                                                                                                                                                                              polarity
                                                                                                                                                                                                                              not_inferred
                                                                                                                                                                                                                              span
                                                                                                                                                                                                                              end
                                                                                                                                                                                                                              16543
                                                                                                                                                                                                                              end exclusive
                                                                                                                                                                                                                              true
                                                                                                                                                                                                                              exact text
                                                                                                                                                                                                                              with or without papillary tumors who are ineligible for or have elected not to undergo cystectomy
                                                                                                                                                                                                                              label id
                                                                                                                                                                                                                              228e1e3f-d207-481f-8e14-9fdcbd0470e9
                                                                                                                                                                                                                              offset unit
                                                                                                                                                                                                                              unicode_code_points
                                                                                                                                                                                                                              source array index
                                                                                                                                                                                                                              0
                                                                                                                                                                                                                              source field
                                                                                                                                                                                                                              indications_and_usage_exact
                                                                                                                                                                                                                              source text sha256
                                                                                                                                                                                                                              e526ba14c91f10737e6d3331fe23a6219f58c0eca6380bfce9bd78b573fea912
                                                                                                                                                                                                                              start
                                                                                                                                                                                                                              16446
                                                                                                                                                                                                                            regulatory links
                                                                                                                                                                                                                              schema version
                                                                                                                                                                                                                              0.1.0
                                                                                                                                                                                                                              source batch sha256
                                                                                                                                                                                                                              fc39a8c5cf96bf95ca20b85578140167b66b2741f7d9217f500d9ba0847ac058
                                                                                                                                                                                                                              source defined aliases
                                                                                                                                                                                                                              1. abbreviation
                                                                                                                                                                                                                                NSCLC
                                                                                                                                                                                                                                definition exact
                                                                                                                                                                                                                                Non-Small Cell Lung Cancer
                                                                                                                                                                                                                                definition span
                                                                                                                                                                                                                                end
                                                                                                                                                                                                                                380
                                                                                                                                                                                                                                end exclusive
                                                                                                                                                                                                                                true
                                                                                                                                                                                                                                exact text
                                                                                                                                                                                                                                Non-Small Cell Lung Cancer (NSCLC)
                                                                                                                                                                                                                                label id
                                                                                                                                                                                                                                228e1e3f-d207-481f-8e14-9fdcbd0470e9
                                                                                                                                                                                                                                offset unit
                                                                                                                                                                                                                                unicode_code_points
                                                                                                                                                                                                                                source array index
                                                                                                                                                                                                                                0
                                                                                                                                                                                                                                source field
                                                                                                                                                                                                                                indications_and_usage_exact
                                                                                                                                                                                                                                source text sha256
                                                                                                                                                                                                                                e526ba14c91f10737e6d3331fe23a6219f58c0eca6380bfce9bd78b573fea912
                                                                                                                                                                                                                                start
                                                                                                                                                                                                                                346
                                                                                                                                                                                                                              2. abbreviation
                                                                                                                                                                                                                                CRC
                                                                                                                                                                                                                                definition exact
                                                                                                                                                                                                                                Colorectal Cancer
                                                                                                                                                                                                                                definition span
                                                                                                                                                                                                                                end
                                                                                                                                                                                                                                5042
                                                                                                                                                                                                                                end exclusive
                                                                                                                                                                                                                                true
                                                                                                                                                                                                                                exact text
                                                                                                                                                                                                                                Colorectal Cancer (CRC)
                                                                                                                                                                                                                                label id
                                                                                                                                                                                                                                228e1e3f-d207-481f-8e14-9fdcbd0470e9
                                                                                                                                                                                                                                offset unit
                                                                                                                                                                                                                                unicode_code_points
                                                                                                                                                                                                                                source array index
                                                                                                                                                                                                                                0
                                                                                                                                                                                                                                source field
                                                                                                                                                                                                                                indications_and_usage_exact
                                                                                                                                                                                                                                source text sha256
                                                                                                                                                                                                                                e526ba14c91f10737e6d3331fe23a6219f58c0eca6380bfce9bd78b573fea912
                                                                                                                                                                                                                                start
                                                                                                                                                                                                                                5019
                                                                                                                                                                                                                              source span
                                                                                                                                                                                                                              end
                                                                                                                                                                                                                              16544
                                                                                                                                                                                                                              end exclusive
                                                                                                                                                                                                                              true
                                                                                                                                                                                                                              exact text
                                                                                                                                                                                                                              KEYTRUDA, as a single agent, is indicated for the treatment of patients with Bacillus Calmette-Guerin (BCG)-unresponsive, high-risk, non-muscle invasive bladder cancer (NMIBC) with carcinoma in situ (CIS) with or without papillary tumors who are ineligible for or have elected not to undergo cystectomy.
                                                                                                                                                                                                                              label id
                                                                                                                                                                                                                              228e1e3f-d207-481f-8e14-9fdcbd0470e9
                                                                                                                                                                                                                              offset unit
                                                                                                                                                                                                                              unicode_code_points
                                                                                                                                                                                                                              source array index
                                                                                                                                                                                                                              0
                                                                                                                                                                                                                              source field
                                                                                                                                                                                                                              indications_and_usage_exact
                                                                                                                                                                                                                              source text sha256
                                                                                                                                                                                                                              e526ba14c91f10737e6d3331fe23a6219f58c0eca6380bfce9bd78b573fea912
                                                                                                                                                                                                                              start
                                                                                                                                                                                                                              16241
                                                                                                                                                                                                                              source url
                                                                                                                                                                                                                              https://api.fda.gov/drug/label.json?search=id%3A%22228e1e3f-d207-481f-8e14-9fdcbd0470e9%22
                                                                                                                                                                                                                              spl effective date
                                                                                                                                                                                                                              2026-07-10
                                                                                                                                                                                                                              spl set id
                                                                                                                                                                                                                              9333c79b-d487-4538-a9f0-71b91a02b287
                                                                                                                                                                                                                              spl version
                                                                                                                                                                                                                              228
                                                                                                                                                                                                                              structured fields status
                                                                                                                                                                                                                              not_extracted_no_values_inferred_from_mentions
                                                                                                                                                                                                                              structured indication
                                                                                                                                                                                                                              age
                                                                                                                                                                                                                              Source null
                                                                                                                                                                                                                              approval pathway
                                                                                                                                                                                                                              Source null
                                                                                                                                                                                                                              biomarker and test
                                                                                                                                                                                                                              Source null
                                                                                                                                                                                                                              disease stage
                                                                                                                                                                                                                              Source null
                                                                                                                                                                                                                              limitations
                                                                                                                                                                                                                              Source null
                                                                                                                                                                                                                              line
                                                                                                                                                                                                                              Source null
                                                                                                                                                                                                                              prior therapy
                                                                                                                                                                                                                              Source null
                                                                                                                                                                                                                              regimen
                                                                                                                                                                                                                              Source null
                                                                                                                                                                                                                              tumor histology
                                                                                                                                                                                                                              Source null
                                                                                                                                                                                                                              use intent
                                                                                                                                                                                                                              tumor_directed_candidate
                                                                                                                                                                                                                              Passage 88 · positive indication candidate
                                                                                                                                                                                                                              application numbers
                                                                                                                                                                                                                              1. BLA125514
                                                                                                                                                                                                                              brand names
                                                                                                                                                                                                                              1. KEYTRUDA
                                                                                                                                                                                                                              classification reasons
                                                                                                                                                                                                                              1. explicit_positive_indication_predicate
                                                                                                                                                                                                                              2. tumor_or_malignant_hematology_words_in_positive_statement
                                                                                                                                                                                                                              clinical review status
                                                                                                                                                                                                                              pending
                                                                                                                                                                                                                              content role
                                                                                                                                                                                                                              positive_indication_candidate
                                                                                                                                                                                                                              context span
                                                                                                                                                                                                                              end
                                                                                                                                                                                                                              17198
                                                                                                                                                                                                                              end exclusive
                                                                                                                                                                                                                              true
                                                                                                                                                                                                                              exact text
                                                                                                                                                                                                                              CG)-unresponsive, high-risk, non-muscle invasive bladder cancer (NMIBC) with carcinoma in situ (CIS) with or without papillary tumors who are ineligible for or have elected not to undergo cystectomy. 1.8 Microsatellite Instability-High or Mismatch Repair Deficient Cancer KEYTRUDA is indicated for the treatment of adult and pediatric patients with unresectable or metastatic microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) solid tumors, as determined by an FDA-authorized test, that have progressed following prior treatment and who have no satisfactory alternative treatment options [see Dosage and Administration (2.1) ] . 1.9 Microsatellite Instability-High or Mismatch Repair Deficient Colorectal Cancer KEYTRUDA is indicated for the treatment of patients with unresectable or metastatic MSI-H or dMMR colorectal cancer
                                                                                                                                                                                                                              label id
                                                                                                                                                                                                                              228e1e3f-d207-481f-8e14-9fdcbd0470e9
                                                                                                                                                                                                                              offset unit
                                                                                                                                                                                                                              unicode_code_points
                                                                                                                                                                                                                              source array index
                                                                                                                                                                                                                              0
                                                                                                                                                                                                                              source field
                                                                                                                                                                                                                              indications_and_usage_exact
                                                                                                                                                                                                                              source text sha256
                                                                                                                                                                                                                              e526ba14c91f10737e6d3331fe23a6219f58c0eca6380bfce9bd78b573fea912
                                                                                                                                                                                                                              start
                                                                                                                                                                                                                              16345
                                                                                                                                                                                                                              current approval status
                                                                                                                                                                                                                              not_reconciled
                                                                                                                                                                                                                              duplicate text group
                                                                                                                                                                                                                              dup-c55209d6ec2306781bf6
                                                                                                                                                                                                                              extraction review status
                                                                                                                                                                                                                              automated_candidate_pending_source_review
                                                                                                                                                                                                                              generic names
                                                                                                                                                                                                                              1. PEMBROLIZUMAB
                                                                                                                                                                                                                              id
                                                                                                                                                                                                                              ind-span-0ed256c3bad94bacb965
                                                                                                                                                                                                                              label id
                                                                                                                                                                                                                              228e1e3f-d207-481f-8e14-9fdcbd0470e9
                                                                                                                                                                                                                              positive predicate support span
                                                                                                                                                                                                                              end
                                                                                                                                                                                                                              16638
                                                                                                                                                                                                                              end exclusive
                                                                                                                                                                                                                              true
                                                                                                                                                                                                                              exact text
                                                                                                                                                                                                                              is indicated
                                                                                                                                                                                                                              label id
                                                                                                                                                                                                                              228e1e3f-d207-481f-8e14-9fdcbd0470e9
                                                                                                                                                                                                                              offset unit
                                                                                                                                                                                                                              unicode_code_points
                                                                                                                                                                                                                              source array index
                                                                                                                                                                                                                              0
                                                                                                                                                                                                                              source field
                                                                                                                                                                                                                              indications_and_usage_exact
                                                                                                                                                                                                                              source text sha256
                                                                                                                                                                                                                              e526ba14c91f10737e6d3331fe23a6219f58c0eca6380bfce9bd78b573fea912
                                                                                                                                                                                                                              start
                                                                                                                                                                                                                              16626
                                                                                                                                                                                                                              qualifier mentions
                                                                                                                                                                                                                              1. context exact
                                                                                                                                                                                                                                Deficient Cancer KEYTRUDA is indicated for the treatment of adult and pediatric patients with unresectable or metastatic micr
                                                                                                                                                                                                                                kind
                                                                                                                                                                                                                                age
                                                                                                                                                                                                                                polarity
                                                                                                                                                                                                                                not_inferred
                                                                                                                                                                                                                                span
                                                                                                                                                                                                                                end
                                                                                                                                                                                                                                16665
                                                                                                                                                                                                                                end exclusive
                                                                                                                                                                                                                                true
                                                                                                                                                                                                                                exact text
                                                                                                                                                                                                                                adult
                                                                                                                                                                                                                                label id
                                                                                                                                                                                                                                228e1e3f-d207-481f-8e14-9fdcbd0470e9
                                                                                                                                                                                                                                offset unit
                                                                                                                                                                                                                                unicode_code_points
                                                                                                                                                                                                                                source array index
                                                                                                                                                                                                                                0
                                                                                                                                                                                                                                source field
                                                                                                                                                                                                                                indications_and_usage_exact
                                                                                                                                                                                                                                source text sha256
                                                                                                                                                                                                                                e526ba14c91f10737e6d3331fe23a6219f58c0eca6380bfce9bd78b573fea912
                                                                                                                                                                                                                                start
                                                                                                                                                                                                                                16660
                                                                                                                                                                                                                              2. context exact
                                                                                                                                                                                                                                Cancer KEYTRUDA is indicated for the treatment of adult and pediatric patients with unresectable or metastatic microsatellite instability-
                                                                                                                                                                                                                                kind
                                                                                                                                                                                                                                age
                                                                                                                                                                                                                                polarity
                                                                                                                                                                                                                                not_inferred
                                                                                                                                                                                                                                span
                                                                                                                                                                                                                                end
                                                                                                                                                                                                                                16688
                                                                                                                                                                                                                                end exclusive
                                                                                                                                                                                                                                true
                                                                                                                                                                                                                                exact text
                                                                                                                                                                                                                                pediatric patients
                                                                                                                                                                                                                                label id
                                                                                                                                                                                                                                228e1e3f-d207-481f-8e14-9fdcbd0470e9
                                                                                                                                                                                                                                offset unit
                                                                                                                                                                                                                                unicode_code_points
                                                                                                                                                                                                                                source array index
                                                                                                                                                                                                                                0
                                                                                                                                                                                                                                source field
                                                                                                                                                                                                                                indications_and_usage_exact
                                                                                                                                                                                                                                source text sha256
                                                                                                                                                                                                                                e526ba14c91f10737e6d3331fe23a6219f58c0eca6380bfce9bd78b573fea912
                                                                                                                                                                                                                                start
                                                                                                                                                                                                                                16670
                                                                                                                                                                                                                              3. context exact
                                                                                                                                                                                                                                atment of adult and pediatric patients with unresectable or metastatic microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) solid tumors, as
                                                                                                                                                                                                                                kind
                                                                                                                                                                                                                                biomarker
                                                                                                                                                                                                                                polarity
                                                                                                                                                                                                                                not_inferred
                                                                                                                                                                                                                                span
                                                                                                                                                                                                                                end
                                                                                                                                                                                                                                16753
                                                                                                                                                                                                                                end exclusive
                                                                                                                                                                                                                                true
                                                                                                                                                                                                                                exact text
                                                                                                                                                                                                                                metastatic microsatellite instability-high
                                                                                                                                                                                                                                label id
                                                                                                                                                                                                                                228e1e3f-d207-481f-8e14-9fdcbd0470e9
                                                                                                                                                                                                                                offset unit
                                                                                                                                                                                                                                unicode_code_points
                                                                                                                                                                                                                                source array index
                                                                                                                                                                                                                                0
                                                                                                                                                                                                                                source field
                                                                                                                                                                                                                                indications_and_usage_exact
                                                                                                                                                                                                                                source text sha256
                                                                                                                                                                                                                                e526ba14c91f10737e6d3331fe23a6219f58c0eca6380bfce9bd78b573fea912
                                                                                                                                                                                                                                start
                                                                                                                                                                                                                                16710
                                                                                                                                                                                                                              4. context exact
                                                                                                                                                                                                                                unresectable or metastatic microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) solid tumors, as determined by an FDA-authorized test, that ha
                                                                                                                                                                                                                                kind
                                                                                                                                                                                                                                biomarker
                                                                                                                                                                                                                                polarity
                                                                                                                                                                                                                                not_inferred
                                                                                                                                                                                                                                span
                                                                                                                                                                                                                                end
                                                                                                                                                                                                                                16799
                                                                                                                                                                                                                                end exclusive
                                                                                                                                                                                                                                true
                                                                                                                                                                                                                                exact text
                                                                                                                                                                                                                                MSI-H) or mismatch repair deficient (dMMR) so
                                                                                                                                                                                                                                label id
                                                                                                                                                                                                                                228e1e3f-d207-481f-8e14-9fdcbd0470e9
                                                                                                                                                                                                                                offset unit
                                                                                                                                                                                                                                unicode_code_points
                                                                                                                                                                                                                                source array index
                                                                                                                                                                                                                                0
                                                                                                                                                                                                                                source field
                                                                                                                                                                                                                                indications_and_usage_exact
                                                                                                                                                                                                                                source text sha256
                                                                                                                                                                                                                                e526ba14c91f10737e6d3331fe23a6219f58c0eca6380bfce9bd78b573fea912
                                                                                                                                                                                                                                start
                                                                                                                                                                                                                                16754
                                                                                                                                                                                                                              5. context exact
                                                                                                                                                                                                                                ated for the treatment of adult and pediatric patients with unresectable or metastatic microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) soli
                                                                                                                                                                                                                                kind
                                                                                                                                                                                                                                stage_or_setting
                                                                                                                                                                                                                                polarity
                                                                                                                                                                                                                                not_inferred
                                                                                                                                                                                                                                span
                                                                                                                                                                                                                                end
                                                                                                                                                                                                                                16741
                                                                                                                                                                                                                                end exclusive
                                                                                                                                                                                                                                true
                                                                                                                                                                                                                                exact text
                                                                                                                                                                                                                                unresectable or metastatic microsatellite insta
                                                                                                                                                                                                                                label id
                                                                                                                                                                                                                                228e1e3f-d207-481f-8e14-9fdcbd0470e9
                                                                                                                                                                                                                                offset unit
                                                                                                                                                                                                                                unicode_code_points
                                                                                                                                                                                                                                source array index
                                                                                                                                                                                                                                0
                                                                                                                                                                                                                                source field
                                                                                                                                                                                                                                indications_and_usage_exact
                                                                                                                                                                                                                                source text sha256
                                                                                                                                                                                                                                e526ba14c91f10737e6d3331fe23a6219f58c0eca6380bfce9bd78b573fea912
                                                                                                                                                                                                                                start
                                                                                                                                                                                                                                16694
                                                                                                                                                                                                                              6. context exact
                                                                                                                                                                                                                                d by an FDA-authorized test, that have progressed following prior treatment and who have no satisfactory alternative treatment options [see Dosage and Administration (2.1) ] .
                                                                                                                                                                                                                                kind
                                                                                                                                                                                                                                prior_therapy_or_line
                                                                                                                                                                                                                                polarity
                                                                                                                                                                                                                                not_inferred
                                                                                                                                                                                                                                span
                                                                                                                                                                                                                                end
                                                                                                                                                                                                                                16991
                                                                                                                                                                                                                                end exclusive
                                                                                                                                                                                                                                true
                                                                                                                                                                                                                                exact text
                                                                                                                                                                                                                                prior treatment and who have no satisfactory alternative treatment options [see Dosage and Administration (2
                                                                                                                                                                                                                                label id
                                                                                                                                                                                                                                228e1e3f-d207-481f-8e14-9fdcbd0470e9
                                                                                                                                                                                                                                offset unit
                                                                                                                                                                                                                                unicode_code_points
                                                                                                                                                                                                                                source array index
                                                                                                                                                                                                                                0
                                                                                                                                                                                                                                source field
                                                                                                                                                                                                                                indications_and_usage_exact
                                                                                                                                                                                                                                source text sha256
                                                                                                                                                                                                                                e526ba14c91f10737e6d3331fe23a6219f58c0eca6380bfce9bd78b573fea912
                                                                                                                                                                                                                                start
                                                                                                                                                                                                                                16883
                                                                                                                                                                                                                              regulatory links
                                                                                                                                                                                                                                schema version
                                                                                                                                                                                                                                0.1.0
                                                                                                                                                                                                                                source batch sha256
                                                                                                                                                                                                                                fc39a8c5cf96bf95ca20b85578140167b66b2741f7d9217f500d9ba0847ac058
                                                                                                                                                                                                                                source defined aliases
                                                                                                                                                                                                                                1. abbreviation
                                                                                                                                                                                                                                  NSCLC
                                                                                                                                                                                                                                  definition exact
                                                                                                                                                                                                                                  Non-Small Cell Lung Cancer
                                                                                                                                                                                                                                  definition span
                                                                                                                                                                                                                                  end
                                                                                                                                                                                                                                  380
                                                                                                                                                                                                                                  end exclusive
                                                                                                                                                                                                                                  true
                                                                                                                                                                                                                                  exact text
                                                                                                                                                                                                                                  Non-Small Cell Lung Cancer (NSCLC)
                                                                                                                                                                                                                                  label id
                                                                                                                                                                                                                                  228e1e3f-d207-481f-8e14-9fdcbd0470e9
                                                                                                                                                                                                                                  offset unit
                                                                                                                                                                                                                                  unicode_code_points
                                                                                                                                                                                                                                  source array index
                                                                                                                                                                                                                                  0
                                                                                                                                                                                                                                  source field
                                                                                                                                                                                                                                  indications_and_usage_exact
                                                                                                                                                                                                                                  source text sha256
                                                                                                                                                                                                                                  e526ba14c91f10737e6d3331fe23a6219f58c0eca6380bfce9bd78b573fea912
                                                                                                                                                                                                                                  start
                                                                                                                                                                                                                                  346
                                                                                                                                                                                                                                2. abbreviation
                                                                                                                                                                                                                                  CRC
                                                                                                                                                                                                                                  definition exact
                                                                                                                                                                                                                                  Colorectal Cancer
                                                                                                                                                                                                                                  definition span
                                                                                                                                                                                                                                  end
                                                                                                                                                                                                                                  5042
                                                                                                                                                                                                                                  end exclusive
                                                                                                                                                                                                                                  true
                                                                                                                                                                                                                                  exact text
                                                                                                                                                                                                                                  Colorectal Cancer (CRC)
                                                                                                                                                                                                                                  label id
                                                                                                                                                                                                                                  228e1e3f-d207-481f-8e14-9fdcbd0470e9
                                                                                                                                                                                                                                  offset unit
                                                                                                                                                                                                                                  unicode_code_points
                                                                                                                                                                                                                                  source array index
                                                                                                                                                                                                                                  0
                                                                                                                                                                                                                                  source field
                                                                                                                                                                                                                                  indications_and_usage_exact
                                                                                                                                                                                                                                  source text sha256
                                                                                                                                                                                                                                  e526ba14c91f10737e6d3331fe23a6219f58c0eca6380bfce9bd78b573fea912
                                                                                                                                                                                                                                  start
                                                                                                                                                                                                                                  5019
                                                                                                                                                                                                                                source span
                                                                                                                                                                                                                                end
                                                                                                                                                                                                                                16998
                                                                                                                                                                                                                                end exclusive
                                                                                                                                                                                                                                true
                                                                                                                                                                                                                                exact text
                                                                                                                                                                                                                                1.8 Microsatellite Instability-High or Mismatch Repair Deficient Cancer KEYTRUDA is indicated for the treatment of adult and pediatric patients with unresectable or metastatic microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) solid tumors, as determined by an FDA-authorized test, that have progressed following prior treatment and who have no satisfactory alternative treatment options [see Dosage and Administration (2.1) ] .
                                                                                                                                                                                                                                label id
                                                                                                                                                                                                                                228e1e3f-d207-481f-8e14-9fdcbd0470e9
                                                                                                                                                                                                                                offset unit
                                                                                                                                                                                                                                unicode_code_points
                                                                                                                                                                                                                                source array index
                                                                                                                                                                                                                                0
                                                                                                                                                                                                                                source field
                                                                                                                                                                                                                                indications_and_usage_exact
                                                                                                                                                                                                                                source text sha256
                                                                                                                                                                                                                                e526ba14c91f10737e6d3331fe23a6219f58c0eca6380bfce9bd78b573fea912
                                                                                                                                                                                                                                start
                                                                                                                                                                                                                                16545
                                                                                                                                                                                                                                source url
                                                                                                                                                                                                                                https://api.fda.gov/drug/label.json?search=id%3A%22228e1e3f-d207-481f-8e14-9fdcbd0470e9%22
                                                                                                                                                                                                                                spl effective date
                                                                                                                                                                                                                                2026-07-10
                                                                                                                                                                                                                                spl set id
                                                                                                                                                                                                                                9333c79b-d487-4538-a9f0-71b91a02b287
                                                                                                                                                                                                                                spl version
                                                                                                                                                                                                                                228
                                                                                                                                                                                                                                structured fields status
                                                                                                                                                                                                                                not_extracted_no_values_inferred_from_mentions
                                                                                                                                                                                                                                structured indication
                                                                                                                                                                                                                                age
                                                                                                                                                                                                                                Source null
                                                                                                                                                                                                                                approval pathway
                                                                                                                                                                                                                                Source null
                                                                                                                                                                                                                                biomarker and test
                                                                                                                                                                                                                                Source null
                                                                                                                                                                                                                                disease stage
                                                                                                                                                                                                                                Source null
                                                                                                                                                                                                                                limitations
                                                                                                                                                                                                                                Source null
                                                                                                                                                                                                                                line
                                                                                                                                                                                                                                Source null
                                                                                                                                                                                                                                prior therapy
                                                                                                                                                                                                                                Source null
                                                                                                                                                                                                                                regimen
                                                                                                                                                                                                                                Source null
                                                                                                                                                                                                                                tumor histology
                                                                                                                                                                                                                                Source null
                                                                                                                                                                                                                                use intent
                                                                                                                                                                                                                                tumor_directed_candidate
                                                                                                                                                                                                                                Passage 89 · positive indication candidate
                                                                                                                                                                                                                                application numbers
                                                                                                                                                                                                                                1. BLA125514
                                                                                                                                                                                                                                brand names
                                                                                                                                                                                                                                1. KEYTRUDA
                                                                                                                                                                                                                                classification reasons
                                                                                                                                                                                                                                1. explicit_positive_indication_predicate
                                                                                                                                                                                                                                2. tumor_or_malignant_hematology_words_in_positive_statement
                                                                                                                                                                                                                                clinical review status
                                                                                                                                                                                                                                pending
                                                                                                                                                                                                                                content role
                                                                                                                                                                                                                                positive_indication_candidate
                                                                                                                                                                                                                                context span
                                                                                                                                                                                                                                end
                                                                                                                                                                                                                                17484
                                                                                                                                                                                                                                end exclusive
                                                                                                                                                                                                                                true
                                                                                                                                                                                                                                exact text
                                                                                                                                                                                                                                lid tumors, as determined by an FDA-authorized test, that have progressed following prior treatment and who have no satisfactory alternative treatment options [see Dosage and Administration (2.1) ] . 1.9 Microsatellite Instability-High or Mismatch Repair Deficient Colorectal Cancer KEYTRUDA is indicated for the treatment of patients with unresectable or metastatic MSI-H or dMMR colorectal cancer (CRC) as determined by an FDA-authorized test [see Dosage and Administration (2.1) ] . 1.10 Gastric Cancer KEYTRUDA, in combination with trastuzumab, fluoropyrimidine- and platinum-containing chemotherapy, is indicated for the first-line treatment of adults with locally advanced unrese
                                                                                                                                                                                                                                label id
                                                                                                                                                                                                                                228e1e3f-d207-481f-8e14-9fdcbd0470e9
                                                                                                                                                                                                                                offset unit
                                                                                                                                                                                                                                unicode_code_points
                                                                                                                                                                                                                                source array index
                                                                                                                                                                                                                                0
                                                                                                                                                                                                                                source field
                                                                                                                                                                                                                                indications_and_usage_exact
                                                                                                                                                                                                                                source text sha256
                                                                                                                                                                                                                                e526ba14c91f10737e6d3331fe23a6219f58c0eca6380bfce9bd78b573fea912
                                                                                                                                                                                                                                start
                                                                                                                                                                                                                                16799
                                                                                                                                                                                                                                current approval status
                                                                                                                                                                                                                                not_reconciled
                                                                                                                                                                                                                                duplicate text group
                                                                                                                                                                                                                                dup-a2d1444e6d7d89c29eec
                                                                                                                                                                                                                                extraction review status
                                                                                                                                                                                                                                automated_candidate_pending_source_review
                                                                                                                                                                                                                                generic names
                                                                                                                                                                                                                                1. PEMBROLIZUMAB
                                                                                                                                                                                                                                id
                                                                                                                                                                                                                                ind-span-497d42e85f5f9823f134
                                                                                                                                                                                                                                label id
                                                                                                                                                                                                                                228e1e3f-d207-481f-8e14-9fdcbd0470e9
                                                                                                                                                                                                                                positive predicate support span
                                                                                                                                                                                                                                end
                                                                                                                                                                                                                                17103
                                                                                                                                                                                                                                end exclusive
                                                                                                                                                                                                                                true
                                                                                                                                                                                                                                exact text
                                                                                                                                                                                                                                is indicated
                                                                                                                                                                                                                                label id
                                                                                                                                                                                                                                228e1e3f-d207-481f-8e14-9fdcbd0470e9
                                                                                                                                                                                                                                offset unit
                                                                                                                                                                                                                                unicode_code_points
                                                                                                                                                                                                                                source array index
                                                                                                                                                                                                                                0
                                                                                                                                                                                                                                source field
                                                                                                                                                                                                                                indications_and_usage_exact
                                                                                                                                                                                                                                source text sha256
                                                                                                                                                                                                                                e526ba14c91f10737e6d3331fe23a6219f58c0eca6380bfce9bd78b573fea912
                                                                                                                                                                                                                                start
                                                                                                                                                                                                                                17091
                                                                                                                                                                                                                                qualifier mentions
                                                                                                                                                                                                                                1. context exact
                                                                                                                                                                                                                                  ndicated for the treatment of patients with unresectable or metastatic MSI-H or dMMR colorectal cancer (CRC) as determined by an FDA-authorized test [see Dosage an
                                                                                                                                                                                                                                  kind
                                                                                                                                                                                                                                  biomarker
                                                                                                                                                                                                                                  polarity
                                                                                                                                                                                                                                  not_inferred
                                                                                                                                                                                                                                  span
                                                                                                                                                                                                                                  end
                                                                                                                                                                                                                                  17198
                                                                                                                                                                                                                                  end exclusive
                                                                                                                                                                                                                                  true
                                                                                                                                                                                                                                  exact text
                                                                                                                                                                                                                                  metastatic MSI-H or dMMR colorectal cancer
                                                                                                                                                                                                                                  label id
                                                                                                                                                                                                                                  228e1e3f-d207-481f-8e14-9fdcbd0470e9
                                                                                                                                                                                                                                  offset unit
                                                                                                                                                                                                                                  unicode_code_points
                                                                                                                                                                                                                                  source array index
                                                                                                                                                                                                                                  0
                                                                                                                                                                                                                                  source field
                                                                                                                                                                                                                                  indications_and_usage_exact
                                                                                                                                                                                                                                  source text sha256
                                                                                                                                                                                                                                  e526ba14c91f10737e6d3331fe23a6219f58c0eca6380bfce9bd78b573fea912
                                                                                                                                                                                                                                  start
                                                                                                                                                                                                                                  17155
                                                                                                                                                                                                                                2. context exact
                                                                                                                                                                                                                                  er KEYTRUDA is indicated for the treatment of patients with unresectable or metastatic MSI-H or dMMR colorectal cancer (CRC) as determined by an FDA-authorized test [s
                                                                                                                                                                                                                                  kind
                                                                                                                                                                                                                                  stage_or_setting
                                                                                                                                                                                                                                  polarity
                                                                                                                                                                                                                                  not_inferred
                                                                                                                                                                                                                                  span
                                                                                                                                                                                                                                  end
                                                                                                                                                                                                                                  17186
                                                                                                                                                                                                                                  end exclusive
                                                                                                                                                                                                                                  true
                                                                                                                                                                                                                                  exact text
                                                                                                                                                                                                                                  unresectable or metastatic MSI-H or dMMR colore
                                                                                                                                                                                                                                  label id
                                                                                                                                                                                                                                  228e1e3f-d207-481f-8e14-9fdcbd0470e9
                                                                                                                                                                                                                                  offset unit
                                                                                                                                                                                                                                  unicode_code_points
                                                                                                                                                                                                                                  source array index
                                                                                                                                                                                                                                  0
                                                                                                                                                                                                                                  source field
                                                                                                                                                                                                                                  indications_and_usage_exact
                                                                                                                                                                                                                                  source text sha256
                                                                                                                                                                                                                                  e526ba14c91f10737e6d3331fe23a6219f58c0eca6380bfce9bd78b573fea912
                                                                                                                                                                                                                                  start
                                                                                                                                                                                                                                  17139
                                                                                                                                                                                                                                regulatory links
                                                                                                                                                                                                                                  schema version
                                                                                                                                                                                                                                  0.1.0
                                                                                                                                                                                                                                  source batch sha256
                                                                                                                                                                                                                                  fc39a8c5cf96bf95ca20b85578140167b66b2741f7d9217f500d9ba0847ac058
                                                                                                                                                                                                                                  source defined aliases
                                                                                                                                                                                                                                  1. abbreviation
                                                                                                                                                                                                                                    NSCLC
                                                                                                                                                                                                                                    definition exact
                                                                                                                                                                                                                                    Non-Small Cell Lung Cancer
                                                                                                                                                                                                                                    definition span
                                                                                                                                                                                                                                    end
                                                                                                                                                                                                                                    380
                                                                                                                                                                                                                                    end exclusive
                                                                                                                                                                                                                                    true
                                                                                                                                                                                                                                    exact text
                                                                                                                                                                                                                                    Non-Small Cell Lung Cancer (NSCLC)
                                                                                                                                                                                                                                    label id
                                                                                                                                                                                                                                    228e1e3f-d207-481f-8e14-9fdcbd0470e9
                                                                                                                                                                                                                                    offset unit
                                                                                                                                                                                                                                    unicode_code_points
                                                                                                                                                                                                                                    source array index
                                                                                                                                                                                                                                    0
                                                                                                                                                                                                                                    source field
                                                                                                                                                                                                                                    indications_and_usage_exact
                                                                                                                                                                                                                                    source text sha256
                                                                                                                                                                                                                                    e526ba14c91f10737e6d3331fe23a6219f58c0eca6380bfce9bd78b573fea912
                                                                                                                                                                                                                                    start
                                                                                                                                                                                                                                    346
                                                                                                                                                                                                                                  2. abbreviation
                                                                                                                                                                                                                                    CRC
                                                                                                                                                                                                                                    definition exact
                                                                                                                                                                                                                                    Colorectal Cancer
                                                                                                                                                                                                                                    definition span
                                                                                                                                                                                                                                    end
                                                                                                                                                                                                                                    5042
                                                                                                                                                                                                                                    end exclusive
                                                                                                                                                                                                                                    true
                                                                                                                                                                                                                                    exact text
                                                                                                                                                                                                                                    Colorectal Cancer (CRC)
                                                                                                                                                                                                                                    label id
                                                                                                                                                                                                                                    228e1e3f-d207-481f-8e14-9fdcbd0470e9
                                                                                                                                                                                                                                    offset unit
                                                                                                                                                                                                                                    unicode_code_points
                                                                                                                                                                                                                                    source array index
                                                                                                                                                                                                                                    0
                                                                                                                                                                                                                                    source field
                                                                                                                                                                                                                                    indications_and_usage_exact
                                                                                                                                                                                                                                    source text sha256
                                                                                                                                                                                                                                    e526ba14c91f10737e6d3331fe23a6219f58c0eca6380bfce9bd78b573fea912
                                                                                                                                                                                                                                    start
                                                                                                                                                                                                                                    5019
                                                                                                                                                                                                                                  source span
                                                                                                                                                                                                                                  end
                                                                                                                                                                                                                                  17284
                                                                                                                                                                                                                                  end exclusive
                                                                                                                                                                                                                                  true
                                                                                                                                                                                                                                  exact text
                                                                                                                                                                                                                                  1.9 Microsatellite Instability-High or Mismatch Repair Deficient Colorectal Cancer KEYTRUDA is indicated for the treatment of patients with unresectable or metastatic MSI-H or dMMR colorectal cancer (CRC) as determined by an FDA-authorized test [see Dosage and Administration (2.1) ] .
                                                                                                                                                                                                                                  label id
                                                                                                                                                                                                                                  228e1e3f-d207-481f-8e14-9fdcbd0470e9
                                                                                                                                                                                                                                  offset unit
                                                                                                                                                                                                                                  unicode_code_points
                                                                                                                                                                                                                                  source array index
                                                                                                                                                                                                                                  0
                                                                                                                                                                                                                                  source field
                                                                                                                                                                                                                                  indications_and_usage_exact
                                                                                                                                                                                                                                  source text sha256
                                                                                                                                                                                                                                  e526ba14c91f10737e6d3331fe23a6219f58c0eca6380bfce9bd78b573fea912
                                                                                                                                                                                                                                  start
                                                                                                                                                                                                                                  16999
                                                                                                                                                                                                                                  source url
                                                                                                                                                                                                                                  https://api.fda.gov/drug/label.json?search=id%3A%22228e1e3f-d207-481f-8e14-9fdcbd0470e9%22
                                                                                                                                                                                                                                  spl effective date
                                                                                                                                                                                                                                  2026-07-10
                                                                                                                                                                                                                                  spl set id
                                                                                                                                                                                                                                  9333c79b-d487-4538-a9f0-71b91a02b287
                                                                                                                                                                                                                                  spl version
                                                                                                                                                                                                                                  228
                                                                                                                                                                                                                                  structured fields status
                                                                                                                                                                                                                                  not_extracted_no_values_inferred_from_mentions
                                                                                                                                                                                                                                  structured indication
                                                                                                                                                                                                                                  age
                                                                                                                                                                                                                                  Source null
                                                                                                                                                                                                                                  approval pathway
                                                                                                                                                                                                                                  Source null
                                                                                                                                                                                                                                  biomarker and test
                                                                                                                                                                                                                                  Source null
                                                                                                                                                                                                                                  disease stage
                                                                                                                                                                                                                                  Source null
                                                                                                                                                                                                                                  limitations
                                                                                                                                                                                                                                  Source null
                                                                                                                                                                                                                                  line
                                                                                                                                                                                                                                  Source null
                                                                                                                                                                                                                                  prior therapy
                                                                                                                                                                                                                                  Source null
                                                                                                                                                                                                                                  regimen
                                                                                                                                                                                                                                  Source null
                                                                                                                                                                                                                                  tumor histology
                                                                                                                                                                                                                                  Source null
                                                                                                                                                                                                                                  use intent
                                                                                                                                                                                                                                  tumor_directed_candidate
                                                                                                                                                                                                                                  Passage 90 · positive indication candidate
                                                                                                                                                                                                                                  application numbers
                                                                                                                                                                                                                                  1. BLA125514
                                                                                                                                                                                                                                  brand names
                                                                                                                                                                                                                                  1. KEYTRUDA
                                                                                                                                                                                                                                  classification reasons
                                                                                                                                                                                                                                  1. explicit_positive_indication_predicate
                                                                                                                                                                                                                                  2. tumor_or_malignant_hematology_words_in_positive_statement
                                                                                                                                                                                                                                  clinical review status
                                                                                                                                                                                                                                  pending
                                                                                                                                                                                                                                  content role
                                                                                                                                                                                                                                  positive_indication_candidate
                                                                                                                                                                                                                                  context span
                                                                                                                                                                                                                                  end
                                                                                                                                                                                                                                  17893
                                                                                                                                                                                                                                  end exclusive
                                                                                                                                                                                                                                  true
                                                                                                                                                                                                                                  exact text
                                                                                                                                                                                                                                  TRUDA is indicated for the treatment of patients with unresectable or metastatic MSI-H or dMMR colorectal cancer (CRC) as determined by an FDA-authorized test [see Dosage and Administration (2.1) ] . 1.10 Gastric Cancer KEYTRUDA, in combination with trastuzumab, fluoropyrimidine- and platinum-containing chemotherapy, is indicated for the first-line treatment of adults with locally advanced unresectable or metastatic HER2-positive gastric or gastroesophageal junction (GEJ) adenocarcinoma whose tumors express PD-L1 (CPS ≥1) as determined by an FDA-authorized test [see Dosage and Administration (2.1) ] . KEYTRUDA, in combination with fluoropyrimidine- and platinum-containing chemotherapy, is indicated for the first-line treatment of adults with locally advanced unresectable or metastatic HER2-negativ
                                                                                                                                                                                                                                  label id
                                                                                                                                                                                                                                  228e1e3f-d207-481f-8e14-9fdcbd0470e9
                                                                                                                                                                                                                                  offset unit
                                                                                                                                                                                                                                  unicode_code_points
                                                                                                                                                                                                                                  source array index
                                                                                                                                                                                                                                  0
                                                                                                                                                                                                                                  source field
                                                                                                                                                                                                                                  indications_and_usage_exact
                                                                                                                                                                                                                                  source text sha256
                                                                                                                                                                                                                                  e526ba14c91f10737e6d3331fe23a6219f58c0eca6380bfce9bd78b573fea912
                                                                                                                                                                                                                                  start
                                                                                                                                                                                                                                  17085
                                                                                                                                                                                                                                  current approval status
                                                                                                                                                                                                                                  not_reconciled
                                                                                                                                                                                                                                  duplicate text group
                                                                                                                                                                                                                                  dup-2f23e10b0caed554802e
                                                                                                                                                                                                                                  extraction review status
                                                                                                                                                                                                                                  automated_candidate_pending_source_review
                                                                                                                                                                                                                                  generic names
                                                                                                                                                                                                                                  1. PEMBROLIZUMAB
                                                                                                                                                                                                                                  id
                                                                                                                                                                                                                                  ind-span-b614880e68389670261c
                                                                                                                                                                                                                                  label id
                                                                                                                                                                                                                                  228e1e3f-d207-481f-8e14-9fdcbd0470e9
                                                                                                                                                                                                                                  positive predicate support span
                                                                                                                                                                                                                                  end
                                                                                                                                                                                                                                  17416
                                                                                                                                                                                                                                  end exclusive
                                                                                                                                                                                                                                  true
                                                                                                                                                                                                                                  exact text
                                                                                                                                                                                                                                  is indicated
                                                                                                                                                                                                                                  label id
                                                                                                                                                                                                                                  228e1e3f-d207-481f-8e14-9fdcbd0470e9
                                                                                                                                                                                                                                  offset unit
                                                                                                                                                                                                                                  unicode_code_points
                                                                                                                                                                                                                                  source array index
                                                                                                                                                                                                                                  0
                                                                                                                                                                                                                                  source field
                                                                                                                                                                                                                                  indications_and_usage_exact
                                                                                                                                                                                                                                  source text sha256
                                                                                                                                                                                                                                  e526ba14c91f10737e6d3331fe23a6219f58c0eca6380bfce9bd78b573fea912
                                                                                                                                                                                                                                  start
                                                                                                                                                                                                                                  17404
                                                                                                                                                                                                                                  qualifier mentions
                                                                                                                                                                                                                                  1. context exact
                                                                                                                                                                                                                                    chemotherapy, is indicated for the first-line treatment of adults with locally advanced unresectable or metastatic HER2-posit
                                                                                                                                                                                                                                    kind
                                                                                                                                                                                                                                    age
                                                                                                                                                                                                                                    polarity
                                                                                                                                                                                                                                    not_inferred
                                                                                                                                                                                                                                    span
                                                                                                                                                                                                                                    end
                                                                                                                                                                                                                                    17455
                                                                                                                                                                                                                                    end exclusive
                                                                                                                                                                                                                                    true
                                                                                                                                                                                                                                    exact text
                                                                                                                                                                                                                                    adults
                                                                                                                                                                                                                                    label id
                                                                                                                                                                                                                                    228e1e3f-d207-481f-8e14-9fdcbd0470e9
                                                                                                                                                                                                                                    offset unit
                                                                                                                                                                                                                                    unicode_code_points
                                                                                                                                                                                                                                    source array index
                                                                                                                                                                                                                                    0
                                                                                                                                                                                                                                    source field
                                                                                                                                                                                                                                    indications_and_usage_exact
                                                                                                                                                                                                                                    source text sha256
                                                                                                                                                                                                                                    e526ba14c91f10737e6d3331fe23a6219f58c0eca6380bfce9bd78b573fea912
                                                                                                                                                                                                                                    start
                                                                                                                                                                                                                                    17449
                                                                                                                                                                                                                                  2. context exact
                                                                                                                                                                                                                                    e treatment of adults with locally advanced unresectable or metastatic HER2-positive gastric or gastroesophageal junction (GEJ) adenocarcinoma whose tumors express
                                                                                                                                                                                                                                    kind
                                                                                                                                                                                                                                    biomarker
                                                                                                                                                                                                                                    polarity
                                                                                                                                                                                                                                    not_inferred
                                                                                                                                                                                                                                    span
                                                                                                                                                                                                                                    end
                                                                                                                                                                                                                                    17537
                                                                                                                                                                                                                                    end exclusive
                                                                                                                                                                                                                                    true
                                                                                                                                                                                                                                    exact text
                                                                                                                                                                                                                                    metastatic HER2-positive gastric or gastroe
                                                                                                                                                                                                                                    label id
                                                                                                                                                                                                                                    228e1e3f-d207-481f-8e14-9fdcbd0470e9
                                                                                                                                                                                                                                    offset unit
                                                                                                                                                                                                                                    unicode_code_points
                                                                                                                                                                                                                                    source array index
                                                                                                                                                                                                                                    0
                                                                                                                                                                                                                                    source field
                                                                                                                                                                                                                                    indications_and_usage_exact
                                                                                                                                                                                                                                    source text sha256
                                                                                                                                                                                                                                    e526ba14c91f10737e6d3331fe23a6219f58c0eca6380bfce9bd78b573fea912
                                                                                                                                                                                                                                    start
                                                                                                                                                                                                                                    17494
                                                                                                                                                                                                                                  3. context exact
                                                                                                                                                                                                                                    ophageal junction (GEJ) adenocarcinoma whose tumors express PD-L1 (CPS ≥1) as determined by an FDA-authorized test [see Dosage and Administration (2.1) ] .
                                                                                                                                                                                                                                    kind
                                                                                                                                                                                                                                    biomarker
                                                                                                                                                                                                                                    polarity
                                                                                                                                                                                                                                    not_inferred
                                                                                                                                                                                                                                    span
                                                                                                                                                                                                                                    end
                                                                                                                                                                                                                                    17643
                                                                                                                                                                                                                                    end exclusive
                                                                                                                                                                                                                                    true
                                                                                                                                                                                                                                    exact text
                                                                                                                                                                                                                                    PD-L1 (CPS ≥1) as determined by an FDA-author
                                                                                                                                                                                                                                    label id
                                                                                                                                                                                                                                    228e1e3f-d207-481f-8e14-9fdcbd0470e9
                                                                                                                                                                                                                                    offset unit
                                                                                                                                                                                                                                    unicode_code_points
                                                                                                                                                                                                                                    source array index
                                                                                                                                                                                                                                    0
                                                                                                                                                                                                                                    source field
                                                                                                                                                                                                                                    indications_and_usage_exact
                                                                                                                                                                                                                                    source text sha256
                                                                                                                                                                                                                                    e526ba14c91f10737e6d3331fe23a6219f58c0eca6380bfce9bd78b573fea912
                                                                                                                                                                                                                                    start
                                                                                                                                                                                                                                    17598
                                                                                                                                                                                                                                  4. context exact
                                                                                                                                                                                                                                    y, is indicated for the first-line treatment of adults with locally advanced unresectable or metastatic HER2-positive gastric or gastroesophageal junction (GEJ) adenocarci
                                                                                                                                                                                                                                    kind
                                                                                                                                                                                                                                    stage_or_setting
                                                                                                                                                                                                                                    polarity
                                                                                                                                                                                                                                    not_inferred
                                                                                                                                                                                                                                    span
                                                                                                                                                                                                                                    end
                                                                                                                                                                                                                                    17512
                                                                                                                                                                                                                                    end exclusive
                                                                                                                                                                                                                                    true
                                                                                                                                                                                                                                    exact text
                                                                                                                                                                                                                                    locally advanced unresectable or metastatic HER2-po
                                                                                                                                                                                                                                    label id
                                                                                                                                                                                                                                    228e1e3f-d207-481f-8e14-9fdcbd0470e9
                                                                                                                                                                                                                                    offset unit
                                                                                                                                                                                                                                    unicode_code_points
                                                                                                                                                                                                                                    source array index
                                                                                                                                                                                                                                    0
                                                                                                                                                                                                                                    source field
                                                                                                                                                                                                                                    indications_and_usage_exact
                                                                                                                                                                                                                                    source text sha256
                                                                                                                                                                                                                                    e526ba14c91f10737e6d3331fe23a6219f58c0eca6380bfce9bd78b573fea912
                                                                                                                                                                                                                                    start
                                                                                                                                                                                                                                    17461
                                                                                                                                                                                                                                  5. context exact
                                                                                                                                                                                                                                    and platinum-containing chemotherapy, is indicated for the first-line treatment of adults with locally advanced unresectable or metastatic HER2-positive gastric or gastroesophageal junction (GEJ) adenocarcinoma whose tumors express PD-L1 (CPS ≥1) as determined by an FDA-authorized test [s
                                                                                                                                                                                                                                    kind
                                                                                                                                                                                                                                    prior_therapy_or_line
                                                                                                                                                                                                                                    polarity
                                                                                                                                                                                                                                    not_inferred
                                                                                                                                                                                                                                    span
                                                                                                                                                                                                                                    end
                                                                                                                                                                                                                                    17595
                                                                                                                                                                                                                                    end exclusive
                                                                                                                                                                                                                                    true
                                                                                                                                                                                                                                    exact text
                                                                                                                                                                                                                                    first-line treatment of adults with locally advanced unresectable or metastatic HER2-positive gastric or gastroesophageal junction (GEJ) adenocarcinoma whose tumors expre
                                                                                                                                                                                                                                    label id
                                                                                                                                                                                                                                    228e1e3f-d207-481f-8e14-9fdcbd0470e9
                                                                                                                                                                                                                                    offset unit
                                                                                                                                                                                                                                    unicode_code_points
                                                                                                                                                                                                                                    source array index
                                                                                                                                                                                                                                    0
                                                                                                                                                                                                                                    source field
                                                                                                                                                                                                                                    indications_and_usage_exact
                                                                                                                                                                                                                                    source text sha256
                                                                                                                                                                                                                                    e526ba14c91f10737e6d3331fe23a6219f58c0eca6380bfce9bd78b573fea912
                                                                                                                                                                                                                                    start
                                                                                                                                                                                                                                    17425
                                                                                                                                                                                                                                  6. context exact
                                                                                                                                                                                                                                    1.10 Gastric Cancer KEYTRUDA, in combination with trastuzumab, fluoropyrimidine- and platinum-containing chemotherapy, is indicated for the first-line treatment of adults with locally advanced unresectable or metastatic HER2-positive gastric or gastroesophageal junctio
                                                                                                                                                                                                                                    kind
                                                                                                                                                                                                                                    regimen
                                                                                                                                                                                                                                    polarity
                                                                                                                                                                                                                                    not_inferred
                                                                                                                                                                                                                                    span
                                                                                                                                                                                                                                    end
                                                                                                                                                                                                                                    17494
                                                                                                                                                                                                                                    end exclusive
                                                                                                                                                                                                                                    true
                                                                                                                                                                                                                                    exact text
                                                                                                                                                                                                                                    in combination with trastuzumab, fluoropyrimidine- and platinum-containing chemotherapy, is indicated for the first-line treatment of adults with locally advanced unresectable or
                                                                                                                                                                                                                                    label id
                                                                                                                                                                                                                                    228e1e3f-d207-481f-8e14-9fdcbd0470e9
                                                                                                                                                                                                                                    offset unit
                                                                                                                                                                                                                                    unicode_code_points
                                                                                                                                                                                                                                    source array index
                                                                                                                                                                                                                                    0
                                                                                                                                                                                                                                    source field
                                                                                                                                                                                                                                    indications_and_usage_exact
                                                                                                                                                                                                                                    source text sha256
                                                                                                                                                                                                                                    e526ba14c91f10737e6d3331fe23a6219f58c0eca6380bfce9bd78b573fea912
                                                                                                                                                                                                                                    start
                                                                                                                                                                                                                                    17315
                                                                                                                                                                                                                                  regulatory links
                                                                                                                                                                                                                                    schema version
                                                                                                                                                                                                                                    0.1.0
                                                                                                                                                                                                                                    source batch sha256
                                                                                                                                                                                                                                    fc39a8c5cf96bf95ca20b85578140167b66b2741f7d9217f500d9ba0847ac058
                                                                                                                                                                                                                                    source defined aliases
                                                                                                                                                                                                                                    1. abbreviation
                                                                                                                                                                                                                                      NSCLC
                                                                                                                                                                                                                                      definition exact
                                                                                                                                                                                                                                      Non-Small Cell Lung Cancer
                                                                                                                                                                                                                                      definition span
                                                                                                                                                                                                                                      end
                                                                                                                                                                                                                                      380
                                                                                                                                                                                                                                      end exclusive
                                                                                                                                                                                                                                      true
                                                                                                                                                                                                                                      exact text
                                                                                                                                                                                                                                      Non-Small Cell Lung Cancer (NSCLC)
                                                                                                                                                                                                                                      label id
                                                                                                                                                                                                                                      228e1e3f-d207-481f-8e14-9fdcbd0470e9
                                                                                                                                                                                                                                      offset unit
                                                                                                                                                                                                                                      unicode_code_points
                                                                                                                                                                                                                                      source array index
                                                                                                                                                                                                                                      0
                                                                                                                                                                                                                                      source field
                                                                                                                                                                                                                                      indications_and_usage_exact
                                                                                                                                                                                                                                      source text sha256
                                                                                                                                                                                                                                      e526ba14c91f10737e6d3331fe23a6219f58c0eca6380bfce9bd78b573fea912
                                                                                                                                                                                                                                      start
                                                                                                                                                                                                                                      346
                                                                                                                                                                                                                                    2. abbreviation
                                                                                                                                                                                                                                      CRC
                                                                                                                                                                                                                                      definition exact
                                                                                                                                                                                                                                      Colorectal Cancer
                                                                                                                                                                                                                                      definition span
                                                                                                                                                                                                                                      end
                                                                                                                                                                                                                                      5042
                                                                                                                                                                                                                                      end exclusive
                                                                                                                                                                                                                                      true
                                                                                                                                                                                                                                      exact text
                                                                                                                                                                                                                                      Colorectal Cancer (CRC)
                                                                                                                                                                                                                                      label id
                                                                                                                                                                                                                                      228e1e3f-d207-481f-8e14-9fdcbd0470e9
                                                                                                                                                                                                                                      offset unit
                                                                                                                                                                                                                                      unicode_code_points
                                                                                                                                                                                                                                      source array index
                                                                                                                                                                                                                                      0
                                                                                                                                                                                                                                      source field
                                                                                                                                                                                                                                      indications_and_usage_exact
                                                                                                                                                                                                                                      source text sha256
                                                                                                                                                                                                                                      e526ba14c91f10737e6d3331fe23a6219f58c0eca6380bfce9bd78b573fea912
                                                                                                                                                                                                                                      start
                                                                                                                                                                                                                                      5019
                                                                                                                                                                                                                                    source span
                                                                                                                                                                                                                                    end
                                                                                                                                                                                                                                    17693
                                                                                                                                                                                                                                    end exclusive
                                                                                                                                                                                                                                    true
                                                                                                                                                                                                                                    exact text
                                                                                                                                                                                                                                    1.10 Gastric Cancer KEYTRUDA, in combination with trastuzumab, fluoropyrimidine- and platinum-containing chemotherapy, is indicated for the first-line treatment of adults with locally advanced unresectable or metastatic HER2-positive gastric or gastroesophageal junction (GEJ) adenocarcinoma whose tumors express PD-L1 (CPS ≥1) as determined by an FDA-authorized test [see Dosage and Administration (2.1) ] .
                                                                                                                                                                                                                                    label id
                                                                                                                                                                                                                                    228e1e3f-d207-481f-8e14-9fdcbd0470e9
                                                                                                                                                                                                                                    offset unit
                                                                                                                                                                                                                                    unicode_code_points
                                                                                                                                                                                                                                    source array index
                                                                                                                                                                                                                                    0
                                                                                                                                                                                                                                    source field
                                                                                                                                                                                                                                    indications_and_usage_exact
                                                                                                                                                                                                                                    source text sha256
                                                                                                                                                                                                                                    e526ba14c91f10737e6d3331fe23a6219f58c0eca6380bfce9bd78b573fea912
                                                                                                                                                                                                                                    start
                                                                                                                                                                                                                                    17285
                                                                                                                                                                                                                                    source url
                                                                                                                                                                                                                                    https://api.fda.gov/drug/label.json?search=id%3A%22228e1e3f-d207-481f-8e14-9fdcbd0470e9%22
                                                                                                                                                                                                                                    spl effective date
                                                                                                                                                                                                                                    2026-07-10
                                                                                                                                                                                                                                    spl set id
                                                                                                                                                                                                                                    9333c79b-d487-4538-a9f0-71b91a02b287
                                                                                                                                                                                                                                    spl version
                                                                                                                                                                                                                                    228
                                                                                                                                                                                                                                    structured fields status
                                                                                                                                                                                                                                    not_extracted_no_values_inferred_from_mentions
                                                                                                                                                                                                                                    structured indication
                                                                                                                                                                                                                                    age
                                                                                                                                                                                                                                    Source null
                                                                                                                                                                                                                                    approval pathway
                                                                                                                                                                                                                                    Source null
                                                                                                                                                                                                                                    biomarker and test
                                                                                                                                                                                                                                    Source null
                                                                                                                                                                                                                                    disease stage
                                                                                                                                                                                                                                    Source null
                                                                                                                                                                                                                                    limitations
                                                                                                                                                                                                                                    Source null
                                                                                                                                                                                                                                    line
                                                                                                                                                                                                                                    Source null
                                                                                                                                                                                                                                    prior therapy
                                                                                                                                                                                                                                    Source null
                                                                                                                                                                                                                                    regimen
                                                                                                                                                                                                                                    Source null
                                                                                                                                                                                                                                    tumor histology
                                                                                                                                                                                                                                    Source null
                                                                                                                                                                                                                                    use intent
                                                                                                                                                                                                                                    tumor_directed_candidate
                                                                                                                                                                                                                                    Passage 91 · positive indication candidate
                                                                                                                                                                                                                                    application numbers
                                                                                                                                                                                                                                    1. BLA125514
                                                                                                                                                                                                                                    brand names
                                                                                                                                                                                                                                    1. KEYTRUDA
                                                                                                                                                                                                                                    classification reasons
                                                                                                                                                                                                                                    1. explicit_positive_indication_predicate
                                                                                                                                                                                                                                    2. tumor_or_malignant_hematology_words_in_positive_statement
                                                                                                                                                                                                                                    clinical review status
                                                                                                                                                                                                                                    pending
                                                                                                                                                                                                                                    content role
                                                                                                                                                                                                                                    positive_indication_candidate
                                                                                                                                                                                                                                    context span
                                                                                                                                                                                                                                    end
                                                                                                                                                                                                                                    18270
                                                                                                                                                                                                                                    end exclusive
                                                                                                                                                                                                                                    true
                                                                                                                                                                                                                                    exact text
                                                                                                                                                                                                                                    metastatic HER2-positive gastric or gastroesophageal junction (GEJ) adenocarcinoma whose tumors express PD-L1 (CPS ≥1) as determined by an FDA-authorized test [see Dosage and Administration (2.1) ] . KEYTRUDA, in combination with fluoropyrimidine- and platinum-containing chemotherapy, is indicated for the first-line treatment of adults with locally advanced unresectable or metastatic HER2-negative gastric or gastroesophageal junction (GEJ) adenocarcinoma whose tumors express PD-L1 (CPS ≥ 1) as determined by an FDA-authorized test [see Dosage and Administration (2.1) ] . 1.11 Esophageal Cancer KEYTRUDA is indicated for the treatment of patients with locally advanced or metastatic esophageal or gastroesophageal junction (GEJ) (tumors with epicenter 1 to 5 centimeters
                                                                                                                                                                                                                                    label id
                                                                                                                                                                                                                                    228e1e3f-d207-481f-8e14-9fdcbd0470e9
                                                                                                                                                                                                                                    offset unit
                                                                                                                                                                                                                                    unicode_code_points
                                                                                                                                                                                                                                    source array index
                                                                                                                                                                                                                                    0
                                                                                                                                                                                                                                    source field
                                                                                                                                                                                                                                    indications_and_usage_exact
                                                                                                                                                                                                                                    source text sha256
                                                                                                                                                                                                                                    e526ba14c91f10737e6d3331fe23a6219f58c0eca6380bfce9bd78b573fea912
                                                                                                                                                                                                                                    start
                                                                                                                                                                                                                                    17494
                                                                                                                                                                                                                                    current approval status
                                                                                                                                                                                                                                    not_reconciled
                                                                                                                                                                                                                                    duplicate text group
                                                                                                                                                                                                                                    dup-c4f4a67dc770f7ab99b7
                                                                                                                                                                                                                                    extraction review status
                                                                                                                                                                                                                                    automated_candidate_pending_source_review
                                                                                                                                                                                                                                    generic names
                                                                                                                                                                                                                                    1. PEMBROLIZUMAB
                                                                                                                                                                                                                                    id
                                                                                                                                                                                                                                    ind-span-e75e9121ccd1dc492295
                                                                                                                                                                                                                                    label id
                                                                                                                                                                                                                                    228e1e3f-d207-481f-8e14-9fdcbd0470e9
                                                                                                                                                                                                                                    positive predicate support span
                                                                                                                                                                                                                                    end
                                                                                                                                                                                                                                    17792
                                                                                                                                                                                                                                    end exclusive
                                                                                                                                                                                                                                    true
                                                                                                                                                                                                                                    exact text
                                                                                                                                                                                                                                    is indicated
                                                                                                                                                                                                                                    label id
                                                                                                                                                                                                                                    228e1e3f-d207-481f-8e14-9fdcbd0470e9
                                                                                                                                                                                                                                    offset unit
                                                                                                                                                                                                                                    unicode_code_points
                                                                                                                                                                                                                                    source array index
                                                                                                                                                                                                                                    0
                                                                                                                                                                                                                                    source field
                                                                                                                                                                                                                                    indications_and_usage_exact
                                                                                                                                                                                                                                    source text sha256
                                                                                                                                                                                                                                    e526ba14c91f10737e6d3331fe23a6219f58c0eca6380bfce9bd78b573fea912
                                                                                                                                                                                                                                    start
                                                                                                                                                                                                                                    17780
                                                                                                                                                                                                                                    qualifier mentions
                                                                                                                                                                                                                                    1. context exact
                                                                                                                                                                                                                                      chemotherapy, is indicated for the first-line treatment of adults with locally advanced unresectable or metastatic HER2-negat
                                                                                                                                                                                                                                      kind
                                                                                                                                                                                                                                      age
                                                                                                                                                                                                                                      polarity
                                                                                                                                                                                                                                      not_inferred
                                                                                                                                                                                                                                      span
                                                                                                                                                                                                                                      end
                                                                                                                                                                                                                                      17831
                                                                                                                                                                                                                                      end exclusive
                                                                                                                                                                                                                                      true
                                                                                                                                                                                                                                      exact text
                                                                                                                                                                                                                                      adults
                                                                                                                                                                                                                                      label id
                                                                                                                                                                                                                                      228e1e3f-d207-481f-8e14-9fdcbd0470e9
                                                                                                                                                                                                                                      offset unit
                                                                                                                                                                                                                                      unicode_code_points
                                                                                                                                                                                                                                      source array index
                                                                                                                                                                                                                                      0
                                                                                                                                                                                                                                      source field
                                                                                                                                                                                                                                      indications_and_usage_exact
                                                                                                                                                                                                                                      source text sha256
                                                                                                                                                                                                                                      e526ba14c91f10737e6d3331fe23a6219f58c0eca6380bfce9bd78b573fea912
                                                                                                                                                                                                                                      start
                                                                                                                                                                                                                                      17825
                                                                                                                                                                                                                                    2. context exact
                                                                                                                                                                                                                                      e treatment of adults with locally advanced unresectable or metastatic HER2-negative gastric or gastroesophageal junction (GEJ) adenocarcinoma whose tumors express
                                                                                                                                                                                                                                      kind
                                                                                                                                                                                                                                      biomarker
                                                                                                                                                                                                                                      polarity
                                                                                                                                                                                                                                      not_inferred
                                                                                                                                                                                                                                      span
                                                                                                                                                                                                                                      end
                                                                                                                                                                                                                                      17913
                                                                                                                                                                                                                                      end exclusive
                                                                                                                                                                                                                                      true
                                                                                                                                                                                                                                      exact text
                                                                                                                                                                                                                                      metastatic HER2-negative gastric or gastroe
                                                                                                                                                                                                                                      label id
                                                                                                                                                                                                                                      228e1e3f-d207-481f-8e14-9fdcbd0470e9
                                                                                                                                                                                                                                      offset unit
                                                                                                                                                                                                                                      unicode_code_points
                                                                                                                                                                                                                                      source array index
                                                                                                                                                                                                                                      0
                                                                                                                                                                                                                                      source field
                                                                                                                                                                                                                                      indications_and_usage_exact
                                                                                                                                                                                                                                      source text sha256
                                                                                                                                                                                                                                      e526ba14c91f10737e6d3331fe23a6219f58c0eca6380bfce9bd78b573fea912
                                                                                                                                                                                                                                      start
                                                                                                                                                                                                                                      17870
                                                                                                                                                                                                                                    3. context exact
                                                                                                                                                                                                                                      ophageal junction (GEJ) adenocarcinoma whose tumors express PD-L1 (CPS ≥ 1) as determined by an FDA-authorized test [see Dosage and Administration (2.1) ] .
                                                                                                                                                                                                                                      kind
                                                                                                                                                                                                                                      biomarker
                                                                                                                                                                                                                                      polarity
                                                                                                                                                                                                                                      not_inferred
                                                                                                                                                                                                                                      span
                                                                                                                                                                                                                                      end
                                                                                                                                                                                                                                      18019
                                                                                                                                                                                                                                      end exclusive
                                                                                                                                                                                                                                      true
                                                                                                                                                                                                                                      exact text
                                                                                                                                                                                                                                      PD-L1 (CPS ≥ 1) as determined by an FDA-autho
                                                                                                                                                                                                                                      label id
                                                                                                                                                                                                                                      228e1e3f-d207-481f-8e14-9fdcbd0470e9
                                                                                                                                                                                                                                      offset unit
                                                                                                                                                                                                                                      unicode_code_points
                                                                                                                                                                                                                                      source array index
                                                                                                                                                                                                                                      0
                                                                                                                                                                                                                                      source field
                                                                                                                                                                                                                                      indications_and_usage_exact
                                                                                                                                                                                                                                      source text sha256
                                                                                                                                                                                                                                      e526ba14c91f10737e6d3331fe23a6219f58c0eca6380bfce9bd78b573fea912
                                                                                                                                                                                                                                      start
                                                                                                                                                                                                                                      17974
                                                                                                                                                                                                                                    4. context exact
                                                                                                                                                                                                                                      y, is indicated for the first-line treatment of adults with locally advanced unresectable or metastatic HER2-negative gastric or gastroesophageal junction (GEJ) adenocarci
                                                                                                                                                                                                                                      kind
                                                                                                                                                                                                                                      stage_or_setting
                                                                                                                                                                                                                                      polarity
                                                                                                                                                                                                                                      not_inferred
                                                                                                                                                                                                                                      span
                                                                                                                                                                                                                                      end
                                                                                                                                                                                                                                      17888
                                                                                                                                                                                                                                      end exclusive
                                                                                                                                                                                                                                      true
                                                                                                                                                                                                                                      exact text
                                                                                                                                                                                                                                      locally advanced unresectable or metastatic HER2-ne
                                                                                                                                                                                                                                      label id
                                                                                                                                                                                                                                      228e1e3f-d207-481f-8e14-9fdcbd0470e9
                                                                                                                                                                                                                                      offset unit
                                                                                                                                                                                                                                      unicode_code_points
                                                                                                                                                                                                                                      source array index
                                                                                                                                                                                                                                      0
                                                                                                                                                                                                                                      source field
                                                                                                                                                                                                                                      indications_and_usage_exact
                                                                                                                                                                                                                                      source text sha256
                                                                                                                                                                                                                                      e526ba14c91f10737e6d3331fe23a6219f58c0eca6380bfce9bd78b573fea912
                                                                                                                                                                                                                                      start
                                                                                                                                                                                                                                      17837
                                                                                                                                                                                                                                    5. context exact
                                                                                                                                                                                                                                      and platinum-containing chemotherapy, is indicated for the first-line treatment of adults with locally advanced unresectable or metastatic HER2-negative gastric or gastroesophageal junction (GEJ) adenocarcinoma whose tumors express PD-L1 (CPS ≥ 1) as determined by an FDA-authorized test [
                                                                                                                                                                                                                                      kind
                                                                                                                                                                                                                                      prior_therapy_or_line
                                                                                                                                                                                                                                      polarity
                                                                                                                                                                                                                                      not_inferred
                                                                                                                                                                                                                                      span
                                                                                                                                                                                                                                      end
                                                                                                                                                                                                                                      17971
                                                                                                                                                                                                                                      end exclusive
                                                                                                                                                                                                                                      true
                                                                                                                                                                                                                                      exact text
                                                                                                                                                                                                                                      first-line treatment of adults with locally advanced unresectable or metastatic HER2-negative gastric or gastroesophageal junction (GEJ) adenocarcinoma whose tumors expre
                                                                                                                                                                                                                                      label id
                                                                                                                                                                                                                                      228e1e3f-d207-481f-8e14-9fdcbd0470e9
                                                                                                                                                                                                                                      offset unit
                                                                                                                                                                                                                                      unicode_code_points
                                                                                                                                                                                                                                      source array index
                                                                                                                                                                                                                                      0
                                                                                                                                                                                                                                      source field
                                                                                                                                                                                                                                      indications_and_usage_exact
                                                                                                                                                                                                                                      source text sha256
                                                                                                                                                                                                                                      e526ba14c91f10737e6d3331fe23a6219f58c0eca6380bfce9bd78b573fea912
                                                                                                                                                                                                                                      start
                                                                                                                                                                                                                                      17801
                                                                                                                                                                                                                                    6. context exact
                                                                                                                                                                                                                                      KEYTRUDA, in combination with fluoropyrimidine- and platinum-containing chemotherapy, is indicated for the first-line treatment of adults with locally advanced unresectable or metastatic HER2-negative gastric or gastroesophageal junction (GEJ) adeno
                                                                                                                                                                                                                                      kind
                                                                                                                                                                                                                                      regimen
                                                                                                                                                                                                                                      polarity
                                                                                                                                                                                                                                      not_inferred
                                                                                                                                                                                                                                      span
                                                                                                                                                                                                                                      end
                                                                                                                                                                                                                                      17883
                                                                                                                                                                                                                                      end exclusive
                                                                                                                                                                                                                                      true
                                                                                                                                                                                                                                      exact text
                                                                                                                                                                                                                                      in combination with fluoropyrimidine- and platinum-containing chemotherapy, is indicated for the first-line treatment of adults with locally advanced unresectable or metastatic HE
                                                                                                                                                                                                                                      label id
                                                                                                                                                                                                                                      228e1e3f-d207-481f-8e14-9fdcbd0470e9
                                                                                                                                                                                                                                      offset unit
                                                                                                                                                                                                                                      unicode_code_points
                                                                                                                                                                                                                                      source array index
                                                                                                                                                                                                                                      0
                                                                                                                                                                                                                                      source field
                                                                                                                                                                                                                                      indications_and_usage_exact
                                                                                                                                                                                                                                      source text sha256
                                                                                                                                                                                                                                      e526ba14c91f10737e6d3331fe23a6219f58c0eca6380bfce9bd78b573fea912
                                                                                                                                                                                                                                      start
                                                                                                                                                                                                                                      17704
                                                                                                                                                                                                                                    regulatory links
                                                                                                                                                                                                                                      schema version
                                                                                                                                                                                                                                      0.1.0
                                                                                                                                                                                                                                      source batch sha256
                                                                                                                                                                                                                                      fc39a8c5cf96bf95ca20b85578140167b66b2741f7d9217f500d9ba0847ac058
                                                                                                                                                                                                                                      source defined aliases
                                                                                                                                                                                                                                      1. abbreviation
                                                                                                                                                                                                                                        NSCLC
                                                                                                                                                                                                                                        definition exact
                                                                                                                                                                                                                                        Non-Small Cell Lung Cancer
                                                                                                                                                                                                                                        definition span
                                                                                                                                                                                                                                        end
                                                                                                                                                                                                                                        380
                                                                                                                                                                                                                                        end exclusive
                                                                                                                                                                                                                                        true
                                                                                                                                                                                                                                        exact text
                                                                                                                                                                                                                                        Non-Small Cell Lung Cancer (NSCLC)
                                                                                                                                                                                                                                        label id
                                                                                                                                                                                                                                        228e1e3f-d207-481f-8e14-9fdcbd0470e9
                                                                                                                                                                                                                                        offset unit
                                                                                                                                                                                                                                        unicode_code_points
                                                                                                                                                                                                                                        source array index
                                                                                                                                                                                                                                        0
                                                                                                                                                                                                                                        source field
                                                                                                                                                                                                                                        indications_and_usage_exact
                                                                                                                                                                                                                                        source text sha256
                                                                                                                                                                                                                                        e526ba14c91f10737e6d3331fe23a6219f58c0eca6380bfce9bd78b573fea912
                                                                                                                                                                                                                                        start
                                                                                                                                                                                                                                        346
                                                                                                                                                                                                                                      2. abbreviation
                                                                                                                                                                                                                                        CRC
                                                                                                                                                                                                                                        definition exact
                                                                                                                                                                                                                                        Colorectal Cancer
                                                                                                                                                                                                                                        definition span
                                                                                                                                                                                                                                        end
                                                                                                                                                                                                                                        5042
                                                                                                                                                                                                                                        end exclusive
                                                                                                                                                                                                                                        true
                                                                                                                                                                                                                                        exact text
                                                                                                                                                                                                                                        Colorectal Cancer (CRC)
                                                                                                                                                                                                                                        label id
                                                                                                                                                                                                                                        228e1e3f-d207-481f-8e14-9fdcbd0470e9
                                                                                                                                                                                                                                        offset unit
                                                                                                                                                                                                                                        unicode_code_points
                                                                                                                                                                                                                                        source array index
                                                                                                                                                                                                                                        0
                                                                                                                                                                                                                                        source field
                                                                                                                                                                                                                                        indications_and_usage_exact
                                                                                                                                                                                                                                        source text sha256
                                                                                                                                                                                                                                        e526ba14c91f10737e6d3331fe23a6219f58c0eca6380bfce9bd78b573fea912
                                                                                                                                                                                                                                        start
                                                                                                                                                                                                                                        5019
                                                                                                                                                                                                                                      source span
                                                                                                                                                                                                                                      end
                                                                                                                                                                                                                                      18070
                                                                                                                                                                                                                                      end exclusive
                                                                                                                                                                                                                                      true
                                                                                                                                                                                                                                      exact text
                                                                                                                                                                                                                                      KEYTRUDA, in combination with fluoropyrimidine- and platinum-containing chemotherapy, is indicated for the first-line treatment of adults with locally advanced unresectable or metastatic HER2-negative gastric or gastroesophageal junction (GEJ) adenocarcinoma whose tumors express PD-L1 (CPS ≥ 1) as determined by an FDA-authorized test [see Dosage and Administration (2.1) ] .
                                                                                                                                                                                                                                      label id
                                                                                                                                                                                                                                      228e1e3f-d207-481f-8e14-9fdcbd0470e9
                                                                                                                                                                                                                                      offset unit
                                                                                                                                                                                                                                      unicode_code_points
                                                                                                                                                                                                                                      source array index
                                                                                                                                                                                                                                      0
                                                                                                                                                                                                                                      source field
                                                                                                                                                                                                                                      indications_and_usage_exact
                                                                                                                                                                                                                                      source text sha256
                                                                                                                                                                                                                                      e526ba14c91f10737e6d3331fe23a6219f58c0eca6380bfce9bd78b573fea912
                                                                                                                                                                                                                                      start
                                                                                                                                                                                                                                      17694
                                                                                                                                                                                                                                      source url
                                                                                                                                                                                                                                      https://api.fda.gov/drug/label.json?search=id%3A%22228e1e3f-d207-481f-8e14-9fdcbd0470e9%22
                                                                                                                                                                                                                                      spl effective date
                                                                                                                                                                                                                                      2026-07-10
                                                                                                                                                                                                                                      spl set id
                                                                                                                                                                                                                                      9333c79b-d487-4538-a9f0-71b91a02b287
                                                                                                                                                                                                                                      spl version
                                                                                                                                                                                                                                      228
                                                                                                                                                                                                                                      structured fields status
                                                                                                                                                                                                                                      not_extracted_no_values_inferred_from_mentions
                                                                                                                                                                                                                                      structured indication
                                                                                                                                                                                                                                      age
                                                                                                                                                                                                                                      Source null
                                                                                                                                                                                                                                      approval pathway
                                                                                                                                                                                                                                      Source null
                                                                                                                                                                                                                                      biomarker and test
                                                                                                                                                                                                                                      Source null
                                                                                                                                                                                                                                      disease stage
                                                                                                                                                                                                                                      Source null
                                                                                                                                                                                                                                      limitations
                                                                                                                                                                                                                                      Source null
                                                                                                                                                                                                                                      line
                                                                                                                                                                                                                                      Source null
                                                                                                                                                                                                                                      prior therapy
                                                                                                                                                                                                                                      Source null
                                                                                                                                                                                                                                      regimen
                                                                                                                                                                                                                                      Source null
                                                                                                                                                                                                                                      tumor histology
                                                                                                                                                                                                                                      Source null
                                                                                                                                                                                                                                      use intent
                                                                                                                                                                                                                                      tumor_directed_candidate
                                                                                                                                                                                                                                      Passage 92 · positive indication candidate
                                                                                                                                                                                                                                      application numbers
                                                                                                                                                                                                                                      1. BLA125514
                                                                                                                                                                                                                                      brand names
                                                                                                                                                                                                                                      1. KEYTRUDA
                                                                                                                                                                                                                                      classification reasons
                                                                                                                                                                                                                                      1. explicit_positive_indication_predicate
                                                                                                                                                                                                                                      2. tumor_or_malignant_hematology_words_in_positive_statement
                                                                                                                                                                                                                                      clinical review status
                                                                                                                                                                                                                                      pending
                                                                                                                                                                                                                                      content role
                                                                                                                                                                                                                                      positive_indication_candidate
                                                                                                                                                                                                                                      context span
                                                                                                                                                                                                                                      end
                                                                                                                                                                                                                                      19012
                                                                                                                                                                                                                                      end exclusive
                                                                                                                                                                                                                                      true
                                                                                                                                                                                                                                      exact text
                                                                                                                                                                                                                                      etastatic HER2-negative gastric or gastroesophageal junction (GEJ) adenocarcinoma whose tumors express PD-L1 (CPS ≥ 1) as determined by an FDA-authorized test [see Dosage and Administration (2.1) ] . 1.11 Esophageal Cancer KEYTRUDA is indicated for the treatment of patients with locally advanced or metastatic esophageal or gastroesophageal junction (GEJ) (tumors with epicenter 1 to 5 centimeters above the GEJ) carcinoma that is not amenable to surgical resection or definitive chemoradiation either: in combination with platinum- and fluoropyrimidine-based chemotherapy for patients with tumors that express PD-L1 (CPS ≥ 1) as determined by an FDA-authorized test [see Dosage and Administration (2.1) ] , or as a single agent after one or more prior lines of systemic therapy for patients with tumors of squamous cell histology that express PD-L1 (CPS ≥10) as determined by an FDA-authorized test [see Dosage and Administration (2.1) ] . 1.12 Cervical Cancer KEYTRUDA, in combination with chemoradiotherapy (CRT), is indicated for the treatment of patients with locally advanced cervical cancer involving the lower third of the vagina, w
                                                                                                                                                                                                                                      label id
                                                                                                                                                                                                                                      228e1e3f-d207-481f-8e14-9fdcbd0470e9
                                                                                                                                                                                                                                      offset unit
                                                                                                                                                                                                                                      unicode_code_points
                                                                                                                                                                                                                                      source array index
                                                                                                                                                                                                                                      0
                                                                                                                                                                                                                                      source field
                                                                                                                                                                                                                                      indications_and_usage_exact
                                                                                                                                                                                                                                      source text sha256
                                                                                                                                                                                                                                      e526ba14c91f10737e6d3331fe23a6219f58c0eca6380bfce9bd78b573fea912
                                                                                                                                                                                                                                      start
                                                                                                                                                                                                                                      17871
                                                                                                                                                                                                                                      current approval status
                                                                                                                                                                                                                                      not_reconciled
                                                                                                                                                                                                                                      duplicate text group
                                                                                                                                                                                                                                      dup-09255b0b34f79a9c2eed
                                                                                                                                                                                                                                      extraction review status
                                                                                                                                                                                                                                      automated_candidate_pending_source_review
                                                                                                                                                                                                                                      generic names
                                                                                                                                                                                                                                      1. PEMBROLIZUMAB
                                                                                                                                                                                                                                      id
                                                                                                                                                                                                                                      ind-span-183a38a5173d761acb1b
                                                                                                                                                                                                                                      label id
                                                                                                                                                                                                                                      228e1e3f-d207-481f-8e14-9fdcbd0470e9
                                                                                                                                                                                                                                      positive predicate support span
                                                                                                                                                                                                                                      end
                                                                                                                                                                                                                                      18115
                                                                                                                                                                                                                                      end exclusive
                                                                                                                                                                                                                                      true
                                                                                                                                                                                                                                      exact text
                                                                                                                                                                                                                                      is indicated
                                                                                                                                                                                                                                      label id
                                                                                                                                                                                                                                      228e1e3f-d207-481f-8e14-9fdcbd0470e9
                                                                                                                                                                                                                                      offset unit
                                                                                                                                                                                                                                      unicode_code_points
                                                                                                                                                                                                                                      source array index
                                                                                                                                                                                                                                      0
                                                                                                                                                                                                                                      source field
                                                                                                                                                                                                                                      indications_and_usage_exact
                                                                                                                                                                                                                                      source text sha256
                                                                                                                                                                                                                                      e526ba14c91f10737e6d3331fe23a6219f58c0eca6380bfce9bd78b573fea912
                                                                                                                                                                                                                                      start
                                                                                                                                                                                                                                      18103
                                                                                                                                                                                                                                      qualifier mentions
                                                                                                                                                                                                                                      1. context exact
                                                                                                                                                                                                                                        ated for the treatment of patients with locally advanced or metastatic esophageal or gastroesophageal junction (GEJ) (tumors with epicenter 1 to 5 centimeters abov
                                                                                                                                                                                                                                        kind
                                                                                                                                                                                                                                        biomarker
                                                                                                                                                                                                                                        polarity
                                                                                                                                                                                                                                        not_inferred
                                                                                                                                                                                                                                        span
                                                                                                                                                                                                                                        end
                                                                                                                                                                                                                                        18214
                                                                                                                                                                                                                                        end exclusive
                                                                                                                                                                                                                                        true
                                                                                                                                                                                                                                        exact text
                                                                                                                                                                                                                                        metastatic esophageal or gastroesophageal j
                                                                                                                                                                                                                                        label id
                                                                                                                                                                                                                                        228e1e3f-d207-481f-8e14-9fdcbd0470e9
                                                                                                                                                                                                                                        offset unit
                                                                                                                                                                                                                                        unicode_code_points
                                                                                                                                                                                                                                        source array index
                                                                                                                                                                                                                                        0
                                                                                                                                                                                                                                        source field
                                                                                                                                                                                                                                        indications_and_usage_exact
                                                                                                                                                                                                                                        source text sha256
                                                                                                                                                                                                                                        e526ba14c91f10737e6d3331fe23a6219f58c0eca6380bfce9bd78b573fea912
                                                                                                                                                                                                                                        start
                                                                                                                                                                                                                                        18171
                                                                                                                                                                                                                                      2. context exact
                                                                                                                                                                                                                                        ne-based chemotherapy for patients with tumors that express PD-L1 (CPS ≥ 1) as determined by an FDA-authorized test [see Dosage and Administration (2.1) ] , or as a
                                                                                                                                                                                                                                        kind
                                                                                                                                                                                                                                        biomarker
                                                                                                                                                                                                                                        polarity
                                                                                                                                                                                                                                        not_inferred
                                                                                                                                                                                                                                        span
                                                                                                                                                                                                                                        end
                                                                                                                                                                                                                                        18528
                                                                                                                                                                                                                                        end exclusive
                                                                                                                                                                                                                                        true
                                                                                                                                                                                                                                        exact text
                                                                                                                                                                                                                                        PD-L1 (CPS ≥ 1) as determined by an FDA-autho
                                                                                                                                                                                                                                        label id
                                                                                                                                                                                                                                        228e1e3f-d207-481f-8e14-9fdcbd0470e9
                                                                                                                                                                                                                                        offset unit
                                                                                                                                                                                                                                        unicode_code_points
                                                                                                                                                                                                                                        source array index
                                                                                                                                                                                                                                        0
                                                                                                                                                                                                                                        source field
                                                                                                                                                                                                                                        indications_and_usage_exact
                                                                                                                                                                                                                                        source text sha256
                                                                                                                                                                                                                                        e526ba14c91f10737e6d3331fe23a6219f58c0eca6380bfce9bd78b573fea912
                                                                                                                                                                                                                                        start
                                                                                                                                                                                                                                        18483
                                                                                                                                                                                                                                      3. context exact
                                                                                                                                                                                                                                        atients with tumors of squamous cell histology that express PD-L1 (CPS ≥10) as determined by an FDA-authorized test [see Dosage and Administration (2.1) ] .
                                                                                                                                                                                                                                        kind
                                                                                                                                                                                                                                        biomarker
                                                                                                                                                                                                                                        polarity
                                                                                                                                                                                                                                        not_inferred
                                                                                                                                                                                                                                        span
                                                                                                                                                                                                                                        end
                                                                                                                                                                                                                                        18761
                                                                                                                                                                                                                                        end exclusive
                                                                                                                                                                                                                                        true
                                                                                                                                                                                                                                        exact text
                                                                                                                                                                                                                                        PD-L1 (CPS ≥10) as determined by an FDA-autho
                                                                                                                                                                                                                                        label id
                                                                                                                                                                                                                                        228e1e3f-d207-481f-8e14-9fdcbd0470e9
                                                                                                                                                                                                                                        offset unit
                                                                                                                                                                                                                                        unicode_code_points
                                                                                                                                                                                                                                        source array index
                                                                                                                                                                                                                                        0
                                                                                                                                                                                                                                        source field
                                                                                                                                                                                                                                        indications_and_usage_exact
                                                                                                                                                                                                                                        source text sha256
                                                                                                                                                                                                                                        e526ba14c91f10737e6d3331fe23a6219f58c0eca6380bfce9bd78b573fea912
                                                                                                                                                                                                                                        start
                                                                                                                                                                                                                                        18716
                                                                                                                                                                                                                                      4. context exact
                                                                                                                                                                                                                                        er KEYTRUDA is indicated for the treatment of patients with locally advanced or metastatic esophageal or gastroesophageal junction (GEJ) (tumors with epicenter 1 to 5 cent
                                                                                                                                                                                                                                        kind
                                                                                                                                                                                                                                        stage_or_setting
                                                                                                                                                                                                                                        polarity
                                                                                                                                                                                                                                        not_inferred
                                                                                                                                                                                                                                        span
                                                                                                                                                                                                                                        end
                                                                                                                                                                                                                                        18202
                                                                                                                                                                                                                                        end exclusive
                                                                                                                                                                                                                                        true
                                                                                                                                                                                                                                        exact text
                                                                                                                                                                                                                                        locally advanced or metastatic esophageal or gastro
                                                                                                                                                                                                                                        label id
                                                                                                                                                                                                                                        228e1e3f-d207-481f-8e14-9fdcbd0470e9
                                                                                                                                                                                                                                        offset unit
                                                                                                                                                                                                                                        unicode_code_points
                                                                                                                                                                                                                                        source array index
                                                                                                                                                                                                                                        0
                                                                                                                                                                                                                                        source field
                                                                                                                                                                                                                                        indications_and_usage_exact
                                                                                                                                                                                                                                        source text sha256
                                                                                                                                                                                                                                        e526ba14c91f10737e6d3331fe23a6219f58c0eca6380bfce9bd78b573fea912
                                                                                                                                                                                                                                        start
                                                                                                                                                                                                                                        18151
                                                                                                                                                                                                                                      5. context exact
                                                                                                                                                                                                                                        to surgical resection or definitive chemoradiation either: in combination with platinum- and fluoropyrimidine-based chemotherapy for patients with tumors that express PD-L1 (CPS ≥ 1) as determined by an FDA-authorized test [see Dosage and Administration (2.1) ] , or as a single agent after one or
                                                                                                                                                                                                                                        kind
                                                                                                                                                                                                                                        regimen
                                                                                                                                                                                                                                        polarity
                                                                                                                                                                                                                                        not_inferred
                                                                                                                                                                                                                                        span
                                                                                                                                                                                                                                        end
                                                                                                                                                                                                                                        18554
                                                                                                                                                                                                                                        end exclusive
                                                                                                                                                                                                                                        true
                                                                                                                                                                                                                                        exact text
                                                                                                                                                                                                                                        in combination with platinum- and fluoropyrimidine-based chemotherapy for patients with tumors that express PD-L1 (CPS ≥ 1) as determined by an FDA-authorized test [see Dosage and
                                                                                                                                                                                                                                        label id
                                                                                                                                                                                                                                        228e1e3f-d207-481f-8e14-9fdcbd0470e9
                                                                                                                                                                                                                                        offset unit
                                                                                                                                                                                                                                        unicode_code_points
                                                                                                                                                                                                                                        source array index
                                                                                                                                                                                                                                        0
                                                                                                                                                                                                                                        source field
                                                                                                                                                                                                                                        indications_and_usage_exact
                                                                                                                                                                                                                                        source text sha256
                                                                                                                                                                                                                                        e526ba14c91f10737e6d3331fe23a6219f58c0eca6380bfce9bd78b573fea912
                                                                                                                                                                                                                                        start
                                                                                                                                                                                                                                        18375
                                                                                                                                                                                                                                      6. context exact
                                                                                                                                                                                                                                        authorized test [see Dosage and Administration (2.1) ] , or as a single agent after one or more prior lines of systemic therapy for patients with tumors of squamous cell histology that express PD-L1 (CPS ≥10) as determined by an FDA-authorized test [see Dosage and Administration (2.1) ] .
                                                                                                                                                                                                                                        kind
                                                                                                                                                                                                                                        regimen
                                                                                                                                                                                                                                        polarity
                                                                                                                                                                                                                                        not_inferred
                                                                                                                                                                                                                                        span
                                                                                                                                                                                                                                        end
                                                                                                                                                                                                                                        18760
                                                                                                                                                                                                                                        end exclusive
                                                                                                                                                                                                                                        true
                                                                                                                                                                                                                                        exact text
                                                                                                                                                                                                                                        as a single agent after one or more prior lines of systemic therapy for patients with tumors of squamous cell histology that express PD-L1 (CPS ≥10) as determined by an FDA-auth
                                                                                                                                                                                                                                        label id
                                                                                                                                                                                                                                        228e1e3f-d207-481f-8e14-9fdcbd0470e9
                                                                                                                                                                                                                                        offset unit
                                                                                                                                                                                                                                        unicode_code_points
                                                                                                                                                                                                                                        source array index
                                                                                                                                                                                                                                        0
                                                                                                                                                                                                                                        source field
                                                                                                                                                                                                                                        indications_and_usage_exact
                                                                                                                                                                                                                                        source text sha256
                                                                                                                                                                                                                                        e526ba14c91f10737e6d3331fe23a6219f58c0eca6380bfce9bd78b573fea912
                                                                                                                                                                                                                                        start
                                                                                                                                                                                                                                        18583
                                                                                                                                                                                                                                      regulatory links
                                                                                                                                                                                                                                        schema version
                                                                                                                                                                                                                                        0.1.0
                                                                                                                                                                                                                                        source batch sha256
                                                                                                                                                                                                                                        fc39a8c5cf96bf95ca20b85578140167b66b2741f7d9217f500d9ba0847ac058
                                                                                                                                                                                                                                        source defined aliases
                                                                                                                                                                                                                                        1. abbreviation
                                                                                                                                                                                                                                          NSCLC
                                                                                                                                                                                                                                          definition exact
                                                                                                                                                                                                                                          Non-Small Cell Lung Cancer
                                                                                                                                                                                                                                          definition span
                                                                                                                                                                                                                                          end
                                                                                                                                                                                                                                          380
                                                                                                                                                                                                                                          end exclusive
                                                                                                                                                                                                                                          true
                                                                                                                                                                                                                                          exact text
                                                                                                                                                                                                                                          Non-Small Cell Lung Cancer (NSCLC)
                                                                                                                                                                                                                                          label id
                                                                                                                                                                                                                                          228e1e3f-d207-481f-8e14-9fdcbd0470e9
                                                                                                                                                                                                                                          offset unit
                                                                                                                                                                                                                                          unicode_code_points
                                                                                                                                                                                                                                          source array index
                                                                                                                                                                                                                                          0
                                                                                                                                                                                                                                          source field
                                                                                                                                                                                                                                          indications_and_usage_exact
                                                                                                                                                                                                                                          source text sha256
                                                                                                                                                                                                                                          e526ba14c91f10737e6d3331fe23a6219f58c0eca6380bfce9bd78b573fea912
                                                                                                                                                                                                                                          start
                                                                                                                                                                                                                                          346
                                                                                                                                                                                                                                        2. abbreviation
                                                                                                                                                                                                                                          CRC
                                                                                                                                                                                                                                          definition exact
                                                                                                                                                                                                                                          Colorectal Cancer
                                                                                                                                                                                                                                          definition span
                                                                                                                                                                                                                                          end
                                                                                                                                                                                                                                          5042
                                                                                                                                                                                                                                          end exclusive
                                                                                                                                                                                                                                          true
                                                                                                                                                                                                                                          exact text
                                                                                                                                                                                                                                          Colorectal Cancer (CRC)
                                                                                                                                                                                                                                          label id
                                                                                                                                                                                                                                          228e1e3f-d207-481f-8e14-9fdcbd0470e9
                                                                                                                                                                                                                                          offset unit
                                                                                                                                                                                                                                          unicode_code_points
                                                                                                                                                                                                                                          source array index
                                                                                                                                                                                                                                          0
                                                                                                                                                                                                                                          source field
                                                                                                                                                                                                                                          indications_and_usage_exact
                                                                                                                                                                                                                                          source text sha256
                                                                                                                                                                                                                                          e526ba14c91f10737e6d3331fe23a6219f58c0eca6380bfce9bd78b573fea912
                                                                                                                                                                                                                                          start
                                                                                                                                                                                                                                          5019
                                                                                                                                                                                                                                        source span
                                                                                                                                                                                                                                        end
                                                                                                                                                                                                                                        18812
                                                                                                                                                                                                                                        end exclusive
                                                                                                                                                                                                                                        true
                                                                                                                                                                                                                                        exact text
                                                                                                                                                                                                                                        1.11 Esophageal Cancer KEYTRUDA is indicated for the treatment of patients with locally advanced or metastatic esophageal or gastroesophageal junction (GEJ) (tumors with epicenter 1 to 5 centimeters above the GEJ) carcinoma that is not amenable to surgical resection or definitive chemoradiation either: in combination with platinum- and fluoropyrimidine-based chemotherapy for patients with tumors that express PD-L1 (CPS ≥ 1) as determined by an FDA-authorized test [see Dosage and Administration (2.1) ] , or as a single agent after one or more prior lines of systemic therapy for patients with tumors of squamous cell histology that express PD-L1 (CPS ≥10) as determined by an FDA-authorized test [see Dosage and Administration (2.1) ] .
                                                                                                                                                                                                                                        label id
                                                                                                                                                                                                                                        228e1e3f-d207-481f-8e14-9fdcbd0470e9
                                                                                                                                                                                                                                        offset unit
                                                                                                                                                                                                                                        unicode_code_points
                                                                                                                                                                                                                                        source array index
                                                                                                                                                                                                                                        0
                                                                                                                                                                                                                                        source field
                                                                                                                                                                                                                                        indications_and_usage_exact
                                                                                                                                                                                                                                        source text sha256
                                                                                                                                                                                                                                        e526ba14c91f10737e6d3331fe23a6219f58c0eca6380bfce9bd78b573fea912
                                                                                                                                                                                                                                        start
                                                                                                                                                                                                                                        18071
                                                                                                                                                                                                                                        source url
                                                                                                                                                                                                                                        https://api.fda.gov/drug/label.json?search=id%3A%22228e1e3f-d207-481f-8e14-9fdcbd0470e9%22
                                                                                                                                                                                                                                        spl effective date
                                                                                                                                                                                                                                        2026-07-10
                                                                                                                                                                                                                                        spl set id
                                                                                                                                                                                                                                        9333c79b-d487-4538-a9f0-71b91a02b287
                                                                                                                                                                                                                                        spl version
                                                                                                                                                                                                                                        228
                                                                                                                                                                                                                                        structured fields status
                                                                                                                                                                                                                                        not_extracted_no_values_inferred_from_mentions
                                                                                                                                                                                                                                        structured indication
                                                                                                                                                                                                                                        age
                                                                                                                                                                                                                                        Source null
                                                                                                                                                                                                                                        approval pathway
                                                                                                                                                                                                                                        Source null
                                                                                                                                                                                                                                        biomarker and test
                                                                                                                                                                                                                                        Source null
                                                                                                                                                                                                                                        disease stage
                                                                                                                                                                                                                                        Source null
                                                                                                                                                                                                                                        limitations
                                                                                                                                                                                                                                        Source null
                                                                                                                                                                                                                                        line
                                                                                                                                                                                                                                        Source null
                                                                                                                                                                                                                                        prior therapy
                                                                                                                                                                                                                                        Source null
                                                                                                                                                                                                                                        regimen
                                                                                                                                                                                                                                        Source null
                                                                                                                                                                                                                                        tumor histology
                                                                                                                                                                                                                                        Source null
                                                                                                                                                                                                                                        use intent
                                                                                                                                                                                                                                        tumor_directed_candidate
                                                                                                                                                                                                                                        Passage 93 · positive indication candidate
                                                                                                                                                                                                                                        application numbers
                                                                                                                                                                                                                                        1. BLA125514
                                                                                                                                                                                                                                        brand names
                                                                                                                                                                                                                                        1. KEYTRUDA
                                                                                                                                                                                                                                        classification reasons
                                                                                                                                                                                                                                        1. explicit_positive_indication_predicate
                                                                                                                                                                                                                                        2. tumor_or_malignant_hematology_words_in_positive_statement
                                                                                                                                                                                                                                        clinical review status
                                                                                                                                                                                                                                        pending
                                                                                                                                                                                                                                        content role
                                                                                                                                                                                                                                        positive_indication_candidate
                                                                                                                                                                                                                                        context span
                                                                                                                                                                                                                                        end
                                                                                                                                                                                                                                        19361
                                                                                                                                                                                                                                        end exclusive
                                                                                                                                                                                                                                        true
                                                                                                                                                                                                                                        exact text
                                                                                                                                                                                                                                        more prior lines of systemic therapy for patients with tumors of squamous cell histology that express PD-L1 (CPS ≥10) as determined by an FDA-authorized test [see Dosage and Administration (2.1) ] . 1.12 Cervical Cancer KEYTRUDA, in combination with chemoradiotherapy (CRT), is indicated for the treatment of patients with locally advanced cervical cancer involving the lower third of the vagina, with or without extension to pelvic sidewall, or hydronephrosis/non-functioning kidney, or spread to adjacent pelvic organs (FIGO 2014 Stage III-IVA). KEYTRUDA, in combination with chemotherapy, with or without bevacizumab, is indicated for the treatment of patients with persistent, recurrent, or metastatic cervical cancer whose tumors express PD-L
                                                                                                                                                                                                                                        label id
                                                                                                                                                                                                                                        228e1e3f-d207-481f-8e14-9fdcbd0470e9
                                                                                                                                                                                                                                        offset unit
                                                                                                                                                                                                                                        unicode_code_points
                                                                                                                                                                                                                                        source array index
                                                                                                                                                                                                                                        0
                                                                                                                                                                                                                                        source field
                                                                                                                                                                                                                                        indications_and_usage_exact
                                                                                                                                                                                                                                        source text sha256
                                                                                                                                                                                                                                        e526ba14c91f10737e6d3331fe23a6219f58c0eca6380bfce9bd78b573fea912
                                                                                                                                                                                                                                        start
                                                                                                                                                                                                                                        18613
                                                                                                                                                                                                                                        current approval status
                                                                                                                                                                                                                                        not_reconciled
                                                                                                                                                                                                                                        duplicate text group
                                                                                                                                                                                                                                        dup-8dfe0663c64a5208bac3
                                                                                                                                                                                                                                        extraction review status
                                                                                                                                                                                                                                        automated_candidate_pending_source_review
                                                                                                                                                                                                                                        generic names
                                                                                                                                                                                                                                        1. PEMBROLIZUMAB
                                                                                                                                                                                                                                        id
                                                                                                                                                                                                                                        ind-span-21e55f038f7ac57f4d7d
                                                                                                                                                                                                                                        label id
                                                                                                                                                                                                                                        228e1e3f-d207-481f-8e14-9fdcbd0470e9
                                                                                                                                                                                                                                        positive predicate support span
                                                                                                                                                                                                                                        end
                                                                                                                                                                                                                                        18901
                                                                                                                                                                                                                                        end exclusive
                                                                                                                                                                                                                                        true
                                                                                                                                                                                                                                        exact text
                                                                                                                                                                                                                                        is indicated
                                                                                                                                                                                                                                        label id
                                                                                                                                                                                                                                        228e1e3f-d207-481f-8e14-9fdcbd0470e9
                                                                                                                                                                                                                                        offset unit
                                                                                                                                                                                                                                        unicode_code_points
                                                                                                                                                                                                                                        source array index
                                                                                                                                                                                                                                        0
                                                                                                                                                                                                                                        source field
                                                                                                                                                                                                                                        indications_and_usage_exact
                                                                                                                                                                                                                                        source text sha256
                                                                                                                                                                                                                                        e526ba14c91f10737e6d3331fe23a6219f58c0eca6380bfce9bd78b573fea912
                                                                                                                                                                                                                                        start
                                                                                                                                                                                                                                        18889
                                                                                                                                                                                                                                        qualifier mentions
                                                                                                                                                                                                                                        1. context exact
                                                                                                                                                                                                                                          rapy (CRT), is indicated for the treatment of patients with locally advanced cervical cancer involving the lower third of the vagina, with or without extension to pelvic s
                                                                                                                                                                                                                                          kind
                                                                                                                                                                                                                                          stage_or_setting
                                                                                                                                                                                                                                          polarity
                                                                                                                                                                                                                                          not_inferred
                                                                                                                                                                                                                                          span
                                                                                                                                                                                                                                          end
                                                                                                                                                                                                                                          18988
                                                                                                                                                                                                                                          end exclusive
                                                                                                                                                                                                                                          true
                                                                                                                                                                                                                                          exact text
                                                                                                                                                                                                                                          locally advanced cervical cancer involving the lowe
                                                                                                                                                                                                                                          label id
                                                                                                                                                                                                                                          228e1e3f-d207-481f-8e14-9fdcbd0470e9
                                                                                                                                                                                                                                          offset unit
                                                                                                                                                                                                                                          unicode_code_points
                                                                                                                                                                                                                                          source array index
                                                                                                                                                                                                                                          0
                                                                                                                                                                                                                                          source field
                                                                                                                                                                                                                                          indications_and_usage_exact
                                                                                                                                                                                                                                          source text sha256
                                                                                                                                                                                                                                          e526ba14c91f10737e6d3331fe23a6219f58c0eca6380bfce9bd78b573fea912
                                                                                                                                                                                                                                          start
                                                                                                                                                                                                                                          18937
                                                                                                                                                                                                                                        2. context exact
                                                                                                                                                                                                                                          1.12 Cervical Cancer KEYTRUDA, in combination with chemoradiotherapy (CRT), is indicated for the treatment of patients with locally advanced cervical cancer involving the lower third of the vagina, with or without extension to pelvic sidewall, or hydronephrosis/non-func
                                                                                                                                                                                                                                          kind
                                                                                                                                                                                                                                          regimen
                                                                                                                                                                                                                                          polarity
                                                                                                                                                                                                                                          not_inferred
                                                                                                                                                                                                                                          span
                                                                                                                                                                                                                                          end
                                                                                                                                                                                                                                          19023
                                                                                                                                                                                                                                          end exclusive
                                                                                                                                                                                                                                          true
                                                                                                                                                                                                                                          exact text
                                                                                                                                                                                                                                          in combination with chemoradiotherapy (CRT), is indicated for the treatment of patients with locally advanced cervical cancer involving the lower third of the vagina, with or with
                                                                                                                                                                                                                                          label id
                                                                                                                                                                                                                                          228e1e3f-d207-481f-8e14-9fdcbd0470e9
                                                                                                                                                                                                                                          offset unit
                                                                                                                                                                                                                                          unicode_code_points
                                                                                                                                                                                                                                          source array index
                                                                                                                                                                                                                                          0
                                                                                                                                                                                                                                          source field
                                                                                                                                                                                                                                          indications_and_usage_exact
                                                                                                                                                                                                                                          source text sha256
                                                                                                                                                                                                                                          e526ba14c91f10737e6d3331fe23a6219f58c0eca6380bfce9bd78b573fea912
                                                                                                                                                                                                                                          start
                                                                                                                                                                                                                                          18844
                                                                                                                                                                                                                                        regulatory links
                                                                                                                                                                                                                                          schema version
                                                                                                                                                                                                                                          0.1.0
                                                                                                                                                                                                                                          source batch sha256
                                                                                                                                                                                                                                          fc39a8c5cf96bf95ca20b85578140167b66b2741f7d9217f500d9ba0847ac058
                                                                                                                                                                                                                                          source defined aliases
                                                                                                                                                                                                                                          1. abbreviation
                                                                                                                                                                                                                                            NSCLC
                                                                                                                                                                                                                                            definition exact
                                                                                                                                                                                                                                            Non-Small Cell Lung Cancer
                                                                                                                                                                                                                                            definition span
                                                                                                                                                                                                                                            end
                                                                                                                                                                                                                                            380
                                                                                                                                                                                                                                            end exclusive
                                                                                                                                                                                                                                            true
                                                                                                                                                                                                                                            exact text
                                                                                                                                                                                                                                            Non-Small Cell Lung Cancer (NSCLC)
                                                                                                                                                                                                                                            label id
                                                                                                                                                                                                                                            228e1e3f-d207-481f-8e14-9fdcbd0470e9
                                                                                                                                                                                                                                            offset unit
                                                                                                                                                                                                                                            unicode_code_points
                                                                                                                                                                                                                                            source array index
                                                                                                                                                                                                                                            0
                                                                                                                                                                                                                                            source field
                                                                                                                                                                                                                                            indications_and_usage_exact
                                                                                                                                                                                                                                            source text sha256
                                                                                                                                                                                                                                            e526ba14c91f10737e6d3331fe23a6219f58c0eca6380bfce9bd78b573fea912
                                                                                                                                                                                                                                            start
                                                                                                                                                                                                                                            346
                                                                                                                                                                                                                                          2. abbreviation
                                                                                                                                                                                                                                            CRC
                                                                                                                                                                                                                                            definition exact
                                                                                                                                                                                                                                            Colorectal Cancer
                                                                                                                                                                                                                                            definition span
                                                                                                                                                                                                                                            end
                                                                                                                                                                                                                                            5042
                                                                                                                                                                                                                                            end exclusive
                                                                                                                                                                                                                                            true
                                                                                                                                                                                                                                            exact text
                                                                                                                                                                                                                                            Colorectal Cancer (CRC)
                                                                                                                                                                                                                                            label id
                                                                                                                                                                                                                                            228e1e3f-d207-481f-8e14-9fdcbd0470e9
                                                                                                                                                                                                                                            offset unit
                                                                                                                                                                                                                                            unicode_code_points
                                                                                                                                                                                                                                            source array index
                                                                                                                                                                                                                                            0
                                                                                                                                                                                                                                            source field
                                                                                                                                                                                                                                            indications_and_usage_exact
                                                                                                                                                                                                                                            source text sha256
                                                                                                                                                                                                                                            e526ba14c91f10737e6d3331fe23a6219f58c0eca6380bfce9bd78b573fea912
                                                                                                                                                                                                                                            start
                                                                                                                                                                                                                                            5019
                                                                                                                                                                                                                                          source span
                                                                                                                                                                                                                                          end
                                                                                                                                                                                                                                          19161
                                                                                                                                                                                                                                          end exclusive
                                                                                                                                                                                                                                          true
                                                                                                                                                                                                                                          exact text
                                                                                                                                                                                                                                          1.12 Cervical Cancer KEYTRUDA, in combination with chemoradiotherapy (CRT), is indicated for the treatment of patients with locally advanced cervical cancer involving the lower third of the vagina, with or without extension to pelvic sidewall, or hydronephrosis/non-functioning kidney, or spread to adjacent pelvic organs (FIGO 2014 Stage III-IVA).
                                                                                                                                                                                                                                          label id
                                                                                                                                                                                                                                          228e1e3f-d207-481f-8e14-9fdcbd0470e9
                                                                                                                                                                                                                                          offset unit
                                                                                                                                                                                                                                          unicode_code_points
                                                                                                                                                                                                                                          source array index
                                                                                                                                                                                                                                          0
                                                                                                                                                                                                                                          source field
                                                                                                                                                                                                                                          indications_and_usage_exact
                                                                                                                                                                                                                                          source text sha256
                                                                                                                                                                                                                                          e526ba14c91f10737e6d3331fe23a6219f58c0eca6380bfce9bd78b573fea912
                                                                                                                                                                                                                                          start
                                                                                                                                                                                                                                          18813
                                                                                                                                                                                                                                          source url
                                                                                                                                                                                                                                          https://api.fda.gov/drug/label.json?search=id%3A%22228e1e3f-d207-481f-8e14-9fdcbd0470e9%22
                                                                                                                                                                                                                                          spl effective date
                                                                                                                                                                                                                                          2026-07-10
                                                                                                                                                                                                                                          spl set id
                                                                                                                                                                                                                                          9333c79b-d487-4538-a9f0-71b91a02b287
                                                                                                                                                                                                                                          spl version
                                                                                                                                                                                                                                          228
                                                                                                                                                                                                                                          structured fields status
                                                                                                                                                                                                                                          not_extracted_no_values_inferred_from_mentions
                                                                                                                                                                                                                                          structured indication
                                                                                                                                                                                                                                          age
                                                                                                                                                                                                                                          Source null
                                                                                                                                                                                                                                          approval pathway
                                                                                                                                                                                                                                          Source null
                                                                                                                                                                                                                                          biomarker and test
                                                                                                                                                                                                                                          Source null
                                                                                                                                                                                                                                          disease stage
                                                                                                                                                                                                                                          Source null
                                                                                                                                                                                                                                          limitations
                                                                                                                                                                                                                                          Source null
                                                                                                                                                                                                                                          line
                                                                                                                                                                                                                                          Source null
                                                                                                                                                                                                                                          prior therapy
                                                                                                                                                                                                                                          Source null
                                                                                                                                                                                                                                          regimen
                                                                                                                                                                                                                                          Source null
                                                                                                                                                                                                                                          tumor histology
                                                                                                                                                                                                                                          Source null
                                                                                                                                                                                                                                          use intent
                                                                                                                                                                                                                                          tumor_directed_candidate
                                                                                                                                                                                                                                          Passage 94 · positive indication candidate
                                                                                                                                                                                                                                          application numbers
                                                                                                                                                                                                                                          1. BLA125514
                                                                                                                                                                                                                                          brand names
                                                                                                                                                                                                                                          1. KEYTRUDA
                                                                                                                                                                                                                                          classification reasons
                                                                                                                                                                                                                                          1. explicit_positive_indication_predicate
                                                                                                                                                                                                                                          2. tumor_or_malignant_hematology_words_in_positive_statement
                                                                                                                                                                                                                                          clinical review status
                                                                                                                                                                                                                                          pending
                                                                                                                                                                                                                                          content role
                                                                                                                                                                                                                                          positive_indication_candidate
                                                                                                                                                                                                                                          context span
                                                                                                                                                                                                                                          end
                                                                                                                                                                                                                                          19651
                                                                                                                                                                                                                                          end exclusive
                                                                                                                                                                                                                                          true
                                                                                                                                                                                                                                          exact text
                                                                                                                                                                                                                                          cancer involving the lower third of the vagina, with or without extension to pelvic sidewall, or hydronephrosis/non-functioning kidney, or spread to adjacent pelvic organs (FIGO 2014 Stage III-IVA). KEYTRUDA, in combination with chemotherapy, with or without bevacizumab, is indicated for the treatment of patients with persistent, recurrent, or metastatic cervical cancer whose tumors express PD-L1 (CPS ≥1) as determined by an FDA-authorized test [see Dosage and Administration (2.1) ]. KEYTRUDA, as a single agent, is indicated for the treatment of patients with recurrent or metastatic cervical cancer with disease progression on or after chemotherapy whose tumors express PD-L1 (CPS
                                                                                                                                                                                                                                          label id
                                                                                                                                                                                                                                          228e1e3f-d207-481f-8e14-9fdcbd0470e9
                                                                                                                                                                                                                                          offset unit
                                                                                                                                                                                                                                          unicode_code_points
                                                                                                                                                                                                                                          source array index
                                                                                                                                                                                                                                          0
                                                                                                                                                                                                                                          source field
                                                                                                                                                                                                                                          indications_and_usage_exact
                                                                                                                                                                                                                                          source text sha256
                                                                                                                                                                                                                                          e526ba14c91f10737e6d3331fe23a6219f58c0eca6380bfce9bd78b573fea912
                                                                                                                                                                                                                                          start
                                                                                                                                                                                                                                          18962
                                                                                                                                                                                                                                          current approval status
                                                                                                                                                                                                                                          not_reconciled
                                                                                                                                                                                                                                          duplicate text group
                                                                                                                                                                                                                                          dup-c5f9043a21d1440d1611
                                                                                                                                                                                                                                          extraction review status
                                                                                                                                                                                                                                          automated_candidate_pending_source_review
                                                                                                                                                                                                                                          generic names
                                                                                                                                                                                                                                          1. PEMBROLIZUMAB
                                                                                                                                                                                                                                          id
                                                                                                                                                                                                                                          ind-span-e0b3147c19afb057c924
                                                                                                                                                                                                                                          label id
                                                                                                                                                                                                                                          228e1e3f-d207-481f-8e14-9fdcbd0470e9
                                                                                                                                                                                                                                          positive predicate support span
                                                                                                                                                                                                                                          end
                                                                                                                                                                                                                                          19247
                                                                                                                                                                                                                                          end exclusive
                                                                                                                                                                                                                                          true
                                                                                                                                                                                                                                          exact text
                                                                                                                                                                                                                                          is indicated
                                                                                                                                                                                                                                          label id
                                                                                                                                                                                                                                          228e1e3f-d207-481f-8e14-9fdcbd0470e9
                                                                                                                                                                                                                                          offset unit
                                                                                                                                                                                                                                          unicode_code_points
                                                                                                                                                                                                                                          source array index
                                                                                                                                                                                                                                          0
                                                                                                                                                                                                                                          source field
                                                                                                                                                                                                                                          indications_and_usage_exact
                                                                                                                                                                                                                                          source text sha256
                                                                                                                                                                                                                                          e526ba14c91f10737e6d3331fe23a6219f58c0eca6380bfce9bd78b573fea912
                                                                                                                                                                                                                                          start
                                                                                                                                                                                                                                          19235
                                                                                                                                                                                                                                          qualifier mentions
                                                                                                                                                                                                                                          1. context exact
                                                                                                                                                                                                                                            or the treatment of patients with persistent, recurrent, or metastatic cervical cancer whose tumors express PD-L1 (CPS ≥1) as determined by an FDA-authorized test
                                                                                                                                                                                                                                            kind
                                                                                                                                                                                                                                            biomarker
                                                                                                                                                                                                                                            polarity
                                                                                                                                                                                                                                            not_inferred
                                                                                                                                                                                                                                            span
                                                                                                                                                                                                                                            end
                                                                                                                                                                                                                                            19352
                                                                                                                                                                                                                                            end exclusive
                                                                                                                                                                                                                                            true
                                                                                                                                                                                                                                            exact text
                                                                                                                                                                                                                                            metastatic cervical cancer whose tumors exp
                                                                                                                                                                                                                                            label id
                                                                                                                                                                                                                                            228e1e3f-d207-481f-8e14-9fdcbd0470e9
                                                                                                                                                                                                                                            offset unit
                                                                                                                                                                                                                                            unicode_code_points
                                                                                                                                                                                                                                            source array index
                                                                                                                                                                                                                                            0
                                                                                                                                                                                                                                            source field
                                                                                                                                                                                                                                            indications_and_usage_exact
                                                                                                                                                                                                                                            source text sha256
                                                                                                                                                                                                                                            e526ba14c91f10737e6d3331fe23a6219f58c0eca6380bfce9bd78b573fea912
                                                                                                                                                                                                                                            start
                                                                                                                                                                                                                                            19309
                                                                                                                                                                                                                                          2. context exact
                                                                                                                                                                                                                                            current, or metastatic cervical cancer whose tumors express PD-L1 (CPS ≥1) as determined by an FDA-authorized test [see Dosage and Administration (2.1) ].
                                                                                                                                                                                                                                            kind
                                                                                                                                                                                                                                            biomarker
                                                                                                                                                                                                                                            polarity
                                                                                                                                                                                                                                            not_inferred
                                                                                                                                                                                                                                            span
                                                                                                                                                                                                                                            end
                                                                                                                                                                                                                                            19402
                                                                                                                                                                                                                                            end exclusive
                                                                                                                                                                                                                                            true
                                                                                                                                                                                                                                            exact text
                                                                                                                                                                                                                                            PD-L1 (CPS ≥1) as determined by an FDA-author
                                                                                                                                                                                                                                            label id
                                                                                                                                                                                                                                            228e1e3f-d207-481f-8e14-9fdcbd0470e9
                                                                                                                                                                                                                                            offset unit
                                                                                                                                                                                                                                            unicode_code_points
                                                                                                                                                                                                                                            source array index
                                                                                                                                                                                                                                            0
                                                                                                                                                                                                                                            source field
                                                                                                                                                                                                                                            indications_and_usage_exact
                                                                                                                                                                                                                                            source text sha256
                                                                                                                                                                                                                                            e526ba14c91f10737e6d3331fe23a6219f58c0eca6380bfce9bd78b573fea912
                                                                                                                                                                                                                                            start
                                                                                                                                                                                                                                            19357
                                                                                                                                                                                                                                          3. context exact
                                                                                                                                                                                                                                            is indicated for the treatment of patients with persistent, recurrent, or metastatic cervical cancer whose tumors express PD-L1 (
                                                                                                                                                                                                                                            kind
                                                                                                                                                                                                                                            stage_or_setting
                                                                                                                                                                                                                                            polarity
                                                                                                                                                                                                                                            not_inferred
                                                                                                                                                                                                                                            span
                                                                                                                                                                                                                                            end
                                                                                                                                                                                                                                            19304
                                                                                                                                                                                                                                            end exclusive
                                                                                                                                                                                                                                            true
                                                                                                                                                                                                                                            exact text
                                                                                                                                                                                                                                            recurrent
                                                                                                                                                                                                                                            label id
                                                                                                                                                                                                                                            228e1e3f-d207-481f-8e14-9fdcbd0470e9
                                                                                                                                                                                                                                            offset unit
                                                                                                                                                                                                                                            unicode_code_points
                                                                                                                                                                                                                                            source array index
                                                                                                                                                                                                                                            0
                                                                                                                                                                                                                                            source field
                                                                                                                                                                                                                                            indications_and_usage_exact
                                                                                                                                                                                                                                            source text sha256
                                                                                                                                                                                                                                            e526ba14c91f10737e6d3331fe23a6219f58c0eca6380bfce9bd78b573fea912
                                                                                                                                                                                                                                            start
                                                                                                                                                                                                                                            19295
                                                                                                                                                                                                                                          4. context exact
                                                                                                                                                                                                                                            or the treatment of patients with persistent, recurrent, or metastatic cervical cancer whose tumors express PD-L1 (CPS ≥1) as determined by an FDA-authorized test [s
                                                                                                                                                                                                                                            kind
                                                                                                                                                                                                                                            stage_or_setting
                                                                                                                                                                                                                                            polarity
                                                                                                                                                                                                                                            not_inferred
                                                                                                                                                                                                                                            span
                                                                                                                                                                                                                                            end
                                                                                                                                                                                                                                            19354
                                                                                                                                                                                                                                            end exclusive
                                                                                                                                                                                                                                            true
                                                                                                                                                                                                                                            exact text
                                                                                                                                                                                                                                            metastatic cervical cancer whose tumors expre
                                                                                                                                                                                                                                            label id
                                                                                                                                                                                                                                            228e1e3f-d207-481f-8e14-9fdcbd0470e9
                                                                                                                                                                                                                                            offset unit
                                                                                                                                                                                                                                            unicode_code_points
                                                                                                                                                                                                                                            source array index
                                                                                                                                                                                                                                            0
                                                                                                                                                                                                                                            source field
                                                                                                                                                                                                                                            indications_and_usage_exact
                                                                                                                                                                                                                                            source text sha256
                                                                                                                                                                                                                                            e526ba14c91f10737e6d3331fe23a6219f58c0eca6380bfce9bd78b573fea912
                                                                                                                                                                                                                                            start
                                                                                                                                                                                                                                            19309
                                                                                                                                                                                                                                          5. context exact
                                                                                                                                                                                                                                            KEYTRUDA, in combination with chemotherapy, with or without bevacizumab, is indicated for the treatment of patients with persistent, recurrent, or metastatic cervical cancer whose tumors express PD-L1 (CPS ≥1) as determined by an FDA-authorized test
                                                                                                                                                                                                                                            kind
                                                                                                                                                                                                                                            regimen
                                                                                                                                                                                                                                            polarity
                                                                                                                                                                                                                                            not_inferred
                                                                                                                                                                                                                                            span
                                                                                                                                                                                                                                            end
                                                                                                                                                                                                                                            19351
                                                                                                                                                                                                                                            end exclusive
                                                                                                                                                                                                                                            true
                                                                                                                                                                                                                                            exact text
                                                                                                                                                                                                                                            in combination with chemotherapy, with or without bevacizumab, is indicated for the treatment of patients with persistent, recurrent, or metastatic cervical cancer whose tumors ex
                                                                                                                                                                                                                                            label id
                                                                                                                                                                                                                                            228e1e3f-d207-481f-8e14-9fdcbd0470e9
                                                                                                                                                                                                                                            offset unit
                                                                                                                                                                                                                                            unicode_code_points
                                                                                                                                                                                                                                            source array index
                                                                                                                                                                                                                                            0
                                                                                                                                                                                                                                            source field
                                                                                                                                                                                                                                            indications_and_usage_exact
                                                                                                                                                                                                                                            source text sha256
                                                                                                                                                                                                                                            e526ba14c91f10737e6d3331fe23a6219f58c0eca6380bfce9bd78b573fea912
                                                                                                                                                                                                                                            start
                                                                                                                                                                                                                                            19172
                                                                                                                                                                                                                                          regulatory links
                                                                                                                                                                                                                                            schema version
                                                                                                                                                                                                                                            0.1.0
                                                                                                                                                                                                                                            source batch sha256
                                                                                                                                                                                                                                            fc39a8c5cf96bf95ca20b85578140167b66b2741f7d9217f500d9ba0847ac058
                                                                                                                                                                                                                                            source defined aliases
                                                                                                                                                                                                                                            1. abbreviation
                                                                                                                                                                                                                                              NSCLC
                                                                                                                                                                                                                                              definition exact
                                                                                                                                                                                                                                              Non-Small Cell Lung Cancer
                                                                                                                                                                                                                                              definition span
                                                                                                                                                                                                                                              end
                                                                                                                                                                                                                                              380
                                                                                                                                                                                                                                              end exclusive
                                                                                                                                                                                                                                              true
                                                                                                                                                                                                                                              exact text
                                                                                                                                                                                                                                              Non-Small Cell Lung Cancer (NSCLC)
                                                                                                                                                                                                                                              label id
                                                                                                                                                                                                                                              228e1e3f-d207-481f-8e14-9fdcbd0470e9
                                                                                                                                                                                                                                              offset unit
                                                                                                                                                                                                                                              unicode_code_points
                                                                                                                                                                                                                                              source array index
                                                                                                                                                                                                                                              0
                                                                                                                                                                                                                                              source field
                                                                                                                                                                                                                                              indications_and_usage_exact
                                                                                                                                                                                                                                              source text sha256
                                                                                                                                                                                                                                              e526ba14c91f10737e6d3331fe23a6219f58c0eca6380bfce9bd78b573fea912
                                                                                                                                                                                                                                              start
                                                                                                                                                                                                                                              346
                                                                                                                                                                                                                                            2. abbreviation
                                                                                                                                                                                                                                              CRC
                                                                                                                                                                                                                                              definition exact
                                                                                                                                                                                                                                              Colorectal Cancer
                                                                                                                                                                                                                                              definition span
                                                                                                                                                                                                                                              end
                                                                                                                                                                                                                                              5042
                                                                                                                                                                                                                                              end exclusive
                                                                                                                                                                                                                                              true
                                                                                                                                                                                                                                              exact text
                                                                                                                                                                                                                                              Colorectal Cancer (CRC)
                                                                                                                                                                                                                                              label id
                                                                                                                                                                                                                                              228e1e3f-d207-481f-8e14-9fdcbd0470e9
                                                                                                                                                                                                                                              offset unit
                                                                                                                                                                                                                                              unicode_code_points
                                                                                                                                                                                                                                              source array index
                                                                                                                                                                                                                                              0
                                                                                                                                                                                                                                              source field
                                                                                                                                                                                                                                              indications_and_usage_exact
                                                                                                                                                                                                                                              source text sha256
                                                                                                                                                                                                                                              e526ba14c91f10737e6d3331fe23a6219f58c0eca6380bfce9bd78b573fea912
                                                                                                                                                                                                                                              start
                                                                                                                                                                                                                                              5019
                                                                                                                                                                                                                                            source span
                                                                                                                                                                                                                                            end
                                                                                                                                                                                                                                            19451
                                                                                                                                                                                                                                            end exclusive
                                                                                                                                                                                                                                            true
                                                                                                                                                                                                                                            exact text
                                                                                                                                                                                                                                            KEYTRUDA, in combination with chemotherapy, with or without bevacizumab, is indicated for the treatment of patients with persistent, recurrent, or metastatic cervical cancer whose tumors express PD-L1 (CPS ≥1) as determined by an FDA-authorized test [see Dosage and Administration (2.1) ].
                                                                                                                                                                                                                                            label id
                                                                                                                                                                                                                                            228e1e3f-d207-481f-8e14-9fdcbd0470e9
                                                                                                                                                                                                                                            offset unit
                                                                                                                                                                                                                                            unicode_code_points
                                                                                                                                                                                                                                            source array index
                                                                                                                                                                                                                                            0
                                                                                                                                                                                                                                            source field
                                                                                                                                                                                                                                            indications_and_usage_exact
                                                                                                                                                                                                                                            source text sha256
                                                                                                                                                                                                                                            e526ba14c91f10737e6d3331fe23a6219f58c0eca6380bfce9bd78b573fea912
                                                                                                                                                                                                                                            start
                                                                                                                                                                                                                                            19162
                                                                                                                                                                                                                                            source url
                                                                                                                                                                                                                                            https://api.fda.gov/drug/label.json?search=id%3A%22228e1e3f-d207-481f-8e14-9fdcbd0470e9%22
                                                                                                                                                                                                                                            spl effective date
                                                                                                                                                                                                                                            2026-07-10
                                                                                                                                                                                                                                            spl set id
                                                                                                                                                                                                                                            9333c79b-d487-4538-a9f0-71b91a02b287
                                                                                                                                                                                                                                            spl version
                                                                                                                                                                                                                                            228
                                                                                                                                                                                                                                            structured fields status
                                                                                                                                                                                                                                            not_extracted_no_values_inferred_from_mentions
                                                                                                                                                                                                                                            structured indication
                                                                                                                                                                                                                                            age
                                                                                                                                                                                                                                            Source null
                                                                                                                                                                                                                                            approval pathway
                                                                                                                                                                                                                                            Source null
                                                                                                                                                                                                                                            biomarker and test
                                                                                                                                                                                                                                            Source null
                                                                                                                                                                                                                                            disease stage
                                                                                                                                                                                                                                            Source null
                                                                                                                                                                                                                                            limitations
                                                                                                                                                                                                                                            Source null
                                                                                                                                                                                                                                            line
                                                                                                                                                                                                                                            Source null
                                                                                                                                                                                                                                            prior therapy
                                                                                                                                                                                                                                            Source null
                                                                                                                                                                                                                                            regimen
                                                                                                                                                                                                                                            Source null
                                                                                                                                                                                                                                            tumor histology
                                                                                                                                                                                                                                            Source null
                                                                                                                                                                                                                                            use intent
                                                                                                                                                                                                                                            tumor_directed_candidate
                                                                                                                                                                                                                                            Passage 95 · positive indication candidate
                                                                                                                                                                                                                                            application numbers
                                                                                                                                                                                                                                            1. BLA125514
                                                                                                                                                                                                                                            brand names
                                                                                                                                                                                                                                            1. KEYTRUDA
                                                                                                                                                                                                                                            classification reasons
                                                                                                                                                                                                                                            1. explicit_positive_indication_predicate
                                                                                                                                                                                                                                            2. tumor_or_malignant_hematology_words_in_positive_statement
                                                                                                                                                                                                                                            clinical review status
                                                                                                                                                                                                                                            pending
                                                                                                                                                                                                                                            content role
                                                                                                                                                                                                                                            positive_indication_candidate
                                                                                                                                                                                                                                            context span
                                                                                                                                                                                                                                            end
                                                                                                                                                                                                                                            19935
                                                                                                                                                                                                                                            end exclusive
                                                                                                                                                                                                                                            true
                                                                                                                                                                                                                                            exact text
                                                                                                                                                                                                                                            the treatment of patients with persistent, recurrent, or metastatic cervical cancer whose tumors express PD-L1 (CPS ≥1) as determined by an FDA-authorized test [see Dosage and Administration (2.1) ]. KEYTRUDA, as a single agent, is indicated for the treatment of patients with recurrent or metastatic cervical cancer with disease progression on or after chemotherapy whose tumors express PD-L1 (CPS ≥1) as determined by an FDA-authorized test [see Dosage and Administration (2.1) ] . 1.13 Hepatocellular Carcinoma KEYTRUDA is indicated for the treatment of patients with hepatocellular carcinoma (HCC) secondary to hepatitis B who have received prior systemic therapy other than a PD
                                                                                                                                                                                                                                            label id
                                                                                                                                                                                                                                            228e1e3f-d207-481f-8e14-9fdcbd0470e9
                                                                                                                                                                                                                                            offset unit
                                                                                                                                                                                                                                            unicode_code_points
                                                                                                                                                                                                                                            source array index
                                                                                                                                                                                                                                            0
                                                                                                                                                                                                                                            source field
                                                                                                                                                                                                                                            indications_and_usage_exact
                                                                                                                                                                                                                                            source text sha256
                                                                                                                                                                                                                                            e526ba14c91f10737e6d3331fe23a6219f58c0eca6380bfce9bd78b573fea912
                                                                                                                                                                                                                                            start
                                                                                                                                                                                                                                            19252
                                                                                                                                                                                                                                            current approval status
                                                                                                                                                                                                                                            not_reconciled
                                                                                                                                                                                                                                            duplicate text group
                                                                                                                                                                                                                                            dup-988d8872e594ac39c408
                                                                                                                                                                                                                                            extraction review status
                                                                                                                                                                                                                                            automated_candidate_pending_source_review
                                                                                                                                                                                                                                            generic names
                                                                                                                                                                                                                                            1. PEMBROLIZUMAB
                                                                                                                                                                                                                                            id
                                                                                                                                                                                                                                            ind-span-3339b23f9c71b06ac083
                                                                                                                                                                                                                                            label id
                                                                                                                                                                                                                                            228e1e3f-d207-481f-8e14-9fdcbd0470e9
                                                                                                                                                                                                                                            positive predicate support span
                                                                                                                                                                                                                                            end
                                                                                                                                                                                                                                            19493
                                                                                                                                                                                                                                            end exclusive
                                                                                                                                                                                                                                            true
                                                                                                                                                                                                                                            exact text
                                                                                                                                                                                                                                            is indicated
                                                                                                                                                                                                                                            label id
                                                                                                                                                                                                                                            228e1e3f-d207-481f-8e14-9fdcbd0470e9
                                                                                                                                                                                                                                            offset unit
                                                                                                                                                                                                                                            unicode_code_points
                                                                                                                                                                                                                                            source array index
                                                                                                                                                                                                                                            0
                                                                                                                                                                                                                                            source field
                                                                                                                                                                                                                                            indications_and_usage_exact
                                                                                                                                                                                                                                            source text sha256
                                                                                                                                                                                                                                            e526ba14c91f10737e6d3331fe23a6219f58c0eca6380bfce9bd78b573fea912
                                                                                                                                                                                                                                            start
                                                                                                                                                                                                                                            19481
                                                                                                                                                                                                                                            qualifier mentions
                                                                                                                                                                                                                                            1. context exact
                                                                                                                                                                                                                                              s indicated for the treatment of patients with recurrent or metastatic cervical cancer with disease progression on or after chemotherapy whose tumors express PD-L1
                                                                                                                                                                                                                                              kind
                                                                                                                                                                                                                                              biomarker
                                                                                                                                                                                                                                              polarity
                                                                                                                                                                                                                                              not_inferred
                                                                                                                                                                                                                                              span
                                                                                                                                                                                                                                              end
                                                                                                                                                                                                                                              19585
                                                                                                                                                                                                                                              end exclusive
                                                                                                                                                                                                                                              true
                                                                                                                                                                                                                                              exact text
                                                                                                                                                                                                                                              metastatic cervical cancer with disease pro
                                                                                                                                                                                                                                              label id
                                                                                                                                                                                                                                              228e1e3f-d207-481f-8e14-9fdcbd0470e9
                                                                                                                                                                                                                                              offset unit
                                                                                                                                                                                                                                              unicode_code_points
                                                                                                                                                                                                                                              source array index
                                                                                                                                                                                                                                              0
                                                                                                                                                                                                                                              source field
                                                                                                                                                                                                                                              indications_and_usage_exact
                                                                                                                                                                                                                                              source text sha256
                                                                                                                                                                                                                                              e526ba14c91f10737e6d3331fe23a6219f58c0eca6380bfce9bd78b573fea912
                                                                                                                                                                                                                                              start
                                                                                                                                                                                                                                              19542
                                                                                                                                                                                                                                            2. context exact
                                                                                                                                                                                                                                              e progression on or after chemotherapy whose tumors express PD-L1 (CPS ≥1) as determined by an FDA-authorized test [see Dosage and Administration (2.1) ] .
                                                                                                                                                                                                                                              kind
                                                                                                                                                                                                                                              biomarker
                                                                                                                                                                                                                                              polarity
                                                                                                                                                                                                                                              not_inferred
                                                                                                                                                                                                                                              span
                                                                                                                                                                                                                                              end
                                                                                                                                                                                                                                              19685
                                                                                                                                                                                                                                              end exclusive
                                                                                                                                                                                                                                              true
                                                                                                                                                                                                                                              exact text
                                                                                                                                                                                                                                              PD-L1 (CPS ≥1) as determined by an FDA-author
                                                                                                                                                                                                                                              label id
                                                                                                                                                                                                                                              228e1e3f-d207-481f-8e14-9fdcbd0470e9
                                                                                                                                                                                                                                              offset unit
                                                                                                                                                                                                                                              unicode_code_points
                                                                                                                                                                                                                                              source array index
                                                                                                                                                                                                                                              0
                                                                                                                                                                                                                                              source field
                                                                                                                                                                                                                                              indications_and_usage_exact
                                                                                                                                                                                                                                              source text sha256
                                                                                                                                                                                                                                              e526ba14c91f10737e6d3331fe23a6219f58c0eca6380bfce9bd78b573fea912
                                                                                                                                                                                                                                              start
                                                                                                                                                                                                                                              19640
                                                                                                                                                                                                                                            3. context exact
                                                                                                                                                                                                                                              ngle agent, is indicated for the treatment of patients with recurrent or metastatic cervical cancer with disease progression on or after chemotherapy whose tumors e
                                                                                                                                                                                                                                              kind
                                                                                                                                                                                                                                              stage_or_setting
                                                                                                                                                                                                                                              polarity
                                                                                                                                                                                                                                              not_inferred
                                                                                                                                                                                                                                              span
                                                                                                                                                                                                                                              end
                                                                                                                                                                                                                                              19573
                                                                                                                                                                                                                                              end exclusive
                                                                                                                                                                                                                                              true
                                                                                                                                                                                                                                              exact text
                                                                                                                                                                                                                                              recurrent or metastatic cervical cancer with
                                                                                                                                                                                                                                              label id
                                                                                                                                                                                                                                              228e1e3f-d207-481f-8e14-9fdcbd0470e9
                                                                                                                                                                                                                                              offset unit
                                                                                                                                                                                                                                              unicode_code_points
                                                                                                                                                                                                                                              source array index
                                                                                                                                                                                                                                              0
                                                                                                                                                                                                                                              source field
                                                                                                                                                                                                                                              indications_and_usage_exact
                                                                                                                                                                                                                                              source text sha256
                                                                                                                                                                                                                                              e526ba14c91f10737e6d3331fe23a6219f58c0eca6380bfce9bd78b573fea912
                                                                                                                                                                                                                                              start
                                                                                                                                                                                                                                              19529
                                                                                                                                                                                                                                            4. context exact
                                                                                                                                                                                                                                              KEYTRUDA, as a single agent, is indicated for the treatment of patients with recurrent or metastatic cervical cancer with disease progression on or after chemotherapy whose tumors express PD-L1 (CPS ≥1) as determined by an FDA-authorized test [see
                                                                                                                                                                                                                                              kind
                                                                                                                                                                                                                                              regimen
                                                                                                                                                                                                                                              polarity
                                                                                                                                                                                                                                              not_inferred
                                                                                                                                                                                                                                              span
                                                                                                                                                                                                                                              end
                                                                                                                                                                                                                                              19639
                                                                                                                                                                                                                                              end exclusive
                                                                                                                                                                                                                                              true
                                                                                                                                                                                                                                              exact text
                                                                                                                                                                                                                                              as a single agent, is indicated for the treatment of patients with recurrent or metastatic cervical cancer with disease progression on or after chemotherapy whose tumors express
                                                                                                                                                                                                                                              label id
                                                                                                                                                                                                                                              228e1e3f-d207-481f-8e14-9fdcbd0470e9
                                                                                                                                                                                                                                              offset unit
                                                                                                                                                                                                                                              unicode_code_points
                                                                                                                                                                                                                                              source array index
                                                                                                                                                                                                                                              0
                                                                                                                                                                                                                                              source field
                                                                                                                                                                                                                                              indications_and_usage_exact
                                                                                                                                                                                                                                              source text sha256
                                                                                                                                                                                                                                              e526ba14c91f10737e6d3331fe23a6219f58c0eca6380bfce9bd78b573fea912
                                                                                                                                                                                                                                              start
                                                                                                                                                                                                                                              19462
                                                                                                                                                                                                                                            regulatory links
                                                                                                                                                                                                                                              schema version
                                                                                                                                                                                                                                              0.1.0
                                                                                                                                                                                                                                              source batch sha256
                                                                                                                                                                                                                                              fc39a8c5cf96bf95ca20b85578140167b66b2741f7d9217f500d9ba0847ac058
                                                                                                                                                                                                                                              source defined aliases
                                                                                                                                                                                                                                              1. abbreviation
                                                                                                                                                                                                                                                NSCLC
                                                                                                                                                                                                                                                definition exact
                                                                                                                                                                                                                                                Non-Small Cell Lung Cancer
                                                                                                                                                                                                                                                definition span
                                                                                                                                                                                                                                                end
                                                                                                                                                                                                                                                380
                                                                                                                                                                                                                                                end exclusive
                                                                                                                                                                                                                                                true
                                                                                                                                                                                                                                                exact text
                                                                                                                                                                                                                                                Non-Small Cell Lung Cancer (NSCLC)
                                                                                                                                                                                                                                                label id
                                                                                                                                                                                                                                                228e1e3f-d207-481f-8e14-9fdcbd0470e9
                                                                                                                                                                                                                                                offset unit
                                                                                                                                                                                                                                                unicode_code_points
                                                                                                                                                                                                                                                source array index
                                                                                                                                                                                                                                                0
                                                                                                                                                                                                                                                source field
                                                                                                                                                                                                                                                indications_and_usage_exact
                                                                                                                                                                                                                                                source text sha256
                                                                                                                                                                                                                                                e526ba14c91f10737e6d3331fe23a6219f58c0eca6380bfce9bd78b573fea912
                                                                                                                                                                                                                                                start
                                                                                                                                                                                                                                                346
                                                                                                                                                                                                                                              2. abbreviation
                                                                                                                                                                                                                                                CRC
                                                                                                                                                                                                                                                definition exact
                                                                                                                                                                                                                                                Colorectal Cancer
                                                                                                                                                                                                                                                definition span
                                                                                                                                                                                                                                                end
                                                                                                                                                                                                                                                5042
                                                                                                                                                                                                                                                end exclusive
                                                                                                                                                                                                                                                true
                                                                                                                                                                                                                                                exact text
                                                                                                                                                                                                                                                Colorectal Cancer (CRC)
                                                                                                                                                                                                                                                label id
                                                                                                                                                                                                                                                228e1e3f-d207-481f-8e14-9fdcbd0470e9
                                                                                                                                                                                                                                                offset unit
                                                                                                                                                                                                                                                unicode_code_points
                                                                                                                                                                                                                                                source array index
                                                                                                                                                                                                                                                0
                                                                                                                                                                                                                                                source field
                                                                                                                                                                                                                                                indications_and_usage_exact
                                                                                                                                                                                                                                                source text sha256
                                                                                                                                                                                                                                                e526ba14c91f10737e6d3331fe23a6219f58c0eca6380bfce9bd78b573fea912
                                                                                                                                                                                                                                                start
                                                                                                                                                                                                                                                5019
                                                                                                                                                                                                                                              source span
                                                                                                                                                                                                                                              end
                                                                                                                                                                                                                                              19735
                                                                                                                                                                                                                                              end exclusive
                                                                                                                                                                                                                                              true
                                                                                                                                                                                                                                              exact text
                                                                                                                                                                                                                                              KEYTRUDA, as a single agent, is indicated for the treatment of patients with recurrent or metastatic cervical cancer with disease progression on or after chemotherapy whose tumors express PD-L1 (CPS ≥1) as determined by an FDA-authorized test [see Dosage and Administration (2.1) ] .
                                                                                                                                                                                                                                              label id
                                                                                                                                                                                                                                              228e1e3f-d207-481f-8e14-9fdcbd0470e9
                                                                                                                                                                                                                                              offset unit
                                                                                                                                                                                                                                              unicode_code_points
                                                                                                                                                                                                                                              source array index
                                                                                                                                                                                                                                              0
                                                                                                                                                                                                                                              source field
                                                                                                                                                                                                                                              indications_and_usage_exact
                                                                                                                                                                                                                                              source text sha256
                                                                                                                                                                                                                                              e526ba14c91f10737e6d3331fe23a6219f58c0eca6380bfce9bd78b573fea912
                                                                                                                                                                                                                                              start
                                                                                                                                                                                                                                              19452
                                                                                                                                                                                                                                              source url
                                                                                                                                                                                                                                              https://api.fda.gov/drug/label.json?search=id%3A%22228e1e3f-d207-481f-8e14-9fdcbd0470e9%22
                                                                                                                                                                                                                                              spl effective date
                                                                                                                                                                                                                                              2026-07-10
                                                                                                                                                                                                                                              spl set id
                                                                                                                                                                                                                                              9333c79b-d487-4538-a9f0-71b91a02b287
                                                                                                                                                                                                                                              spl version
                                                                                                                                                                                                                                              228
                                                                                                                                                                                                                                              structured fields status
                                                                                                                                                                                                                                              not_extracted_no_values_inferred_from_mentions
                                                                                                                                                                                                                                              structured indication
                                                                                                                                                                                                                                              age
                                                                                                                                                                                                                                              Source null
                                                                                                                                                                                                                                              approval pathway
                                                                                                                                                                                                                                              Source null
                                                                                                                                                                                                                                              biomarker and test
                                                                                                                                                                                                                                              Source null
                                                                                                                                                                                                                                              disease stage
                                                                                                                                                                                                                                              Source null
                                                                                                                                                                                                                                              limitations
                                                                                                                                                                                                                                              Source null
                                                                                                                                                                                                                                              line
                                                                                                                                                                                                                                              Source null
                                                                                                                                                                                                                                              prior therapy
                                                                                                                                                                                                                                              Source null
                                                                                                                                                                                                                                              regimen
                                                                                                                                                                                                                                              Source null
                                                                                                                                                                                                                                              tumor histology
                                                                                                                                                                                                                                              Source null
                                                                                                                                                                                                                                              use intent
                                                                                                                                                                                                                                              tumor_directed_candidate
                                                                                                                                                                                                                                              Passage 96 · positive indication candidate
                                                                                                                                                                                                                                              application numbers
                                                                                                                                                                                                                                              1. BLA125514
                                                                                                                                                                                                                                              brand names
                                                                                                                                                                                                                                              1. KEYTRUDA
                                                                                                                                                                                                                                              classification reasons
                                                                                                                                                                                                                                              1. explicit_positive_indication_predicate
                                                                                                                                                                                                                                              2. tumor_or_malignant_hematology_words_in_positive_statement
                                                                                                                                                                                                                                              clinical review status
                                                                                                                                                                                                                                              pending
                                                                                                                                                                                                                                              content role
                                                                                                                                                                                                                                              positive_indication_candidate
                                                                                                                                                                                                                                              context span
                                                                                                                                                                                                                                              end
                                                                                                                                                                                                                                              20163
                                                                                                                                                                                                                                              end exclusive
                                                                                                                                                                                                                                              true
                                                                                                                                                                                                                                              exact text
                                                                                                                                                                                                                                              nt or metastatic cervical cancer with disease progression on or after chemotherapy whose tumors express PD-L1 (CPS ≥1) as determined by an FDA-authorized test [see Dosage and Administration (2.1) ] . 1.13 Hepatocellular Carcinoma KEYTRUDA is indicated for the treatment of patients with hepatocellular carcinoma (HCC) secondary to hepatitis B who have received prior systemic therapy other than a PD-1/PD-L1-containing regimen. 1.14 Biliary Tract Cancer KEYTRUDA, in combination with gemcitabine and cisplatin, is indicated for the treatment of patients with locally advanced unresectable or metastatic biliary tract cancer (BT
                                                                                                                                                                                                                                              label id
                                                                                                                                                                                                                                              228e1e3f-d207-481f-8e14-9fdcbd0470e9
                                                                                                                                                                                                                                              offset unit
                                                                                                                                                                                                                                              unicode_code_points
                                                                                                                                                                                                                                              source array index
                                                                                                                                                                                                                                              0
                                                                                                                                                                                                                                              source field
                                                                                                                                                                                                                                              indications_and_usage_exact
                                                                                                                                                                                                                                              source text sha256
                                                                                                                                                                                                                                              e526ba14c91f10737e6d3331fe23a6219f58c0eca6380bfce9bd78b573fea912
                                                                                                                                                                                                                                              start
                                                                                                                                                                                                                                              19536
                                                                                                                                                                                                                                              current approval status
                                                                                                                                                                                                                                              not_reconciled
                                                                                                                                                                                                                                              duplicate text group
                                                                                                                                                                                                                                              dup-4b5ba8a55a3c6e4397d8
                                                                                                                                                                                                                                              extraction review status
                                                                                                                                                                                                                                              automated_candidate_pending_source_review
                                                                                                                                                                                                                                              generic names
                                                                                                                                                                                                                                              1. PEMBROLIZUMAB
                                                                                                                                                                                                                                              id
                                                                                                                                                                                                                                              ind-span-f69d1804cc4f2697beb4
                                                                                                                                                                                                                                              label id
                                                                                                                                                                                                                                              228e1e3f-d207-481f-8e14-9fdcbd0470e9
                                                                                                                                                                                                                                              positive predicate support span
                                                                                                                                                                                                                                              end
                                                                                                                                                                                                                                              19787
                                                                                                                                                                                                                                              end exclusive
                                                                                                                                                                                                                                              true
                                                                                                                                                                                                                                              exact text
                                                                                                                                                                                                                                              is indicated
                                                                                                                                                                                                                                              label id
                                                                                                                                                                                                                                              228e1e3f-d207-481f-8e14-9fdcbd0470e9
                                                                                                                                                                                                                                              offset unit
                                                                                                                                                                                                                                              unicode_code_points
                                                                                                                                                                                                                                              source array index
                                                                                                                                                                                                                                              0
                                                                                                                                                                                                                                              source field
                                                                                                                                                                                                                                              indications_and_usage_exact
                                                                                                                                                                                                                                              source text sha256
                                                                                                                                                                                                                                              e526ba14c91f10737e6d3331fe23a6219f58c0eca6380bfce9bd78b573fea912
                                                                                                                                                                                                                                              start
                                                                                                                                                                                                                                              19775
                                                                                                                                                                                                                                              qualifier mentions
                                                                                                                                                                                                                                              1. context exact
                                                                                                                                                                                                                                                who have received prior systemic therapy other than a PD-1/PD-L1-containing regimen.
                                                                                                                                                                                                                                                kind
                                                                                                                                                                                                                                                biomarker
                                                                                                                                                                                                                                                polarity
                                                                                                                                                                                                                                                not_inferred
                                                                                                                                                                                                                                                span
                                                                                                                                                                                                                                                end
                                                                                                                                                                                                                                                19962
                                                                                                                                                                                                                                                end exclusive
                                                                                                                                                                                                                                                true
                                                                                                                                                                                                                                                exact text
                                                                                                                                                                                                                                                PD-L1-containing regimen
                                                                                                                                                                                                                                                label id
                                                                                                                                                                                                                                                228e1e3f-d207-481f-8e14-9fdcbd0470e9
                                                                                                                                                                                                                                                offset unit
                                                                                                                                                                                                                                                unicode_code_points
                                                                                                                                                                                                                                                source array index
                                                                                                                                                                                                                                                0
                                                                                                                                                                                                                                                source field
                                                                                                                                                                                                                                                indications_and_usage_exact
                                                                                                                                                                                                                                                source text sha256
                                                                                                                                                                                                                                                e526ba14c91f10737e6d3331fe23a6219f58c0eca6380bfce9bd78b573fea912
                                                                                                                                                                                                                                                start
                                                                                                                                                                                                                                                19938
                                                                                                                                                                                                                                              2. context exact
                                                                                                                                                                                                                                                ith hepatocellular carcinoma (HCC) secondary to hepatitis B who have received prior systemic therapy other than a PD-1/PD-L1-containing regimen.
                                                                                                                                                                                                                                                kind
                                                                                                                                                                                                                                                prior_therapy_or_line
                                                                                                                                                                                                                                                polarity
                                                                                                                                                                                                                                                not_inferred
                                                                                                                                                                                                                                                span
                                                                                                                                                                                                                                                end
                                                                                                                                                                                                                                                19962
                                                                                                                                                                                                                                                end exclusive
                                                                                                                                                                                                                                                true
                                                                                                                                                                                                                                                exact text
                                                                                                                                                                                                                                                who have received prior systemic therapy other than a PD-1/PD-L1-containing regimen
                                                                                                                                                                                                                                                label id
                                                                                                                                                                                                                                                228e1e3f-d207-481f-8e14-9fdcbd0470e9
                                                                                                                                                                                                                                                offset unit
                                                                                                                                                                                                                                                unicode_code_points
                                                                                                                                                                                                                                                source array index
                                                                                                                                                                                                                                                0
                                                                                                                                                                                                                                                source field
                                                                                                                                                                                                                                                indications_and_usage_exact
                                                                                                                                                                                                                                                source text sha256
                                                                                                                                                                                                                                                e526ba14c91f10737e6d3331fe23a6219f58c0eca6380bfce9bd78b573fea912
                                                                                                                                                                                                                                                start
                                                                                                                                                                                                                                                19879
                                                                                                                                                                                                                                              regulatory links
                                                                                                                                                                                                                                                schema version
                                                                                                                                                                                                                                                0.1.0
                                                                                                                                                                                                                                                source batch sha256
                                                                                                                                                                                                                                                fc39a8c5cf96bf95ca20b85578140167b66b2741f7d9217f500d9ba0847ac058
                                                                                                                                                                                                                                                source defined aliases
                                                                                                                                                                                                                                                1. abbreviation
                                                                                                                                                                                                                                                  NSCLC
                                                                                                                                                                                                                                                  definition exact
                                                                                                                                                                                                                                                  Non-Small Cell Lung Cancer
                                                                                                                                                                                                                                                  definition span
                                                                                                                                                                                                                                                  end
                                                                                                                                                                                                                                                  380
                                                                                                                                                                                                                                                  end exclusive
                                                                                                                                                                                                                                                  true
                                                                                                                                                                                                                                                  exact text
                                                                                                                                                                                                                                                  Non-Small Cell Lung Cancer (NSCLC)
                                                                                                                                                                                                                                                  label id
                                                                                                                                                                                                                                                  228e1e3f-d207-481f-8e14-9fdcbd0470e9
                                                                                                                                                                                                                                                  offset unit
                                                                                                                                                                                                                                                  unicode_code_points
                                                                                                                                                                                                                                                  source array index
                                                                                                                                                                                                                                                  0
                                                                                                                                                                                                                                                  source field
                                                                                                                                                                                                                                                  indications_and_usage_exact
                                                                                                                                                                                                                                                  source text sha256
                                                                                                                                                                                                                                                  e526ba14c91f10737e6d3331fe23a6219f58c0eca6380bfce9bd78b573fea912
                                                                                                                                                                                                                                                  start
                                                                                                                                                                                                                                                  346
                                                                                                                                                                                                                                                2. abbreviation
                                                                                                                                                                                                                                                  CRC
                                                                                                                                                                                                                                                  definition exact
                                                                                                                                                                                                                                                  Colorectal Cancer
                                                                                                                                                                                                                                                  definition span
                                                                                                                                                                                                                                                  end
                                                                                                                                                                                                                                                  5042
                                                                                                                                                                                                                                                  end exclusive
                                                                                                                                                                                                                                                  true
                                                                                                                                                                                                                                                  exact text
                                                                                                                                                                                                                                                  Colorectal Cancer (CRC)
                                                                                                                                                                                                                                                  label id
                                                                                                                                                                                                                                                  228e1e3f-d207-481f-8e14-9fdcbd0470e9
                                                                                                                                                                                                                                                  offset unit
                                                                                                                                                                                                                                                  unicode_code_points
                                                                                                                                                                                                                                                  source array index
                                                                                                                                                                                                                                                  0
                                                                                                                                                                                                                                                  source field
                                                                                                                                                                                                                                                  indications_and_usage_exact
                                                                                                                                                                                                                                                  source text sha256
                                                                                                                                                                                                                                                  e526ba14c91f10737e6d3331fe23a6219f58c0eca6380bfce9bd78b573fea912
                                                                                                                                                                                                                                                  start
                                                                                                                                                                                                                                                  5019
                                                                                                                                                                                                                                                source span
                                                                                                                                                                                                                                                end
                                                                                                                                                                                                                                                19963
                                                                                                                                                                                                                                                end exclusive
                                                                                                                                                                                                                                                true
                                                                                                                                                                                                                                                exact text
                                                                                                                                                                                                                                                1.13 Hepatocellular Carcinoma KEYTRUDA is indicated for the treatment of patients with hepatocellular carcinoma (HCC) secondary to hepatitis B who have received prior systemic therapy other than a PD-1/PD-L1-containing regimen.
                                                                                                                                                                                                                                                label id
                                                                                                                                                                                                                                                228e1e3f-d207-481f-8e14-9fdcbd0470e9
                                                                                                                                                                                                                                                offset unit
                                                                                                                                                                                                                                                unicode_code_points
                                                                                                                                                                                                                                                source array index
                                                                                                                                                                                                                                                0
                                                                                                                                                                                                                                                source field
                                                                                                                                                                                                                                                indications_and_usage_exact
                                                                                                                                                                                                                                                source text sha256
                                                                                                                                                                                                                                                e526ba14c91f10737e6d3331fe23a6219f58c0eca6380bfce9bd78b573fea912
                                                                                                                                                                                                                                                start
                                                                                                                                                                                                                                                19736
                                                                                                                                                                                                                                                source url
                                                                                                                                                                                                                                                https://api.fda.gov/drug/label.json?search=id%3A%22228e1e3f-d207-481f-8e14-9fdcbd0470e9%22
                                                                                                                                                                                                                                                spl effective date
                                                                                                                                                                                                                                                2026-07-10
                                                                                                                                                                                                                                                spl set id
                                                                                                                                                                                                                                                9333c79b-d487-4538-a9f0-71b91a02b287
                                                                                                                                                                                                                                                spl version
                                                                                                                                                                                                                                                228
                                                                                                                                                                                                                                                structured fields status
                                                                                                                                                                                                                                                not_extracted_no_values_inferred_from_mentions
                                                                                                                                                                                                                                                structured indication
                                                                                                                                                                                                                                                age
                                                                                                                                                                                                                                                Source null
                                                                                                                                                                                                                                                approval pathway
                                                                                                                                                                                                                                                Source null
                                                                                                                                                                                                                                                biomarker and test
                                                                                                                                                                                                                                                Source null
                                                                                                                                                                                                                                                disease stage
                                                                                                                                                                                                                                                Source null
                                                                                                                                                                                                                                                limitations
                                                                                                                                                                                                                                                Source null
                                                                                                                                                                                                                                                line
                                                                                                                                                                                                                                                Source null
                                                                                                                                                                                                                                                prior therapy
                                                                                                                                                                                                                                                Source null
                                                                                                                                                                                                                                                regimen
                                                                                                                                                                                                                                                Source null
                                                                                                                                                                                                                                                tumor histology
                                                                                                                                                                                                                                                Source null
                                                                                                                                                                                                                                                use intent
                                                                                                                                                                                                                                                tumor_directed_candidate
                                                                                                                                                                                                                                                Passage 97 · positive indication candidate
                                                                                                                                                                                                                                                application numbers
                                                                                                                                                                                                                                                1. BLA125514
                                                                                                                                                                                                                                                brand names
                                                                                                                                                                                                                                                1. KEYTRUDA
                                                                                                                                                                                                                                                classification reasons
                                                                                                                                                                                                                                                1. explicit_positive_indication_predicate
                                                                                                                                                                                                                                                2. tumor_or_malignant_hematology_words_in_positive_statement
                                                                                                                                                                                                                                                clinical review status
                                                                                                                                                                                                                                                pending
                                                                                                                                                                                                                                                content role
                                                                                                                                                                                                                                                positive_indication_candidate
                                                                                                                                                                                                                                                context span
                                                                                                                                                                                                                                                end
                                                                                                                                                                                                                                                20366
                                                                                                                                                                                                                                                end exclusive
                                                                                                                                                                                                                                                true
                                                                                                                                                                                                                                                exact text
                                                                                                                                                                                                                                                a KEYTRUDA is indicated for the treatment of patients with hepatocellular carcinoma (HCC) secondary to hepatitis B who have received prior systemic therapy other than a PD-1/PD-L1-containing regimen. 1.14 Biliary Tract Cancer KEYTRUDA, in combination with gemcitabine and cisplatin, is indicated for the treatment of patients with locally advanced unresectable or metastatic biliary tract cancer (BTC). 1.15 Merkel Cell Carcinoma KEYTRUDA is indicated for the treatment of adult and pediatric patients with recurrent locally advanced or metastatic Merkel cell carcinoma (MCC). 1.16 Renal Cell Carcinoma
                                                                                                                                                                                                                                                label id
                                                                                                                                                                                                                                                228e1e3f-d207-481f-8e14-9fdcbd0470e9
                                                                                                                                                                                                                                                offset unit
                                                                                                                                                                                                                                                unicode_code_points
                                                                                                                                                                                                                                                source array index
                                                                                                                                                                                                                                                0
                                                                                                                                                                                                                                                source field
                                                                                                                                                                                                                                                indications_and_usage_exact
                                                                                                                                                                                                                                                source text sha256
                                                                                                                                                                                                                                                e526ba14c91f10737e6d3331fe23a6219f58c0eca6380bfce9bd78b573fea912
                                                                                                                                                                                                                                                start
                                                                                                                                                                                                                                                19764
                                                                                                                                                                                                                                                current approval status
                                                                                                                                                                                                                                                not_reconciled
                                                                                                                                                                                                                                                duplicate text group
                                                                                                                                                                                                                                                dup-13fb179d2341f358f5ce
                                                                                                                                                                                                                                                extraction review status
                                                                                                                                                                                                                                                automated_candidate_pending_source_review
                                                                                                                                                                                                                                                generic names
                                                                                                                                                                                                                                                1. PEMBROLIZUMAB
                                                                                                                                                                                                                                                id
                                                                                                                                                                                                                                                ind-span-1eed40ba30ac04eb756a
                                                                                                                                                                                                                                                label id
                                                                                                                                                                                                                                                228e1e3f-d207-481f-8e14-9fdcbd0470e9
                                                                                                                                                                                                                                                positive predicate support span
                                                                                                                                                                                                                                                end
                                                                                                                                                                                                                                                20059
                                                                                                                                                                                                                                                end exclusive
                                                                                                                                                                                                                                                true
                                                                                                                                                                                                                                                exact text
                                                                                                                                                                                                                                                is indicated
                                                                                                                                                                                                                                                label id
                                                                                                                                                                                                                                                228e1e3f-d207-481f-8e14-9fdcbd0470e9
                                                                                                                                                                                                                                                offset unit
                                                                                                                                                                                                                                                unicode_code_points
                                                                                                                                                                                                                                                source array index
                                                                                                                                                                                                                                                0
                                                                                                                                                                                                                                                source field
                                                                                                                                                                                                                                                indications_and_usage_exact
                                                                                                                                                                                                                                                source text sha256
                                                                                                                                                                                                                                                e526ba14c91f10737e6d3331fe23a6219f58c0eca6380bfce9bd78b573fea912
                                                                                                                                                                                                                                                start
                                                                                                                                                                                                                                                20047
                                                                                                                                                                                                                                                qualifier mentions
                                                                                                                                                                                                                                                1. context exact
                                                                                                                                                                                                                                                  treatment of patients with locally advanced unresectable or metastatic biliary tract cancer (BTC).
                                                                                                                                                                                                                                                  kind
                                                                                                                                                                                                                                                  biomarker
                                                                                                                                                                                                                                                  polarity
                                                                                                                                                                                                                                                  not_inferred
                                                                                                                                                                                                                                                  span
                                                                                                                                                                                                                                                  end
                                                                                                                                                                                                                                                  20165
                                                                                                                                                                                                                                                  end exclusive
                                                                                                                                                                                                                                                  true
                                                                                                                                                                                                                                                  exact text
                                                                                                                                                                                                                                                  metastatic biliary tract cancer (BTC)
                                                                                                                                                                                                                                                  label id
                                                                                                                                                                                                                                                  228e1e3f-d207-481f-8e14-9fdcbd0470e9
                                                                                                                                                                                                                                                  offset unit
                                                                                                                                                                                                                                                  unicode_code_points
                                                                                                                                                                                                                                                  source array index
                                                                                                                                                                                                                                                  0
                                                                                                                                                                                                                                                  source field
                                                                                                                                                                                                                                                  indications_and_usage_exact
                                                                                                                                                                                                                                                  source text sha256
                                                                                                                                                                                                                                                  e526ba14c91f10737e6d3331fe23a6219f58c0eca6380bfce9bd78b573fea912
                                                                                                                                                                                                                                                  start
                                                                                                                                                                                                                                                  20128
                                                                                                                                                                                                                                                2. context exact
                                                                                                                                                                                                                                                  cisplatin, is indicated for the treatment of patients with locally advanced unresectable or metastatic biliary tract cancer (BTC).
                                                                                                                                                                                                                                                  kind
                                                                                                                                                                                                                                                  stage_or_setting
                                                                                                                                                                                                                                                  polarity
                                                                                                                                                                                                                                                  not_inferred
                                                                                                                                                                                                                                                  span
                                                                                                                                                                                                                                                  end
                                                                                                                                                                                                                                                  20146
                                                                                                                                                                                                                                                  end exclusive
                                                                                                                                                                                                                                                  true
                                                                                                                                                                                                                                                  exact text
                                                                                                                                                                                                                                                  locally advanced unresectable or metastatic biliary
                                                                                                                                                                                                                                                  label id
                                                                                                                                                                                                                                                  228e1e3f-d207-481f-8e14-9fdcbd0470e9
                                                                                                                                                                                                                                                  offset unit
                                                                                                                                                                                                                                                  unicode_code_points
                                                                                                                                                                                                                                                  source array index
                                                                                                                                                                                                                                                  0
                                                                                                                                                                                                                                                  source field
                                                                                                                                                                                                                                                  indications_and_usage_exact
                                                                                                                                                                                                                                                  source text sha256
                                                                                                                                                                                                                                                  e526ba14c91f10737e6d3331fe23a6219f58c0eca6380bfce9bd78b573fea912
                                                                                                                                                                                                                                                  start
                                                                                                                                                                                                                                                  20095
                                                                                                                                                                                                                                                3. context exact
                                                                                                                                                                                                                                                  1.14 Biliary Tract Cancer KEYTRUDA, in combination with gemcitabine and cisplatin, is indicated for the treatment of patients with locally advanced unresectable or metastatic biliary tract cancer (BTC).
                                                                                                                                                                                                                                                  kind
                                                                                                                                                                                                                                                  regimen
                                                                                                                                                                                                                                                  polarity
                                                                                                                                                                                                                                                  not_inferred
                                                                                                                                                                                                                                                  span
                                                                                                                                                                                                                                                  end
                                                                                                                                                                                                                                                  20165
                                                                                                                                                                                                                                                  end exclusive
                                                                                                                                                                                                                                                  true
                                                                                                                                                                                                                                                  exact text
                                                                                                                                                                                                                                                  in combination with gemcitabine and cisplatin, is indicated for the treatment of patients with locally advanced unresectable or metastatic biliary tract cancer (BTC)
                                                                                                                                                                                                                                                  label id
                                                                                                                                                                                                                                                  228e1e3f-d207-481f-8e14-9fdcbd0470e9
                                                                                                                                                                                                                                                  offset unit
                                                                                                                                                                                                                                                  unicode_code_points
                                                                                                                                                                                                                                                  source array index
                                                                                                                                                                                                                                                  0
                                                                                                                                                                                                                                                  source field
                                                                                                                                                                                                                                                  indications_and_usage_exact
                                                                                                                                                                                                                                                  source text sha256
                                                                                                                                                                                                                                                  e526ba14c91f10737e6d3331fe23a6219f58c0eca6380bfce9bd78b573fea912
                                                                                                                                                                                                                                                  start
                                                                                                                                                                                                                                                  20000
                                                                                                                                                                                                                                                regulatory links
                                                                                                                                                                                                                                                  schema version
                                                                                                                                                                                                                                                  0.1.0
                                                                                                                                                                                                                                                  source batch sha256
                                                                                                                                                                                                                                                  fc39a8c5cf96bf95ca20b85578140167b66b2741f7d9217f500d9ba0847ac058
                                                                                                                                                                                                                                                  source defined aliases
                                                                                                                                                                                                                                                  1. abbreviation
                                                                                                                                                                                                                                                    NSCLC
                                                                                                                                                                                                                                                    definition exact
                                                                                                                                                                                                                                                    Non-Small Cell Lung Cancer
                                                                                                                                                                                                                                                    definition span
                                                                                                                                                                                                                                                    end
                                                                                                                                                                                                                                                    380
                                                                                                                                                                                                                                                    end exclusive
                                                                                                                                                                                                                                                    true
                                                                                                                                                                                                                                                    exact text
                                                                                                                                                                                                                                                    Non-Small Cell Lung Cancer (NSCLC)
                                                                                                                                                                                                                                                    label id
                                                                                                                                                                                                                                                    228e1e3f-d207-481f-8e14-9fdcbd0470e9
                                                                                                                                                                                                                                                    offset unit
                                                                                                                                                                                                                                                    unicode_code_points
                                                                                                                                                                                                                                                    source array index
                                                                                                                                                                                                                                                    0
                                                                                                                                                                                                                                                    source field
                                                                                                                                                                                                                                                    indications_and_usage_exact
                                                                                                                                                                                                                                                    source text sha256
                                                                                                                                                                                                                                                    e526ba14c91f10737e6d3331fe23a6219f58c0eca6380bfce9bd78b573fea912
                                                                                                                                                                                                                                                    start
                                                                                                                                                                                                                                                    346
                                                                                                                                                                                                                                                  2. abbreviation
                                                                                                                                                                                                                                                    CRC
                                                                                                                                                                                                                                                    definition exact
                                                                                                                                                                                                                                                    Colorectal Cancer
                                                                                                                                                                                                                                                    definition span
                                                                                                                                                                                                                                                    end
                                                                                                                                                                                                                                                    5042
                                                                                                                                                                                                                                                    end exclusive
                                                                                                                                                                                                                                                    true
                                                                                                                                                                                                                                                    exact text
                                                                                                                                                                                                                                                    Colorectal Cancer (CRC)
                                                                                                                                                                                                                                                    label id
                                                                                                                                                                                                                                                    228e1e3f-d207-481f-8e14-9fdcbd0470e9
                                                                                                                                                                                                                                                    offset unit
                                                                                                                                                                                                                                                    unicode_code_points
                                                                                                                                                                                                                                                    source array index
                                                                                                                                                                                                                                                    0
                                                                                                                                                                                                                                                    source field
                                                                                                                                                                                                                                                    indications_and_usage_exact
                                                                                                                                                                                                                                                    source text sha256
                                                                                                                                                                                                                                                    e526ba14c91f10737e6d3331fe23a6219f58c0eca6380bfce9bd78b573fea912
                                                                                                                                                                                                                                                    start
                                                                                                                                                                                                                                                    5019
                                                                                                                                                                                                                                                  source span
                                                                                                                                                                                                                                                  end
                                                                                                                                                                                                                                                  20166
                                                                                                                                                                                                                                                  end exclusive
                                                                                                                                                                                                                                                  true
                                                                                                                                                                                                                                                  exact text
                                                                                                                                                                                                                                                  1.14 Biliary Tract Cancer KEYTRUDA, in combination with gemcitabine and cisplatin, is indicated for the treatment of patients with locally advanced unresectable or metastatic biliary tract cancer (BTC).
                                                                                                                                                                                                                                                  label id
                                                                                                                                                                                                                                                  228e1e3f-d207-481f-8e14-9fdcbd0470e9
                                                                                                                                                                                                                                                  offset unit
                                                                                                                                                                                                                                                  unicode_code_points
                                                                                                                                                                                                                                                  source array index
                                                                                                                                                                                                                                                  0
                                                                                                                                                                                                                                                  source field
                                                                                                                                                                                                                                                  indications_and_usage_exact
                                                                                                                                                                                                                                                  source text sha256
                                                                                                                                                                                                                                                  e526ba14c91f10737e6d3331fe23a6219f58c0eca6380bfce9bd78b573fea912
                                                                                                                                                                                                                                                  start
                                                                                                                                                                                                                                                  19964
                                                                                                                                                                                                                                                  source url
                                                                                                                                                                                                                                                  https://api.fda.gov/drug/label.json?search=id%3A%22228e1e3f-d207-481f-8e14-9fdcbd0470e9%22
                                                                                                                                                                                                                                                  spl effective date
                                                                                                                                                                                                                                                  2026-07-10
                                                                                                                                                                                                                                                  spl set id
                                                                                                                                                                                                                                                  9333c79b-d487-4538-a9f0-71b91a02b287
                                                                                                                                                                                                                                                  spl version
                                                                                                                                                                                                                                                  228
                                                                                                                                                                                                                                                  structured fields status
                                                                                                                                                                                                                                                  not_extracted_no_values_inferred_from_mentions
                                                                                                                                                                                                                                                  structured indication
                                                                                                                                                                                                                                                  age
                                                                                                                                                                                                                                                  Source null
                                                                                                                                                                                                                                                  approval pathway
                                                                                                                                                                                                                                                  Source null
                                                                                                                                                                                                                                                  biomarker and test
                                                                                                                                                                                                                                                  Source null
                                                                                                                                                                                                                                                  disease stage
                                                                                                                                                                                                                                                  Source null
                                                                                                                                                                                                                                                  limitations
                                                                                                                                                                                                                                                  Source null
                                                                                                                                                                                                                                                  line
                                                                                                                                                                                                                                                  Source null
                                                                                                                                                                                                                                                  prior therapy
                                                                                                                                                                                                                                                  Source null
                                                                                                                                                                                                                                                  regimen
                                                                                                                                                                                                                                                  Source null
                                                                                                                                                                                                                                                  tumor histology
                                                                                                                                                                                                                                                  Source null
                                                                                                                                                                                                                                                  use intent
                                                                                                                                                                                                                                                  tumor_directed_candidate
                                                                                                                                                                                                                                                  Passage 98 · positive indication candidate
                                                                                                                                                                                                                                                  application numbers
                                                                                                                                                                                                                                                  1. BLA125514
                                                                                                                                                                                                                                                  brand names
                                                                                                                                                                                                                                                  1. KEYTRUDA
                                                                                                                                                                                                                                                  classification reasons
                                                                                                                                                                                                                                                  1. explicit_positive_indication_predicate
                                                                                                                                                                                                                                                  2. tumor_or_malignant_hematology_words_in_positive_statement
                                                                                                                                                                                                                                                  clinical review status
                                                                                                                                                                                                                                                  pending
                                                                                                                                                                                                                                                  content role
                                                                                                                                                                                                                                                  positive_indication_candidate
                                                                                                                                                                                                                                                  context span
                                                                                                                                                                                                                                                  end
                                                                                                                                                                                                                                                  20540
                                                                                                                                                                                                                                                  end exclusive
                                                                                                                                                                                                                                                  true
                                                                                                                                                                                                                                                  exact text
                                                                                                                                                                                                                                                  4 Biliary Tract Cancer KEYTRUDA, in combination with gemcitabine and cisplatin, is indicated for the treatment of patients with locally advanced unresectable or metastatic biliary tract cancer (BTC). 1.15 Merkel Cell Carcinoma KEYTRUDA is indicated for the treatment of adult and pediatric patients with recurrent locally advanced or metastatic Merkel cell carcinoma (MCC). 1.16 Renal Cell Carcinoma KEYTRUDA, in combination with axitinib, is indicated for the first-line treatment of adult patients with advanced renal cell carcinoma (RCC). KEYTRUDA, in combination with l
                                                                                                                                                                                                                                                  label id
                                                                                                                                                                                                                                                  228e1e3f-d207-481f-8e14-9fdcbd0470e9
                                                                                                                                                                                                                                                  offset unit
                                                                                                                                                                                                                                                  unicode_code_points
                                                                                                                                                                                                                                                  source array index
                                                                                                                                                                                                                                                  0
                                                                                                                                                                                                                                                  source field
                                                                                                                                                                                                                                                  indications_and_usage_exact
                                                                                                                                                                                                                                                  source text sha256
                                                                                                                                                                                                                                                  e526ba14c91f10737e6d3331fe23a6219f58c0eca6380bfce9bd78b573fea912
                                                                                                                                                                                                                                                  start
                                                                                                                                                                                                                                                  19967
                                                                                                                                                                                                                                                  current approval status
                                                                                                                                                                                                                                                  not_reconciled
                                                                                                                                                                                                                                                  duplicate text group
                                                                                                                                                                                                                                                  dup-f418b553eac0b5d4de41
                                                                                                                                                                                                                                                  extraction review status
                                                                                                                                                                                                                                                  automated_candidate_pending_source_review
                                                                                                                                                                                                                                                  generic names
                                                                                                                                                                                                                                                  1. PEMBROLIZUMAB
                                                                                                                                                                                                                                                  id
                                                                                                                                                                                                                                                  ind-span-a5b36c3967a059b3b4ba
                                                                                                                                                                                                                                                  label id
                                                                                                                                                                                                                                                  228e1e3f-d207-481f-8e14-9fdcbd0470e9
                                                                                                                                                                                                                                                  positive predicate support span
                                                                                                                                                                                                                                                  end
                                                                                                                                                                                                                                                  20215
                                                                                                                                                                                                                                                  end exclusive
                                                                                                                                                                                                                                                  true
                                                                                                                                                                                                                                                  exact text
                                                                                                                                                                                                                                                  is indicated
                                                                                                                                                                                                                                                  label id
                                                                                                                                                                                                                                                  228e1e3f-d207-481f-8e14-9fdcbd0470e9
                                                                                                                                                                                                                                                  offset unit
                                                                                                                                                                                                                                                  unicode_code_points
                                                                                                                                                                                                                                                  source array index
                                                                                                                                                                                                                                                  0
                                                                                                                                                                                                                                                  source field
                                                                                                                                                                                                                                                  indications_and_usage_exact
                                                                                                                                                                                                                                                  source text sha256
                                                                                                                                                                                                                                                  e526ba14c91f10737e6d3331fe23a6219f58c0eca6380bfce9bd78b573fea912
                                                                                                                                                                                                                                                  start
                                                                                                                                                                                                                                                  20203
                                                                                                                                                                                                                                                  qualifier mentions
                                                                                                                                                                                                                                                  1. context exact
                                                                                                                                                                                                                                                    l Cell Carcinoma KEYTRUDA is indicated for the treatment of adult and pediatric patients with recurrent locally advanced or m
                                                                                                                                                                                                                                                    kind
                                                                                                                                                                                                                                                    age
                                                                                                                                                                                                                                                    polarity
                                                                                                                                                                                                                                                    not_inferred
                                                                                                                                                                                                                                                    span
                                                                                                                                                                                                                                                    end
                                                                                                                                                                                                                                                    20242
                                                                                                                                                                                                                                                    end exclusive
                                                                                                                                                                                                                                                    true
                                                                                                                                                                                                                                                    exact text
                                                                                                                                                                                                                                                    adult
                                                                                                                                                                                                                                                    label id
                                                                                                                                                                                                                                                    228e1e3f-d207-481f-8e14-9fdcbd0470e9
                                                                                                                                                                                                                                                    offset unit
                                                                                                                                                                                                                                                    unicode_code_points
                                                                                                                                                                                                                                                    source array index
                                                                                                                                                                                                                                                    0
                                                                                                                                                                                                                                                    source field
                                                                                                                                                                                                                                                    indications_and_usage_exact
                                                                                                                                                                                                                                                    source text sha256
                                                                                                                                                                                                                                                    e526ba14c91f10737e6d3331fe23a6219f58c0eca6380bfce9bd78b573fea912
                                                                                                                                                                                                                                                    start
                                                                                                                                                                                                                                                    20237
                                                                                                                                                                                                                                                  2. context exact
                                                                                                                                                                                                                                                    cinoma KEYTRUDA is indicated for the treatment of adult and pediatric patients with recurrent locally advanced or metastatic Merkel cell c
                                                                                                                                                                                                                                                    kind
                                                                                                                                                                                                                                                    age
                                                                                                                                                                                                                                                    polarity
                                                                                                                                                                                                                                                    not_inferred
                                                                                                                                                                                                                                                    span
                                                                                                                                                                                                                                                    end
                                                                                                                                                                                                                                                    20265
                                                                                                                                                                                                                                                    end exclusive
                                                                                                                                                                                                                                                    true
                                                                                                                                                                                                                                                    exact text
                                                                                                                                                                                                                                                    pediatric patients
                                                                                                                                                                                                                                                    label id
                                                                                                                                                                                                                                                    228e1e3f-d207-481f-8e14-9fdcbd0470e9
                                                                                                                                                                                                                                                    offset unit
                                                                                                                                                                                                                                                    unicode_code_points
                                                                                                                                                                                                                                                    source array index
                                                                                                                                                                                                                                                    0
                                                                                                                                                                                                                                                    source field
                                                                                                                                                                                                                                                    indications_and_usage_exact
                                                                                                                                                                                                                                                    source text sha256
                                                                                                                                                                                                                                                    e526ba14c91f10737e6d3331fe23a6219f58c0eca6380bfce9bd78b573fea912
                                                                                                                                                                                                                                                    start
                                                                                                                                                                                                                                                    20247
                                                                                                                                                                                                                                                  3. context exact
                                                                                                                                                                                                                                                    t and pediatric patients with recurrent locally advanced or metastatic Merkel cell carcinoma (MCC).
                                                                                                                                                                                                                                                    kind
                                                                                                                                                                                                                                                    biomarker
                                                                                                                                                                                                                                                    polarity
                                                                                                                                                                                                                                                    not_inferred
                                                                                                                                                                                                                                                    span
                                                                                                                                                                                                                                                    end
                                                                                                                                                                                                                                                    20339
                                                                                                                                                                                                                                                    end exclusive
                                                                                                                                                                                                                                                    true
                                                                                                                                                                                                                                                    exact text
                                                                                                                                                                                                                                                    metastatic Merkel cell carcinoma (MCC)
                                                                                                                                                                                                                                                    label id
                                                                                                                                                                                                                                                    228e1e3f-d207-481f-8e14-9fdcbd0470e9
                                                                                                                                                                                                                                                    offset unit
                                                                                                                                                                                                                                                    unicode_code_points
                                                                                                                                                                                                                                                    source array index
                                                                                                                                                                                                                                                    0
                                                                                                                                                                                                                                                    source field
                                                                                                                                                                                                                                                    indications_and_usage_exact
                                                                                                                                                                                                                                                    source text sha256
                                                                                                                                                                                                                                                    e526ba14c91f10737e6d3331fe23a6219f58c0eca6380bfce9bd78b573fea912
                                                                                                                                                                                                                                                    start
                                                                                                                                                                                                                                                    20301
                                                                                                                                                                                                                                                  4. context exact
                                                                                                                                                                                                                                                    ated for the treatment of adult and pediatric patients with recurrent locally advanced or metastatic Merkel cell carcinoma (MCC).
                                                                                                                                                                                                                                                    kind
                                                                                                                                                                                                                                                    stage_or_setting
                                                                                                                                                                                                                                                    polarity
                                                                                                                                                                                                                                                    not_inferred
                                                                                                                                                                                                                                                    span
                                                                                                                                                                                                                                                    end
                                                                                                                                                                                                                                                    20315
                                                                                                                                                                                                                                                    end exclusive
                                                                                                                                                                                                                                                    true
                                                                                                                                                                                                                                                    exact text
                                                                                                                                                                                                                                                    recurrent locally advanced or metastatic Mer
                                                                                                                                                                                                                                                    label id
                                                                                                                                                                                                                                                    228e1e3f-d207-481f-8e14-9fdcbd0470e9
                                                                                                                                                                                                                                                    offset unit
                                                                                                                                                                                                                                                    unicode_code_points
                                                                                                                                                                                                                                                    source array index
                                                                                                                                                                                                                                                    0
                                                                                                                                                                                                                                                    source field
                                                                                                                                                                                                                                                    indications_and_usage_exact
                                                                                                                                                                                                                                                    source text sha256
                                                                                                                                                                                                                                                    e526ba14c91f10737e6d3331fe23a6219f58c0eca6380bfce9bd78b573fea912
                                                                                                                                                                                                                                                    start
                                                                                                                                                                                                                                                    20271
                                                                                                                                                                                                                                                  regulatory links
                                                                                                                                                                                                                                                    schema version
                                                                                                                                                                                                                                                    0.1.0
                                                                                                                                                                                                                                                    source batch sha256
                                                                                                                                                                                                                                                    fc39a8c5cf96bf95ca20b85578140167b66b2741f7d9217f500d9ba0847ac058
                                                                                                                                                                                                                                                    source defined aliases
                                                                                                                                                                                                                                                    1. abbreviation
                                                                                                                                                                                                                                                      NSCLC
                                                                                                                                                                                                                                                      definition exact
                                                                                                                                                                                                                                                      Non-Small Cell Lung Cancer
                                                                                                                                                                                                                                                      definition span
                                                                                                                                                                                                                                                      end
                                                                                                                                                                                                                                                      380
                                                                                                                                                                                                                                                      end exclusive
                                                                                                                                                                                                                                                      true
                                                                                                                                                                                                                                                      exact text
                                                                                                                                                                                                                                                      Non-Small Cell Lung Cancer (NSCLC)
                                                                                                                                                                                                                                                      label id
                                                                                                                                                                                                                                                      228e1e3f-d207-481f-8e14-9fdcbd0470e9
                                                                                                                                                                                                                                                      offset unit
                                                                                                                                                                                                                                                      unicode_code_points
                                                                                                                                                                                                                                                      source array index
                                                                                                                                                                                                                                                      0
                                                                                                                                                                                                                                                      source field
                                                                                                                                                                                                                                                      indications_and_usage_exact
                                                                                                                                                                                                                                                      source text sha256
                                                                                                                                                                                                                                                      e526ba14c91f10737e6d3331fe23a6219f58c0eca6380bfce9bd78b573fea912
                                                                                                                                                                                                                                                      start
                                                                                                                                                                                                                                                      346
                                                                                                                                                                                                                                                    2. abbreviation
                                                                                                                                                                                                                                                      CRC
                                                                                                                                                                                                                                                      definition exact
                                                                                                                                                                                                                                                      Colorectal Cancer
                                                                                                                                                                                                                                                      definition span
                                                                                                                                                                                                                                                      end
                                                                                                                                                                                                                                                      5042
                                                                                                                                                                                                                                                      end exclusive
                                                                                                                                                                                                                                                      true
                                                                                                                                                                                                                                                      exact text
                                                                                                                                                                                                                                                      Colorectal Cancer (CRC)
                                                                                                                                                                                                                                                      label id
                                                                                                                                                                                                                                                      228e1e3f-d207-481f-8e14-9fdcbd0470e9
                                                                                                                                                                                                                                                      offset unit
                                                                                                                                                                                                                                                      unicode_code_points
                                                                                                                                                                                                                                                      source array index
                                                                                                                                                                                                                                                      0
                                                                                                                                                                                                                                                      source field
                                                                                                                                                                                                                                                      indications_and_usage_exact
                                                                                                                                                                                                                                                      source text sha256
                                                                                                                                                                                                                                                      e526ba14c91f10737e6d3331fe23a6219f58c0eca6380bfce9bd78b573fea912
                                                                                                                                                                                                                                                      start
                                                                                                                                                                                                                                                      5019
                                                                                                                                                                                                                                                    source span
                                                                                                                                                                                                                                                    end
                                                                                                                                                                                                                                                    20340
                                                                                                                                                                                                                                                    end exclusive
                                                                                                                                                                                                                                                    true
                                                                                                                                                                                                                                                    exact text
                                                                                                                                                                                                                                                    1.15 Merkel Cell Carcinoma KEYTRUDA is indicated for the treatment of adult and pediatric patients with recurrent locally advanced or metastatic Merkel cell carcinoma (MCC).
                                                                                                                                                                                                                                                    label id
                                                                                                                                                                                                                                                    228e1e3f-d207-481f-8e14-9fdcbd0470e9
                                                                                                                                                                                                                                                    offset unit
                                                                                                                                                                                                                                                    unicode_code_points
                                                                                                                                                                                                                                                    source array index
                                                                                                                                                                                                                                                    0
                                                                                                                                                                                                                                                    source field
                                                                                                                                                                                                                                                    indications_and_usage_exact
                                                                                                                                                                                                                                                    source text sha256
                                                                                                                                                                                                                                                    e526ba14c91f10737e6d3331fe23a6219f58c0eca6380bfce9bd78b573fea912
                                                                                                                                                                                                                                                    start
                                                                                                                                                                                                                                                    20167
                                                                                                                                                                                                                                                    source url
                                                                                                                                                                                                                                                    https://api.fda.gov/drug/label.json?search=id%3A%22228e1e3f-d207-481f-8e14-9fdcbd0470e9%22
                                                                                                                                                                                                                                                    spl effective date
                                                                                                                                                                                                                                                    2026-07-10
                                                                                                                                                                                                                                                    spl set id
                                                                                                                                                                                                                                                    9333c79b-d487-4538-a9f0-71b91a02b287
                                                                                                                                                                                                                                                    spl version
                                                                                                                                                                                                                                                    228
                                                                                                                                                                                                                                                    structured fields status
                                                                                                                                                                                                                                                    not_extracted_no_values_inferred_from_mentions
                                                                                                                                                                                                                                                    structured indication
                                                                                                                                                                                                                                                    age
                                                                                                                                                                                                                                                    Source null
                                                                                                                                                                                                                                                    approval pathway
                                                                                                                                                                                                                                                    Source null
                                                                                                                                                                                                                                                    biomarker and test
                                                                                                                                                                                                                                                    Source null
                                                                                                                                                                                                                                                    disease stage
                                                                                                                                                                                                                                                    Source null
                                                                                                                                                                                                                                                    limitations
                                                                                                                                                                                                                                                    Source null
                                                                                                                                                                                                                                                    line
                                                                                                                                                                                                                                                    Source null
                                                                                                                                                                                                                                                    prior therapy
                                                                                                                                                                                                                                                    Source null
                                                                                                                                                                                                                                                    regimen
                                                                                                                                                                                                                                                    Source null
                                                                                                                                                                                                                                                    tumor histology
                                                                                                                                                                                                                                                    Source null
                                                                                                                                                                                                                                                    use intent
                                                                                                                                                                                                                                                    tumor_directed_candidate
                                                                                                                                                                                                                                                    Passage 99 · positive indication candidate
                                                                                                                                                                                                                                                    application numbers
                                                                                                                                                                                                                                                    1. BLA125514
                                                                                                                                                                                                                                                    brand names
                                                                                                                                                                                                                                                    1. KEYTRUDA
                                                                                                                                                                                                                                                    classification reasons
                                                                                                                                                                                                                                                    1. explicit_positive_indication_predicate
                                                                                                                                                                                                                                                    2. tumor_or_malignant_hematology_words_in_positive_statement
                                                                                                                                                                                                                                                    clinical review status
                                                                                                                                                                                                                                                    pending
                                                                                                                                                                                                                                                    content role
                                                                                                                                                                                                                                                    positive_indication_candidate
                                                                                                                                                                                                                                                    context span
                                                                                                                                                                                                                                                    end
                                                                                                                                                                                                                                                    20708
                                                                                                                                                                                                                                                    end exclusive
                                                                                                                                                                                                                                                    true
                                                                                                                                                                                                                                                    exact text
                                                                                                                                                                                                                                                    liary tract cancer (BTC). 1.15 Merkel Cell Carcinoma KEYTRUDA is indicated for the treatment of adult and pediatric patients with recurrent locally advanced or metastatic Merkel cell carcinoma (MCC). 1.16 Renal Cell Carcinoma KEYTRUDA, in combination with axitinib, is indicated for the first-line treatment of adult patients with advanced renal cell carcinoma (RCC). KEYTRUDA, in combination with lenvatinib, is indicated for the first-line treatment of adult patients with advanced RCC. KEYTRUDA is indicated for the adjuvant treatment of patients with RCC at inter
                                                                                                                                                                                                                                                    label id
                                                                                                                                                                                                                                                    228e1e3f-d207-481f-8e14-9fdcbd0470e9
                                                                                                                                                                                                                                                    offset unit
                                                                                                                                                                                                                                                    unicode_code_points
                                                                                                                                                                                                                                                    source array index
                                                                                                                                                                                                                                                    0
                                                                                                                                                                                                                                                    source field
                                                                                                                                                                                                                                                    indications_and_usage_exact
                                                                                                                                                                                                                                                    source text sha256
                                                                                                                                                                                                                                                    e526ba14c91f10737e6d3331fe23a6219f58c0eca6380bfce9bd78b573fea912
                                                                                                                                                                                                                                                    start
                                                                                                                                                                                                                                                    20141
                                                                                                                                                                                                                                                    current approval status
                                                                                                                                                                                                                                                    not_reconciled
                                                                                                                                                                                                                                                    duplicate text group
                                                                                                                                                                                                                                                    dup-21923f9ebdd22da65285
                                                                                                                                                                                                                                                    extraction review status
                                                                                                                                                                                                                                                    automated_candidate_pending_source_review
                                                                                                                                                                                                                                                    generic names
                                                                                                                                                                                                                                                    1. PEMBROLIZUMAB
                                                                                                                                                                                                                                                    id
                                                                                                                                                                                                                                                    ind-span-b9b2bfb2306ada10b3e3
                                                                                                                                                                                                                                                    label id
                                                                                                                                                                                                                                                    228e1e3f-d207-481f-8e14-9fdcbd0470e9
                                                                                                                                                                                                                                                    positive predicate support span
                                                                                                                                                                                                                                                    end
                                                                                                                                                                                                                                                    20419
                                                                                                                                                                                                                                                    end exclusive
                                                                                                                                                                                                                                                    true
                                                                                                                                                                                                                                                    exact text
                                                                                                                                                                                                                                                    is indicated
                                                                                                                                                                                                                                                    label id
                                                                                                                                                                                                                                                    228e1e3f-d207-481f-8e14-9fdcbd0470e9
                                                                                                                                                                                                                                                    offset unit
                                                                                                                                                                                                                                                    unicode_code_points
                                                                                                                                                                                                                                                    source array index
                                                                                                                                                                                                                                                    0
                                                                                                                                                                                                                                                    source field
                                                                                                                                                                                                                                                    indications_and_usage_exact
                                                                                                                                                                                                                                                    source text sha256
                                                                                                                                                                                                                                                    e526ba14c91f10737e6d3331fe23a6219f58c0eca6380bfce9bd78b573fea912
                                                                                                                                                                                                                                                    start
                                                                                                                                                                                                                                                    20407
                                                                                                                                                                                                                                                    qualifier mentions
                                                                                                                                                                                                                                                    1. context exact
                                                                                                                                                                                                                                                      with axitinib, is indicated for the first-line treatment of adult patients with advanced renal cell carcinoma (RCC).
                                                                                                                                                                                                                                                      kind
                                                                                                                                                                                                                                                      age
                                                                                                                                                                                                                                                      polarity
                                                                                                                                                                                                                                                      not_inferred
                                                                                                                                                                                                                                                      span
                                                                                                                                                                                                                                                      end
                                                                                                                                                                                                                                                      20466
                                                                                                                                                                                                                                                      end exclusive
                                                                                                                                                                                                                                                      true
                                                                                                                                                                                                                                                      exact text
                                                                                                                                                                                                                                                      adult patients
                                                                                                                                                                                                                                                      label id
                                                                                                                                                                                                                                                      228e1e3f-d207-481f-8e14-9fdcbd0470e9
                                                                                                                                                                                                                                                      offset unit
                                                                                                                                                                                                                                                      unicode_code_points
                                                                                                                                                                                                                                                      source array index
                                                                                                                                                                                                                                                      0
                                                                                                                                                                                                                                                      source field
                                                                                                                                                                                                                                                      indications_and_usage_exact
                                                                                                                                                                                                                                                      source text sha256
                                                                                                                                                                                                                                                      e526ba14c91f10737e6d3331fe23a6219f58c0eca6380bfce9bd78b573fea912
                                                                                                                                                                                                                                                      start
                                                                                                                                                                                                                                                      20452
                                                                                                                                                                                                                                                    2. context exact
                                                                                                                                                                                                                                                      dicated for the first-line treatment of adult patients with advanced renal cell carcinoma (RCC).
                                                                                                                                                                                                                                                      kind
                                                                                                                                                                                                                                                      stage_or_setting
                                                                                                                                                                                                                                                      polarity
                                                                                                                                                                                                                                                      not_inferred
                                                                                                                                                                                                                                                      span
                                                                                                                                                                                                                                                      end
                                                                                                                                                                                                                                                      20507
                                                                                                                                                                                                                                                      end exclusive
                                                                                                                                                                                                                                                      true
                                                                                                                                                                                                                                                      exact text
                                                                                                                                                                                                                                                      advanced renal cell carcinoma (RCC)
                                                                                                                                                                                                                                                      label id
                                                                                                                                                                                                                                                      228e1e3f-d207-481f-8e14-9fdcbd0470e9
                                                                                                                                                                                                                                                      offset unit
                                                                                                                                                                                                                                                      unicode_code_points
                                                                                                                                                                                                                                                      source array index
                                                                                                                                                                                                                                                      0
                                                                                                                                                                                                                                                      source field
                                                                                                                                                                                                                                                      indications_and_usage_exact
                                                                                                                                                                                                                                                      source text sha256
                                                                                                                                                                                                                                                      e526ba14c91f10737e6d3331fe23a6219f58c0eca6380bfce9bd78b573fea912
                                                                                                                                                                                                                                                      start
                                                                                                                                                                                                                                                      20472
                                                                                                                                                                                                                                                    3. context exact
                                                                                                                                                                                                                                                      EYTRUDA, in combination with axitinib, is indicated for the first-line treatment of adult patients with advanced renal cell carcinoma (RCC).
                                                                                                                                                                                                                                                      kind
                                                                                                                                                                                                                                                      prior_therapy_or_line
                                                                                                                                                                                                                                                      polarity
                                                                                                                                                                                                                                                      not_inferred
                                                                                                                                                                                                                                                      span
                                                                                                                                                                                                                                                      end
                                                                                                                                                                                                                                                      20507
                                                                                                                                                                                                                                                      end exclusive
                                                                                                                                                                                                                                                      true
                                                                                                                                                                                                                                                      exact text
                                                                                                                                                                                                                                                      first-line treatment of adult patients with advanced renal cell carcinoma (RCC)
                                                                                                                                                                                                                                                      label id
                                                                                                                                                                                                                                                      228e1e3f-d207-481f-8e14-9fdcbd0470e9
                                                                                                                                                                                                                                                      offset unit
                                                                                                                                                                                                                                                      unicode_code_points
                                                                                                                                                                                                                                                      source array index
                                                                                                                                                                                                                                                      0
                                                                                                                                                                                                                                                      source field
                                                                                                                                                                                                                                                      indications_and_usage_exact
                                                                                                                                                                                                                                                      source text sha256
                                                                                                                                                                                                                                                      e526ba14c91f10737e6d3331fe23a6219f58c0eca6380bfce9bd78b573fea912
                                                                                                                                                                                                                                                      start
                                                                                                                                                                                                                                                      20428
                                                                                                                                                                                                                                                    4. context exact
                                                                                                                                                                                                                                                      1.16 Renal Cell Carcinoma KEYTRUDA, in combination with axitinib, is indicated for the first-line treatment of adult patients with advanced renal cell carcinoma (RCC).
                                                                                                                                                                                                                                                      kind
                                                                                                                                                                                                                                                      regimen
                                                                                                                                                                                                                                                      polarity
                                                                                                                                                                                                                                                      not_inferred
                                                                                                                                                                                                                                                      span
                                                                                                                                                                                                                                                      end
                                                                                                                                                                                                                                                      20507
                                                                                                                                                                                                                                                      end exclusive
                                                                                                                                                                                                                                                      true
                                                                                                                                                                                                                                                      exact text
                                                                                                                                                                                                                                                      in combination with axitinib, is indicated for the first-line treatment of adult patients with advanced renal cell carcinoma (RCC)
                                                                                                                                                                                                                                                      label id
                                                                                                                                                                                                                                                      228e1e3f-d207-481f-8e14-9fdcbd0470e9
                                                                                                                                                                                                                                                      offset unit
                                                                                                                                                                                                                                                      unicode_code_points
                                                                                                                                                                                                                                                      source array index
                                                                                                                                                                                                                                                      0
                                                                                                                                                                                                                                                      source field
                                                                                                                                                                                                                                                      indications_and_usage_exact
                                                                                                                                                                                                                                                      source text sha256
                                                                                                                                                                                                                                                      e526ba14c91f10737e6d3331fe23a6219f58c0eca6380bfce9bd78b573fea912
                                                                                                                                                                                                                                                      start
                                                                                                                                                                                                                                                      20377
                                                                                                                                                                                                                                                    regulatory links
                                                                                                                                                                                                                                                      schema version
                                                                                                                                                                                                                                                      0.1.0
                                                                                                                                                                                                                                                      source batch sha256
                                                                                                                                                                                                                                                      fc39a8c5cf96bf95ca20b85578140167b66b2741f7d9217f500d9ba0847ac058
                                                                                                                                                                                                                                                      source defined aliases
                                                                                                                                                                                                                                                      1. abbreviation
                                                                                                                                                                                                                                                        NSCLC
                                                                                                                                                                                                                                                        definition exact
                                                                                                                                                                                                                                                        Non-Small Cell Lung Cancer
                                                                                                                                                                                                                                                        definition span
                                                                                                                                                                                                                                                        end
                                                                                                                                                                                                                                                        380
                                                                                                                                                                                                                                                        end exclusive
                                                                                                                                                                                                                                                        true
                                                                                                                                                                                                                                                        exact text
                                                                                                                                                                                                                                                        Non-Small Cell Lung Cancer (NSCLC)
                                                                                                                                                                                                                                                        label id
                                                                                                                                                                                                                                                        228e1e3f-d207-481f-8e14-9fdcbd0470e9
                                                                                                                                                                                                                                                        offset unit
                                                                                                                                                                                                                                                        unicode_code_points
                                                                                                                                                                                                                                                        source array index
                                                                                                                                                                                                                                                        0
                                                                                                                                                                                                                                                        source field
                                                                                                                                                                                                                                                        indications_and_usage_exact
                                                                                                                                                                                                                                                        source text sha256
                                                                                                                                                                                                                                                        e526ba14c91f10737e6d3331fe23a6219f58c0eca6380bfce9bd78b573fea912
                                                                                                                                                                                                                                                        start
                                                                                                                                                                                                                                                        346
                                                                                                                                                                                                                                                      2. abbreviation
                                                                                                                                                                                                                                                        CRC
                                                                                                                                                                                                                                                        definition exact
                                                                                                                                                                                                                                                        Colorectal Cancer
                                                                                                                                                                                                                                                        definition span
                                                                                                                                                                                                                                                        end
                                                                                                                                                                                                                                                        5042
                                                                                                                                                                                                                                                        end exclusive
                                                                                                                                                                                                                                                        true
                                                                                                                                                                                                                                                        exact text
                                                                                                                                                                                                                                                        Colorectal Cancer (CRC)
                                                                                                                                                                                                                                                        label id
                                                                                                                                                                                                                                                        228e1e3f-d207-481f-8e14-9fdcbd0470e9
                                                                                                                                                                                                                                                        offset unit
                                                                                                                                                                                                                                                        unicode_code_points
                                                                                                                                                                                                                                                        source array index
                                                                                                                                                                                                                                                        0
                                                                                                                                                                                                                                                        source field
                                                                                                                                                                                                                                                        indications_and_usage_exact
                                                                                                                                                                                                                                                        source text sha256
                                                                                                                                                                                                                                                        e526ba14c91f10737e6d3331fe23a6219f58c0eca6380bfce9bd78b573fea912
                                                                                                                                                                                                                                                        start
                                                                                                                                                                                                                                                        5019
                                                                                                                                                                                                                                                      source span
                                                                                                                                                                                                                                                      end
                                                                                                                                                                                                                                                      20508
                                                                                                                                                                                                                                                      end exclusive
                                                                                                                                                                                                                                                      true
                                                                                                                                                                                                                                                      exact text
                                                                                                                                                                                                                                                      1.16 Renal Cell Carcinoma KEYTRUDA, in combination with axitinib, is indicated for the first-line treatment of adult patients with advanced renal cell carcinoma (RCC).
                                                                                                                                                                                                                                                      label id
                                                                                                                                                                                                                                                      228e1e3f-d207-481f-8e14-9fdcbd0470e9
                                                                                                                                                                                                                                                      offset unit
                                                                                                                                                                                                                                                      unicode_code_points
                                                                                                                                                                                                                                                      source array index
                                                                                                                                                                                                                                                      0
                                                                                                                                                                                                                                                      source field
                                                                                                                                                                                                                                                      indications_and_usage_exact
                                                                                                                                                                                                                                                      source text sha256
                                                                                                                                                                                                                                                      e526ba14c91f10737e6d3331fe23a6219f58c0eca6380bfce9bd78b573fea912
                                                                                                                                                                                                                                                      start
                                                                                                                                                                                                                                                      20341
                                                                                                                                                                                                                                                      source url
                                                                                                                                                                                                                                                      https://api.fda.gov/drug/label.json?search=id%3A%22228e1e3f-d207-481f-8e14-9fdcbd0470e9%22
                                                                                                                                                                                                                                                      spl effective date
                                                                                                                                                                                                                                                      2026-07-10
                                                                                                                                                                                                                                                      spl set id
                                                                                                                                                                                                                                                      9333c79b-d487-4538-a9f0-71b91a02b287
                                                                                                                                                                                                                                                      spl version
                                                                                                                                                                                                                                                      228
                                                                                                                                                                                                                                                      structured fields status
                                                                                                                                                                                                                                                      not_extracted_no_values_inferred_from_mentions
                                                                                                                                                                                                                                                      structured indication
                                                                                                                                                                                                                                                      age
                                                                                                                                                                                                                                                      Source null
                                                                                                                                                                                                                                                      approval pathway
                                                                                                                                                                                                                                                      Source null
                                                                                                                                                                                                                                                      biomarker and test
                                                                                                                                                                                                                                                      Source null
                                                                                                                                                                                                                                                      disease stage
                                                                                                                                                                                                                                                      Source null
                                                                                                                                                                                                                                                      limitations
                                                                                                                                                                                                                                                      Source null
                                                                                                                                                                                                                                                      line
                                                                                                                                                                                                                                                      Source null
                                                                                                                                                                                                                                                      prior therapy
                                                                                                                                                                                                                                                      Source null
                                                                                                                                                                                                                                                      regimen
                                                                                                                                                                                                                                                      Source null
                                                                                                                                                                                                                                                      tumor histology
                                                                                                                                                                                                                                                      Source null
                                                                                                                                                                                                                                                      use intent
                                                                                                                                                                                                                                                      tumor_directed_candidate
                                                                                                                                                                                                                                                      Passage 100 · positive indication candidate
                                                                                                                                                                                                                                                      application numbers
                                                                                                                                                                                                                                                      1. BLA125514
                                                                                                                                                                                                                                                      brand names
                                                                                                                                                                                                                                                      1. KEYTRUDA
                                                                                                                                                                                                                                                      classification reasons
                                                                                                                                                                                                                                                      1. explicit_positive_indication_predicate
                                                                                                                                                                                                                                                      2. no_tumor_directed_keyword_in_positive_statement
                                                                                                                                                                                                                                                      clinical review status
                                                                                                                                                                                                                                                      pending
                                                                                                                                                                                                                                                      content role
                                                                                                                                                                                                                                                      positive_indication_candidate
                                                                                                                                                                                                                                                      context span
                                                                                                                                                                                                                                                      end
                                                                                                                                                                                                                                                      20829
                                                                                                                                                                                                                                                      end exclusive
                                                                                                                                                                                                                                                      true
                                                                                                                                                                                                                                                      exact text
                                                                                                                                                                                                                                                      ic Merkel cell carcinoma (MCC). 1.16 Renal Cell Carcinoma KEYTRUDA, in combination with axitinib, is indicated for the first-line treatment of adult patients with advanced renal cell carcinoma (RCC). KEYTRUDA, in combination with lenvatinib, is indicated for the first-line treatment of adult patients with advanced RCC. KEYTRUDA is indicated for the adjuvant treatment of patients with RCC at intermediate-high or high risk of recurrence following nephrectomy, or following nephrectomy and resection of metastatic lesio
                                                                                                                                                                                                                                                      label id
                                                                                                                                                                                                                                                      228e1e3f-d207-481f-8e14-9fdcbd0470e9
                                                                                                                                                                                                                                                      offset unit
                                                                                                                                                                                                                                                      unicode_code_points
                                                                                                                                                                                                                                                      source array index
                                                                                                                                                                                                                                                      0
                                                                                                                                                                                                                                                      source field
                                                                                                                                                                                                                                                      indications_and_usage_exact
                                                                                                                                                                                                                                                      source text sha256
                                                                                                                                                                                                                                                      e526ba14c91f10737e6d3331fe23a6219f58c0eca6380bfce9bd78b573fea912
                                                                                                                                                                                                                                                      start
                                                                                                                                                                                                                                                      20309
                                                                                                                                                                                                                                                      current approval status
                                                                                                                                                                                                                                                      not_reconciled
                                                                                                                                                                                                                                                      duplicate text group
                                                                                                                                                                                                                                                      dup-2de67bf219b0a15923ab
                                                                                                                                                                                                                                                      extraction review status
                                                                                                                                                                                                                                                      automated_candidate_pending_source_review
                                                                                                                                                                                                                                                      generic names
                                                                                                                                                                                                                                                      1. PEMBROLIZUMAB
                                                                                                                                                                                                                                                      id
                                                                                                                                                                                                                                                      ind-span-483a13a55598b11054f4
                                                                                                                                                                                                                                                      label id
                                                                                                                                                                                                                                                      228e1e3f-d207-481f-8e14-9fdcbd0470e9
                                                                                                                                                                                                                                                      positive predicate support span
                                                                                                                                                                                                                                                      end
                                                                                                                                                                                                                                                      20563
                                                                                                                                                                                                                                                      end exclusive
                                                                                                                                                                                                                                                      true
                                                                                                                                                                                                                                                      exact text
                                                                                                                                                                                                                                                      is indicated
                                                                                                                                                                                                                                                      label id
                                                                                                                                                                                                                                                      228e1e3f-d207-481f-8e14-9fdcbd0470e9
                                                                                                                                                                                                                                                      offset unit
                                                                                                                                                                                                                                                      unicode_code_points
                                                                                                                                                                                                                                                      source array index
                                                                                                                                                                                                                                                      0
                                                                                                                                                                                                                                                      source field
                                                                                                                                                                                                                                                      indications_and_usage_exact
                                                                                                                                                                                                                                                      source text sha256
                                                                                                                                                                                                                                                      e526ba14c91f10737e6d3331fe23a6219f58c0eca6380bfce9bd78b573fea912
                                                                                                                                                                                                                                                      start
                                                                                                                                                                                                                                                      20551
                                                                                                                                                                                                                                                      qualifier mentions
                                                                                                                                                                                                                                                      1. context exact
                                                                                                                                                                                                                                                        th lenvatinib, is indicated for the first-line treatment of adult patients with advanced RCC.
                                                                                                                                                                                                                                                        kind
                                                                                                                                                                                                                                                        age
                                                                                                                                                                                                                                                        polarity
                                                                                                                                                                                                                                                        not_inferred
                                                                                                                                                                                                                                                        span
                                                                                                                                                                                                                                                        end
                                                                                                                                                                                                                                                        20610
                                                                                                                                                                                                                                                        end exclusive
                                                                                                                                                                                                                                                        true
                                                                                                                                                                                                                                                        exact text
                                                                                                                                                                                                                                                        adult patients
                                                                                                                                                                                                                                                        label id
                                                                                                                                                                                                                                                        228e1e3f-d207-481f-8e14-9fdcbd0470e9
                                                                                                                                                                                                                                                        offset unit
                                                                                                                                                                                                                                                        unicode_code_points
                                                                                                                                                                                                                                                        source array index
                                                                                                                                                                                                                                                        0
                                                                                                                                                                                                                                                        source field
                                                                                                                                                                                                                                                        indications_and_usage_exact
                                                                                                                                                                                                                                                        source text sha256
                                                                                                                                                                                                                                                        e526ba14c91f10737e6d3331fe23a6219f58c0eca6380bfce9bd78b573fea912
                                                                                                                                                                                                                                                        start
                                                                                                                                                                                                                                                        20596
                                                                                                                                                                                                                                                      2. context exact
                                                                                                                                                                                                                                                        dicated for the first-line treatment of adult patients with advanced RCC.
                                                                                                                                                                                                                                                        kind
                                                                                                                                                                                                                                                        stage_or_setting
                                                                                                                                                                                                                                                        polarity
                                                                                                                                                                                                                                                        not_inferred
                                                                                                                                                                                                                                                        span
                                                                                                                                                                                                                                                        end
                                                                                                                                                                                                                                                        20628
                                                                                                                                                                                                                                                        end exclusive
                                                                                                                                                                                                                                                        true
                                                                                                                                                                                                                                                        exact text
                                                                                                                                                                                                                                                        advanced RCC
                                                                                                                                                                                                                                                        label id
                                                                                                                                                                                                                                                        228e1e3f-d207-481f-8e14-9fdcbd0470e9
                                                                                                                                                                                                                                                        offset unit
                                                                                                                                                                                                                                                        unicode_code_points
                                                                                                                                                                                                                                                        source array index
                                                                                                                                                                                                                                                        0
                                                                                                                                                                                                                                                        source field
                                                                                                                                                                                                                                                        indications_and_usage_exact
                                                                                                                                                                                                                                                        source text sha256
                                                                                                                                                                                                                                                        e526ba14c91f10737e6d3331fe23a6219f58c0eca6380bfce9bd78b573fea912
                                                                                                                                                                                                                                                        start
                                                                                                                                                                                                                                                        20616
                                                                                                                                                                                                                                                      3. context exact
                                                                                                                                                                                                                                                        TRUDA, in combination with lenvatinib, is indicated for the first-line treatment of adult patients with advanced RCC.
                                                                                                                                                                                                                                                        kind
                                                                                                                                                                                                                                                        prior_therapy_or_line
                                                                                                                                                                                                                                                        polarity
                                                                                                                                                                                                                                                        not_inferred
                                                                                                                                                                                                                                                        span
                                                                                                                                                                                                                                                        end
                                                                                                                                                                                                                                                        20628
                                                                                                                                                                                                                                                        end exclusive
                                                                                                                                                                                                                                                        true
                                                                                                                                                                                                                                                        exact text
                                                                                                                                                                                                                                                        first-line treatment of adult patients with advanced RCC
                                                                                                                                                                                                                                                        label id
                                                                                                                                                                                                                                                        228e1e3f-d207-481f-8e14-9fdcbd0470e9
                                                                                                                                                                                                                                                        offset unit
                                                                                                                                                                                                                                                        unicode_code_points
                                                                                                                                                                                                                                                        source array index
                                                                                                                                                                                                                                                        0
                                                                                                                                                                                                                                                        source field
                                                                                                                                                                                                                                                        indications_and_usage_exact
                                                                                                                                                                                                                                                        source text sha256
                                                                                                                                                                                                                                                        e526ba14c91f10737e6d3331fe23a6219f58c0eca6380bfce9bd78b573fea912
                                                                                                                                                                                                                                                        start
                                                                                                                                                                                                                                                        20572
                                                                                                                                                                                                                                                      4. context exact
                                                                                                                                                                                                                                                        KEYTRUDA, in combination with lenvatinib, is indicated for the first-line treatment of adult patients with advanced RCC.
                                                                                                                                                                                                                                                        kind
                                                                                                                                                                                                                                                        regimen
                                                                                                                                                                                                                                                        polarity
                                                                                                                                                                                                                                                        not_inferred
                                                                                                                                                                                                                                                        span
                                                                                                                                                                                                                                                        end
                                                                                                                                                                                                                                                        20628
                                                                                                                                                                                                                                                        end exclusive
                                                                                                                                                                                                                                                        true
                                                                                                                                                                                                                                                        exact text
                                                                                                                                                                                                                                                        in combination with lenvatinib, is indicated for the first-line treatment of adult patients with advanced RCC
                                                                                                                                                                                                                                                        label id
                                                                                                                                                                                                                                                        228e1e3f-d207-481f-8e14-9fdcbd0470e9
                                                                                                                                                                                                                                                        offset unit
                                                                                                                                                                                                                                                        unicode_code_points
                                                                                                                                                                                                                                                        source array index
                                                                                                                                                                                                                                                        0
                                                                                                                                                                                                                                                        source field
                                                                                                                                                                                                                                                        indications_and_usage_exact
                                                                                                                                                                                                                                                        source text sha256
                                                                                                                                                                                                                                                        e526ba14c91f10737e6d3331fe23a6219f58c0eca6380bfce9bd78b573fea912
                                                                                                                                                                                                                                                        start
                                                                                                                                                                                                                                                        20519
                                                                                                                                                                                                                                                      regulatory links
                                                                                                                                                                                                                                                        schema version
                                                                                                                                                                                                                                                        0.1.0
                                                                                                                                                                                                                                                        source batch sha256
                                                                                                                                                                                                                                                        fc39a8c5cf96bf95ca20b85578140167b66b2741f7d9217f500d9ba0847ac058
                                                                                                                                                                                                                                                        source defined aliases
                                                                                                                                                                                                                                                        1. abbreviation
                                                                                                                                                                                                                                                          NSCLC
                                                                                                                                                                                                                                                          definition exact
                                                                                                                                                                                                                                                          Non-Small Cell Lung Cancer
                                                                                                                                                                                                                                                          definition span
                                                                                                                                                                                                                                                          end
                                                                                                                                                                                                                                                          380
                                                                                                                                                                                                                                                          end exclusive
                                                                                                                                                                                                                                                          true
                                                                                                                                                                                                                                                          exact text
                                                                                                                                                                                                                                                          Non-Small Cell Lung Cancer (NSCLC)
                                                                                                                                                                                                                                                          label id
                                                                                                                                                                                                                                                          228e1e3f-d207-481f-8e14-9fdcbd0470e9
                                                                                                                                                                                                                                                          offset unit
                                                                                                                                                                                                                                                          unicode_code_points
                                                                                                                                                                                                                                                          source array index
                                                                                                                                                                                                                                                          0
                                                                                                                                                                                                                                                          source field
                                                                                                                                                                                                                                                          indications_and_usage_exact
                                                                                                                                                                                                                                                          source text sha256
                                                                                                                                                                                                                                                          e526ba14c91f10737e6d3331fe23a6219f58c0eca6380bfce9bd78b573fea912
                                                                                                                                                                                                                                                          start
                                                                                                                                                                                                                                                          346
                                                                                                                                                                                                                                                        2. abbreviation
                                                                                                                                                                                                                                                          CRC
                                                                                                                                                                                                                                                          definition exact
                                                                                                                                                                                                                                                          Colorectal Cancer
                                                                                                                                                                                                                                                          definition span
                                                                                                                                                                                                                                                          end
                                                                                                                                                                                                                                                          5042
                                                                                                                                                                                                                                                          end exclusive
                                                                                                                                                                                                                                                          true
                                                                                                                                                                                                                                                          exact text
                                                                                                                                                                                                                                                          Colorectal Cancer (CRC)
                                                                                                                                                                                                                                                          label id
                                                                                                                                                                                                                                                          228e1e3f-d207-481f-8e14-9fdcbd0470e9
                                                                                                                                                                                                                                                          offset unit
                                                                                                                                                                                                                                                          unicode_code_points
                                                                                                                                                                                                                                                          source array index
                                                                                                                                                                                                                                                          0
                                                                                                                                                                                                                                                          source field
                                                                                                                                                                                                                                                          indications_and_usage_exact
                                                                                                                                                                                                                                                          source text sha256
                                                                                                                                                                                                                                                          e526ba14c91f10737e6d3331fe23a6219f58c0eca6380bfce9bd78b573fea912
                                                                                                                                                                                                                                                          start
                                                                                                                                                                                                                                                          5019
                                                                                                                                                                                                                                                        source span
                                                                                                                                                                                                                                                        end
                                                                                                                                                                                                                                                        20629
                                                                                                                                                                                                                                                        end exclusive
                                                                                                                                                                                                                                                        true
                                                                                                                                                                                                                                                        exact text
                                                                                                                                                                                                                                                        KEYTRUDA, in combination with lenvatinib, is indicated for the first-line treatment of adult patients with advanced RCC.
                                                                                                                                                                                                                                                        label id
                                                                                                                                                                                                                                                        228e1e3f-d207-481f-8e14-9fdcbd0470e9
                                                                                                                                                                                                                                                        offset unit
                                                                                                                                                                                                                                                        unicode_code_points
                                                                                                                                                                                                                                                        source array index
                                                                                                                                                                                                                                                        0
                                                                                                                                                                                                                                                        source field
                                                                                                                                                                                                                                                        indications_and_usage_exact
                                                                                                                                                                                                                                                        source text sha256
                                                                                                                                                                                                                                                        e526ba14c91f10737e6d3331fe23a6219f58c0eca6380bfce9bd78b573fea912
                                                                                                                                                                                                                                                        start
                                                                                                                                                                                                                                                        20509
                                                                                                                                                                                                                                                        source url
                                                                                                                                                                                                                                                        https://api.fda.gov/drug/label.json?search=id%3A%22228e1e3f-d207-481f-8e14-9fdcbd0470e9%22
                                                                                                                                                                                                                                                        spl effective date
                                                                                                                                                                                                                                                        2026-07-10
                                                                                                                                                                                                                                                        spl set id
                                                                                                                                                                                                                                                        9333c79b-d487-4538-a9f0-71b91a02b287
                                                                                                                                                                                                                                                        spl version
                                                                                                                                                                                                                                                        228
                                                                                                                                                                                                                                                        structured fields status
                                                                                                                                                                                                                                                        not_extracted_no_values_inferred_from_mentions
                                                                                                                                                                                                                                                        structured indication
                                                                                                                                                                                                                                                        age
                                                                                                                                                                                                                                                        Source null
                                                                                                                                                                                                                                                        approval pathway
                                                                                                                                                                                                                                                        Source null
                                                                                                                                                                                                                                                        biomarker and test
                                                                                                                                                                                                                                                        Source null
                                                                                                                                                                                                                                                        disease stage
                                                                                                                                                                                                                                                        Source null
                                                                                                                                                                                                                                                        limitations
                                                                                                                                                                                                                                                        Source null
                                                                                                                                                                                                                                                        line
                                                                                                                                                                                                                                                        Source null
                                                                                                                                                                                                                                                        prior therapy
                                                                                                                                                                                                                                                        Source null
                                                                                                                                                                                                                                                        regimen
                                                                                                                                                                                                                                                        Source null
                                                                                                                                                                                                                                                        tumor histology
                                                                                                                                                                                                                                                        Source null
                                                                                                                                                                                                                                                        use intent
                                                                                                                                                                                                                                                        non_oncology_or_unclear_candidate
                                                                                                                                                                                                                                                        Passage 101 · positive indication candidate
                                                                                                                                                                                                                                                        application numbers
                                                                                                                                                                                                                                                        1. BLA125514
                                                                                                                                                                                                                                                        brand names
                                                                                                                                                                                                                                                        1. KEYTRUDA
                                                                                                                                                                                                                                                        classification reasons
                                                                                                                                                                                                                                                        1. explicit_positive_indication_predicate
                                                                                                                                                                                                                                                        2. no_tumor_directed_keyword_in_positive_statement
                                                                                                                                                                                                                                                        3. positive_statement_also_contains_qualification_review_required
                                                                                                                                                                                                                                                        clinical review status
                                                                                                                                                                                                                                                        pending
                                                                                                                                                                                                                                                        content role
                                                                                                                                                                                                                                                        positive_indication_candidate
                                                                                                                                                                                                                                                        context span
                                                                                                                                                                                                                                                        end
                                                                                                                                                                                                                                                        21065
                                                                                                                                                                                                                                                        end exclusive
                                                                                                                                                                                                                                                        true
                                                                                                                                                                                                                                                        exact text
                                                                                                                                                                                                                                                        rst-line treatment of adult patients with advanced renal cell carcinoma (RCC). KEYTRUDA, in combination with lenvatinib, is indicated for the first-line treatment of adult patients with advanced RCC. KEYTRUDA is indicated for the adjuvant treatment of patients with RCC at intermediate-high or high risk of recurrence following nephrectomy, or following nephrectomy and resection of metastatic lesions [see Clinical Studies (14.16) ] . KEYTRUDA, in combination with belzutifan, is indicated for the adjuvant treatment of adult patients with RCC with a clear cell component (ccRCC) at intermediate-high or high risk of recurrence follow
                                                                                                                                                                                                                                                        label id
                                                                                                                                                                                                                                                        228e1e3f-d207-481f-8e14-9fdcbd0470e9
                                                                                                                                                                                                                                                        offset unit
                                                                                                                                                                                                                                                        unicode_code_points
                                                                                                                                                                                                                                                        source array index
                                                                                                                                                                                                                                                        0
                                                                                                                                                                                                                                                        source field
                                                                                                                                                                                                                                                        indications_and_usage_exact
                                                                                                                                                                                                                                                        source text sha256
                                                                                                                                                                                                                                                        e526ba14c91f10737e6d3331fe23a6219f58c0eca6380bfce9bd78b573fea912
                                                                                                                                                                                                                                                        start
                                                                                                                                                                                                                                                        20430
                                                                                                                                                                                                                                                        current approval status
                                                                                                                                                                                                                                                        not_reconciled
                                                                                                                                                                                                                                                        duplicate text group
                                                                                                                                                                                                                                                        dup-c81a2b87f0ebf3a605f6
                                                                                                                                                                                                                                                        extraction review status
                                                                                                                                                                                                                                                        automated_candidate_pending_source_review
                                                                                                                                                                                                                                                        generic names
                                                                                                                                                                                                                                                        1. PEMBROLIZUMAB
                                                                                                                                                                                                                                                        id
                                                                                                                                                                                                                                                        ind-span-b33b50ce5d67685852bd
                                                                                                                                                                                                                                                        label id
                                                                                                                                                                                                                                                        228e1e3f-d207-481f-8e14-9fdcbd0470e9
                                                                                                                                                                                                                                                        positive predicate support span
                                                                                                                                                                                                                                                        end
                                                                                                                                                                                                                                                        20651
                                                                                                                                                                                                                                                        end exclusive
                                                                                                                                                                                                                                                        true
                                                                                                                                                                                                                                                        exact text
                                                                                                                                                                                                                                                        is indicated
                                                                                                                                                                                                                                                        label id
                                                                                                                                                                                                                                                        228e1e3f-d207-481f-8e14-9fdcbd0470e9
                                                                                                                                                                                                                                                        offset unit
                                                                                                                                                                                                                                                        unicode_code_points
                                                                                                                                                                                                                                                        source array index
                                                                                                                                                                                                                                                        0
                                                                                                                                                                                                                                                        source field
                                                                                                                                                                                                                                                        indications_and_usage_exact
                                                                                                                                                                                                                                                        source text sha256
                                                                                                                                                                                                                                                        e526ba14c91f10737e6d3331fe23a6219f58c0eca6380bfce9bd78b573fea912
                                                                                                                                                                                                                                                        start
                                                                                                                                                                                                                                                        20639
                                                                                                                                                                                                                                                        qualifier mentions
                                                                                                                                                                                                                                                        1. context exact
                                                                                                                                                                                                                                                          wing nephrectomy, or following nephrectomy and resection of metastatic lesions [see Clinical Studies (14.16) ] .
                                                                                                                                                                                                                                                          kind
                                                                                                                                                                                                                                                          biomarker
                                                                                                                                                                                                                                                          polarity
                                                                                                                                                                                                                                                          not_inferred
                                                                                                                                                                                                                                                          span
                                                                                                                                                                                                                                                          end
                                                                                                                                                                                                                                                          20856
                                                                                                                                                                                                                                                          end exclusive
                                                                                                                                                                                                                                                          true
                                                                                                                                                                                                                                                          exact text
                                                                                                                                                                                                                                                          metastatic lesions [see Clinical Studies (1
                                                                                                                                                                                                                                                          label id
                                                                                                                                                                                                                                                          228e1e3f-d207-481f-8e14-9fdcbd0470e9
                                                                                                                                                                                                                                                          offset unit
                                                                                                                                                                                                                                                          unicode_code_points
                                                                                                                                                                                                                                                          source array index
                                                                                                                                                                                                                                                          0
                                                                                                                                                                                                                                                          source field
                                                                                                                                                                                                                                                          indications_and_usage_exact
                                                                                                                                                                                                                                                          source text sha256
                                                                                                                                                                                                                                                          e526ba14c91f10737e6d3331fe23a6219f58c0eca6380bfce9bd78b573fea912
                                                                                                                                                                                                                                                          start
                                                                                                                                                                                                                                                          20813
                                                                                                                                                                                                                                                        2. context exact
                                                                                                                                                                                                                                                          KEYTRUDA is indicated for the adjuvant treatment of patients with RCC at intermediate-high or high risk of recurrence following nephr
                                                                                                                                                                                                                                                          kind
                                                                                                                                                                                                                                                          stage_or_setting
                                                                                                                                                                                                                                                          polarity
                                                                                                                                                                                                                                                          not_inferred
                                                                                                                                                                                                                                                          span
                                                                                                                                                                                                                                                          end
                                                                                                                                                                                                                                                          20703
                                                                                                                                                                                                                                                          end exclusive
                                                                                                                                                                                                                                                          true
                                                                                                                                                                                                                                                          exact text
                                                                                                                                                                                                                                                          adjuvant treatment of patients with RCC at
                                                                                                                                                                                                                                                          label id
                                                                                                                                                                                                                                                          228e1e3f-d207-481f-8e14-9fdcbd0470e9
                                                                                                                                                                                                                                                          offset unit
                                                                                                                                                                                                                                                          unicode_code_points
                                                                                                                                                                                                                                                          source array index
                                                                                                                                                                                                                                                          0
                                                                                                                                                                                                                                                          source field
                                                                                                                                                                                                                                                          indications_and_usage_exact
                                                                                                                                                                                                                                                          source text sha256
                                                                                                                                                                                                                                                          e526ba14c91f10737e6d3331fe23a6219f58c0eca6380bfce9bd78b573fea912
                                                                                                                                                                                                                                                          start
                                                                                                                                                                                                                                                          20660
                                                                                                                                                                                                                                                        3. context exact
                                                                                                                                                                                                                                                          wing nephrectomy, or following nephrectomy and resection of metastatic lesions [see Clinical Studies (14.16) ] .
                                                                                                                                                                                                                                                          kind
                                                                                                                                                                                                                                                          stage_or_setting
                                                                                                                                                                                                                                                          polarity
                                                                                                                                                                                                                                                          not_inferred
                                                                                                                                                                                                                                                          span
                                                                                                                                                                                                                                                          end
                                                                                                                                                                                                                                                          20857
                                                                                                                                                                                                                                                          end exclusive
                                                                                                                                                                                                                                                          true
                                                                                                                                                                                                                                                          exact text
                                                                                                                                                                                                                                                          metastatic lesions [see Clinical Studies (14
                                                                                                                                                                                                                                                          label id
                                                                                                                                                                                                                                                          228e1e3f-d207-481f-8e14-9fdcbd0470e9
                                                                                                                                                                                                                                                          offset unit
                                                                                                                                                                                                                                                          unicode_code_points
                                                                                                                                                                                                                                                          source array index
                                                                                                                                                                                                                                                          0
                                                                                                                                                                                                                                                          source field
                                                                                                                                                                                                                                                          indications_and_usage_exact
                                                                                                                                                                                                                                                          source text sha256
                                                                                                                                                                                                                                                          e526ba14c91f10737e6d3331fe23a6219f58c0eca6380bfce9bd78b573fea912
                                                                                                                                                                                                                                                          start
                                                                                                                                                                                                                                                          20813
                                                                                                                                                                                                                                                        regulatory links
                                                                                                                                                                                                                                                          schema version
                                                                                                                                                                                                                                                          0.1.0
                                                                                                                                                                                                                                                          source batch sha256
                                                                                                                                                                                                                                                          fc39a8c5cf96bf95ca20b85578140167b66b2741f7d9217f500d9ba0847ac058
                                                                                                                                                                                                                                                          source defined aliases
                                                                                                                                                                                                                                                          1. abbreviation
                                                                                                                                                                                                                                                            NSCLC
                                                                                                                                                                                                                                                            definition exact
                                                                                                                                                                                                                                                            Non-Small Cell Lung Cancer
                                                                                                                                                                                                                                                            definition span
                                                                                                                                                                                                                                                            end
                                                                                                                                                                                                                                                            380
                                                                                                                                                                                                                                                            end exclusive
                                                                                                                                                                                                                                                            true
                                                                                                                                                                                                                                                            exact text
                                                                                                                                                                                                                                                            Non-Small Cell Lung Cancer (NSCLC)
                                                                                                                                                                                                                                                            label id
                                                                                                                                                                                                                                                            228e1e3f-d207-481f-8e14-9fdcbd0470e9
                                                                                                                                                                                                                                                            offset unit
                                                                                                                                                                                                                                                            unicode_code_points
                                                                                                                                                                                                                                                            source array index
                                                                                                                                                                                                                                                            0
                                                                                                                                                                                                                                                            source field
                                                                                                                                                                                                                                                            indications_and_usage_exact
                                                                                                                                                                                                                                                            source text sha256
                                                                                                                                                                                                                                                            e526ba14c91f10737e6d3331fe23a6219f58c0eca6380bfce9bd78b573fea912
                                                                                                                                                                                                                                                            start
                                                                                                                                                                                                                                                            346
                                                                                                                                                                                                                                                          2. abbreviation
                                                                                                                                                                                                                                                            CRC
                                                                                                                                                                                                                                                            definition exact
                                                                                                                                                                                                                                                            Colorectal Cancer
                                                                                                                                                                                                                                                            definition span
                                                                                                                                                                                                                                                            end
                                                                                                                                                                                                                                                            5042
                                                                                                                                                                                                                                                            end exclusive
                                                                                                                                                                                                                                                            true
                                                                                                                                                                                                                                                            exact text
                                                                                                                                                                                                                                                            Colorectal Cancer (CRC)
                                                                                                                                                                                                                                                            label id
                                                                                                                                                                                                                                                            228e1e3f-d207-481f-8e14-9fdcbd0470e9
                                                                                                                                                                                                                                                            offset unit
                                                                                                                                                                                                                                                            unicode_code_points
                                                                                                                                                                                                                                                            source array index
                                                                                                                                                                                                                                                            0
                                                                                                                                                                                                                                                            source field
                                                                                                                                                                                                                                                            indications_and_usage_exact
                                                                                                                                                                                                                                                            source text sha256
                                                                                                                                                                                                                                                            e526ba14c91f10737e6d3331fe23a6219f58c0eca6380bfce9bd78b573fea912
                                                                                                                                                                                                                                                            start
                                                                                                                                                                                                                                                            5019
                                                                                                                                                                                                                                                          source span
                                                                                                                                                                                                                                                          end
                                                                                                                                                                                                                                                          20865
                                                                                                                                                                                                                                                          end exclusive
                                                                                                                                                                                                                                                          true
                                                                                                                                                                                                                                                          exact text
                                                                                                                                                                                                                                                          KEYTRUDA is indicated for the adjuvant treatment of patients with RCC at intermediate-high or high risk of recurrence following nephrectomy, or following nephrectomy and resection of metastatic lesions [see Clinical Studies (14.16) ] .
                                                                                                                                                                                                                                                          label id
                                                                                                                                                                                                                                                          228e1e3f-d207-481f-8e14-9fdcbd0470e9
                                                                                                                                                                                                                                                          offset unit
                                                                                                                                                                                                                                                          unicode_code_points
                                                                                                                                                                                                                                                          source array index
                                                                                                                                                                                                                                                          0
                                                                                                                                                                                                                                                          source field
                                                                                                                                                                                                                                                          indications_and_usage_exact
                                                                                                                                                                                                                                                          source text sha256
                                                                                                                                                                                                                                                          e526ba14c91f10737e6d3331fe23a6219f58c0eca6380bfce9bd78b573fea912
                                                                                                                                                                                                                                                          start
                                                                                                                                                                                                                                                          20630
                                                                                                                                                                                                                                                          source url
                                                                                                                                                                                                                                                          https://api.fda.gov/drug/label.json?search=id%3A%22228e1e3f-d207-481f-8e14-9fdcbd0470e9%22
                                                                                                                                                                                                                                                          spl effective date
                                                                                                                                                                                                                                                          2026-07-10
                                                                                                                                                                                                                                                          spl set id
                                                                                                                                                                                                                                                          9333c79b-d487-4538-a9f0-71b91a02b287
                                                                                                                                                                                                                                                          spl version
                                                                                                                                                                                                                                                          228
                                                                                                                                                                                                                                                          structured fields status
                                                                                                                                                                                                                                                          not_extracted_no_values_inferred_from_mentions
                                                                                                                                                                                                                                                          structured indication
                                                                                                                                                                                                                                                          age
                                                                                                                                                                                                                                                          Source null
                                                                                                                                                                                                                                                          approval pathway
                                                                                                                                                                                                                                                          Source null
                                                                                                                                                                                                                                                          biomarker and test
                                                                                                                                                                                                                                                          Source null
                                                                                                                                                                                                                                                          disease stage
                                                                                                                                                                                                                                                          Source null
                                                                                                                                                                                                                                                          limitations
                                                                                                                                                                                                                                                          Source null
                                                                                                                                                                                                                                                          line
                                                                                                                                                                                                                                                          Source null
                                                                                                                                                                                                                                                          prior therapy
                                                                                                                                                                                                                                                          Source null
                                                                                                                                                                                                                                                          regimen
                                                                                                                                                                                                                                                          Source null
                                                                                                                                                                                                                                                          tumor histology
                                                                                                                                                                                                                                                          Source null
                                                                                                                                                                                                                                                          use intent
                                                                                                                                                                                                                                                          non_oncology_or_unclear_candidate
                                                                                                                                                                                                                                                          Passage 102 · positive indication candidate
                                                                                                                                                                                                                                                          application numbers
                                                                                                                                                                                                                                                          1. BLA125514
                                                                                                                                                                                                                                                          brand names
                                                                                                                                                                                                                                                          1. KEYTRUDA
                                                                                                                                                                                                                                                          classification reasons
                                                                                                                                                                                                                                                          1. explicit_positive_indication_predicate
                                                                                                                                                                                                                                                          2. no_tumor_directed_keyword_in_positive_statement
                                                                                                                                                                                                                                                          3. positive_statement_also_contains_qualification_review_required
                                                                                                                                                                                                                                                          clinical review status
                                                                                                                                                                                                                                                          pending
                                                                                                                                                                                                                                                          content role
                                                                                                                                                                                                                                                          positive_indication_candidate
                                                                                                                                                                                                                                                          context span
                                                                                                                                                                                                                                                          end
                                                                                                                                                                                                                                                          21343
                                                                                                                                                                                                                                                          end exclusive
                                                                                                                                                                                                                                                          true
                                                                                                                                                                                                                                                          exact text
                                                                                                                                                                                                                                                          nt treatment of patients with RCC at intermediate-high or high risk of recurrence following nephrectomy, or following nephrectomy and resection of metastatic lesions [see Clinical Studies (14.16) ] . KEYTRUDA, in combination with belzutifan, is indicated for the adjuvant treatment of adult patients with RCC with a clear cell component (ccRCC) at intermediate-high or high risk of recurrence following nephrectomy, or following nephrectomy and resection of metastatic lesions. 1.17 Endometrial Carcinoma KEYTRUDA, in combination with carboplatin and paclitaxel, followed by KEYTRUDA as a single agent, is indicated for the treatment of adult patients with primary advanced or
                                                                                                                                                                                                                                                          label id
                                                                                                                                                                                                                                                          228e1e3f-d207-481f-8e14-9fdcbd0470e9
                                                                                                                                                                                                                                                          offset unit
                                                                                                                                                                                                                                                          unicode_code_points
                                                                                                                                                                                                                                                          source array index
                                                                                                                                                                                                                                                          0
                                                                                                                                                                                                                                                          source field
                                                                                                                                                                                                                                                          indications_and_usage_exact
                                                                                                                                                                                                                                                          source text sha256
                                                                                                                                                                                                                                                          e526ba14c91f10737e6d3331fe23a6219f58c0eca6380bfce9bd78b573fea912
                                                                                                                                                                                                                                                          start
                                                                                                                                                                                                                                                          20666
                                                                                                                                                                                                                                                          current approval status
                                                                                                                                                                                                                                                          not_reconciled
                                                                                                                                                                                                                                                          duplicate text group
                                                                                                                                                                                                                                                          dup-9fb3c2e0700a89cfd92a
                                                                                                                                                                                                                                                          extraction review status
                                                                                                                                                                                                                                                          automated_candidate_pending_source_review
                                                                                                                                                                                                                                                          generic names
                                                                                                                                                                                                                                                          1. PEMBROLIZUMAB
                                                                                                                                                                                                                                                          id
                                                                                                                                                                                                                                                          ind-span-288312c00fb462b1eb4b
                                                                                                                                                                                                                                                          label id
                                                                                                                                                                                                                                                          228e1e3f-d207-481f-8e14-9fdcbd0470e9
                                                                                                                                                                                                                                                          positive predicate support span
                                                                                                                                                                                                                                                          end
                                                                                                                                                                                                                                                          20920
                                                                                                                                                                                                                                                          end exclusive
                                                                                                                                                                                                                                                          true
                                                                                                                                                                                                                                                          exact text
                                                                                                                                                                                                                                                          is indicated
                                                                                                                                                                                                                                                          label id
                                                                                                                                                                                                                                                          228e1e3f-d207-481f-8e14-9fdcbd0470e9
                                                                                                                                                                                                                                                          offset unit
                                                                                                                                                                                                                                                          unicode_code_points
                                                                                                                                                                                                                                                          source array index
                                                                                                                                                                                                                                                          0
                                                                                                                                                                                                                                                          source field
                                                                                                                                                                                                                                                          indications_and_usage_exact
                                                                                                                                                                                                                                                          source text sha256
                                                                                                                                                                                                                                                          e526ba14c91f10737e6d3331fe23a6219f58c0eca6380bfce9bd78b573fea912
                                                                                                                                                                                                                                                          start
                                                                                                                                                                                                                                                          20908
                                                                                                                                                                                                                                                          qualifier mentions
                                                                                                                                                                                                                                                          1. context exact
                                                                                                                                                                                                                                                            with belzutifan, is indicated for the adjuvant treatment of adult patients with RCC with a clear cell component (ccRCC) at intermediat
                                                                                                                                                                                                                                                            kind
                                                                                                                                                                                                                                                            age
                                                                                                                                                                                                                                                            polarity
                                                                                                                                                                                                                                                            not_inferred
                                                                                                                                                                                                                                                            span
                                                                                                                                                                                                                                                            end
                                                                                                                                                                                                                                                            20965
                                                                                                                                                                                                                                                            end exclusive
                                                                                                                                                                                                                                                            true
                                                                                                                                                                                                                                                            exact text
                                                                                                                                                                                                                                                            adult patients
                                                                                                                                                                                                                                                            label id
                                                                                                                                                                                                                                                            228e1e3f-d207-481f-8e14-9fdcbd0470e9
                                                                                                                                                                                                                                                            offset unit
                                                                                                                                                                                                                                                            unicode_code_points
                                                                                                                                                                                                                                                            source array index
                                                                                                                                                                                                                                                            0
                                                                                                                                                                                                                                                            source field
                                                                                                                                                                                                                                                            indications_and_usage_exact
                                                                                                                                                                                                                                                            source text sha256
                                                                                                                                                                                                                                                            e526ba14c91f10737e6d3331fe23a6219f58c0eca6380bfce9bd78b573fea912
                                                                                                                                                                                                                                                            start
                                                                                                                                                                                                                                                            20951
                                                                                                                                                                                                                                                          2. context exact
                                                                                                                                                                                                                                                            wing nephrectomy, or following nephrectomy and resection of metastatic lesions.
                                                                                                                                                                                                                                                            kind
                                                                                                                                                                                                                                                            biomarker
                                                                                                                                                                                                                                                            polarity
                                                                                                                                                                                                                                                            not_inferred
                                                                                                                                                                                                                                                            span
                                                                                                                                                                                                                                                            end
                                                                                                                                                                                                                                                            21142
                                                                                                                                                                                                                                                            end exclusive
                                                                                                                                                                                                                                                            true
                                                                                                                                                                                                                                                            exact text
                                                                                                                                                                                                                                                            metastatic lesions
                                                                                                                                                                                                                                                            label id
                                                                                                                                                                                                                                                            228e1e3f-d207-481f-8e14-9fdcbd0470e9
                                                                                                                                                                                                                                                            offset unit
                                                                                                                                                                                                                                                            unicode_code_points
                                                                                                                                                                                                                                                            source array index
                                                                                                                                                                                                                                                            0
                                                                                                                                                                                                                                                            source field
                                                                                                                                                                                                                                                            indications_and_usage_exact
                                                                                                                                                                                                                                                            source text sha256
                                                                                                                                                                                                                                                            e526ba14c91f10737e6d3331fe23a6219f58c0eca6380bfce9bd78b573fea912
                                                                                                                                                                                                                                                            start
                                                                                                                                                                                                                                                            21124
                                                                                                                                                                                                                                                          3. context exact
                                                                                                                                                                                                                                                            TRUDA, in combination with belzutifan, is indicated for the adjuvant treatment of adult patients with RCC with a clear cell component (ccRCC) at intermediate-high
                                                                                                                                                                                                                                                            kind
                                                                                                                                                                                                                                                            stage_or_setting
                                                                                                                                                                                                                                                            polarity
                                                                                                                                                                                                                                                            not_inferred
                                                                                                                                                                                                                                                            span
                                                                                                                                                                                                                                                            end
                                                                                                                                                                                                                                                            20972
                                                                                                                                                                                                                                                            end exclusive
                                                                                                                                                                                                                                                            true
                                                                                                                                                                                                                                                            exact text
                                                                                                                                                                                                                                                            adjuvant treatment of adult patients with R
                                                                                                                                                                                                                                                            label id
                                                                                                                                                                                                                                                            228e1e3f-d207-481f-8e14-9fdcbd0470e9
                                                                                                                                                                                                                                                            offset unit
                                                                                                                                                                                                                                                            unicode_code_points
                                                                                                                                                                                                                                                            source array index
                                                                                                                                                                                                                                                            0
                                                                                                                                                                                                                                                            source field
                                                                                                                                                                                                                                                            indications_and_usage_exact
                                                                                                                                                                                                                                                            source text sha256
                                                                                                                                                                                                                                                            e526ba14c91f10737e6d3331fe23a6219f58c0eca6380bfce9bd78b573fea912
                                                                                                                                                                                                                                                            start
                                                                                                                                                                                                                                                            20929
                                                                                                                                                                                                                                                          4. context exact
                                                                                                                                                                                                                                                            wing nephrectomy, or following nephrectomy and resection of metastatic lesions.
                                                                                                                                                                                                                                                            kind
                                                                                                                                                                                                                                                            stage_or_setting
                                                                                                                                                                                                                                                            polarity
                                                                                                                                                                                                                                                            not_inferred
                                                                                                                                                                                                                                                            span
                                                                                                                                                                                                                                                            end
                                                                                                                                                                                                                                                            21142
                                                                                                                                                                                                                                                            end exclusive
                                                                                                                                                                                                                                                            true
                                                                                                                                                                                                                                                            exact text
                                                                                                                                                                                                                                                            metastatic lesions
                                                                                                                                                                                                                                                            label id
                                                                                                                                                                                                                                                            228e1e3f-d207-481f-8e14-9fdcbd0470e9
                                                                                                                                                                                                                                                            offset unit
                                                                                                                                                                                                                                                            unicode_code_points
                                                                                                                                                                                                                                                            source array index
                                                                                                                                                                                                                                                            0
                                                                                                                                                                                                                                                            source field
                                                                                                                                                                                                                                                            indications_and_usage_exact
                                                                                                                                                                                                                                                            source text sha256
                                                                                                                                                                                                                                                            e526ba14c91f10737e6d3331fe23a6219f58c0eca6380bfce9bd78b573fea912
                                                                                                                                                                                                                                                            start
                                                                                                                                                                                                                                                            21124
                                                                                                                                                                                                                                                          5. context exact
                                                                                                                                                                                                                                                            KEYTRUDA, in combination with belzutifan, is indicated for the adjuvant treatment of adult patients with RCC with a clear cell component (ccRCC) at intermediate-high or high risk of recurrence following nephrectomy, or following nephrectomy and rese
                                                                                                                                                                                                                                                            kind
                                                                                                                                                                                                                                                            regimen
                                                                                                                                                                                                                                                            polarity
                                                                                                                                                                                                                                                            not_inferred
                                                                                                                                                                                                                                                            span
                                                                                                                                                                                                                                                            end
                                                                                                                                                                                                                                                            21055
                                                                                                                                                                                                                                                            end exclusive
                                                                                                                                                                                                                                                            true
                                                                                                                                                                                                                                                            exact text
                                                                                                                                                                                                                                                            in combination with belzutifan, is indicated for the adjuvant treatment of adult patients with RCC with a clear cell component (ccRCC) at intermediate-high or high risk of recurre
                                                                                                                                                                                                                                                            label id
                                                                                                                                                                                                                                                            228e1e3f-d207-481f-8e14-9fdcbd0470e9
                                                                                                                                                                                                                                                            offset unit
                                                                                                                                                                                                                                                            unicode_code_points
                                                                                                                                                                                                                                                            source array index
                                                                                                                                                                                                                                                            0
                                                                                                                                                                                                                                                            source field
                                                                                                                                                                                                                                                            indications_and_usage_exact
                                                                                                                                                                                                                                                            source text sha256
                                                                                                                                                                                                                                                            e526ba14c91f10737e6d3331fe23a6219f58c0eca6380bfce9bd78b573fea912
                                                                                                                                                                                                                                                            start
                                                                                                                                                                                                                                                            20876
                                                                                                                                                                                                                                                          regulatory links
                                                                                                                                                                                                                                                            schema version
                                                                                                                                                                                                                                                            0.1.0
                                                                                                                                                                                                                                                            source batch sha256
                                                                                                                                                                                                                                                            fc39a8c5cf96bf95ca20b85578140167b66b2741f7d9217f500d9ba0847ac058
                                                                                                                                                                                                                                                            source defined aliases
                                                                                                                                                                                                                                                            1. abbreviation
                                                                                                                                                                                                                                                              NSCLC
                                                                                                                                                                                                                                                              definition exact
                                                                                                                                                                                                                                                              Non-Small Cell Lung Cancer
                                                                                                                                                                                                                                                              definition span
                                                                                                                                                                                                                                                              end
                                                                                                                                                                                                                                                              380
                                                                                                                                                                                                                                                              end exclusive
                                                                                                                                                                                                                                                              true
                                                                                                                                                                                                                                                              exact text
                                                                                                                                                                                                                                                              Non-Small Cell Lung Cancer (NSCLC)
                                                                                                                                                                                                                                                              label id
                                                                                                                                                                                                                                                              228e1e3f-d207-481f-8e14-9fdcbd0470e9
                                                                                                                                                                                                                                                              offset unit
                                                                                                                                                                                                                                                              unicode_code_points
                                                                                                                                                                                                                                                              source array index
                                                                                                                                                                                                                                                              0
                                                                                                                                                                                                                                                              source field
                                                                                                                                                                                                                                                              indications_and_usage_exact
                                                                                                                                                                                                                                                              source text sha256
                                                                                                                                                                                                                                                              e526ba14c91f10737e6d3331fe23a6219f58c0eca6380bfce9bd78b573fea912
                                                                                                                                                                                                                                                              start
                                                                                                                                                                                                                                                              346
                                                                                                                                                                                                                                                            2. abbreviation
                                                                                                                                                                                                                                                              CRC
                                                                                                                                                                                                                                                              definition exact
                                                                                                                                                                                                                                                              Colorectal Cancer
                                                                                                                                                                                                                                                              definition span
                                                                                                                                                                                                                                                              end
                                                                                                                                                                                                                                                              5042
                                                                                                                                                                                                                                                              end exclusive
                                                                                                                                                                                                                                                              true
                                                                                                                                                                                                                                                              exact text
                                                                                                                                                                                                                                                              Colorectal Cancer (CRC)
                                                                                                                                                                                                                                                              label id
                                                                                                                                                                                                                                                              228e1e3f-d207-481f-8e14-9fdcbd0470e9
                                                                                                                                                                                                                                                              offset unit
                                                                                                                                                                                                                                                              unicode_code_points
                                                                                                                                                                                                                                                              source array index
                                                                                                                                                                                                                                                              0
                                                                                                                                                                                                                                                              source field
                                                                                                                                                                                                                                                              indications_and_usage_exact
                                                                                                                                                                                                                                                              source text sha256
                                                                                                                                                                                                                                                              e526ba14c91f10737e6d3331fe23a6219f58c0eca6380bfce9bd78b573fea912
                                                                                                                                                                                                                                                              start
                                                                                                                                                                                                                                                              5019
                                                                                                                                                                                                                                                            source span
                                                                                                                                                                                                                                                            end
                                                                                                                                                                                                                                                            21143
                                                                                                                                                                                                                                                            end exclusive
                                                                                                                                                                                                                                                            true
                                                                                                                                                                                                                                                            exact text
                                                                                                                                                                                                                                                            KEYTRUDA, in combination with belzutifan, is indicated for the adjuvant treatment of adult patients with RCC with a clear cell component (ccRCC) at intermediate-high or high risk of recurrence following nephrectomy, or following nephrectomy and resection of metastatic lesions.
                                                                                                                                                                                                                                                            label id
                                                                                                                                                                                                                                                            228e1e3f-d207-481f-8e14-9fdcbd0470e9
                                                                                                                                                                                                                                                            offset unit
                                                                                                                                                                                                                                                            unicode_code_points
                                                                                                                                                                                                                                                            source array index
                                                                                                                                                                                                                                                            0
                                                                                                                                                                                                                                                            source field
                                                                                                                                                                                                                                                            indications_and_usage_exact
                                                                                                                                                                                                                                                            source text sha256
                                                                                                                                                                                                                                                            e526ba14c91f10737e6d3331fe23a6219f58c0eca6380bfce9bd78b573fea912
                                                                                                                                                                                                                                                            start
                                                                                                                                                                                                                                                            20866
                                                                                                                                                                                                                                                            source url
                                                                                                                                                                                                                                                            https://api.fda.gov/drug/label.json?search=id%3A%22228e1e3f-d207-481f-8e14-9fdcbd0470e9%22
                                                                                                                                                                                                                                                            spl effective date
                                                                                                                                                                                                                                                            2026-07-10
                                                                                                                                                                                                                                                            spl set id
                                                                                                                                                                                                                                                            9333c79b-d487-4538-a9f0-71b91a02b287
                                                                                                                                                                                                                                                            spl version
                                                                                                                                                                                                                                                            228
                                                                                                                                                                                                                                                            structured fields status
                                                                                                                                                                                                                                                            not_extracted_no_values_inferred_from_mentions
                                                                                                                                                                                                                                                            structured indication
                                                                                                                                                                                                                                                            age
                                                                                                                                                                                                                                                            Source null
                                                                                                                                                                                                                                                            approval pathway
                                                                                                                                                                                                                                                            Source null
                                                                                                                                                                                                                                                            biomarker and test
                                                                                                                                                                                                                                                            Source null
                                                                                                                                                                                                                                                            disease stage
                                                                                                                                                                                                                                                            Source null
                                                                                                                                                                                                                                                            limitations
                                                                                                                                                                                                                                                            Source null
                                                                                                                                                                                                                                                            line
                                                                                                                                                                                                                                                            Source null
                                                                                                                                                                                                                                                            prior therapy
                                                                                                                                                                                                                                                            Source null
                                                                                                                                                                                                                                                            regimen
                                                                                                                                                                                                                                                            Source null
                                                                                                                                                                                                                                                            tumor histology
                                                                                                                                                                                                                                                            Source null
                                                                                                                                                                                                                                                            use intent
                                                                                                                                                                                                                                                            non_oncology_or_unclear_candidate
                                                                                                                                                                                                                                                            Passage 103 · positive indication candidate
                                                                                                                                                                                                                                                            application numbers
                                                                                                                                                                                                                                                            1. BLA125514
                                                                                                                                                                                                                                                            brand names
                                                                                                                                                                                                                                                            1. KEYTRUDA
                                                                                                                                                                                                                                                            classification reasons
                                                                                                                                                                                                                                                            1. explicit_positive_indication_predicate
                                                                                                                                                                                                                                                            2. tumor_or_malignant_hematology_words_in_positive_statement
                                                                                                                                                                                                                                                            clinical review status
                                                                                                                                                                                                                                                            pending
                                                                                                                                                                                                                                                            content role
                                                                                                                                                                                                                                                            positive_indication_candidate
                                                                                                                                                                                                                                                            context span
                                                                                                                                                                                                                                                            end
                                                                                                                                                                                                                                                            21575
                                                                                                                                                                                                                                                            end exclusive
                                                                                                                                                                                                                                                            true
                                                                                                                                                                                                                                                            exact text
                                                                                                                                                                                                                                                            ent of adult patients with RCC with a clear cell component (ccRCC) at intermediate-high or high risk of recurrence following nephrectomy, or following nephrectomy and resection of metastatic lesions. 1.17 Endometrial Carcinoma KEYTRUDA, in combination with carboplatin and paclitaxel, followed by KEYTRUDA as a single agent, is indicated for the treatment of adult patients with primary advanced or recurrent endometrial carcinoma. KEYTRUDA, in combination with lenvatinib, is indicated for the treatment of adult patients with advanced endometrial carcinoma that is mismatch repair proficient (pMMR) or not MSI-H as determined by
                                                                                                                                                                                                                                                            label id
                                                                                                                                                                                                                                                            228e1e3f-d207-481f-8e14-9fdcbd0470e9
                                                                                                                                                                                                                                                            offset unit
                                                                                                                                                                                                                                                            unicode_code_points
                                                                                                                                                                                                                                                            source array index
                                                                                                                                                                                                                                                            0
                                                                                                                                                                                                                                                            source field
                                                                                                                                                                                                                                                            indications_and_usage_exact
                                                                                                                                                                                                                                                            source text sha256
                                                                                                                                                                                                                                                            e526ba14c91f10737e6d3331fe23a6219f58c0eca6380bfce9bd78b573fea912
                                                                                                                                                                                                                                                            start
                                                                                                                                                                                                                                                            20944
                                                                                                                                                                                                                                                            current approval status
                                                                                                                                                                                                                                                            not_reconciled
                                                                                                                                                                                                                                                            duplicate text group
                                                                                                                                                                                                                                                            dup-252a9523450dc73d0f56
                                                                                                                                                                                                                                                            extraction review status
                                                                                                                                                                                                                                                            automated_candidate_pending_source_review
                                                                                                                                                                                                                                                            generic names
                                                                                                                                                                                                                                                            1. PEMBROLIZUMAB
                                                                                                                                                                                                                                                            id
                                                                                                                                                                                                                                                            ind-span-bf72568b47a8d54a16c6
                                                                                                                                                                                                                                                            label id
                                                                                                                                                                                                                                                            228e1e3f-d207-481f-8e14-9fdcbd0470e9
                                                                                                                                                                                                                                                            positive predicate support span
                                                                                                                                                                                                                                                            end
                                                                                                                                                                                                                                                            21281
                                                                                                                                                                                                                                                            end exclusive
                                                                                                                                                                                                                                                            true
                                                                                                                                                                                                                                                            exact text
                                                                                                                                                                                                                                                            is indicated
                                                                                                                                                                                                                                                            label id
                                                                                                                                                                                                                                                            228e1e3f-d207-481f-8e14-9fdcbd0470e9
                                                                                                                                                                                                                                                            offset unit
                                                                                                                                                                                                                                                            unicode_code_points
                                                                                                                                                                                                                                                            source array index
                                                                                                                                                                                                                                                            0
                                                                                                                                                                                                                                                            source field
                                                                                                                                                                                                                                                            indications_and_usage_exact
                                                                                                                                                                                                                                                            source text sha256
                                                                                                                                                                                                                                                            e526ba14c91f10737e6d3331fe23a6219f58c0eca6380bfce9bd78b573fea912
                                                                                                                                                                                                                                                            start
                                                                                                                                                                                                                                                            21269
                                                                                                                                                                                                                                                            qualifier mentions
                                                                                                                                                                                                                                                            1. context exact
                                                                                                                                                                                                                                                              YTRUDA as a single agent, is indicated for the treatment of adult patients with primary advanced or recurrent endometrial carcinoma.
                                                                                                                                                                                                                                                              kind
                                                                                                                                                                                                                                                              age
                                                                                                                                                                                                                                                              polarity
                                                                                                                                                                                                                                                              not_inferred
                                                                                                                                                                                                                                                              span
                                                                                                                                                                                                                                                              end
                                                                                                                                                                                                                                                              21317
                                                                                                                                                                                                                                                              end exclusive
                                                                                                                                                                                                                                                              true
                                                                                                                                                                                                                                                              exact text
                                                                                                                                                                                                                                                              adult patients
                                                                                                                                                                                                                                                              label id
                                                                                                                                                                                                                                                              228e1e3f-d207-481f-8e14-9fdcbd0470e9
                                                                                                                                                                                                                                                              offset unit
                                                                                                                                                                                                                                                              unicode_code_points
                                                                                                                                                                                                                                                              source array index
                                                                                                                                                                                                                                                              0
                                                                                                                                                                                                                                                              source field
                                                                                                                                                                                                                                                              indications_and_usage_exact
                                                                                                                                                                                                                                                              source text sha256
                                                                                                                                                                                                                                                              e526ba14c91f10737e6d3331fe23a6219f58c0eca6380bfce9bd78b573fea912
                                                                                                                                                                                                                                                              start
                                                                                                                                                                                                                                                              21303
                                                                                                                                                                                                                                                            2. context exact
                                                                                                                                                                                                                                                              indicated for the treatment of adult patients with primary advanced or recurrent endometrial carcinoma.
                                                                                                                                                                                                                                                              kind
                                                                                                                                                                                                                                                              stage_or_setting
                                                                                                                                                                                                                                                              polarity
                                                                                                                                                                                                                                                              not_inferred
                                                                                                                                                                                                                                                              span
                                                                                                                                                                                                                                                              end
                                                                                                                                                                                                                                                              21374
                                                                                                                                                                                                                                                              end exclusive
                                                                                                                                                                                                                                                              true
                                                                                                                                                                                                                                                              exact text
                                                                                                                                                                                                                                                              advanced or recurrent endometrial carcinoma
                                                                                                                                                                                                                                                              label id
                                                                                                                                                                                                                                                              228e1e3f-d207-481f-8e14-9fdcbd0470e9
                                                                                                                                                                                                                                                              offset unit
                                                                                                                                                                                                                                                              unicode_code_points
                                                                                                                                                                                                                                                              source array index
                                                                                                                                                                                                                                                              0
                                                                                                                                                                                                                                                              source field
                                                                                                                                                                                                                                                              indications_and_usage_exact
                                                                                                                                                                                                                                                              source text sha256
                                                                                                                                                                                                                                                              e526ba14c91f10737e6d3331fe23a6219f58c0eca6380bfce9bd78b573fea912
                                                                                                                                                                                                                                                              start
                                                                                                                                                                                                                                                              21331
                                                                                                                                                                                                                                                            3. context exact
                                                                                                                                                                                                                                                              1.17 Endometrial Carcinoma KEYTRUDA, in combination with carboplatin and paclitaxel, followed by KEYTRUDA as a single agent, is indicated for the treatment of adult patients with primary advanced or recurrent endometrial carcinoma.
                                                                                                                                                                                                                                                              kind
                                                                                                                                                                                                                                                              regimen
                                                                                                                                                                                                                                                              polarity
                                                                                                                                                                                                                                                              not_inferred
                                                                                                                                                                                                                                                              span
                                                                                                                                                                                                                                                              end
                                                                                                                                                                                                                                                              21360
                                                                                                                                                                                                                                                              end exclusive
                                                                                                                                                                                                                                                              true
                                                                                                                                                                                                                                                              exact text
                                                                                                                                                                                                                                                              in combination with carboplatin and paclitaxel, followed by KEYTRUDA as a single agent, is indicated for the treatment of adult patients with primary advanced or recurrent endomet
                                                                                                                                                                                                                                                              label id
                                                                                                                                                                                                                                                              228e1e3f-d207-481f-8e14-9fdcbd0470e9
                                                                                                                                                                                                                                                              offset unit
                                                                                                                                                                                                                                                              unicode_code_points
                                                                                                                                                                                                                                                              source array index
                                                                                                                                                                                                                                                              0
                                                                                                                                                                                                                                                              source field
                                                                                                                                                                                                                                                              indications_and_usage_exact
                                                                                                                                                                                                                                                              source text sha256
                                                                                                                                                                                                                                                              e526ba14c91f10737e6d3331fe23a6219f58c0eca6380bfce9bd78b573fea912
                                                                                                                                                                                                                                                              start
                                                                                                                                                                                                                                                              21181
                                                                                                                                                                                                                                                            regulatory links
                                                                                                                                                                                                                                                              schema version
                                                                                                                                                                                                                                                              0.1.0
                                                                                                                                                                                                                                                              source batch sha256
                                                                                                                                                                                                                                                              fc39a8c5cf96bf95ca20b85578140167b66b2741f7d9217f500d9ba0847ac058
                                                                                                                                                                                                                                                              source defined aliases
                                                                                                                                                                                                                                                              1. abbreviation
                                                                                                                                                                                                                                                                NSCLC
                                                                                                                                                                                                                                                                definition exact
                                                                                                                                                                                                                                                                Non-Small Cell Lung Cancer
                                                                                                                                                                                                                                                                definition span
                                                                                                                                                                                                                                                                end
                                                                                                                                                                                                                                                                380
                                                                                                                                                                                                                                                                end exclusive
                                                                                                                                                                                                                                                                true
                                                                                                                                                                                                                                                                exact text
                                                                                                                                                                                                                                                                Non-Small Cell Lung Cancer (NSCLC)
                                                                                                                                                                                                                                                                label id
                                                                                                                                                                                                                                                                228e1e3f-d207-481f-8e14-9fdcbd0470e9
                                                                                                                                                                                                                                                                offset unit
                                                                                                                                                                                                                                                                unicode_code_points
                                                                                                                                                                                                                                                                source array index
                                                                                                                                                                                                                                                                0
                                                                                                                                                                                                                                                                source field
                                                                                                                                                                                                                                                                indications_and_usage_exact
                                                                                                                                                                                                                                                                source text sha256
                                                                                                                                                                                                                                                                e526ba14c91f10737e6d3331fe23a6219f58c0eca6380bfce9bd78b573fea912
                                                                                                                                                                                                                                                                start
                                                                                                                                                                                                                                                                346
                                                                                                                                                                                                                                                              2. abbreviation
                                                                                                                                                                                                                                                                CRC
                                                                                                                                                                                                                                                                definition exact
                                                                                                                                                                                                                                                                Colorectal Cancer
                                                                                                                                                                                                                                                                definition span
                                                                                                                                                                                                                                                                end
                                                                                                                                                                                                                                                                5042
                                                                                                                                                                                                                                                                end exclusive
                                                                                                                                                                                                                                                                true
                                                                                                                                                                                                                                                                exact text
                                                                                                                                                                                                                                                                Colorectal Cancer (CRC)
                                                                                                                                                                                                                                                                label id
                                                                                                                                                                                                                                                                228e1e3f-d207-481f-8e14-9fdcbd0470e9
                                                                                                                                                                                                                                                                offset unit
                                                                                                                                                                                                                                                                unicode_code_points
                                                                                                                                                                                                                                                                source array index
                                                                                                                                                                                                                                                                0
                                                                                                                                                                                                                                                                source field
                                                                                                                                                                                                                                                                indications_and_usage_exact
                                                                                                                                                                                                                                                                source text sha256
                                                                                                                                                                                                                                                                e526ba14c91f10737e6d3331fe23a6219f58c0eca6380bfce9bd78b573fea912
                                                                                                                                                                                                                                                                start
                                                                                                                                                                                                                                                                5019
                                                                                                                                                                                                                                                              source span
                                                                                                                                                                                                                                                              end
                                                                                                                                                                                                                                                              21375
                                                                                                                                                                                                                                                              end exclusive
                                                                                                                                                                                                                                                              true
                                                                                                                                                                                                                                                              exact text
                                                                                                                                                                                                                                                              1.17 Endometrial Carcinoma KEYTRUDA, in combination with carboplatin and paclitaxel, followed by KEYTRUDA as a single agent, is indicated for the treatment of adult patients with primary advanced or recurrent endometrial carcinoma.
                                                                                                                                                                                                                                                              label id
                                                                                                                                                                                                                                                              228e1e3f-d207-481f-8e14-9fdcbd0470e9
                                                                                                                                                                                                                                                              offset unit
                                                                                                                                                                                                                                                              unicode_code_points
                                                                                                                                                                                                                                                              source array index
                                                                                                                                                                                                                                                              0
                                                                                                                                                                                                                                                              source field
                                                                                                                                                                                                                                                              indications_and_usage_exact
                                                                                                                                                                                                                                                              source text sha256
                                                                                                                                                                                                                                                              e526ba14c91f10737e6d3331fe23a6219f58c0eca6380bfce9bd78b573fea912
                                                                                                                                                                                                                                                              start
                                                                                                                                                                                                                                                              21144
                                                                                                                                                                                                                                                              source url
                                                                                                                                                                                                                                                              https://api.fda.gov/drug/label.json?search=id%3A%22228e1e3f-d207-481f-8e14-9fdcbd0470e9%22
                                                                                                                                                                                                                                                              spl effective date
                                                                                                                                                                                                                                                              2026-07-10
                                                                                                                                                                                                                                                              spl set id
                                                                                                                                                                                                                                                              9333c79b-d487-4538-a9f0-71b91a02b287
                                                                                                                                                                                                                                                              spl version
                                                                                                                                                                                                                                                              228
                                                                                                                                                                                                                                                              structured fields status
                                                                                                                                                                                                                                                              not_extracted_no_values_inferred_from_mentions
                                                                                                                                                                                                                                                              structured indication
                                                                                                                                                                                                                                                              age
                                                                                                                                                                                                                                                              Source null
                                                                                                                                                                                                                                                              approval pathway
                                                                                                                                                                                                                                                              Source null
                                                                                                                                                                                                                                                              biomarker and test
                                                                                                                                                                                                                                                              Source null
                                                                                                                                                                                                                                                              disease stage
                                                                                                                                                                                                                                                              Source null
                                                                                                                                                                                                                                                              limitations
                                                                                                                                                                                                                                                              Source null
                                                                                                                                                                                                                                                              line
                                                                                                                                                                                                                                                              Source null
                                                                                                                                                                                                                                                              prior therapy
                                                                                                                                                                                                                                                              Source null
                                                                                                                                                                                                                                                              regimen
                                                                                                                                                                                                                                                              Source null
                                                                                                                                                                                                                                                              tumor histology
                                                                                                                                                                                                                                                              Source null
                                                                                                                                                                                                                                                              use intent
                                                                                                                                                                                                                                                              tumor_directed_candidate
                                                                                                                                                                                                                                                              Passage 104 · positive indication candidate
                                                                                                                                                                                                                                                              application numbers
                                                                                                                                                                                                                                                              1. BLA125514
                                                                                                                                                                                                                                                              brand names
                                                                                                                                                                                                                                                              1. KEYTRUDA
                                                                                                                                                                                                                                                              classification reasons
                                                                                                                                                                                                                                                              1. explicit_positive_indication_predicate
                                                                                                                                                                                                                                                              2. tumor_or_malignant_hematology_words_in_positive_statement
                                                                                                                                                                                                                                                              clinical review status
                                                                                                                                                                                                                                                              pending
                                                                                                                                                                                                                                                              content role
                                                                                                                                                                                                                                                              positive_indication_candidate
                                                                                                                                                                                                                                                              context span
                                                                                                                                                                                                                                                              end
                                                                                                                                                                                                                                                              21973
                                                                                                                                                                                                                                                              end exclusive
                                                                                                                                                                                                                                                              true
                                                                                                                                                                                                                                                              exact text
                                                                                                                                                                                                                                                              UDA, in combination with carboplatin and paclitaxel, followed by KEYTRUDA as a single agent, is indicated for the treatment of adult patients with primary advanced or recurrent endometrial carcinoma. KEYTRUDA, in combination with lenvatinib, is indicated for the treatment of adult patients with advanced endometrial carcinoma that is mismatch repair proficient (pMMR) or not MSI-H as determined by an FDA-authorized test, who have disease progression following prior systemic therapy in any setting and are not candidates for curative surgery or radiation [see Dosage and Administration (2.1) ] . KEYTRUDA, as a single agent, is indicated for the treatment of adult patients with advanced endometrial carcinoma that is MSI-H or dMMR, as determined by an FDA-authorized test, who have disease prog
                                                                                                                                                                                                                                                              label id
                                                                                                                                                                                                                                                              228e1e3f-d207-481f-8e14-9fdcbd0470e9
                                                                                                                                                                                                                                                              offset unit
                                                                                                                                                                                                                                                              unicode_code_points
                                                                                                                                                                                                                                                              source array index
                                                                                                                                                                                                                                                              0
                                                                                                                                                                                                                                                              source field
                                                                                                                                                                                                                                                              indications_and_usage_exact
                                                                                                                                                                                                                                                              source text sha256
                                                                                                                                                                                                                                                              e526ba14c91f10737e6d3331fe23a6219f58c0eca6380bfce9bd78b573fea912
                                                                                                                                                                                                                                                              start
                                                                                                                                                                                                                                                              21176
                                                                                                                                                                                                                                                              current approval status
                                                                                                                                                                                                                                                              not_reconciled
                                                                                                                                                                                                                                                              duplicate text group
                                                                                                                                                                                                                                                              dup-352a04b1fce679e5d6e4
                                                                                                                                                                                                                                                              extraction review status
                                                                                                                                                                                                                                                              automated_candidate_pending_source_review
                                                                                                                                                                                                                                                              generic names
                                                                                                                                                                                                                                                              1. PEMBROLIZUMAB
                                                                                                                                                                                                                                                              id
                                                                                                                                                                                                                                                              ind-span-0671d4d4572cf56bb66b
                                                                                                                                                                                                                                                              label id
                                                                                                                                                                                                                                                              228e1e3f-d207-481f-8e14-9fdcbd0470e9
                                                                                                                                                                                                                                                              positive predicate support span
                                                                                                                                                                                                                                                              end
                                                                                                                                                                                                                                                              21430
                                                                                                                                                                                                                                                              end exclusive
                                                                                                                                                                                                                                                              true
                                                                                                                                                                                                                                                              exact text
                                                                                                                                                                                                                                                              is indicated
                                                                                                                                                                                                                                                              label id
                                                                                                                                                                                                                                                              228e1e3f-d207-481f-8e14-9fdcbd0470e9
                                                                                                                                                                                                                                                              offset unit
                                                                                                                                                                                                                                                              unicode_code_points
                                                                                                                                                                                                                                                              source array index
                                                                                                                                                                                                                                                              0
                                                                                                                                                                                                                                                              source field
                                                                                                                                                                                                                                                              indications_and_usage_exact
                                                                                                                                                                                                                                                              source text sha256
                                                                                                                                                                                                                                                              e526ba14c91f10737e6d3331fe23a6219f58c0eca6380bfce9bd78b573fea912
                                                                                                                                                                                                                                                              start
                                                                                                                                                                                                                                                              21418
                                                                                                                                                                                                                                                              qualifier mentions
                                                                                                                                                                                                                                                              1. context exact
                                                                                                                                                                                                                                                                bination with lenvatinib, is indicated for the treatment of adult patients with advanced endometrial carcinoma that is mismatch repair
                                                                                                                                                                                                                                                                kind
                                                                                                                                                                                                                                                                age
                                                                                                                                                                                                                                                                polarity
                                                                                                                                                                                                                                                                not_inferred
                                                                                                                                                                                                                                                                span
                                                                                                                                                                                                                                                                end
                                                                                                                                                                                                                                                                21466
                                                                                                                                                                                                                                                                end exclusive
                                                                                                                                                                                                                                                                true
                                                                                                                                                                                                                                                                exact text
                                                                                                                                                                                                                                                                adult patients
                                                                                                                                                                                                                                                                label id
                                                                                                                                                                                                                                                                228e1e3f-d207-481f-8e14-9fdcbd0470e9
                                                                                                                                                                                                                                                                offset unit
                                                                                                                                                                                                                                                                unicode_code_points
                                                                                                                                                                                                                                                                source array index
                                                                                                                                                                                                                                                                0
                                                                                                                                                                                                                                                                source field
                                                                                                                                                                                                                                                                indications_and_usage_exact
                                                                                                                                                                                                                                                                source text sha256
                                                                                                                                                                                                                                                                e526ba14c91f10737e6d3331fe23a6219f58c0eca6380bfce9bd78b573fea912
                                                                                                                                                                                                                                                                start
                                                                                                                                                                                                                                                                21452
                                                                                                                                                                                                                                                              2. context exact
                                                                                                                                                                                                                                                                carcinoma that is mismatch repair proficient (pMMR) or not MSI-H as determined by an FDA-authorized test, who have disease progression following prior systemic ther
                                                                                                                                                                                                                                                                kind
                                                                                                                                                                                                                                                                biomarker
                                                                                                                                                                                                                                                                polarity
                                                                                                                                                                                                                                                                not_inferred
                                                                                                                                                                                                                                                                span
                                                                                                                                                                                                                                                                end
                                                                                                                                                                                                                                                                21597
                                                                                                                                                                                                                                                                end exclusive
                                                                                                                                                                                                                                                                true
                                                                                                                                                                                                                                                                exact text
                                                                                                                                                                                                                                                                MSI-H as determined by an FDA-authorized test
                                                                                                                                                                                                                                                                label id
                                                                                                                                                                                                                                                                228e1e3f-d207-481f-8e14-9fdcbd0470e9
                                                                                                                                                                                                                                                                offset unit
                                                                                                                                                                                                                                                                unicode_code_points
                                                                                                                                                                                                                                                                source array index
                                                                                                                                                                                                                                                                0
                                                                                                                                                                                                                                                                source field
                                                                                                                                                                                                                                                                indications_and_usage_exact
                                                                                                                                                                                                                                                                source text sha256
                                                                                                                                                                                                                                                                e526ba14c91f10737e6d3331fe23a6219f58c0eca6380bfce9bd78b573fea912
                                                                                                                                                                                                                                                                start
                                                                                                                                                                                                                                                                21552
                                                                                                                                                                                                                                                              3. context exact
                                                                                                                                                                                                                                                                inib, is indicated for the treatment of adult patients with advanced endometrial carcinoma that is mismatch repair proficient (pMMR) or not MSI-H as determined by
                                                                                                                                                                                                                                                                kind
                                                                                                                                                                                                                                                                stage_or_setting
                                                                                                                                                                                                                                                                polarity
                                                                                                                                                                                                                                                                not_inferred
                                                                                                                                                                                                                                                                span
                                                                                                                                                                                                                                                                end
                                                                                                                                                                                                                                                                21515
                                                                                                                                                                                                                                                                end exclusive
                                                                                                                                                                                                                                                                true
                                                                                                                                                                                                                                                                exact text
                                                                                                                                                                                                                                                                advanced endometrial carcinoma that is mism
                                                                                                                                                                                                                                                                label id
                                                                                                                                                                                                                                                                228e1e3f-d207-481f-8e14-9fdcbd0470e9
                                                                                                                                                                                                                                                                offset unit
                                                                                                                                                                                                                                                                unicode_code_points
                                                                                                                                                                                                                                                                source array index
                                                                                                                                                                                                                                                                0
                                                                                                                                                                                                                                                                source field
                                                                                                                                                                                                                                                                indications_and_usage_exact
                                                                                                                                                                                                                                                                source text sha256
                                                                                                                                                                                                                                                                e526ba14c91f10737e6d3331fe23a6219f58c0eca6380bfce9bd78b573fea912
                                                                                                                                                                                                                                                                start
                                                                                                                                                                                                                                                                21472
                                                                                                                                                                                                                                                              4. context exact
                                                                                                                                                                                                                                                                FDA-authorized test, who have disease progression following prior systemic therapy in any setting and are not candidates for curative surgery or radiation [see Dosage and Administration (2.1) ] .
                                                                                                                                                                                                                                                                kind
                                                                                                                                                                                                                                                                prior_therapy_or_line
                                                                                                                                                                                                                                                                polarity
                                                                                                                                                                                                                                                                not_inferred
                                                                                                                                                                                                                                                                span
                                                                                                                                                                                                                                                                end
                                                                                                                                                                                                                                                                21766
                                                                                                                                                                                                                                                                end exclusive
                                                                                                                                                                                                                                                                true
                                                                                                                                                                                                                                                                exact text
                                                                                                                                                                                                                                                                prior systemic therapy in any setting and are not candidates for curative surgery or radiation [see Dosage and Administration (2
                                                                                                                                                                                                                                                                label id
                                                                                                                                                                                                                                                                228e1e3f-d207-481f-8e14-9fdcbd0470e9
                                                                                                                                                                                                                                                                offset unit
                                                                                                                                                                                                                                                                unicode_code_points
                                                                                                                                                                                                                                                                source array index
                                                                                                                                                                                                                                                                0
                                                                                                                                                                                                                                                                source field
                                                                                                                                                                                                                                                                indications_and_usage_exact
                                                                                                                                                                                                                                                                source text sha256
                                                                                                                                                                                                                                                                e526ba14c91f10737e6d3331fe23a6219f58c0eca6380bfce9bd78b573fea912
                                                                                                                                                                                                                                                                start
                                                                                                                                                                                                                                                                21638
                                                                                                                                                                                                                                                              5. context exact
                                                                                                                                                                                                                                                                KEYTRUDA, in combination with lenvatinib, is indicated for the treatment of adult patients with advanced endometrial carcinoma that is mismatch repair proficient (pMMR) or not MSI-H as determined by an FDA-authorized test, who have disease progressi
                                                                                                                                                                                                                                                                kind
                                                                                                                                                                                                                                                                regimen
                                                                                                                                                                                                                                                                polarity
                                                                                                                                                                                                                                                                not_inferred
                                                                                                                                                                                                                                                                span
                                                                                                                                                                                                                                                                end
                                                                                                                                                                                                                                                                21565
                                                                                                                                                                                                                                                                end exclusive
                                                                                                                                                                                                                                                                true
                                                                                                                                                                                                                                                                exact text
                                                                                                                                                                                                                                                                in combination with lenvatinib, is indicated for the treatment of adult patients with advanced endometrial carcinoma that is mismatch repair proficient (pMMR) or not MSI-H as dete
                                                                                                                                                                                                                                                                label id
                                                                                                                                                                                                                                                                228e1e3f-d207-481f-8e14-9fdcbd0470e9
                                                                                                                                                                                                                                                                offset unit
                                                                                                                                                                                                                                                                unicode_code_points
                                                                                                                                                                                                                                                                source array index
                                                                                                                                                                                                                                                                0
                                                                                                                                                                                                                                                                source field
                                                                                                                                                                                                                                                                indications_and_usage_exact
                                                                                                                                                                                                                                                                source text sha256
                                                                                                                                                                                                                                                                e526ba14c91f10737e6d3331fe23a6219f58c0eca6380bfce9bd78b573fea912
                                                                                                                                                                                                                                                                start
                                                                                                                                                                                                                                                                21386
                                                                                                                                                                                                                                                              regulatory links
                                                                                                                                                                                                                                                                schema version
                                                                                                                                                                                                                                                                0.1.0
                                                                                                                                                                                                                                                                source batch sha256
                                                                                                                                                                                                                                                                fc39a8c5cf96bf95ca20b85578140167b66b2741f7d9217f500d9ba0847ac058
                                                                                                                                                                                                                                                                source defined aliases
                                                                                                                                                                                                                                                                1. abbreviation
                                                                                                                                                                                                                                                                  NSCLC
                                                                                                                                                                                                                                                                  definition exact
                                                                                                                                                                                                                                                                  Non-Small Cell Lung Cancer
                                                                                                                                                                                                                                                                  definition span
                                                                                                                                                                                                                                                                  end
                                                                                                                                                                                                                                                                  380
                                                                                                                                                                                                                                                                  end exclusive
                                                                                                                                                                                                                                                                  true
                                                                                                                                                                                                                                                                  exact text
                                                                                                                                                                                                                                                                  Non-Small Cell Lung Cancer (NSCLC)
                                                                                                                                                                                                                                                                  label id
                                                                                                                                                                                                                                                                  228e1e3f-d207-481f-8e14-9fdcbd0470e9
                                                                                                                                                                                                                                                                  offset unit
                                                                                                                                                                                                                                                                  unicode_code_points
                                                                                                                                                                                                                                                                  source array index
                                                                                                                                                                                                                                                                  0
                                                                                                                                                                                                                                                                  source field
                                                                                                                                                                                                                                                                  indications_and_usage_exact
                                                                                                                                                                                                                                                                  source text sha256
                                                                                                                                                                                                                                                                  e526ba14c91f10737e6d3331fe23a6219f58c0eca6380bfce9bd78b573fea912
                                                                                                                                                                                                                                                                  start
                                                                                                                                                                                                                                                                  346
                                                                                                                                                                                                                                                                2. abbreviation
                                                                                                                                                                                                                                                                  CRC
                                                                                                                                                                                                                                                                  definition exact
                                                                                                                                                                                                                                                                  Colorectal Cancer
                                                                                                                                                                                                                                                                  definition span
                                                                                                                                                                                                                                                                  end
                                                                                                                                                                                                                                                                  5042
                                                                                                                                                                                                                                                                  end exclusive
                                                                                                                                                                                                                                                                  true
                                                                                                                                                                                                                                                                  exact text
                                                                                                                                                                                                                                                                  Colorectal Cancer (CRC)
                                                                                                                                                                                                                                                                  label id
                                                                                                                                                                                                                                                                  228e1e3f-d207-481f-8e14-9fdcbd0470e9
                                                                                                                                                                                                                                                                  offset unit
                                                                                                                                                                                                                                                                  unicode_code_points
                                                                                                                                                                                                                                                                  source array index
                                                                                                                                                                                                                                                                  0
                                                                                                                                                                                                                                                                  source field
                                                                                                                                                                                                                                                                  indications_and_usage_exact
                                                                                                                                                                                                                                                                  source text sha256
                                                                                                                                                                                                                                                                  e526ba14c91f10737e6d3331fe23a6219f58c0eca6380bfce9bd78b573fea912
                                                                                                                                                                                                                                                                  start
                                                                                                                                                                                                                                                                  5019
                                                                                                                                                                                                                                                                source span
                                                                                                                                                                                                                                                                end
                                                                                                                                                                                                                                                                21773
                                                                                                                                                                                                                                                                end exclusive
                                                                                                                                                                                                                                                                true
                                                                                                                                                                                                                                                                exact text
                                                                                                                                                                                                                                                                KEYTRUDA, in combination with lenvatinib, is indicated for the treatment of adult patients with advanced endometrial carcinoma that is mismatch repair proficient (pMMR) or not MSI-H as determined by an FDA-authorized test, who have disease progression following prior systemic therapy in any setting and are not candidates for curative surgery or radiation [see Dosage and Administration (2.1) ] .
                                                                                                                                                                                                                                                                label id
                                                                                                                                                                                                                                                                228e1e3f-d207-481f-8e14-9fdcbd0470e9
                                                                                                                                                                                                                                                                offset unit
                                                                                                                                                                                                                                                                unicode_code_points
                                                                                                                                                                                                                                                                source array index
                                                                                                                                                                                                                                                                0
                                                                                                                                                                                                                                                                source field
                                                                                                                                                                                                                                                                indications_and_usage_exact
                                                                                                                                                                                                                                                                source text sha256
                                                                                                                                                                                                                                                                e526ba14c91f10737e6d3331fe23a6219f58c0eca6380bfce9bd78b573fea912
                                                                                                                                                                                                                                                                start
                                                                                                                                                                                                                                                                21376
                                                                                                                                                                                                                                                                source url
                                                                                                                                                                                                                                                                https://api.fda.gov/drug/label.json?search=id%3A%22228e1e3f-d207-481f-8e14-9fdcbd0470e9%22
                                                                                                                                                                                                                                                                spl effective date
                                                                                                                                                                                                                                                                2026-07-10
                                                                                                                                                                                                                                                                spl set id
                                                                                                                                                                                                                                                                9333c79b-d487-4538-a9f0-71b91a02b287
                                                                                                                                                                                                                                                                spl version
                                                                                                                                                                                                                                                                228
                                                                                                                                                                                                                                                                structured fields status
                                                                                                                                                                                                                                                                not_extracted_no_values_inferred_from_mentions
                                                                                                                                                                                                                                                                structured indication
                                                                                                                                                                                                                                                                age
                                                                                                                                                                                                                                                                Source null
                                                                                                                                                                                                                                                                approval pathway
                                                                                                                                                                                                                                                                Source null
                                                                                                                                                                                                                                                                biomarker and test
                                                                                                                                                                                                                                                                Source null
                                                                                                                                                                                                                                                                disease stage
                                                                                                                                                                                                                                                                Source null
                                                                                                                                                                                                                                                                limitations
                                                                                                                                                                                                                                                                Source null
                                                                                                                                                                                                                                                                line
                                                                                                                                                                                                                                                                Source null
                                                                                                                                                                                                                                                                prior therapy
                                                                                                                                                                                                                                                                Source null
                                                                                                                                                                                                                                                                regimen
                                                                                                                                                                                                                                                                Source null
                                                                                                                                                                                                                                                                tumor histology
                                                                                                                                                                                                                                                                Source null
                                                                                                                                                                                                                                                                use intent
                                                                                                                                                                                                                                                                tumor_directed_candidate
                                                                                                                                                                                                                                                                Passage 105 · positive indication candidate
                                                                                                                                                                                                                                                                application numbers
                                                                                                                                                                                                                                                                1. BLA125514
                                                                                                                                                                                                                                                                brand names
                                                                                                                                                                                                                                                                1. KEYTRUDA
                                                                                                                                                                                                                                                                classification reasons
                                                                                                                                                                                                                                                                1. explicit_positive_indication_predicate
                                                                                                                                                                                                                                                                2. tumor_or_malignant_hematology_words_in_positive_statement
                                                                                                                                                                                                                                                                clinical review status
                                                                                                                                                                                                                                                                pending
                                                                                                                                                                                                                                                                content role
                                                                                                                                                                                                                                                                positive_indication_candidate
                                                                                                                                                                                                                                                                context span
                                                                                                                                                                                                                                                                end
                                                                                                                                                                                                                                                                22326
                                                                                                                                                                                                                                                                end exclusive
                                                                                                                                                                                                                                                                true
                                                                                                                                                                                                                                                                exact text
                                                                                                                                                                                                                                                                an FDA-authorized test, who have disease progression following prior systemic therapy in any setting and are not candidates for curative surgery or radiation [see Dosage and Administration (2.1) ] . KEYTRUDA, as a single agent, is indicated for the treatment of adult patients with advanced endometrial carcinoma that is MSI-H or dMMR, as determined by an FDA-authorized test, who have disease progression following prior systemic therapy in any setting and are not candidates for curative surgery or radiation [see Dosage and Administration (2.1) ] . 1.18 Tumor Mutational Burden-High Cancer KEYTRUDA is indicated for the treatment of adult and pediatric patients with unresectable or metastatic tumor mutational burden-high (TMB-H) [≥10 mutations/me
                                                                                                                                                                                                                                                                label id
                                                                                                                                                                                                                                                                228e1e3f-d207-481f-8e14-9fdcbd0470e9
                                                                                                                                                                                                                                                                offset unit
                                                                                                                                                                                                                                                                unicode_code_points
                                                                                                                                                                                                                                                                source array index
                                                                                                                                                                                                                                                                0
                                                                                                                                                                                                                                                                source field
                                                                                                                                                                                                                                                                indications_and_usage_exact
                                                                                                                                                                                                                                                                source text sha256
                                                                                                                                                                                                                                                                e526ba14c91f10737e6d3331fe23a6219f58c0eca6380bfce9bd78b573fea912
                                                                                                                                                                                                                                                                start
                                                                                                                                                                                                                                                                21574
                                                                                                                                                                                                                                                                current approval status
                                                                                                                                                                                                                                                                not_reconciled
                                                                                                                                                                                                                                                                duplicate text group
                                                                                                                                                                                                                                                                dup-0b167179674fd0cdc09f
                                                                                                                                                                                                                                                                extraction review status
                                                                                                                                                                                                                                                                automated_candidate_pending_source_review
                                                                                                                                                                                                                                                                generic names
                                                                                                                                                                                                                                                                1. PEMBROLIZUMAB
                                                                                                                                                                                                                                                                id
                                                                                                                                                                                                                                                                ind-span-2861c32473546cd2bacf
                                                                                                                                                                                                                                                                label id
                                                                                                                                                                                                                                                                228e1e3f-d207-481f-8e14-9fdcbd0470e9
                                                                                                                                                                                                                                                                positive predicate support span
                                                                                                                                                                                                                                                                end
                                                                                                                                                                                                                                                                21815
                                                                                                                                                                                                                                                                end exclusive
                                                                                                                                                                                                                                                                true
                                                                                                                                                                                                                                                                exact text
                                                                                                                                                                                                                                                                is indicated
                                                                                                                                                                                                                                                                label id
                                                                                                                                                                                                                                                                228e1e3f-d207-481f-8e14-9fdcbd0470e9
                                                                                                                                                                                                                                                                offset unit
                                                                                                                                                                                                                                                                unicode_code_points
                                                                                                                                                                                                                                                                source array index
                                                                                                                                                                                                                                                                0
                                                                                                                                                                                                                                                                source field
                                                                                                                                                                                                                                                                indications_and_usage_exact
                                                                                                                                                                                                                                                                source text sha256
                                                                                                                                                                                                                                                                e526ba14c91f10737e6d3331fe23a6219f58c0eca6380bfce9bd78b573fea912
                                                                                                                                                                                                                                                                start
                                                                                                                                                                                                                                                                21803
                                                                                                                                                                                                                                                                qualifier mentions
                                                                                                                                                                                                                                                                1. context exact
                                                                                                                                                                                                                                                                  TRUDA, as a single agent, is indicated for the treatment of adult patients with advanced endometrial carcinoma that is MSI-H or dMMR,
                                                                                                                                                                                                                                                                  kind
                                                                                                                                                                                                                                                                  age
                                                                                                                                                                                                                                                                  polarity
                                                                                                                                                                                                                                                                  not_inferred
                                                                                                                                                                                                                                                                  span
                                                                                                                                                                                                                                                                  end
                                                                                                                                                                                                                                                                  21851
                                                                                                                                                                                                                                                                  end exclusive
                                                                                                                                                                                                                                                                  true
                                                                                                                                                                                                                                                                  exact text
                                                                                                                                                                                                                                                                  adult patients
                                                                                                                                                                                                                                                                  label id
                                                                                                                                                                                                                                                                  228e1e3f-d207-481f-8e14-9fdcbd0470e9
                                                                                                                                                                                                                                                                  offset unit
                                                                                                                                                                                                                                                                  unicode_code_points
                                                                                                                                                                                                                                                                  source array index
                                                                                                                                                                                                                                                                  0
                                                                                                                                                                                                                                                                  source field
                                                                                                                                                                                                                                                                  indications_and_usage_exact
                                                                                                                                                                                                                                                                  source text sha256
                                                                                                                                                                                                                                                                  e526ba14c91f10737e6d3331fe23a6219f58c0eca6380bfce9bd78b573fea912
                                                                                                                                                                                                                                                                  start
                                                                                                                                                                                                                                                                  21837
                                                                                                                                                                                                                                                                2. context exact
                                                                                                                                                                                                                                                                  adult patients with advanced endometrial carcinoma that is MSI-H or dMMR, as determined by an FDA-authorized test, who have disease
                                                                                                                                                                                                                                                                  kind
                                                                                                                                                                                                                                                                  biomarker
                                                                                                                                                                                                                                                                  polarity
                                                                                                                                                                                                                                                                  not_inferred
                                                                                                                                                                                                                                                                  span
                                                                                                                                                                                                                                                                  end
                                                                                                                                                                                                                                                                  21909
                                                                                                                                                                                                                                                                  end exclusive
                                                                                                                                                                                                                                                                  true
                                                                                                                                                                                                                                                                  exact text
                                                                                                                                                                                                                                                                  MSI-H or dMMR
                                                                                                                                                                                                                                                                  label id
                                                                                                                                                                                                                                                                  228e1e3f-d207-481f-8e14-9fdcbd0470e9
                                                                                                                                                                                                                                                                  offset unit
                                                                                                                                                                                                                                                                  unicode_code_points
                                                                                                                                                                                                                                                                  source array index
                                                                                                                                                                                                                                                                  0
                                                                                                                                                                                                                                                                  source field
                                                                                                                                                                                                                                                                  indications_and_usage_exact
                                                                                                                                                                                                                                                                  source text sha256
                                                                                                                                                                                                                                                                  e526ba14c91f10737e6d3331fe23a6219f58c0eca6380bfce9bd78b573fea912
                                                                                                                                                                                                                                                                  start
                                                                                                                                                                                                                                                                  21896
                                                                                                                                                                                                                                                                3. context exact
                                                                                                                                                                                                                                                                  gent, is indicated for the treatment of adult patients with advanced endometrial carcinoma that is MSI-H or dMMR, as determined by an FDA-authorized test, who have
                                                                                                                                                                                                                                                                  kind
                                                                                                                                                                                                                                                                  stage_or_setting
                                                                                                                                                                                                                                                                  polarity
                                                                                                                                                                                                                                                                  not_inferred
                                                                                                                                                                                                                                                                  span
                                                                                                                                                                                                                                                                  end
                                                                                                                                                                                                                                                                  21900
                                                                                                                                                                                                                                                                  end exclusive
                                                                                                                                                                                                                                                                  true
                                                                                                                                                                                                                                                                  exact text
                                                                                                                                                                                                                                                                  advanced endometrial carcinoma that is MSI-
                                                                                                                                                                                                                                                                  label id
                                                                                                                                                                                                                                                                  228e1e3f-d207-481f-8e14-9fdcbd0470e9
                                                                                                                                                                                                                                                                  offset unit
                                                                                                                                                                                                                                                                  unicode_code_points
                                                                                                                                                                                                                                                                  source array index
                                                                                                                                                                                                                                                                  0
                                                                                                                                                                                                                                                                  source field
                                                                                                                                                                                                                                                                  indications_and_usage_exact
                                                                                                                                                                                                                                                                  source text sha256
                                                                                                                                                                                                                                                                  e526ba14c91f10737e6d3331fe23a6219f58c0eca6380bfce9bd78b573fea912
                                                                                                                                                                                                                                                                  start
                                                                                                                                                                                                                                                                  21857
                                                                                                                                                                                                                                                                4. context exact
                                                                                                                                                                                                                                                                  FDA-authorized test, who have disease progression following prior systemic therapy in any setting and are not candidates for curative surgery or radiation [see Dosage and Administration (2.1) ] .
                                                                                                                                                                                                                                                                  kind
                                                                                                                                                                                                                                                                  prior_therapy_or_line
                                                                                                                                                                                                                                                                  polarity
                                                                                                                                                                                                                                                                  not_inferred
                                                                                                                                                                                                                                                                  span
                                                                                                                                                                                                                                                                  end
                                                                                                                                                                                                                                                                  22119
                                                                                                                                                                                                                                                                  end exclusive
                                                                                                                                                                                                                                                                  true
                                                                                                                                                                                                                                                                  exact text
                                                                                                                                                                                                                                                                  prior systemic therapy in any setting and are not candidates for curative surgery or radiation [see Dosage and Administration (2
                                                                                                                                                                                                                                                                  label id
                                                                                                                                                                                                                                                                  228e1e3f-d207-481f-8e14-9fdcbd0470e9
                                                                                                                                                                                                                                                                  offset unit
                                                                                                                                                                                                                                                                  unicode_code_points
                                                                                                                                                                                                                                                                  source array index
                                                                                                                                                                                                                                                                  0
                                                                                                                                                                                                                                                                  source field
                                                                                                                                                                                                                                                                  indications_and_usage_exact
                                                                                                                                                                                                                                                                  source text sha256
                                                                                                                                                                                                                                                                  e526ba14c91f10737e6d3331fe23a6219f58c0eca6380bfce9bd78b573fea912
                                                                                                                                                                                                                                                                  start
                                                                                                                                                                                                                                                                  21991
                                                                                                                                                                                                                                                                5. context exact
                                                                                                                                                                                                                                                                  KEYTRUDA, as a single agent, is indicated for the treatment of adult patients with advanced endometrial carcinoma that is MSI-H or dMMR, as determined by an FDA-authorized test, who have disease progression following prior systemic therapy in any
                                                                                                                                                                                                                                                                  kind
                                                                                                                                                                                                                                                                  regimen
                                                                                                                                                                                                                                                                  polarity
                                                                                                                                                                                                                                                                  not_inferred
                                                                                                                                                                                                                                                                  span
                                                                                                                                                                                                                                                                  end
                                                                                                                                                                                                                                                                  21961
                                                                                                                                                                                                                                                                  end exclusive
                                                                                                                                                                                                                                                                  true
                                                                                                                                                                                                                                                                  exact text
                                                                                                                                                                                                                                                                  as a single agent, is indicated for the treatment of adult patients with advanced endometrial carcinoma that is MSI-H or dMMR, as determined by an FDA-authorized test, who have
                                                                                                                                                                                                                                                                  label id
                                                                                                                                                                                                                                                                  228e1e3f-d207-481f-8e14-9fdcbd0470e9
                                                                                                                                                                                                                                                                  offset unit
                                                                                                                                                                                                                                                                  unicode_code_points
                                                                                                                                                                                                                                                                  source array index
                                                                                                                                                                                                                                                                  0
                                                                                                                                                                                                                                                                  source field
                                                                                                                                                                                                                                                                  indications_and_usage_exact
                                                                                                                                                                                                                                                                  source text sha256
                                                                                                                                                                                                                                                                  e526ba14c91f10737e6d3331fe23a6219f58c0eca6380bfce9bd78b573fea912
                                                                                                                                                                                                                                                                  start
                                                                                                                                                                                                                                                                  21784
                                                                                                                                                                                                                                                                regulatory links
                                                                                                                                                                                                                                                                  schema version
                                                                                                                                                                                                                                                                  0.1.0
                                                                                                                                                                                                                                                                  source batch sha256
                                                                                                                                                                                                                                                                  fc39a8c5cf96bf95ca20b85578140167b66b2741f7d9217f500d9ba0847ac058
                                                                                                                                                                                                                                                                  source defined aliases
                                                                                                                                                                                                                                                                  1. abbreviation
                                                                                                                                                                                                                                                                    NSCLC
                                                                                                                                                                                                                                                                    definition exact
                                                                                                                                                                                                                                                                    Non-Small Cell Lung Cancer
                                                                                                                                                                                                                                                                    definition span
                                                                                                                                                                                                                                                                    end
                                                                                                                                                                                                                                                                    380
                                                                                                                                                                                                                                                                    end exclusive
                                                                                                                                                                                                                                                                    true
                                                                                                                                                                                                                                                                    exact text
                                                                                                                                                                                                                                                                    Non-Small Cell Lung Cancer (NSCLC)
                                                                                                                                                                                                                                                                    label id
                                                                                                                                                                                                                                                                    228e1e3f-d207-481f-8e14-9fdcbd0470e9
                                                                                                                                                                                                                                                                    offset unit
                                                                                                                                                                                                                                                                    unicode_code_points
                                                                                                                                                                                                                                                                    source array index
                                                                                                                                                                                                                                                                    0
                                                                                                                                                                                                                                                                    source field
                                                                                                                                                                                                                                                                    indications_and_usage_exact
                                                                                                                                                                                                                                                                    source text sha256
                                                                                                                                                                                                                                                                    e526ba14c91f10737e6d3331fe23a6219f58c0eca6380bfce9bd78b573fea912
                                                                                                                                                                                                                                                                    start
                                                                                                                                                                                                                                                                    346
                                                                                                                                                                                                                                                                  2. abbreviation
                                                                                                                                                                                                                                                                    CRC
                                                                                                                                                                                                                                                                    definition exact
                                                                                                                                                                                                                                                                    Colorectal Cancer
                                                                                                                                                                                                                                                                    definition span
                                                                                                                                                                                                                                                                    end
                                                                                                                                                                                                                                                                    5042
                                                                                                                                                                                                                                                                    end exclusive
                                                                                                                                                                                                                                                                    true
                                                                                                                                                                                                                                                                    exact text
                                                                                                                                                                                                                                                                    Colorectal Cancer (CRC)
                                                                                                                                                                                                                                                                    label id
                                                                                                                                                                                                                                                                    228e1e3f-d207-481f-8e14-9fdcbd0470e9
                                                                                                                                                                                                                                                                    offset unit
                                                                                                                                                                                                                                                                    unicode_code_points
                                                                                                                                                                                                                                                                    source array index
                                                                                                                                                                                                                                                                    0
                                                                                                                                                                                                                                                                    source field
                                                                                                                                                                                                                                                                    indications_and_usage_exact
                                                                                                                                                                                                                                                                    source text sha256
                                                                                                                                                                                                                                                                    e526ba14c91f10737e6d3331fe23a6219f58c0eca6380bfce9bd78b573fea912
                                                                                                                                                                                                                                                                    start
                                                                                                                                                                                                                                                                    5019
                                                                                                                                                                                                                                                                  source span
                                                                                                                                                                                                                                                                  end
                                                                                                                                                                                                                                                                  22126
                                                                                                                                                                                                                                                                  end exclusive
                                                                                                                                                                                                                                                                  true
                                                                                                                                                                                                                                                                  exact text
                                                                                                                                                                                                                                                                  KEYTRUDA, as a single agent, is indicated for the treatment of adult patients with advanced endometrial carcinoma that is MSI-H or dMMR, as determined by an FDA-authorized test, who have disease progression following prior systemic therapy in any setting and are not candidates for curative surgery or radiation [see Dosage and Administration (2.1) ] .
                                                                                                                                                                                                                                                                  label id
                                                                                                                                                                                                                                                                  228e1e3f-d207-481f-8e14-9fdcbd0470e9
                                                                                                                                                                                                                                                                  offset unit
                                                                                                                                                                                                                                                                  unicode_code_points
                                                                                                                                                                                                                                                                  source array index
                                                                                                                                                                                                                                                                  0
                                                                                                                                                                                                                                                                  source field
                                                                                                                                                                                                                                                                  indications_and_usage_exact
                                                                                                                                                                                                                                                                  source text sha256
                                                                                                                                                                                                                                                                  e526ba14c91f10737e6d3331fe23a6219f58c0eca6380bfce9bd78b573fea912
                                                                                                                                                                                                                                                                  start
                                                                                                                                                                                                                                                                  21774
                                                                                                                                                                                                                                                                  source url
                                                                                                                                                                                                                                                                  https://api.fda.gov/drug/label.json?search=id%3A%22228e1e3f-d207-481f-8e14-9fdcbd0470e9%22
                                                                                                                                                                                                                                                                  spl effective date
                                                                                                                                                                                                                                                                  2026-07-10
                                                                                                                                                                                                                                                                  spl set id
                                                                                                                                                                                                                                                                  9333c79b-d487-4538-a9f0-71b91a02b287
                                                                                                                                                                                                                                                                  spl version
                                                                                                                                                                                                                                                                  228
                                                                                                                                                                                                                                                                  structured fields status
                                                                                                                                                                                                                                                                  not_extracted_no_values_inferred_from_mentions
                                                                                                                                                                                                                                                                  structured indication
                                                                                                                                                                                                                                                                  age
                                                                                                                                                                                                                                                                  Source null
                                                                                                                                                                                                                                                                  approval pathway
                                                                                                                                                                                                                                                                  Source null
                                                                                                                                                                                                                                                                  biomarker and test
                                                                                                                                                                                                                                                                  Source null
                                                                                                                                                                                                                                                                  disease stage
                                                                                                                                                                                                                                                                  Source null
                                                                                                                                                                                                                                                                  limitations
                                                                                                                                                                                                                                                                  Source null
                                                                                                                                                                                                                                                                  line
                                                                                                                                                                                                                                                                  Source null
                                                                                                                                                                                                                                                                  prior therapy
                                                                                                                                                                                                                                                                  Source null
                                                                                                                                                                                                                                                                  regimen
                                                                                                                                                                                                                                                                  Source null
                                                                                                                                                                                                                                                                  tumor histology
                                                                                                                                                                                                                                                                  Source null
                                                                                                                                                                                                                                                                  use intent
                                                                                                                                                                                                                                                                  tumor_directed_candidate
                                                                                                                                                                                                                                                                  Passage 106 · positive indication candidate
                                                                                                                                                                                                                                                                  application numbers
                                                                                                                                                                                                                                                                  1. BLA125514
                                                                                                                                                                                                                                                                  brand names
                                                                                                                                                                                                                                                                  1. KEYTRUDA
                                                                                                                                                                                                                                                                  classification reasons
                                                                                                                                                                                                                                                                  1. explicit_positive_indication_predicate
                                                                                                                                                                                                                                                                  2. tumor_or_malignant_hematology_words_in_positive_statement
                                                                                                                                                                                                                                                                  clinical review status
                                                                                                                                                                                                                                                                  pending
                                                                                                                                                                                                                                                                  content role
                                                                                                                                                                                                                                                                  positive_indication_candidate
                                                                                                                                                                                                                                                                  context span
                                                                                                                                                                                                                                                                  end
                                                                                                                                                                                                                                                                  22744
                                                                                                                                                                                                                                                                  end exclusive
                                                                                                                                                                                                                                                                  true
                                                                                                                                                                                                                                                                  exact text
                                                                                                                                                                                                                                                                  an FDA-authorized test, who have disease progression following prior systemic therapy in any setting and are not candidates for curative surgery or radiation [see Dosage and Administration (2.1) ] . 1.18 Tumor Mutational Burden-High Cancer KEYTRUDA is indicated for the treatment of adult and pediatric patients with unresectable or metastatic tumor mutational burden-high (TMB-H) [≥10 mutations/megabase (mut/Mb)] solid tumors, as determined by an FDA-authorized test [see Dosage and Administration (2.1) ] , that have progressed following prior treatment and who have no satisfactory alternative treatment options. This indication is approved under accelerated approval based on tumor response rate and durability of response [see Clinical Studies (14.18) ] . Continued approval for this indication may be continge
                                                                                                                                                                                                                                                                  label id
                                                                                                                                                                                                                                                                  228e1e3f-d207-481f-8e14-9fdcbd0470e9
                                                                                                                                                                                                                                                                  offset unit
                                                                                                                                                                                                                                                                  unicode_code_points
                                                                                                                                                                                                                                                                  source array index
                                                                                                                                                                                                                                                                  0
                                                                                                                                                                                                                                                                  source field
                                                                                                                                                                                                                                                                  indications_and_usage_exact
                                                                                                                                                                                                                                                                  source text sha256
                                                                                                                                                                                                                                                                  e526ba14c91f10737e6d3331fe23a6219f58c0eca6380bfce9bd78b573fea912
                                                                                                                                                                                                                                                                  start
                                                                                                                                                                                                                                                                  21927
                                                                                                                                                                                                                                                                  current approval status
                                                                                                                                                                                                                                                                  not_reconciled
                                                                                                                                                                                                                                                                  duplicate text group
                                                                                                                                                                                                                                                                  dup-20fb7e73a80832d3d109
                                                                                                                                                                                                                                                                  extraction review status
                                                                                                                                                                                                                                                                  automated_candidate_pending_source_review
                                                                                                                                                                                                                                                                  generic names
                                                                                                                                                                                                                                                                  1. PEMBROLIZUMAB
                                                                                                                                                                                                                                                                  id
                                                                                                                                                                                                                                                                  ind-span-4cd9d829295280901dec
                                                                                                                                                                                                                                                                  label id
                                                                                                                                                                                                                                                                  228e1e3f-d207-481f-8e14-9fdcbd0470e9
                                                                                                                                                                                                                                                                  positive predicate support span
                                                                                                                                                                                                                                                                  end
                                                                                                                                                                                                                                                                  22189
                                                                                                                                                                                                                                                                  end exclusive
                                                                                                                                                                                                                                                                  true
                                                                                                                                                                                                                                                                  exact text
                                                                                                                                                                                                                                                                  is indicated
                                                                                                                                                                                                                                                                  label id
                                                                                                                                                                                                                                                                  228e1e3f-d207-481f-8e14-9fdcbd0470e9
                                                                                                                                                                                                                                                                  offset unit
                                                                                                                                                                                                                                                                  unicode_code_points
                                                                                                                                                                                                                                                                  source array index
                                                                                                                                                                                                                                                                  0
                                                                                                                                                                                                                                                                  source field
                                                                                                                                                                                                                                                                  indications_and_usage_exact
                                                                                                                                                                                                                                                                  source text sha256
                                                                                                                                                                                                                                                                  e526ba14c91f10737e6d3331fe23a6219f58c0eca6380bfce9bd78b573fea912
                                                                                                                                                                                                                                                                  start
                                                                                                                                                                                                                                                                  22177
                                                                                                                                                                                                                                                                  qualifier mentions
                                                                                                                                                                                                                                                                  1. context exact
                                                                                                                                                                                                                                                                    rden-High Cancer KEYTRUDA is indicated for the treatment of adult and pediatric patients with unresectable or metastatic tumo
                                                                                                                                                                                                                                                                    kind
                                                                                                                                                                                                                                                                    age
                                                                                                                                                                                                                                                                    polarity
                                                                                                                                                                                                                                                                    not_inferred
                                                                                                                                                                                                                                                                    span
                                                                                                                                                                                                                                                                    end
                                                                                                                                                                                                                                                                    22216
                                                                                                                                                                                                                                                                    end exclusive
                                                                                                                                                                                                                                                                    true
                                                                                                                                                                                                                                                                    exact text
                                                                                                                                                                                                                                                                    adult
                                                                                                                                                                                                                                                                    label id
                                                                                                                                                                                                                                                                    228e1e3f-d207-481f-8e14-9fdcbd0470e9
                                                                                                                                                                                                                                                                    offset unit
                                                                                                                                                                                                                                                                    unicode_code_points
                                                                                                                                                                                                                                                                    source array index
                                                                                                                                                                                                                                                                    0
                                                                                                                                                                                                                                                                    source field
                                                                                                                                                                                                                                                                    indications_and_usage_exact
                                                                                                                                                                                                                                                                    source text sha256
                                                                                                                                                                                                                                                                    e526ba14c91f10737e6d3331fe23a6219f58c0eca6380bfce9bd78b573fea912
                                                                                                                                                                                                                                                                    start
                                                                                                                                                                                                                                                                    22211
                                                                                                                                                                                                                                                                  2. context exact
                                                                                                                                                                                                                                                                    Cancer KEYTRUDA is indicated for the treatment of adult and pediatric patients with unresectable or metastatic tumor mutational burden-hig
                                                                                                                                                                                                                                                                    kind
                                                                                                                                                                                                                                                                    age
                                                                                                                                                                                                                                                                    polarity
                                                                                                                                                                                                                                                                    not_inferred
                                                                                                                                                                                                                                                                    span
                                                                                                                                                                                                                                                                    end
                                                                                                                                                                                                                                                                    22239
                                                                                                                                                                                                                                                                    end exclusive
                                                                                                                                                                                                                                                                    true
                                                                                                                                                                                                                                                                    exact text
                                                                                                                                                                                                                                                                    pediatric patients
                                                                                                                                                                                                                                                                    label id
                                                                                                                                                                                                                                                                    228e1e3f-d207-481f-8e14-9fdcbd0470e9
                                                                                                                                                                                                                                                                    offset unit
                                                                                                                                                                                                                                                                    unicode_code_points
                                                                                                                                                                                                                                                                    source array index
                                                                                                                                                                                                                                                                    0
                                                                                                                                                                                                                                                                    source field
                                                                                                                                                                                                                                                                    indications_and_usage_exact
                                                                                                                                                                                                                                                                    source text sha256
                                                                                                                                                                                                                                                                    e526ba14c91f10737e6d3331fe23a6219f58c0eca6380bfce9bd78b573fea912
                                                                                                                                                                                                                                                                    start
                                                                                                                                                                                                                                                                    22221
                                                                                                                                                                                                                                                                  3. context exact
                                                                                                                                                                                                                                                                    atment of adult and pediatric patients with unresectable or metastatic tumor mutational burden-high (TMB-H) [≥10 mutations/megabase (mut/Mb)] solid tumors, as dete
                                                                                                                                                                                                                                                                    kind
                                                                                                                                                                                                                                                                    biomarker
                                                                                                                                                                                                                                                                    polarity
                                                                                                                                                                                                                                                                    not_inferred
                                                                                                                                                                                                                                                                    span
                                                                                                                                                                                                                                                                    end
                                                                                                                                                                                                                                                                    22304
                                                                                                                                                                                                                                                                    end exclusive
                                                                                                                                                                                                                                                                    true
                                                                                                                                                                                                                                                                    exact text
                                                                                                                                                                                                                                                                    metastatic tumor mutational burden-high (TM
                                                                                                                                                                                                                                                                    label id
                                                                                                                                                                                                                                                                    228e1e3f-d207-481f-8e14-9fdcbd0470e9
                                                                                                                                                                                                                                                                    offset unit
                                                                                                                                                                                                                                                                    unicode_code_points
                                                                                                                                                                                                                                                                    source array index
                                                                                                                                                                                                                                                                    0
                                                                                                                                                                                                                                                                    source field
                                                                                                                                                                                                                                                                    indications_and_usage_exact
                                                                                                                                                                                                                                                                    source text sha256
                                                                                                                                                                                                                                                                    e526ba14c91f10737e6d3331fe23a6219f58c0eca6380bfce9bd78b573fea912
                                                                                                                                                                                                                                                                    start
                                                                                                                                                                                                                                                                    22261
                                                                                                                                                                                                                                                                  4. context exact
                                                                                                                                                                                                                                                                    ated for the treatment of adult and pediatric patients with unresectable or metastatic tumor mutational burden-high (TMB-H) [≥10 mutations/megabase (mut/Mb)] solid tum
                                                                                                                                                                                                                                                                    kind
                                                                                                                                                                                                                                                                    stage_or_setting
                                                                                                                                                                                                                                                                    polarity
                                                                                                                                                                                                                                                                    not_inferred
                                                                                                                                                                                                                                                                    span
                                                                                                                                                                                                                                                                    end
                                                                                                                                                                                                                                                                    22292
                                                                                                                                                                                                                                                                    end exclusive
                                                                                                                                                                                                                                                                    true
                                                                                                                                                                                                                                                                    exact text
                                                                                                                                                                                                                                                                    unresectable or metastatic tumor mutational bur
                                                                                                                                                                                                                                                                    label id
                                                                                                                                                                                                                                                                    228e1e3f-d207-481f-8e14-9fdcbd0470e9
                                                                                                                                                                                                                                                                    offset unit
                                                                                                                                                                                                                                                                    unicode_code_points
                                                                                                                                                                                                                                                                    source array index
                                                                                                                                                                                                                                                                    0
                                                                                                                                                                                                                                                                    source field
                                                                                                                                                                                                                                                                    indications_and_usage_exact
                                                                                                                                                                                                                                                                    source text sha256
                                                                                                                                                                                                                                                                    e526ba14c91f10737e6d3331fe23a6219f58c0eca6380bfce9bd78b573fea912
                                                                                                                                                                                                                                                                    start
                                                                                                                                                                                                                                                                    22245
                                                                                                                                                                                                                                                                  5. context exact
                                                                                                                                                                                                                                                                    and Administration (2.1) ] , that have progressed following prior treatment and who have no satisfactory alternative treatment options.
                                                                                                                                                                                                                                                                    kind
                                                                                                                                                                                                                                                                    prior_therapy_or_line
                                                                                                                                                                                                                                                                    polarity
                                                                                                                                                                                                                                                                    not_inferred
                                                                                                                                                                                                                                                                    span
                                                                                                                                                                                                                                                                    end
                                                                                                                                                                                                                                                                    22543
                                                                                                                                                                                                                                                                    end exclusive
                                                                                                                                                                                                                                                                    true
                                                                                                                                                                                                                                                                    exact text
                                                                                                                                                                                                                                                                    prior treatment and who have no satisfactory alternative treatment options
                                                                                                                                                                                                                                                                    label id
                                                                                                                                                                                                                                                                    228e1e3f-d207-481f-8e14-9fdcbd0470e9
                                                                                                                                                                                                                                                                    offset unit
                                                                                                                                                                                                                                                                    unicode_code_points
                                                                                                                                                                                                                                                                    source array index
                                                                                                                                                                                                                                                                    0
                                                                                                                                                                                                                                                                    source field
                                                                                                                                                                                                                                                                    indications_and_usage_exact
                                                                                                                                                                                                                                                                    source text sha256
                                                                                                                                                                                                                                                                    e526ba14c91f10737e6d3331fe23a6219f58c0eca6380bfce9bd78b573fea912
                                                                                                                                                                                                                                                                    start
                                                                                                                                                                                                                                                                    22469
                                                                                                                                                                                                                                                                  regulatory links
                                                                                                                                                                                                                                                                    schema version
                                                                                                                                                                                                                                                                    0.1.0
                                                                                                                                                                                                                                                                    source batch sha256
                                                                                                                                                                                                                                                                    fc39a8c5cf96bf95ca20b85578140167b66b2741f7d9217f500d9ba0847ac058
                                                                                                                                                                                                                                                                    source defined aliases
                                                                                                                                                                                                                                                                    1. abbreviation
                                                                                                                                                                                                                                                                      NSCLC
                                                                                                                                                                                                                                                                      definition exact
                                                                                                                                                                                                                                                                      Non-Small Cell Lung Cancer
                                                                                                                                                                                                                                                                      definition span
                                                                                                                                                                                                                                                                      end
                                                                                                                                                                                                                                                                      380
                                                                                                                                                                                                                                                                      end exclusive
                                                                                                                                                                                                                                                                      true
                                                                                                                                                                                                                                                                      exact text
                                                                                                                                                                                                                                                                      Non-Small Cell Lung Cancer (NSCLC)
                                                                                                                                                                                                                                                                      label id
                                                                                                                                                                                                                                                                      228e1e3f-d207-481f-8e14-9fdcbd0470e9
                                                                                                                                                                                                                                                                      offset unit
                                                                                                                                                                                                                                                                      unicode_code_points
                                                                                                                                                                                                                                                                      source array index
                                                                                                                                                                                                                                                                      0
                                                                                                                                                                                                                                                                      source field
                                                                                                                                                                                                                                                                      indications_and_usage_exact
                                                                                                                                                                                                                                                                      source text sha256
                                                                                                                                                                                                                                                                      e526ba14c91f10737e6d3331fe23a6219f58c0eca6380bfce9bd78b573fea912
                                                                                                                                                                                                                                                                      start
                                                                                                                                                                                                                                                                      346
                                                                                                                                                                                                                                                                    2. abbreviation
                                                                                                                                                                                                                                                                      CRC
                                                                                                                                                                                                                                                                      definition exact
                                                                                                                                                                                                                                                                      Colorectal Cancer
                                                                                                                                                                                                                                                                      definition span
                                                                                                                                                                                                                                                                      end
                                                                                                                                                                                                                                                                      5042
                                                                                                                                                                                                                                                                      end exclusive
                                                                                                                                                                                                                                                                      true
                                                                                                                                                                                                                                                                      exact text
                                                                                                                                                                                                                                                                      Colorectal Cancer (CRC)
                                                                                                                                                                                                                                                                      label id
                                                                                                                                                                                                                                                                      228e1e3f-d207-481f-8e14-9fdcbd0470e9
                                                                                                                                                                                                                                                                      offset unit
                                                                                                                                                                                                                                                                      unicode_code_points
                                                                                                                                                                                                                                                                      source array index
                                                                                                                                                                                                                                                                      0
                                                                                                                                                                                                                                                                      source field
                                                                                                                                                                                                                                                                      indications_and_usage_exact
                                                                                                                                                                                                                                                                      source text sha256
                                                                                                                                                                                                                                                                      e526ba14c91f10737e6d3331fe23a6219f58c0eca6380bfce9bd78b573fea912
                                                                                                                                                                                                                                                                      start
                                                                                                                                                                                                                                                                      5019
                                                                                                                                                                                                                                                                    source span
                                                                                                                                                                                                                                                                    end
                                                                                                                                                                                                                                                                    22544
                                                                                                                                                                                                                                                                    end exclusive
                                                                                                                                                                                                                                                                    true
                                                                                                                                                                                                                                                                    exact text
                                                                                                                                                                                                                                                                    1.18 Tumor Mutational Burden-High Cancer KEYTRUDA is indicated for the treatment of adult and pediatric patients with unresectable or metastatic tumor mutational burden-high (TMB-H) [≥10 mutations/megabase (mut/Mb)] solid tumors, as determined by an FDA-authorized test [see Dosage and Administration (2.1) ] , that have progressed following prior treatment and who have no satisfactory alternative treatment options.
                                                                                                                                                                                                                                                                    label id
                                                                                                                                                                                                                                                                    228e1e3f-d207-481f-8e14-9fdcbd0470e9
                                                                                                                                                                                                                                                                    offset unit
                                                                                                                                                                                                                                                                    unicode_code_points
                                                                                                                                                                                                                                                                    source array index
                                                                                                                                                                                                                                                                    0
                                                                                                                                                                                                                                                                    source field
                                                                                                                                                                                                                                                                    indications_and_usage_exact
                                                                                                                                                                                                                                                                    source text sha256
                                                                                                                                                                                                                                                                    e526ba14c91f10737e6d3331fe23a6219f58c0eca6380bfce9bd78b573fea912
                                                                                                                                                                                                                                                                    start
                                                                                                                                                                                                                                                                    22127
                                                                                                                                                                                                                                                                    source url
                                                                                                                                                                                                                                                                    https://api.fda.gov/drug/label.json?search=id%3A%22228e1e3f-d207-481f-8e14-9fdcbd0470e9%22
                                                                                                                                                                                                                                                                    spl effective date
                                                                                                                                                                                                                                                                    2026-07-10
                                                                                                                                                                                                                                                                    spl set id
                                                                                                                                                                                                                                                                    9333c79b-d487-4538-a9f0-71b91a02b287
                                                                                                                                                                                                                                                                    spl version
                                                                                                                                                                                                                                                                    228
                                                                                                                                                                                                                                                                    structured fields status
                                                                                                                                                                                                                                                                    not_extracted_no_values_inferred_from_mentions
                                                                                                                                                                                                                                                                    structured indication
                                                                                                                                                                                                                                                                    age
                                                                                                                                                                                                                                                                    Source null
                                                                                                                                                                                                                                                                    approval pathway
                                                                                                                                                                                                                                                                    Source null
                                                                                                                                                                                                                                                                    biomarker and test
                                                                                                                                                                                                                                                                    Source null
                                                                                                                                                                                                                                                                    disease stage
                                                                                                                                                                                                                                                                    Source null
                                                                                                                                                                                                                                                                    limitations
                                                                                                                                                                                                                                                                    Source null
                                                                                                                                                                                                                                                                    line
                                                                                                                                                                                                                                                                    Source null
                                                                                                                                                                                                                                                                    prior therapy
                                                                                                                                                                                                                                                                    Source null
                                                                                                                                                                                                                                                                    regimen
                                                                                                                                                                                                                                                                    Source null
                                                                                                                                                                                                                                                                    tumor histology
                                                                                                                                                                                                                                                                    Source null
                                                                                                                                                                                                                                                                    use intent
                                                                                                                                                                                                                                                                    tumor_directed_candidate
                                                                                                                                                                                                                                                                    Passage 107 · approval contingency
                                                                                                                                                                                                                                                                    application numbers
                                                                                                                                                                                                                                                                    1. BLA125514
                                                                                                                                                                                                                                                                    brand names
                                                                                                                                                                                                                                                                    1. KEYTRUDA
                                                                                                                                                                                                                                                                    classification reasons
                                                                                                                                                                                                                                                                    1. approval_contingency_words
                                                                                                                                                                                                                                                                    clinical review status
                                                                                                                                                                                                                                                                    pending
                                                                                                                                                                                                                                                                    content role
                                                                                                                                                                                                                                                                    approval_contingency
                                                                                                                                                                                                                                                                    context span
                                                                                                                                                                                                                                                                    end
                                                                                                                                                                                                                                                                    22889
                                                                                                                                                                                                                                                                    end exclusive
                                                                                                                                                                                                                                                                    true
                                                                                                                                                                                                                                                                    exact text
                                                                                                                                                                                                                                                                    lid tumors, as determined by an FDA-authorized test [see Dosage and Administration (2.1) ] , that have progressed following prior treatment and who have no satisfactory alternative treatment options. This indication is approved under accelerated approval based on tumor response rate and durability of response [see Clinical Studies (14.18) ] . Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trials. Limitations of Use : The safety and effectiveness of KEYTRUD
                                                                                                                                                                                                                                                                    label id
                                                                                                                                                                                                                                                                    228e1e3f-d207-481f-8e14-9fdcbd0470e9
                                                                                                                                                                                                                                                                    offset unit
                                                                                                                                                                                                                                                                    unicode_code_points
                                                                                                                                                                                                                                                                    source array index
                                                                                                                                                                                                                                                                    0
                                                                                                                                                                                                                                                                    source field
                                                                                                                                                                                                                                                                    indications_and_usage_exact
                                                                                                                                                                                                                                                                    source text sha256
                                                                                                                                                                                                                                                                    e526ba14c91f10737e6d3331fe23a6219f58c0eca6380bfce9bd78b573fea912
                                                                                                                                                                                                                                                                    start
                                                                                                                                                                                                                                                                    22345
                                                                                                                                                                                                                                                                    current approval status
                                                                                                                                                                                                                                                                    not_reconciled
                                                                                                                                                                                                                                                                    duplicate text group
                                                                                                                                                                                                                                                                    dup-a1825d0e61f59492a8aa
                                                                                                                                                                                                                                                                    extraction review status
                                                                                                                                                                                                                                                                    automated_candidate_pending_source_review
                                                                                                                                                                                                                                                                    generic names
                                                                                                                                                                                                                                                                    1. PEMBROLIZUMAB
                                                                                                                                                                                                                                                                    id
                                                                                                                                                                                                                                                                    ind-span-a6c8a2057d9cd00440a9
                                                                                                                                                                                                                                                                    label id
                                                                                                                                                                                                                                                                    228e1e3f-d207-481f-8e14-9fdcbd0470e9
                                                                                                                                                                                                                                                                    positive predicate support span
                                                                                                                                                                                                                                                                    Source null
                                                                                                                                                                                                                                                                    qualifier mentions
                                                                                                                                                                                                                                                                      regulatory links
                                                                                                                                                                                                                                                                        schema version
                                                                                                                                                                                                                                                                        0.1.0
                                                                                                                                                                                                                                                                        source batch sha256
                                                                                                                                                                                                                                                                        fc39a8c5cf96bf95ca20b85578140167b66b2741f7d9217f500d9ba0847ac058
                                                                                                                                                                                                                                                                        source defined aliases
                                                                                                                                                                                                                                                                        1. abbreviation
                                                                                                                                                                                                                                                                          NSCLC
                                                                                                                                                                                                                                                                          definition exact
                                                                                                                                                                                                                                                                          Non-Small Cell Lung Cancer
                                                                                                                                                                                                                                                                          definition span
                                                                                                                                                                                                                                                                          end
                                                                                                                                                                                                                                                                          380
                                                                                                                                                                                                                                                                          end exclusive
                                                                                                                                                                                                                                                                          true
                                                                                                                                                                                                                                                                          exact text
                                                                                                                                                                                                                                                                          Non-Small Cell Lung Cancer (NSCLC)
                                                                                                                                                                                                                                                                          label id
                                                                                                                                                                                                                                                                          228e1e3f-d207-481f-8e14-9fdcbd0470e9
                                                                                                                                                                                                                                                                          offset unit
                                                                                                                                                                                                                                                                          unicode_code_points
                                                                                                                                                                                                                                                                          source array index
                                                                                                                                                                                                                                                                          0
                                                                                                                                                                                                                                                                          source field
                                                                                                                                                                                                                                                                          indications_and_usage_exact
                                                                                                                                                                                                                                                                          source text sha256
                                                                                                                                                                                                                                                                          e526ba14c91f10737e6d3331fe23a6219f58c0eca6380bfce9bd78b573fea912
                                                                                                                                                                                                                                                                          start
                                                                                                                                                                                                                                                                          346
                                                                                                                                                                                                                                                                        2. abbreviation
                                                                                                                                                                                                                                                                          CRC
                                                                                                                                                                                                                                                                          definition exact
                                                                                                                                                                                                                                                                          Colorectal Cancer
                                                                                                                                                                                                                                                                          definition span
                                                                                                                                                                                                                                                                          end
                                                                                                                                                                                                                                                                          5042
                                                                                                                                                                                                                                                                          end exclusive
                                                                                                                                                                                                                                                                          true
                                                                                                                                                                                                                                                                          exact text
                                                                                                                                                                                                                                                                          Colorectal Cancer (CRC)
                                                                                                                                                                                                                                                                          label id
                                                                                                                                                                                                                                                                          228e1e3f-d207-481f-8e14-9fdcbd0470e9
                                                                                                                                                                                                                                                                          offset unit
                                                                                                                                                                                                                                                                          unicode_code_points
                                                                                                                                                                                                                                                                          source array index
                                                                                                                                                                                                                                                                          0
                                                                                                                                                                                                                                                                          source field
                                                                                                                                                                                                                                                                          indications_and_usage_exact
                                                                                                                                                                                                                                                                          source text sha256
                                                                                                                                                                                                                                                                          e526ba14c91f10737e6d3331fe23a6219f58c0eca6380bfce9bd78b573fea912
                                                                                                                                                                                                                                                                          start
                                                                                                                                                                                                                                                                          5019
                                                                                                                                                                                                                                                                        source span
                                                                                                                                                                                                                                                                        end
                                                                                                                                                                                                                                                                        22689
                                                                                                                                                                                                                                                                        end exclusive
                                                                                                                                                                                                                                                                        true
                                                                                                                                                                                                                                                                        exact text
                                                                                                                                                                                                                                                                        This indication is approved under accelerated approval based on tumor response rate and durability of response [see Clinical Studies (14.18) ] .
                                                                                                                                                                                                                                                                        label id
                                                                                                                                                                                                                                                                        228e1e3f-d207-481f-8e14-9fdcbd0470e9
                                                                                                                                                                                                                                                                        offset unit
                                                                                                                                                                                                                                                                        unicode_code_points
                                                                                                                                                                                                                                                                        source array index
                                                                                                                                                                                                                                                                        0
                                                                                                                                                                                                                                                                        source field
                                                                                                                                                                                                                                                                        indications_and_usage_exact
                                                                                                                                                                                                                                                                        source text sha256
                                                                                                                                                                                                                                                                        e526ba14c91f10737e6d3331fe23a6219f58c0eca6380bfce9bd78b573fea912
                                                                                                                                                                                                                                                                        start
                                                                                                                                                                                                                                                                        22545
                                                                                                                                                                                                                                                                        source url
                                                                                                                                                                                                                                                                        https://api.fda.gov/drug/label.json?search=id%3A%22228e1e3f-d207-481f-8e14-9fdcbd0470e9%22
                                                                                                                                                                                                                                                                        spl effective date
                                                                                                                                                                                                                                                                        2026-07-10
                                                                                                                                                                                                                                                                        spl set id
                                                                                                                                                                                                                                                                        9333c79b-d487-4538-a9f0-71b91a02b287
                                                                                                                                                                                                                                                                        spl version
                                                                                                                                                                                                                                                                        228
                                                                                                                                                                                                                                                                        structured fields status
                                                                                                                                                                                                                                                                        not_extracted_no_values_inferred_from_mentions
                                                                                                                                                                                                                                                                        structured indication
                                                                                                                                                                                                                                                                        age
                                                                                                                                                                                                                                                                        Source null
                                                                                                                                                                                                                                                                        approval pathway
                                                                                                                                                                                                                                                                        Source null
                                                                                                                                                                                                                                                                        biomarker and test
                                                                                                                                                                                                                                                                        Source null
                                                                                                                                                                                                                                                                        disease stage
                                                                                                                                                                                                                                                                        Source null
                                                                                                                                                                                                                                                                        limitations
                                                                                                                                                                                                                                                                        Source null
                                                                                                                                                                                                                                                                        line
                                                                                                                                                                                                                                                                        Source null
                                                                                                                                                                                                                                                                        prior therapy
                                                                                                                                                                                                                                                                        Source null
                                                                                                                                                                                                                                                                        regimen
                                                                                                                                                                                                                                                                        Source null
                                                                                                                                                                                                                                                                        tumor histology
                                                                                                                                                                                                                                                                        Source null
                                                                                                                                                                                                                                                                        use intent
                                                                                                                                                                                                                                                                        not_applicable
                                                                                                                                                                                                                                                                        Passage 108 · approval contingency
                                                                                                                                                                                                                                                                        application numbers
                                                                                                                                                                                                                                                                        1. BLA125514
                                                                                                                                                                                                                                                                        brand names
                                                                                                                                                                                                                                                                        1. KEYTRUDA
                                                                                                                                                                                                                                                                        classification reasons
                                                                                                                                                                                                                                                                        1. approval_contingency_words
                                                                                                                                                                                                                                                                        clinical review status
                                                                                                                                                                                                                                                                        pending
                                                                                                                                                                                                                                                                        content role
                                                                                                                                                                                                                                                                        approval_contingency
                                                                                                                                                                                                                                                                        context span
                                                                                                                                                                                                                                                                        end
                                                                                                                                                                                                                                                                        23028
                                                                                                                                                                                                                                                                        end exclusive
                                                                                                                                                                                                                                                                        true
                                                                                                                                                                                                                                                                        exact text
                                                                                                                                                                                                                                                                        ho have no satisfactory alternative treatment options. This indication is approved under accelerated approval based on tumor response rate and durability of response [see Clinical Studies (14.18) ] . Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trials. Limitations of Use : The safety and effectiveness of KEYTRUDA in pediatric patients with TMB-H central nervous system cancers have not been established. 1.19 Cutaneous Squamous Cell Carcinoma KEYTRUD
                                                                                                                                                                                                                                                                        label id
                                                                                                                                                                                                                                                                        228e1e3f-d207-481f-8e14-9fdcbd0470e9
                                                                                                                                                                                                                                                                        offset unit
                                                                                                                                                                                                                                                                        unicode_code_points
                                                                                                                                                                                                                                                                        source array index
                                                                                                                                                                                                                                                                        0
                                                                                                                                                                                                                                                                        source field
                                                                                                                                                                                                                                                                        indications_and_usage_exact
                                                                                                                                                                                                                                                                        source text sha256
                                                                                                                                                                                                                                                                        e526ba14c91f10737e6d3331fe23a6219f58c0eca6380bfce9bd78b573fea912
                                                                                                                                                                                                                                                                        start
                                                                                                                                                                                                                                                                        22490
                                                                                                                                                                                                                                                                        current approval status
                                                                                                                                                                                                                                                                        not_reconciled
                                                                                                                                                                                                                                                                        duplicate text group
                                                                                                                                                                                                                                                                        dup-81b781d538d32f2c330f
                                                                                                                                                                                                                                                                        extraction review status
                                                                                                                                                                                                                                                                        automated_candidate_pending_source_review
                                                                                                                                                                                                                                                                        generic names
                                                                                                                                                                                                                                                                        1. PEMBROLIZUMAB
                                                                                                                                                                                                                                                                        id
                                                                                                                                                                                                                                                                        ind-span-5efbcad9ad61b6dc6725
                                                                                                                                                                                                                                                                        label id
                                                                                                                                                                                                                                                                        228e1e3f-d207-481f-8e14-9fdcbd0470e9
                                                                                                                                                                                                                                                                        positive predicate support span
                                                                                                                                                                                                                                                                        Source null
                                                                                                                                                                                                                                                                        qualifier mentions
                                                                                                                                                                                                                                                                          regulatory links
                                                                                                                                                                                                                                                                            schema version
                                                                                                                                                                                                                                                                            0.1.0
                                                                                                                                                                                                                                                                            source batch sha256
                                                                                                                                                                                                                                                                            fc39a8c5cf96bf95ca20b85578140167b66b2741f7d9217f500d9ba0847ac058
                                                                                                                                                                                                                                                                            source defined aliases
                                                                                                                                                                                                                                                                            1. abbreviation
                                                                                                                                                                                                                                                                              NSCLC
                                                                                                                                                                                                                                                                              definition exact
                                                                                                                                                                                                                                                                              Non-Small Cell Lung Cancer
                                                                                                                                                                                                                                                                              definition span
                                                                                                                                                                                                                                                                              end
                                                                                                                                                                                                                                                                              380
                                                                                                                                                                                                                                                                              end exclusive
                                                                                                                                                                                                                                                                              true
                                                                                                                                                                                                                                                                              exact text
                                                                                                                                                                                                                                                                              Non-Small Cell Lung Cancer (NSCLC)
                                                                                                                                                                                                                                                                              label id
                                                                                                                                                                                                                                                                              228e1e3f-d207-481f-8e14-9fdcbd0470e9
                                                                                                                                                                                                                                                                              offset unit
                                                                                                                                                                                                                                                                              unicode_code_points
                                                                                                                                                                                                                                                                              source array index
                                                                                                                                                                                                                                                                              0
                                                                                                                                                                                                                                                                              source field
                                                                                                                                                                                                                                                                              indications_and_usage_exact
                                                                                                                                                                                                                                                                              source text sha256
                                                                                                                                                                                                                                                                              e526ba14c91f10737e6d3331fe23a6219f58c0eca6380bfce9bd78b573fea912
                                                                                                                                                                                                                                                                              start
                                                                                                                                                                                                                                                                              346
                                                                                                                                                                                                                                                                            2. abbreviation
                                                                                                                                                                                                                                                                              CRC
                                                                                                                                                                                                                                                                              definition exact
                                                                                                                                                                                                                                                                              Colorectal Cancer
                                                                                                                                                                                                                                                                              definition span
                                                                                                                                                                                                                                                                              end
                                                                                                                                                                                                                                                                              5042
                                                                                                                                                                                                                                                                              end exclusive
                                                                                                                                                                                                                                                                              true
                                                                                                                                                                                                                                                                              exact text
                                                                                                                                                                                                                                                                              Colorectal Cancer (CRC)
                                                                                                                                                                                                                                                                              label id
                                                                                                                                                                                                                                                                              228e1e3f-d207-481f-8e14-9fdcbd0470e9
                                                                                                                                                                                                                                                                              offset unit
                                                                                                                                                                                                                                                                              unicode_code_points
                                                                                                                                                                                                                                                                              source array index
                                                                                                                                                                                                                                                                              0
                                                                                                                                                                                                                                                                              source field
                                                                                                                                                                                                                                                                              indications_and_usage_exact
                                                                                                                                                                                                                                                                              source text sha256
                                                                                                                                                                                                                                                                              e526ba14c91f10737e6d3331fe23a6219f58c0eca6380bfce9bd78b573fea912
                                                                                                                                                                                                                                                                              start
                                                                                                                                                                                                                                                                              5019
                                                                                                                                                                                                                                                                            source span
                                                                                                                                                                                                                                                                            end
                                                                                                                                                                                                                                                                            22828
                                                                                                                                                                                                                                                                            end exclusive
                                                                                                                                                                                                                                                                            true
                                                                                                                                                                                                                                                                            exact text
                                                                                                                                                                                                                                                                            Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trials.
                                                                                                                                                                                                                                                                            label id
                                                                                                                                                                                                                                                                            228e1e3f-d207-481f-8e14-9fdcbd0470e9
                                                                                                                                                                                                                                                                            offset unit
                                                                                                                                                                                                                                                                            unicode_code_points
                                                                                                                                                                                                                                                                            source array index
                                                                                                                                                                                                                                                                            0
                                                                                                                                                                                                                                                                            source field
                                                                                                                                                                                                                                                                            indications_and_usage_exact
                                                                                                                                                                                                                                                                            source text sha256
                                                                                                                                                                                                                                                                            e526ba14c91f10737e6d3331fe23a6219f58c0eca6380bfce9bd78b573fea912
                                                                                                                                                                                                                                                                            start
                                                                                                                                                                                                                                                                            22690
                                                                                                                                                                                                                                                                            source url
                                                                                                                                                                                                                                                                            https://api.fda.gov/drug/label.json?search=id%3A%22228e1e3f-d207-481f-8e14-9fdcbd0470e9%22
                                                                                                                                                                                                                                                                            spl effective date
                                                                                                                                                                                                                                                                            2026-07-10
                                                                                                                                                                                                                                                                            spl set id
                                                                                                                                                                                                                                                                            9333c79b-d487-4538-a9f0-71b91a02b287
                                                                                                                                                                                                                                                                            spl version
                                                                                                                                                                                                                                                                            228
                                                                                                                                                                                                                                                                            structured fields status
                                                                                                                                                                                                                                                                            not_extracted_no_values_inferred_from_mentions
                                                                                                                                                                                                                                                                            structured indication
                                                                                                                                                                                                                                                                            age
                                                                                                                                                                                                                                                                            Source null
                                                                                                                                                                                                                                                                            approval pathway
                                                                                                                                                                                                                                                                            Source null
                                                                                                                                                                                                                                                                            biomarker and test
                                                                                                                                                                                                                                                                            Source null
                                                                                                                                                                                                                                                                            disease stage
                                                                                                                                                                                                                                                                            Source null
                                                                                                                                                                                                                                                                            limitations
                                                                                                                                                                                                                                                                            Source null
                                                                                                                                                                                                                                                                            line
                                                                                                                                                                                                                                                                            Source null
                                                                                                                                                                                                                                                                            prior therapy
                                                                                                                                                                                                                                                                            Source null
                                                                                                                                                                                                                                                                            regimen
                                                                                                                                                                                                                                                                            Source null
                                                                                                                                                                                                                                                                            tumor histology
                                                                                                                                                                                                                                                                            Source null
                                                                                                                                                                                                                                                                            use intent
                                                                                                                                                                                                                                                                            not_applicable
                                                                                                                                                                                                                                                                            Passage 109 · limitation of use
                                                                                                                                                                                                                                                                            application numbers
                                                                                                                                                                                                                                                                            1. BLA125514
                                                                                                                                                                                                                                                                            brand names
                                                                                                                                                                                                                                                                            1. KEYTRUDA
                                                                                                                                                                                                                                                                            classification reasons
                                                                                                                                                                                                                                                                            1. negative_or_not_established_clause
                                                                                                                                                                                                                                                                            clinical review status
                                                                                                                                                                                                                                                                            pending
                                                                                                                                                                                                                                                                            content role
                                                                                                                                                                                                                                                                            limitation_of_use
                                                                                                                                                                                                                                                                            context span
                                                                                                                                                                                                                                                                            end
                                                                                                                                                                                                                                                                            23181
                                                                                                                                                                                                                                                                            end exclusive
                                                                                                                                                                                                                                                                            true
                                                                                                                                                                                                                                                                            exact text
                                                                                                                                                                                                                                                                            and durability of response [see Clinical Studies (14.18) ] . Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trials. Limitations of Use : The safety and effectiveness of KEYTRUDA in pediatric patients with TMB-H central nervous system cancers have not been established. 1.19 Cutaneous Squamous Cell Carcinoma KEYTRUDA is indicated for the treatment of patients with recurrent or metastatic cutaneous squamous cell carcinoma (cSCC) or locally advanced cSCC that is not c
                                                                                                                                                                                                                                                                            label id
                                                                                                                                                                                                                                                                            228e1e3f-d207-481f-8e14-9fdcbd0470e9
                                                                                                                                                                                                                                                                            offset unit
                                                                                                                                                                                                                                                                            unicode_code_points
                                                                                                                                                                                                                                                                            source array index
                                                                                                                                                                                                                                                                            0
                                                                                                                                                                                                                                                                            source field
                                                                                                                                                                                                                                                                            indications_and_usage_exact
                                                                                                                                                                                                                                                                            source text sha256
                                                                                                                                                                                                                                                                            e526ba14c91f10737e6d3331fe23a6219f58c0eca6380bfce9bd78b573fea912
                                                                                                                                                                                                                                                                            start
                                                                                                                                                                                                                                                                            22629
                                                                                                                                                                                                                                                                            current approval status
                                                                                                                                                                                                                                                                            not_reconciled
                                                                                                                                                                                                                                                                            duplicate text group
                                                                                                                                                                                                                                                                            dup-c910e48f6b7597f6576d
                                                                                                                                                                                                                                                                            extraction review status
                                                                                                                                                                                                                                                                            automated_candidate_pending_source_review
                                                                                                                                                                                                                                                                            generic names
                                                                                                                                                                                                                                                                            1. PEMBROLIZUMAB
                                                                                                                                                                                                                                                                            id
                                                                                                                                                                                                                                                                            ind-span-1dacf5e58a768cc4e796
                                                                                                                                                                                                                                                                            label id
                                                                                                                                                                                                                                                                            228e1e3f-d207-481f-8e14-9fdcbd0470e9
                                                                                                                                                                                                                                                                            positive predicate support span
                                                                                                                                                                                                                                                                            Source null
                                                                                                                                                                                                                                                                            qualifier mentions
                                                                                                                                                                                                                                                                            1. context exact
                                                                                                                                                                                                                                                                              ations of Use : The safety and effectiveness of KEYTRUDA in pediatric patients with TMB-H central nervous system cancers have not been est
                                                                                                                                                                                                                                                                              kind
                                                                                                                                                                                                                                                                              age
                                                                                                                                                                                                                                                                              polarity
                                                                                                                                                                                                                                                                              not_inferred
                                                                                                                                                                                                                                                                              span
                                                                                                                                                                                                                                                                              end
                                                                                                                                                                                                                                                                              22912
                                                                                                                                                                                                                                                                              end exclusive
                                                                                                                                                                                                                                                                              true
                                                                                                                                                                                                                                                                              exact text
                                                                                                                                                                                                                                                                              pediatric patients
                                                                                                                                                                                                                                                                              label id
                                                                                                                                                                                                                                                                              228e1e3f-d207-481f-8e14-9fdcbd0470e9
                                                                                                                                                                                                                                                                              offset unit
                                                                                                                                                                                                                                                                              unicode_code_points
                                                                                                                                                                                                                                                                              source array index
                                                                                                                                                                                                                                                                              0
                                                                                                                                                                                                                                                                              source field
                                                                                                                                                                                                                                                                              indications_and_usage_exact
                                                                                                                                                                                                                                                                              source text sha256
                                                                                                                                                                                                                                                                              e526ba14c91f10737e6d3331fe23a6219f58c0eca6380bfce9bd78b573fea912
                                                                                                                                                                                                                                                                              start
                                                                                                                                                                                                                                                                              22894
                                                                                                                                                                                                                                                                            2. context exact
                                                                                                                                                                                                                                                                              ty and effectiveness of KEYTRUDA in pediatric patients with TMB-H central nervous system cancers have not been established.
                                                                                                                                                                                                                                                                              kind
                                                                                                                                                                                                                                                                              biomarker
                                                                                                                                                                                                                                                                              polarity
                                                                                                                                                                                                                                                                              not_inferred
                                                                                                                                                                                                                                                                              span
                                                                                                                                                                                                                                                                              end
                                                                                                                                                                                                                                                                              22961
                                                                                                                                                                                                                                                                              end exclusive
                                                                                                                                                                                                                                                                              true
                                                                                                                                                                                                                                                                              exact text
                                                                                                                                                                                                                                                                              TMB-H central nervous system cancers have n
                                                                                                                                                                                                                                                                              label id
                                                                                                                                                                                                                                                                              228e1e3f-d207-481f-8e14-9fdcbd0470e9
                                                                                                                                                                                                                                                                              offset unit
                                                                                                                                                                                                                                                                              unicode_code_points
                                                                                                                                                                                                                                                                              source array index
                                                                                                                                                                                                                                                                              0
                                                                                                                                                                                                                                                                              source field
                                                                                                                                                                                                                                                                              indications_and_usage_exact
                                                                                                                                                                                                                                                                              source text sha256
                                                                                                                                                                                                                                                                              e526ba14c91f10737e6d3331fe23a6219f58c0eca6380bfce9bd78b573fea912
                                                                                                                                                                                                                                                                              start
                                                                                                                                                                                                                                                                              22918
                                                                                                                                                                                                                                                                            regulatory links
                                                                                                                                                                                                                                                                              schema version
                                                                                                                                                                                                                                                                              0.1.0
                                                                                                                                                                                                                                                                              source batch sha256
                                                                                                                                                                                                                                                                              fc39a8c5cf96bf95ca20b85578140167b66b2741f7d9217f500d9ba0847ac058
                                                                                                                                                                                                                                                                              source defined aliases
                                                                                                                                                                                                                                                                              1. abbreviation
                                                                                                                                                                                                                                                                                NSCLC
                                                                                                                                                                                                                                                                                definition exact
                                                                                                                                                                                                                                                                                Non-Small Cell Lung Cancer
                                                                                                                                                                                                                                                                                definition span
                                                                                                                                                                                                                                                                                end
                                                                                                                                                                                                                                                                                380
                                                                                                                                                                                                                                                                                end exclusive
                                                                                                                                                                                                                                                                                true
                                                                                                                                                                                                                                                                                exact text
                                                                                                                                                                                                                                                                                Non-Small Cell Lung Cancer (NSCLC)
                                                                                                                                                                                                                                                                                label id
                                                                                                                                                                                                                                                                                228e1e3f-d207-481f-8e14-9fdcbd0470e9
                                                                                                                                                                                                                                                                                offset unit
                                                                                                                                                                                                                                                                                unicode_code_points
                                                                                                                                                                                                                                                                                source array index
                                                                                                                                                                                                                                                                                0
                                                                                                                                                                                                                                                                                source field
                                                                                                                                                                                                                                                                                indications_and_usage_exact
                                                                                                                                                                                                                                                                                source text sha256
                                                                                                                                                                                                                                                                                e526ba14c91f10737e6d3331fe23a6219f58c0eca6380bfce9bd78b573fea912
                                                                                                                                                                                                                                                                                start
                                                                                                                                                                                                                                                                                346
                                                                                                                                                                                                                                                                              2. abbreviation
                                                                                                                                                                                                                                                                                CRC
                                                                                                                                                                                                                                                                                definition exact
                                                                                                                                                                                                                                                                                Colorectal Cancer
                                                                                                                                                                                                                                                                                definition span
                                                                                                                                                                                                                                                                                end
                                                                                                                                                                                                                                                                                5042
                                                                                                                                                                                                                                                                                end exclusive
                                                                                                                                                                                                                                                                                true
                                                                                                                                                                                                                                                                                exact text
                                                                                                                                                                                                                                                                                Colorectal Cancer (CRC)
                                                                                                                                                                                                                                                                                label id
                                                                                                                                                                                                                                                                                228e1e3f-d207-481f-8e14-9fdcbd0470e9
                                                                                                                                                                                                                                                                                offset unit
                                                                                                                                                                                                                                                                                unicode_code_points
                                                                                                                                                                                                                                                                                source array index
                                                                                                                                                                                                                                                                                0
                                                                                                                                                                                                                                                                                source field
                                                                                                                                                                                                                                                                                indications_and_usage_exact
                                                                                                                                                                                                                                                                                source text sha256
                                                                                                                                                                                                                                                                                e526ba14c91f10737e6d3331fe23a6219f58c0eca6380bfce9bd78b573fea912
                                                                                                                                                                                                                                                                                start
                                                                                                                                                                                                                                                                                5019
                                                                                                                                                                                                                                                                              source span
                                                                                                                                                                                                                                                                              end
                                                                                                                                                                                                                                                                              22981
                                                                                                                                                                                                                                                                              end exclusive
                                                                                                                                                                                                                                                                              true
                                                                                                                                                                                                                                                                              exact text
                                                                                                                                                                                                                                                                              Limitations of Use : The safety and effectiveness of KEYTRUDA in pediatric patients with TMB-H central nervous system cancers have not been established.
                                                                                                                                                                                                                                                                              label id
                                                                                                                                                                                                                                                                              228e1e3f-d207-481f-8e14-9fdcbd0470e9
                                                                                                                                                                                                                                                                              offset unit
                                                                                                                                                                                                                                                                              unicode_code_points
                                                                                                                                                                                                                                                                              source array index
                                                                                                                                                                                                                                                                              0
                                                                                                                                                                                                                                                                              source field
                                                                                                                                                                                                                                                                              indications_and_usage_exact
                                                                                                                                                                                                                                                                              source text sha256
                                                                                                                                                                                                                                                                              e526ba14c91f10737e6d3331fe23a6219f58c0eca6380bfce9bd78b573fea912
                                                                                                                                                                                                                                                                              start
                                                                                                                                                                                                                                                                              22829
                                                                                                                                                                                                                                                                              source url
                                                                                                                                                                                                                                                                              https://api.fda.gov/drug/label.json?search=id%3A%22228e1e3f-d207-481f-8e14-9fdcbd0470e9%22
                                                                                                                                                                                                                                                                              spl effective date
                                                                                                                                                                                                                                                                              2026-07-10
                                                                                                                                                                                                                                                                              spl set id
                                                                                                                                                                                                                                                                              9333c79b-d487-4538-a9f0-71b91a02b287
                                                                                                                                                                                                                                                                              spl version
                                                                                                                                                                                                                                                                              228
                                                                                                                                                                                                                                                                              structured fields status
                                                                                                                                                                                                                                                                              not_extracted_no_values_inferred_from_mentions
                                                                                                                                                                                                                                                                              structured indication
                                                                                                                                                                                                                                                                              age
                                                                                                                                                                                                                                                                              Source null
                                                                                                                                                                                                                                                                              approval pathway
                                                                                                                                                                                                                                                                              Source null
                                                                                                                                                                                                                                                                              biomarker and test
                                                                                                                                                                                                                                                                              Source null
                                                                                                                                                                                                                                                                              disease stage
                                                                                                                                                                                                                                                                              Source null
                                                                                                                                                                                                                                                                              limitations
                                                                                                                                                                                                                                                                              Source null
                                                                                                                                                                                                                                                                              line
                                                                                                                                                                                                                                                                              Source null
                                                                                                                                                                                                                                                                              prior therapy
                                                                                                                                                                                                                                                                              Source null
                                                                                                                                                                                                                                                                              regimen
                                                                                                                                                                                                                                                                              Source null
                                                                                                                                                                                                                                                                              tumor histology
                                                                                                                                                                                                                                                                              Source null
                                                                                                                                                                                                                                                                              use intent
                                                                                                                                                                                                                                                                              not_applicable
                                                                                                                                                                                                                                                                              Passage 110 · positive indication candidate
                                                                                                                                                                                                                                                                              application numbers
                                                                                                                                                                                                                                                                              1. BLA125514
                                                                                                                                                                                                                                                                              brand names
                                                                                                                                                                                                                                                                              1. KEYTRUDA
                                                                                                                                                                                                                                                                              classification reasons
                                                                                                                                                                                                                                                                              1. explicit_positive_indication_predicate
                                                                                                                                                                                                                                                                              2. tumor_or_malignant_hematology_words_in_positive_statement
                                                                                                                                                                                                                                                                              clinical review status
                                                                                                                                                                                                                                                                              pending
                                                                                                                                                                                                                                                                              content role
                                                                                                                                                                                                                                                                              positive_indication_candidate
                                                                                                                                                                                                                                                                              context span
                                                                                                                                                                                                                                                                              end
                                                                                                                                                                                                                                                                              23412
                                                                                                                                                                                                                                                                              end exclusive
                                                                                                                                                                                                                                                                              true
                                                                                                                                                                                                                                                                              exact text
                                                                                                                                                                                                                                                                              f clinical benefit in the confirmatory trials. Limitations of Use : The safety and effectiveness of KEYTRUDA in pediatric patients with TMB-H central nervous system cancers have not been established. 1.19 Cutaneous Squamous Cell Carcinoma KEYTRUDA is indicated for the treatment of patients with recurrent or metastatic cutaneous squamous cell carcinoma (cSCC) or locally advanced cSCC that is not curable by surgery or radiation. 1.20 Triple-Negative Breast Cancer KEYTRUDA is indicated for the treatment of patients with high-risk early-stage triple-negative breast cancer (TNBC) in combination with chemotherapy as neoadjuvant
                                                                                                                                                                                                                                                                              label id
                                                                                                                                                                                                                                                                              228e1e3f-d207-481f-8e14-9fdcbd0470e9
                                                                                                                                                                                                                                                                              offset unit
                                                                                                                                                                                                                                                                              unicode_code_points
                                                                                                                                                                                                                                                                              source array index
                                                                                                                                                                                                                                                                              0
                                                                                                                                                                                                                                                                              source field
                                                                                                                                                                                                                                                                              indications_and_usage_exact
                                                                                                                                                                                                                                                                              source text sha256
                                                                                                                                                                                                                                                                              e526ba14c91f10737e6d3331fe23a6219f58c0eca6380bfce9bd78b573fea912
                                                                                                                                                                                                                                                                              start
                                                                                                                                                                                                                                                                              22782
                                                                                                                                                                                                                                                                              current approval status
                                                                                                                                                                                                                                                                              not_reconciled
                                                                                                                                                                                                                                                                              duplicate text group
                                                                                                                                                                                                                                                                              dup-8031ee4f5751581857b7
                                                                                                                                                                                                                                                                              extraction review status
                                                                                                                                                                                                                                                                              automated_candidate_pending_source_review
                                                                                                                                                                                                                                                                              generic names
                                                                                                                                                                                                                                                                              1. PEMBROLIZUMAB
                                                                                                                                                                                                                                                                              id
                                                                                                                                                                                                                                                                              ind-span-388fd0ee9ab34cc39565
                                                                                                                                                                                                                                                                              label id
                                                                                                                                                                                                                                                                              228e1e3f-d207-481f-8e14-9fdcbd0470e9
                                                                                                                                                                                                                                                                              positive predicate support span
                                                                                                                                                                                                                                                                              end
                                                                                                                                                                                                                                                                              23042
                                                                                                                                                                                                                                                                              end exclusive
                                                                                                                                                                                                                                                                              true
                                                                                                                                                                                                                                                                              exact text
                                                                                                                                                                                                                                                                              is indicated
                                                                                                                                                                                                                                                                              label id
                                                                                                                                                                                                                                                                              228e1e3f-d207-481f-8e14-9fdcbd0470e9
                                                                                                                                                                                                                                                                              offset unit
                                                                                                                                                                                                                                                                              unicode_code_points
                                                                                                                                                                                                                                                                              source array index
                                                                                                                                                                                                                                                                              0
                                                                                                                                                                                                                                                                              source field
                                                                                                                                                                                                                                                                              indications_and_usage_exact
                                                                                                                                                                                                                                                                              source text sha256
                                                                                                                                                                                                                                                                              e526ba14c91f10737e6d3331fe23a6219f58c0eca6380bfce9bd78b573fea912
                                                                                                                                                                                                                                                                              start
                                                                                                                                                                                                                                                                              23030
                                                                                                                                                                                                                                                                              qualifier mentions
                                                                                                                                                                                                                                                                              1. context exact
                                                                                                                                                                                                                                                                                s indicated for the treatment of patients with recurrent or metastatic cutaneous squamous cell carcinoma (cSCC) or locally advanced cSCC that is not curable by sur
                                                                                                                                                                                                                                                                                kind
                                                                                                                                                                                                                                                                                biomarker
                                                                                                                                                                                                                                                                                polarity
                                                                                                                                                                                                                                                                                not_inferred
                                                                                                                                                                                                                                                                                span
                                                                                                                                                                                                                                                                                end
                                                                                                                                                                                                                                                                                23134
                                                                                                                                                                                                                                                                                end exclusive
                                                                                                                                                                                                                                                                                true
                                                                                                                                                                                                                                                                                exact text
                                                                                                                                                                                                                                                                                metastatic cutaneous squamous cell carcinom
                                                                                                                                                                                                                                                                                label id
                                                                                                                                                                                                                                                                                228e1e3f-d207-481f-8e14-9fdcbd0470e9
                                                                                                                                                                                                                                                                                offset unit
                                                                                                                                                                                                                                                                                unicode_code_points
                                                                                                                                                                                                                                                                                source array index
                                                                                                                                                                                                                                                                                0
                                                                                                                                                                                                                                                                                source field
                                                                                                                                                                                                                                                                                indications_and_usage_exact
                                                                                                                                                                                                                                                                                source text sha256
                                                                                                                                                                                                                                                                                e526ba14c91f10737e6d3331fe23a6219f58c0eca6380bfce9bd78b573fea912
                                                                                                                                                                                                                                                                                start
                                                                                                                                                                                                                                                                                23091
                                                                                                                                                                                                                                                                              2. context exact
                                                                                                                                                                                                                                                                                ma KEYTRUDA is indicated for the treatment of patients with recurrent or metastatic cutaneous squamous cell carcinoma (cSCC) or locally advanced cSCC that is not cu
                                                                                                                                                                                                                                                                                kind
                                                                                                                                                                                                                                                                                stage_or_setting
                                                                                                                                                                                                                                                                                polarity
                                                                                                                                                                                                                                                                                not_inferred
                                                                                                                                                                                                                                                                                span
                                                                                                                                                                                                                                                                                end
                                                                                                                                                                                                                                                                                23122
                                                                                                                                                                                                                                                                                end exclusive
                                                                                                                                                                                                                                                                                true
                                                                                                                                                                                                                                                                                exact text
                                                                                                                                                                                                                                                                                recurrent or metastatic cutaneous squamous c
                                                                                                                                                                                                                                                                                label id
                                                                                                                                                                                                                                                                                228e1e3f-d207-481f-8e14-9fdcbd0470e9
                                                                                                                                                                                                                                                                                offset unit
                                                                                                                                                                                                                                                                                unicode_code_points
                                                                                                                                                                                                                                                                                source array index
                                                                                                                                                                                                                                                                                0
                                                                                                                                                                                                                                                                                source field
                                                                                                                                                                                                                                                                                indications_and_usage_exact
                                                                                                                                                                                                                                                                                source text sha256
                                                                                                                                                                                                                                                                                e526ba14c91f10737e6d3331fe23a6219f58c0eca6380bfce9bd78b573fea912
                                                                                                                                                                                                                                                                                start
                                                                                                                                                                                                                                                                                23078
                                                                                                                                                                                                                                                                              3. context exact
                                                                                                                                                                                                                                                                                t or metastatic cutaneous squamous cell carcinoma (cSCC) or locally advanced cSCC that is not curable by surgery or radiation.
                                                                                                                                                                                                                                                                                kind
                                                                                                                                                                                                                                                                                stage_or_setting
                                                                                                                                                                                                                                                                                polarity
                                                                                                                                                                                                                                                                                not_inferred
                                                                                                                                                                                                                                                                                span
                                                                                                                                                                                                                                                                                end
                                                                                                                                                                                                                                                                                23197
                                                                                                                                                                                                                                                                                end exclusive
                                                                                                                                                                                                                                                                                true
                                                                                                                                                                                                                                                                                exact text
                                                                                                                                                                                                                                                                                locally advanced cSCC that is not curable by surger
                                                                                                                                                                                                                                                                                label id
                                                                                                                                                                                                                                                                                228e1e3f-d207-481f-8e14-9fdcbd0470e9
                                                                                                                                                                                                                                                                                offset unit
                                                                                                                                                                                                                                                                                unicode_code_points
                                                                                                                                                                                                                                                                                source array index
                                                                                                                                                                                                                                                                                0
                                                                                                                                                                                                                                                                                source field
                                                                                                                                                                                                                                                                                indications_and_usage_exact
                                                                                                                                                                                                                                                                                source text sha256
                                                                                                                                                                                                                                                                                e526ba14c91f10737e6d3331fe23a6219f58c0eca6380bfce9bd78b573fea912
                                                                                                                                                                                                                                                                                start
                                                                                                                                                                                                                                                                                23146
                                                                                                                                                                                                                                                                              regulatory links
                                                                                                                                                                                                                                                                                schema version
                                                                                                                                                                                                                                                                                0.1.0
                                                                                                                                                                                                                                                                                source batch sha256
                                                                                                                                                                                                                                                                                fc39a8c5cf96bf95ca20b85578140167b66b2741f7d9217f500d9ba0847ac058
                                                                                                                                                                                                                                                                                source defined aliases
                                                                                                                                                                                                                                                                                1. abbreviation
                                                                                                                                                                                                                                                                                  NSCLC
                                                                                                                                                                                                                                                                                  definition exact
                                                                                                                                                                                                                                                                                  Non-Small Cell Lung Cancer
                                                                                                                                                                                                                                                                                  definition span
                                                                                                                                                                                                                                                                                  end
                                                                                                                                                                                                                                                                                  380
                                                                                                                                                                                                                                                                                  end exclusive
                                                                                                                                                                                                                                                                                  true
                                                                                                                                                                                                                                                                                  exact text
                                                                                                                                                                                                                                                                                  Non-Small Cell Lung Cancer (NSCLC)
                                                                                                                                                                                                                                                                                  label id
                                                                                                                                                                                                                                                                                  228e1e3f-d207-481f-8e14-9fdcbd0470e9
                                                                                                                                                                                                                                                                                  offset unit
                                                                                                                                                                                                                                                                                  unicode_code_points
                                                                                                                                                                                                                                                                                  source array index
                                                                                                                                                                                                                                                                                  0
                                                                                                                                                                                                                                                                                  source field
                                                                                                                                                                                                                                                                                  indications_and_usage_exact
                                                                                                                                                                                                                                                                                  source text sha256
                                                                                                                                                                                                                                                                                  e526ba14c91f10737e6d3331fe23a6219f58c0eca6380bfce9bd78b573fea912
                                                                                                                                                                                                                                                                                  start
                                                                                                                                                                                                                                                                                  346
                                                                                                                                                                                                                                                                                2. abbreviation
                                                                                                                                                                                                                                                                                  CRC
                                                                                                                                                                                                                                                                                  definition exact
                                                                                                                                                                                                                                                                                  Colorectal Cancer
                                                                                                                                                                                                                                                                                  definition span
                                                                                                                                                                                                                                                                                  end
                                                                                                                                                                                                                                                                                  5042
                                                                                                                                                                                                                                                                                  end exclusive
                                                                                                                                                                                                                                                                                  true
                                                                                                                                                                                                                                                                                  exact text
                                                                                                                                                                                                                                                                                  Colorectal Cancer (CRC)
                                                                                                                                                                                                                                                                                  label id
                                                                                                                                                                                                                                                                                  228e1e3f-d207-481f-8e14-9fdcbd0470e9
                                                                                                                                                                                                                                                                                  offset unit
                                                                                                                                                                                                                                                                                  unicode_code_points
                                                                                                                                                                                                                                                                                  source array index
                                                                                                                                                                                                                                                                                  0
                                                                                                                                                                                                                                                                                  source field
                                                                                                                                                                                                                                                                                  indications_and_usage_exact
                                                                                                                                                                                                                                                                                  source text sha256
                                                                                                                                                                                                                                                                                  e526ba14c91f10737e6d3331fe23a6219f58c0eca6380bfce9bd78b573fea912
                                                                                                                                                                                                                                                                                  start
                                                                                                                                                                                                                                                                                  5019
                                                                                                                                                                                                                                                                                source span
                                                                                                                                                                                                                                                                                end
                                                                                                                                                                                                                                                                                23212
                                                                                                                                                                                                                                                                                end exclusive
                                                                                                                                                                                                                                                                                true
                                                                                                                                                                                                                                                                                exact text
                                                                                                                                                                                                                                                                                1.19 Cutaneous Squamous Cell Carcinoma KEYTRUDA is indicated for the treatment of patients with recurrent or metastatic cutaneous squamous cell carcinoma (cSCC) or locally advanced cSCC that is not curable by surgery or radiation.
                                                                                                                                                                                                                                                                                label id
                                                                                                                                                                                                                                                                                228e1e3f-d207-481f-8e14-9fdcbd0470e9
                                                                                                                                                                                                                                                                                offset unit
                                                                                                                                                                                                                                                                                unicode_code_points
                                                                                                                                                                                                                                                                                source array index
                                                                                                                                                                                                                                                                                0
                                                                                                                                                                                                                                                                                source field
                                                                                                                                                                                                                                                                                indications_and_usage_exact
                                                                                                                                                                                                                                                                                source text sha256
                                                                                                                                                                                                                                                                                e526ba14c91f10737e6d3331fe23a6219f58c0eca6380bfce9bd78b573fea912
                                                                                                                                                                                                                                                                                start
                                                                                                                                                                                                                                                                                22982
                                                                                                                                                                                                                                                                                source url
                                                                                                                                                                                                                                                                                https://api.fda.gov/drug/label.json?search=id%3A%22228e1e3f-d207-481f-8e14-9fdcbd0470e9%22
                                                                                                                                                                                                                                                                                spl effective date
                                                                                                                                                                                                                                                                                2026-07-10
                                                                                                                                                                                                                                                                                spl set id
                                                                                                                                                                                                                                                                                9333c79b-d487-4538-a9f0-71b91a02b287
                                                                                                                                                                                                                                                                                spl version
                                                                                                                                                                                                                                                                                228
                                                                                                                                                                                                                                                                                structured fields status
                                                                                                                                                                                                                                                                                not_extracted_no_values_inferred_from_mentions
                                                                                                                                                                                                                                                                                structured indication
                                                                                                                                                                                                                                                                                age
                                                                                                                                                                                                                                                                                Source null
                                                                                                                                                                                                                                                                                approval pathway
                                                                                                                                                                                                                                                                                Source null
                                                                                                                                                                                                                                                                                biomarker and test
                                                                                                                                                                                                                                                                                Source null
                                                                                                                                                                                                                                                                                disease stage
                                                                                                                                                                                                                                                                                Source null
                                                                                                                                                                                                                                                                                limitations
                                                                                                                                                                                                                                                                                Source null
                                                                                                                                                                                                                                                                                line
                                                                                                                                                                                                                                                                                Source null
                                                                                                                                                                                                                                                                                prior therapy
                                                                                                                                                                                                                                                                                Source null
                                                                                                                                                                                                                                                                                regimen
                                                                                                                                                                                                                                                                                Source null
                                                                                                                                                                                                                                                                                tumor histology
                                                                                                                                                                                                                                                                                Source null
                                                                                                                                                                                                                                                                                use intent
                                                                                                                                                                                                                                                                                tumor_directed_candidate
                                                                                                                                                                                                                                                                                Passage 111 · positive indication candidate
                                                                                                                                                                                                                                                                                application numbers
                                                                                                                                                                                                                                                                                1. BLA125514
                                                                                                                                                                                                                                                                                brand names
                                                                                                                                                                                                                                                                                1. KEYTRUDA
                                                                                                                                                                                                                                                                                classification reasons
                                                                                                                                                                                                                                                                                1. explicit_positive_indication_predicate
                                                                                                                                                                                                                                                                                2. tumor_or_malignant_hematology_words_in_positive_statement
                                                                                                                                                                                                                                                                                clinical review status
                                                                                                                                                                                                                                                                                pending
                                                                                                                                                                                                                                                                                content role
                                                                                                                                                                                                                                                                                positive_indication_candidate
                                                                                                                                                                                                                                                                                context span
                                                                                                                                                                                                                                                                                end
                                                                                                                                                                                                                                                                                23696
                                                                                                                                                                                                                                                                                end exclusive
                                                                                                                                                                                                                                                                                true
                                                                                                                                                                                                                                                                                exact text
                                                                                                                                                                                                                                                                                rcinoma KEYTRUDA is indicated for the treatment of patients with recurrent or metastatic cutaneous squamous cell carcinoma (cSCC) or locally advanced cSCC that is not curable by surgery or radiation. 1.20 Triple-Negative Breast Cancer KEYTRUDA is indicated for the treatment of patients with high-risk early-stage triple-negative breast cancer (TNBC) in combination with chemotherapy as neoadjuvant treatment, and then continued as a single agent as adjuvant treatment after surgery. KEYTRUDA, in combination with sacituzumab govitecan-hziy, is indicated for the first-line treatment of adult patients with unresectable locally advanced or metastatic TNBC whose tumors express PD-L1
                                                                                                                                                                                                                                                                                label id
                                                                                                                                                                                                                                                                                228e1e3f-d207-481f-8e14-9fdcbd0470e9
                                                                                                                                                                                                                                                                                offset unit
                                                                                                                                                                                                                                                                                unicode_code_points
                                                                                                                                                                                                                                                                                source array index
                                                                                                                                                                                                                                                                                0
                                                                                                                                                                                                                                                                                source field
                                                                                                                                                                                                                                                                                indications_and_usage_exact
                                                                                                                                                                                                                                                                                source text sha256
                                                                                                                                                                                                                                                                                e526ba14c91f10737e6d3331fe23a6219f58c0eca6380bfce9bd78b573fea912
                                                                                                                                                                                                                                                                                start
                                                                                                                                                                                                                                                                                23013
                                                                                                                                                                                                                                                                                current approval status
                                                                                                                                                                                                                                                                                not_reconciled
                                                                                                                                                                                                                                                                                duplicate text group
                                                                                                                                                                                                                                                                                dup-0190798cf73a01389185
                                                                                                                                                                                                                                                                                extraction review status
                                                                                                                                                                                                                                                                                automated_candidate_pending_source_review
                                                                                                                                                                                                                                                                                generic names
                                                                                                                                                                                                                                                                                1. PEMBROLIZUMAB
                                                                                                                                                                                                                                                                                id
                                                                                                                                                                                                                                                                                ind-span-3bb5fe0bdab322061afb
                                                                                                                                                                                                                                                                                label id
                                                                                                                                                                                                                                                                                228e1e3f-d207-481f-8e14-9fdcbd0470e9
                                                                                                                                                                                                                                                                                positive predicate support span
                                                                                                                                                                                                                                                                                end
                                                                                                                                                                                                                                                                                23269
                                                                                                                                                                                                                                                                                end exclusive
                                                                                                                                                                                                                                                                                true
                                                                                                                                                                                                                                                                                exact text
                                                                                                                                                                                                                                                                                is indicated
                                                                                                                                                                                                                                                                                label id
                                                                                                                                                                                                                                                                                228e1e3f-d207-481f-8e14-9fdcbd0470e9
                                                                                                                                                                                                                                                                                offset unit
                                                                                                                                                                                                                                                                                unicode_code_points
                                                                                                                                                                                                                                                                                source array index
                                                                                                                                                                                                                                                                                0
                                                                                                                                                                                                                                                                                source field
                                                                                                                                                                                                                                                                                indications_and_usage_exact
                                                                                                                                                                                                                                                                                source text sha256
                                                                                                                                                                                                                                                                                e526ba14c91f10737e6d3331fe23a6219f58c0eca6380bfce9bd78b573fea912
                                                                                                                                                                                                                                                                                start
                                                                                                                                                                                                                                                                                23257
                                                                                                                                                                                                                                                                                qualifier mentions
                                                                                                                                                                                                                                                                                1. context exact
                                                                                                                                                                                                                                                                                  A is indicated for the treatment of patients with high-risk early-stage triple-negative breast cancer (TNBC) in combination with chemotherapy as neoadjuvant treatment
                                                                                                                                                                                                                                                                                  kind
                                                                                                                                                                                                                                                                                  stage_or_setting
                                                                                                                                                                                                                                                                                  polarity
                                                                                                                                                                                                                                                                                  not_inferred
                                                                                                                                                                                                                                                                                  span
                                                                                                                                                                                                                                                                                  end
                                                                                                                                                                                                                                                                                  23361
                                                                                                                                                                                                                                                                                  end exclusive
                                                                                                                                                                                                                                                                                  true
                                                                                                                                                                                                                                                                                  exact text
                                                                                                                                                                                                                                                                                  early-stage triple-negative breast cancer (TNB
                                                                                                                                                                                                                                                                                  label id
                                                                                                                                                                                                                                                                                  228e1e3f-d207-481f-8e14-9fdcbd0470e9
                                                                                                                                                                                                                                                                                  offset unit
                                                                                                                                                                                                                                                                                  unicode_code_points
                                                                                                                                                                                                                                                                                  source array index
                                                                                                                                                                                                                                                                                  0
                                                                                                                                                                                                                                                                                  source field
                                                                                                                                                                                                                                                                                  indications_and_usage_exact
                                                                                                                                                                                                                                                                                  source text sha256
                                                                                                                                                                                                                                                                                  e526ba14c91f10737e6d3331fe23a6219f58c0eca6380bfce9bd78b573fea912
                                                                                                                                                                                                                                                                                  start
                                                                                                                                                                                                                                                                                  23315
                                                                                                                                                                                                                                                                                2. context exact
                                                                                                                                                                                                                                                                                  ve breast cancer (TNBC) in combination with chemotherapy as neoadjuvant treatment, and then continued as a single agent as adjuvant treatment
                                                                                                                                                                                                                                                                                  kind
                                                                                                                                                                                                                                                                                  stage_or_setting
                                                                                                                                                                                                                                                                                  polarity
                                                                                                                                                                                                                                                                                  not_inferred
                                                                                                                                                                                                                                                                                  span
                                                                                                                                                                                                                                                                                  end
                                                                                                                                                                                                                                                                                  23421
                                                                                                                                                                                                                                                                                  end exclusive
                                                                                                                                                                                                                                                                                  true
                                                                                                                                                                                                                                                                                  exact text
                                                                                                                                                                                                                                                                                  neoadjuvant treatment
                                                                                                                                                                                                                                                                                  label id
                                                                                                                                                                                                                                                                                  228e1e3f-d207-481f-8e14-9fdcbd0470e9
                                                                                                                                                                                                                                                                                  offset unit
                                                                                                                                                                                                                                                                                  unicode_code_points
                                                                                                                                                                                                                                                                                  source array index
                                                                                                                                                                                                                                                                                  0
                                                                                                                                                                                                                                                                                  source field
                                                                                                                                                                                                                                                                                  indications_and_usage_exact
                                                                                                                                                                                                                                                                                  source text sha256
                                                                                                                                                                                                                                                                                  e526ba14c91f10737e6d3331fe23a6219f58c0eca6380bfce9bd78b573fea912
                                                                                                                                                                                                                                                                                  start
                                                                                                                                                                                                                                                                                  23400
                                                                                                                                                                                                                                                                                3. context exact
                                                                                                                                                                                                                                                                                  adjuvant treatment, and then continued as a single agent as adjuvant treatment after surgery.
                                                                                                                                                                                                                                                                                  kind
                                                                                                                                                                                                                                                                                  stage_or_setting
                                                                                                                                                                                                                                                                                  polarity
                                                                                                                                                                                                                                                                                  not_inferred
                                                                                                                                                                                                                                                                                  span
                                                                                                                                                                                                                                                                                  end
                                                                                                                                                                                                                                                                                  23495
                                                                                                                                                                                                                                                                                  end exclusive
                                                                                                                                                                                                                                                                                  true
                                                                                                                                                                                                                                                                                  exact text
                                                                                                                                                                                                                                                                                  adjuvant treatment after surgery
                                                                                                                                                                                                                                                                                  label id
                                                                                                                                                                                                                                                                                  228e1e3f-d207-481f-8e14-9fdcbd0470e9
                                                                                                                                                                                                                                                                                  offset unit
                                                                                                                                                                                                                                                                                  unicode_code_points
                                                                                                                                                                                                                                                                                  source array index
                                                                                                                                                                                                                                                                                  0
                                                                                                                                                                                                                                                                                  source field
                                                                                                                                                                                                                                                                                  indications_and_usage_exact
                                                                                                                                                                                                                                                                                  source text sha256
                                                                                                                                                                                                                                                                                  e526ba14c91f10737e6d3331fe23a6219f58c0eca6380bfce9bd78b573fea912
                                                                                                                                                                                                                                                                                  start
                                                                                                                                                                                                                                                                                  23463
                                                                                                                                                                                                                                                                                4. context exact
                                                                                                                                                                                                                                                                                  high-risk early-stage triple-negative breast cancer (TNBC) in combination with chemotherapy as neoadjuvant treatment, and then continued as a single agent as adjuvant treatment after surgery.
                                                                                                                                                                                                                                                                                  kind
                                                                                                                                                                                                                                                                                  regimen
                                                                                                                                                                                                                                                                                  polarity
                                                                                                                                                                                                                                                                                  not_inferred
                                                                                                                                                                                                                                                                                  span
                                                                                                                                                                                                                                                                                  end
                                                                                                                                                                                                                                                                                  23495
                                                                                                                                                                                                                                                                                  end exclusive
                                                                                                                                                                                                                                                                                  true
                                                                                                                                                                                                                                                                                  exact text
                                                                                                                                                                                                                                                                                  in combination with chemotherapy as neoadjuvant treatment, and then continued as a single agent as adjuvant treatment after surgery
                                                                                                                                                                                                                                                                                  label id
                                                                                                                                                                                                                                                                                  228e1e3f-d207-481f-8e14-9fdcbd0470e9
                                                                                                                                                                                                                                                                                  offset unit
                                                                                                                                                                                                                                                                                  unicode_code_points
                                                                                                                                                                                                                                                                                  source array index
                                                                                                                                                                                                                                                                                  0
                                                                                                                                                                                                                                                                                  source field
                                                                                                                                                                                                                                                                                  indications_and_usage_exact
                                                                                                                                                                                                                                                                                  source text sha256
                                                                                                                                                                                                                                                                                  e526ba14c91f10737e6d3331fe23a6219f58c0eca6380bfce9bd78b573fea912
                                                                                                                                                                                                                                                                                  start
                                                                                                                                                                                                                                                                                  23364
                                                                                                                                                                                                                                                                                regulatory links
                                                                                                                                                                                                                                                                                  schema version
                                                                                                                                                                                                                                                                                  0.1.0
                                                                                                                                                                                                                                                                                  source batch sha256
                                                                                                                                                                                                                                                                                  fc39a8c5cf96bf95ca20b85578140167b66b2741f7d9217f500d9ba0847ac058
                                                                                                                                                                                                                                                                                  source defined aliases
                                                                                                                                                                                                                                                                                  1. abbreviation
                                                                                                                                                                                                                                                                                    NSCLC
                                                                                                                                                                                                                                                                                    definition exact
                                                                                                                                                                                                                                                                                    Non-Small Cell Lung Cancer
                                                                                                                                                                                                                                                                                    definition span
                                                                                                                                                                                                                                                                                    end
                                                                                                                                                                                                                                                                                    380
                                                                                                                                                                                                                                                                                    end exclusive
                                                                                                                                                                                                                                                                                    true
                                                                                                                                                                                                                                                                                    exact text
                                                                                                                                                                                                                                                                                    Non-Small Cell Lung Cancer (NSCLC)
                                                                                                                                                                                                                                                                                    label id
                                                                                                                                                                                                                                                                                    228e1e3f-d207-481f-8e14-9fdcbd0470e9
                                                                                                                                                                                                                                                                                    offset unit
                                                                                                                                                                                                                                                                                    unicode_code_points
                                                                                                                                                                                                                                                                                    source array index
                                                                                                                                                                                                                                                                                    0
                                                                                                                                                                                                                                                                                    source field
                                                                                                                                                                                                                                                                                    indications_and_usage_exact
                                                                                                                                                                                                                                                                                    source text sha256
                                                                                                                                                                                                                                                                                    e526ba14c91f10737e6d3331fe23a6219f58c0eca6380bfce9bd78b573fea912
                                                                                                                                                                                                                                                                                    start
                                                                                                                                                                                                                                                                                    346
                                                                                                                                                                                                                                                                                  2. abbreviation
                                                                                                                                                                                                                                                                                    CRC
                                                                                                                                                                                                                                                                                    definition exact
                                                                                                                                                                                                                                                                                    Colorectal Cancer
                                                                                                                                                                                                                                                                                    definition span
                                                                                                                                                                                                                                                                                    end
                                                                                                                                                                                                                                                                                    5042
                                                                                                                                                                                                                                                                                    end exclusive
                                                                                                                                                                                                                                                                                    true
                                                                                                                                                                                                                                                                                    exact text
                                                                                                                                                                                                                                                                                    Colorectal Cancer (CRC)
                                                                                                                                                                                                                                                                                    label id
                                                                                                                                                                                                                                                                                    228e1e3f-d207-481f-8e14-9fdcbd0470e9
                                                                                                                                                                                                                                                                                    offset unit
                                                                                                                                                                                                                                                                                    unicode_code_points
                                                                                                                                                                                                                                                                                    source array index
                                                                                                                                                                                                                                                                                    0
                                                                                                                                                                                                                                                                                    source field
                                                                                                                                                                                                                                                                                    indications_and_usage_exact
                                                                                                                                                                                                                                                                                    source text sha256
                                                                                                                                                                                                                                                                                    e526ba14c91f10737e6d3331fe23a6219f58c0eca6380bfce9bd78b573fea912
                                                                                                                                                                                                                                                                                    start
                                                                                                                                                                                                                                                                                    5019
                                                                                                                                                                                                                                                                                  source span
                                                                                                                                                                                                                                                                                  end
                                                                                                                                                                                                                                                                                  23496
                                                                                                                                                                                                                                                                                  end exclusive
                                                                                                                                                                                                                                                                                  true
                                                                                                                                                                                                                                                                                  exact text
                                                                                                                                                                                                                                                                                  1.20 Triple-Negative Breast Cancer KEYTRUDA is indicated for the treatment of patients with high-risk early-stage triple-negative breast cancer (TNBC) in combination with chemotherapy as neoadjuvant treatment, and then continued as a single agent as adjuvant treatment after surgery.
                                                                                                                                                                                                                                                                                  label id
                                                                                                                                                                                                                                                                                  228e1e3f-d207-481f-8e14-9fdcbd0470e9
                                                                                                                                                                                                                                                                                  offset unit
                                                                                                                                                                                                                                                                                  unicode_code_points
                                                                                                                                                                                                                                                                                  source array index
                                                                                                                                                                                                                                                                                  0
                                                                                                                                                                                                                                                                                  source field
                                                                                                                                                                                                                                                                                  indications_and_usage_exact
                                                                                                                                                                                                                                                                                  source text sha256
                                                                                                                                                                                                                                                                                  e526ba14c91f10737e6d3331fe23a6219f58c0eca6380bfce9bd78b573fea912
                                                                                                                                                                                                                                                                                  start
                                                                                                                                                                                                                                                                                  23213
                                                                                                                                                                                                                                                                                  source url
                                                                                                                                                                                                                                                                                  https://api.fda.gov/drug/label.json?search=id%3A%22228e1e3f-d207-481f-8e14-9fdcbd0470e9%22
                                                                                                                                                                                                                                                                                  spl effective date
                                                                                                                                                                                                                                                                                  2026-07-10
                                                                                                                                                                                                                                                                                  spl set id
                                                                                                                                                                                                                                                                                  9333c79b-d487-4538-a9f0-71b91a02b287
                                                                                                                                                                                                                                                                                  spl version
                                                                                                                                                                                                                                                                                  228
                                                                                                                                                                                                                                                                                  structured fields status
                                                                                                                                                                                                                                                                                  not_extracted_no_values_inferred_from_mentions
                                                                                                                                                                                                                                                                                  structured indication
                                                                                                                                                                                                                                                                                  age
                                                                                                                                                                                                                                                                                  Source null
                                                                                                                                                                                                                                                                                  approval pathway
                                                                                                                                                                                                                                                                                  Source null
                                                                                                                                                                                                                                                                                  biomarker and test
                                                                                                                                                                                                                                                                                  Source null
                                                                                                                                                                                                                                                                                  disease stage
                                                                                                                                                                                                                                                                                  Source null
                                                                                                                                                                                                                                                                                  limitations
                                                                                                                                                                                                                                                                                  Source null
                                                                                                                                                                                                                                                                                  line
                                                                                                                                                                                                                                                                                  Source null
                                                                                                                                                                                                                                                                                  prior therapy
                                                                                                                                                                                                                                                                                  Source null
                                                                                                                                                                                                                                                                                  regimen
                                                                                                                                                                                                                                                                                  Source null
                                                                                                                                                                                                                                                                                  tumor histology
                                                                                                                                                                                                                                                                                  Source null
                                                                                                                                                                                                                                                                                  use intent
                                                                                                                                                                                                                                                                                  tumor_directed_candidate
                                                                                                                                                                                                                                                                                  Passage 112 · positive indication candidate
                                                                                                                                                                                                                                                                                  application numbers
                                                                                                                                                                                                                                                                                  1. BLA125514
                                                                                                                                                                                                                                                                                  brand names
                                                                                                                                                                                                                                                                                  1. KEYTRUDA
                                                                                                                                                                                                                                                                                  classification reasons
                                                                                                                                                                                                                                                                                  1. explicit_positive_indication_predicate
                                                                                                                                                                                                                                                                                  2. tumor_or_malignant_hematology_words_in_positive_statement
                                                                                                                                                                                                                                                                                  clinical review status
                                                                                                                                                                                                                                                                                  pending
                                                                                                                                                                                                                                                                                  content role
                                                                                                                                                                                                                                                                                  positive_indication_candidate
                                                                                                                                                                                                                                                                                  context span
                                                                                                                                                                                                                                                                                  end
                                                                                                                                                                                                                                                                                  23986
                                                                                                                                                                                                                                                                                  end exclusive
                                                                                                                                                                                                                                                                                  true
                                                                                                                                                                                                                                                                                  exact text
                                                                                                                                                                                                                                                                                  ts with high-risk early-stage triple-negative breast cancer (TNBC) in combination with chemotherapy as neoadjuvant treatment, and then continued as a single agent as adjuvant treatment after surgery. KEYTRUDA, in combination with sacituzumab govitecan-hziy, is indicated for the first-line treatment of adult patients with unresectable locally advanced or metastatic TNBC whose tumors express PD-L1 (CPS ≥10) as determined by an FDA-authorized test [see Dosage and Administration (2.1) ] . KEYTRUDA, in combination with chemotherapy, is indicated for the treatment of patients with locally recurrent unresectable or metastatic TNBC whose tumors express PD-L1 (CPS ≥10) as determined by an
                                                                                                                                                                                                                                                                                  label id
                                                                                                                                                                                                                                                                                  228e1e3f-d207-481f-8e14-9fdcbd0470e9
                                                                                                                                                                                                                                                                                  offset unit
                                                                                                                                                                                                                                                                                  unicode_code_points
                                                                                                                                                                                                                                                                                  source array index
                                                                                                                                                                                                                                                                                  0
                                                                                                                                                                                                                                                                                  source field
                                                                                                                                                                                                                                                                                  indications_and_usage_exact
                                                                                                                                                                                                                                                                                  source text sha256
                                                                                                                                                                                                                                                                                  e526ba14c91f10737e6d3331fe23a6219f58c0eca6380bfce9bd78b573fea912
                                                                                                                                                                                                                                                                                  start
                                                                                                                                                                                                                                                                                  23297
                                                                                                                                                                                                                                                                                  current approval status
                                                                                                                                                                                                                                                                                  not_reconciled
                                                                                                                                                                                                                                                                                  duplicate text group
                                                                                                                                                                                                                                                                                  dup-f495b0abcd59b096d3f0
                                                                                                                                                                                                                                                                                  extraction review status
                                                                                                                                                                                                                                                                                  automated_candidate_pending_source_review
                                                                                                                                                                                                                                                                                  generic names
                                                                                                                                                                                                                                                                                  1. PEMBROLIZUMAB
                                                                                                                                                                                                                                                                                  id
                                                                                                                                                                                                                                                                                  ind-span-1f4d410543a763364f16
                                                                                                                                                                                                                                                                                  label id
                                                                                                                                                                                                                                                                                  228e1e3f-d207-481f-8e14-9fdcbd0470e9
                                                                                                                                                                                                                                                                                  positive predicate support span
                                                                                                                                                                                                                                                                                  end
                                                                                                                                                                                                                                                                                  23567
                                                                                                                                                                                                                                                                                  end exclusive
                                                                                                                                                                                                                                                                                  true
                                                                                                                                                                                                                                                                                  exact text
                                                                                                                                                                                                                                                                                  is indicated
                                                                                                                                                                                                                                                                                  label id
                                                                                                                                                                                                                                                                                  228e1e3f-d207-481f-8e14-9fdcbd0470e9
                                                                                                                                                                                                                                                                                  offset unit
                                                                                                                                                                                                                                                                                  unicode_code_points
                                                                                                                                                                                                                                                                                  source array index
                                                                                                                                                                                                                                                                                  0
                                                                                                                                                                                                                                                                                  source field
                                                                                                                                                                                                                                                                                  indications_and_usage_exact
                                                                                                                                                                                                                                                                                  source text sha256
                                                                                                                                                                                                                                                                                  e526ba14c91f10737e6d3331fe23a6219f58c0eca6380bfce9bd78b573fea912
                                                                                                                                                                                                                                                                                  start
                                                                                                                                                                                                                                                                                  23555
                                                                                                                                                                                                                                                                                  qualifier mentions
                                                                                                                                                                                                                                                                                  1. context exact
                                                                                                                                                                                                                                                                                    ovitecan-hziy, is indicated for the first-line treatment of adult patients with unresectable locally advanced or metastatic TNBC whose
                                                                                                                                                                                                                                                                                    kind
                                                                                                                                                                                                                                                                                    age
                                                                                                                                                                                                                                                                                    polarity
                                                                                                                                                                                                                                                                                    not_inferred
                                                                                                                                                                                                                                                                                    span
                                                                                                                                                                                                                                                                                    end
                                                                                                                                                                                                                                                                                    23614
                                                                                                                                                                                                                                                                                    end exclusive
                                                                                                                                                                                                                                                                                    true
                                                                                                                                                                                                                                                                                    exact text
                                                                                                                                                                                                                                                                                    adult patients
                                                                                                                                                                                                                                                                                    label id
                                                                                                                                                                                                                                                                                    228e1e3f-d207-481f-8e14-9fdcbd0470e9
                                                                                                                                                                                                                                                                                    offset unit
                                                                                                                                                                                                                                                                                    unicode_code_points
                                                                                                                                                                                                                                                                                    source array index
                                                                                                                                                                                                                                                                                    0
                                                                                                                                                                                                                                                                                    source field
                                                                                                                                                                                                                                                                                    indications_and_usage_exact
                                                                                                                                                                                                                                                                                    source text sha256
                                                                                                                                                                                                                                                                                    e526ba14c91f10737e6d3331fe23a6219f58c0eca6380bfce9bd78b573fea912
                                                                                                                                                                                                                                                                                    start
                                                                                                                                                                                                                                                                                    23600
                                                                                                                                                                                                                                                                                  2. context exact
                                                                                                                                                                                                                                                                                    ent of adult patients with unresectable locally advanced or metastatic TNBC whose tumors express PD-L1 (CPS ≥10) as determined by an FDA-authorized test [see Dosag
                                                                                                                                                                                                                                                                                    kind
                                                                                                                                                                                                                                                                                    biomarker
                                                                                                                                                                                                                                                                                    polarity
                                                                                                                                                                                                                                                                                    not_inferred
                                                                                                                                                                                                                                                                                    span
                                                                                                                                                                                                                                                                                    end
                                                                                                                                                                                                                                                                                    23696
                                                                                                                                                                                                                                                                                    end exclusive
                                                                                                                                                                                                                                                                                    true
                                                                                                                                                                                                                                                                                    exact text
                                                                                                                                                                                                                                                                                    metastatic TNBC whose tumors express PD-L1
                                                                                                                                                                                                                                                                                    label id
                                                                                                                                                                                                                                                                                    228e1e3f-d207-481f-8e14-9fdcbd0470e9
                                                                                                                                                                                                                                                                                    offset unit
                                                                                                                                                                                                                                                                                    unicode_code_points
                                                                                                                                                                                                                                                                                    source array index
                                                                                                                                                                                                                                                                                    0
                                                                                                                                                                                                                                                                                    source field
                                                                                                                                                                                                                                                                                    indications_and_usage_exact
                                                                                                                                                                                                                                                                                    source text sha256
                                                                                                                                                                                                                                                                                    e526ba14c91f10737e6d3331fe23a6219f58c0eca6380bfce9bd78b573fea912
                                                                                                                                                                                                                                                                                    start
                                                                                                                                                                                                                                                                                    23653
                                                                                                                                                                                                                                                                                  3. context exact
                                                                                                                                                                                                                                                                                    dicated for the first-line treatment of adult patients with unresectable locally advanced or metastatic TNBC whose tumors express PD-L1 (CPS ≥10) as determined by an F
                                                                                                                                                                                                                                                                                    kind
                                                                                                                                                                                                                                                                                    stage_or_setting
                                                                                                                                                                                                                                                                                    polarity
                                                                                                                                                                                                                                                                                    not_inferred
                                                                                                                                                                                                                                                                                    span
                                                                                                                                                                                                                                                                                    end
                                                                                                                                                                                                                                                                                    23667
                                                                                                                                                                                                                                                                                    end exclusive
                                                                                                                                                                                                                                                                                    true
                                                                                                                                                                                                                                                                                    exact text
                                                                                                                                                                                                                                                                                    unresectable locally advanced or metastatic TNB
                                                                                                                                                                                                                                                                                    label id
                                                                                                                                                                                                                                                                                    228e1e3f-d207-481f-8e14-9fdcbd0470e9
                                                                                                                                                                                                                                                                                    offset unit
                                                                                                                                                                                                                                                                                    unicode_code_points
                                                                                                                                                                                                                                                                                    source array index
                                                                                                                                                                                                                                                                                    0
                                                                                                                                                                                                                                                                                    source field
                                                                                                                                                                                                                                                                                    indications_and_usage_exact
                                                                                                                                                                                                                                                                                    source text sha256
                                                                                                                                                                                                                                                                                    e526ba14c91f10737e6d3331fe23a6219f58c0eca6380bfce9bd78b573fea912
                                                                                                                                                                                                                                                                                    start
                                                                                                                                                                                                                                                                                    23620
                                                                                                                                                                                                                                                                                  4. context exact
                                                                                                                                                                                                                                                                                    ation with sacituzumab govitecan-hziy, is indicated for the first-line treatment of adult patients with unresectable locally advanced or metastatic TNBC whose tumors express PD-L1 (CPS ≥10) as determined by an FDA-authorized test [see Dosage and Administration (2.1) ] .
                                                                                                                                                                                                                                                                                    kind
                                                                                                                                                                                                                                                                                    prior_therapy_or_line
                                                                                                                                                                                                                                                                                    polarity
                                                                                                                                                                                                                                                                                    not_inferred
                                                                                                                                                                                                                                                                                    span
                                                                                                                                                                                                                                                                                    end
                                                                                                                                                                                                                                                                                    23746
                                                                                                                                                                                                                                                                                    end exclusive
                                                                                                                                                                                                                                                                                    true
                                                                                                                                                                                                                                                                                    exact text
                                                                                                                                                                                                                                                                                    first-line treatment of adult patients with unresectable locally advanced or metastatic TNBC whose tumors express PD-L1 (CPS ≥10) as determined by an FDA-authorized test
                                                                                                                                                                                                                                                                                    label id
                                                                                                                                                                                                                                                                                    228e1e3f-d207-481f-8e14-9fdcbd0470e9
                                                                                                                                                                                                                                                                                    offset unit
                                                                                                                                                                                                                                                                                    unicode_code_points
                                                                                                                                                                                                                                                                                    source array index
                                                                                                                                                                                                                                                                                    0
                                                                                                                                                                                                                                                                                    source field
                                                                                                                                                                                                                                                                                    indications_and_usage_exact
                                                                                                                                                                                                                                                                                    source text sha256
                                                                                                                                                                                                                                                                                    e526ba14c91f10737e6d3331fe23a6219f58c0eca6380bfce9bd78b573fea912
                                                                                                                                                                                                                                                                                    start
                                                                                                                                                                                                                                                                                    23576
                                                                                                                                                                                                                                                                                  5. context exact
                                                                                                                                                                                                                                                                                    KEYTRUDA, in combination with sacituzumab govitecan-hziy, is indicated for the first-line treatment of adult patients with unresectable locally advanced or metastatic TNBC whose tumors express PD-L1 (CPS ≥10) as determined by an FDA-authorized test
                                                                                                                                                                                                                                                                                    kind
                                                                                                                                                                                                                                                                                    regimen
                                                                                                                                                                                                                                                                                    polarity
                                                                                                                                                                                                                                                                                    not_inferred
                                                                                                                                                                                                                                                                                    span
                                                                                                                                                                                                                                                                                    end
                                                                                                                                                                                                                                                                                    23686
                                                                                                                                                                                                                                                                                    end exclusive
                                                                                                                                                                                                                                                                                    true
                                                                                                                                                                                                                                                                                    exact text
                                                                                                                                                                                                                                                                                    in combination with sacituzumab govitecan-hziy, is indicated for the first-line treatment of adult patients with unresectable locally advanced or metastatic TNBC whose tumors expr
                                                                                                                                                                                                                                                                                    label id
                                                                                                                                                                                                                                                                                    228e1e3f-d207-481f-8e14-9fdcbd0470e9
                                                                                                                                                                                                                                                                                    offset unit
                                                                                                                                                                                                                                                                                    unicode_code_points
                                                                                                                                                                                                                                                                                    source array index
                                                                                                                                                                                                                                                                                    0
                                                                                                                                                                                                                                                                                    source field
                                                                                                                                                                                                                                                                                    indications_and_usage_exact
                                                                                                                                                                                                                                                                                    source text sha256
                                                                                                                                                                                                                                                                                    e526ba14c91f10737e6d3331fe23a6219f58c0eca6380bfce9bd78b573fea912
                                                                                                                                                                                                                                                                                    start
                                                                                                                                                                                                                                                                                    23507
                                                                                                                                                                                                                                                                                  regulatory links
                                                                                                                                                                                                                                                                                    schema version
                                                                                                                                                                                                                                                                                    0.1.0
                                                                                                                                                                                                                                                                                    source batch sha256
                                                                                                                                                                                                                                                                                    fc39a8c5cf96bf95ca20b85578140167b66b2741f7d9217f500d9ba0847ac058
                                                                                                                                                                                                                                                                                    source defined aliases
                                                                                                                                                                                                                                                                                    1. abbreviation
                                                                                                                                                                                                                                                                                      NSCLC
                                                                                                                                                                                                                                                                                      definition exact
                                                                                                                                                                                                                                                                                      Non-Small Cell Lung Cancer
                                                                                                                                                                                                                                                                                      definition span
                                                                                                                                                                                                                                                                                      end
                                                                                                                                                                                                                                                                                      380
                                                                                                                                                                                                                                                                                      end exclusive
                                                                                                                                                                                                                                                                                      true
                                                                                                                                                                                                                                                                                      exact text
                                                                                                                                                                                                                                                                                      Non-Small Cell Lung Cancer (NSCLC)
                                                                                                                                                                                                                                                                                      label id
                                                                                                                                                                                                                                                                                      228e1e3f-d207-481f-8e14-9fdcbd0470e9
                                                                                                                                                                                                                                                                                      offset unit
                                                                                                                                                                                                                                                                                      unicode_code_points
                                                                                                                                                                                                                                                                                      source array index
                                                                                                                                                                                                                                                                                      0
                                                                                                                                                                                                                                                                                      source field
                                                                                                                                                                                                                                                                                      indications_and_usage_exact
                                                                                                                                                                                                                                                                                      source text sha256
                                                                                                                                                                                                                                                                                      e526ba14c91f10737e6d3331fe23a6219f58c0eca6380bfce9bd78b573fea912
                                                                                                                                                                                                                                                                                      start
                                                                                                                                                                                                                                                                                      346
                                                                                                                                                                                                                                                                                    2. abbreviation
                                                                                                                                                                                                                                                                                      CRC
                                                                                                                                                                                                                                                                                      definition exact
                                                                                                                                                                                                                                                                                      Colorectal Cancer
                                                                                                                                                                                                                                                                                      definition span
                                                                                                                                                                                                                                                                                      end
                                                                                                                                                                                                                                                                                      5042
                                                                                                                                                                                                                                                                                      end exclusive
                                                                                                                                                                                                                                                                                      true
                                                                                                                                                                                                                                                                                      exact text
                                                                                                                                                                                                                                                                                      Colorectal Cancer (CRC)
                                                                                                                                                                                                                                                                                      label id
                                                                                                                                                                                                                                                                                      228e1e3f-d207-481f-8e14-9fdcbd0470e9
                                                                                                                                                                                                                                                                                      offset unit
                                                                                                                                                                                                                                                                                      unicode_code_points
                                                                                                                                                                                                                                                                                      source array index
                                                                                                                                                                                                                                                                                      0
                                                                                                                                                                                                                                                                                      source field
                                                                                                                                                                                                                                                                                      indications_and_usage_exact
                                                                                                                                                                                                                                                                                      source text sha256
                                                                                                                                                                                                                                                                                      e526ba14c91f10737e6d3331fe23a6219f58c0eca6380bfce9bd78b573fea912
                                                                                                                                                                                                                                                                                      start
                                                                                                                                                                                                                                                                                      5019
                                                                                                                                                                                                                                                                                    source span
                                                                                                                                                                                                                                                                                    end
                                                                                                                                                                                                                                                                                    23786
                                                                                                                                                                                                                                                                                    end exclusive
                                                                                                                                                                                                                                                                                    true
                                                                                                                                                                                                                                                                                    exact text
                                                                                                                                                                                                                                                                                    KEYTRUDA, in combination with sacituzumab govitecan-hziy, is indicated for the first-line treatment of adult patients with unresectable locally advanced or metastatic TNBC whose tumors express PD-L1 (CPS ≥10) as determined by an FDA-authorized test [see Dosage and Administration (2.1) ] .
                                                                                                                                                                                                                                                                                    label id
                                                                                                                                                                                                                                                                                    228e1e3f-d207-481f-8e14-9fdcbd0470e9
                                                                                                                                                                                                                                                                                    offset unit
                                                                                                                                                                                                                                                                                    unicode_code_points
                                                                                                                                                                                                                                                                                    source array index
                                                                                                                                                                                                                                                                                    0
                                                                                                                                                                                                                                                                                    source field
                                                                                                                                                                                                                                                                                    indications_and_usage_exact
                                                                                                                                                                                                                                                                                    source text sha256
                                                                                                                                                                                                                                                                                    e526ba14c91f10737e6d3331fe23a6219f58c0eca6380bfce9bd78b573fea912
                                                                                                                                                                                                                                                                                    start
                                                                                                                                                                                                                                                                                    23497
                                                                                                                                                                                                                                                                                    source url
                                                                                                                                                                                                                                                                                    https://api.fda.gov/drug/label.json?search=id%3A%22228e1e3f-d207-481f-8e14-9fdcbd0470e9%22
                                                                                                                                                                                                                                                                                    spl effective date
                                                                                                                                                                                                                                                                                    2026-07-10
                                                                                                                                                                                                                                                                                    spl set id
                                                                                                                                                                                                                                                                                    9333c79b-d487-4538-a9f0-71b91a02b287
                                                                                                                                                                                                                                                                                    spl version
                                                                                                                                                                                                                                                                                    228
                                                                                                                                                                                                                                                                                    structured fields status
                                                                                                                                                                                                                                                                                    not_extracted_no_values_inferred_from_mentions
                                                                                                                                                                                                                                                                                    structured indication
                                                                                                                                                                                                                                                                                    age
                                                                                                                                                                                                                                                                                    Source null
                                                                                                                                                                                                                                                                                    approval pathway
                                                                                                                                                                                                                                                                                    Source null
                                                                                                                                                                                                                                                                                    biomarker and test
                                                                                                                                                                                                                                                                                    Source null
                                                                                                                                                                                                                                                                                    disease stage
                                                                                                                                                                                                                                                                                    Source null
                                                                                                                                                                                                                                                                                    limitations
                                                                                                                                                                                                                                                                                    Source null
                                                                                                                                                                                                                                                                                    line
                                                                                                                                                                                                                                                                                    Source null
                                                                                                                                                                                                                                                                                    prior therapy
                                                                                                                                                                                                                                                                                    Source null
                                                                                                                                                                                                                                                                                    regimen
                                                                                                                                                                                                                                                                                    Source null
                                                                                                                                                                                                                                                                                    tumor histology
                                                                                                                                                                                                                                                                                    Source null
                                                                                                                                                                                                                                                                                    use intent
                                                                                                                                                                                                                                                                                    tumor_directed_candidate
                                                                                                                                                                                                                                                                                    Passage 113 · positive indication candidate
                                                                                                                                                                                                                                                                                    application numbers
                                                                                                                                                                                                                                                                                    1. BLA125514
                                                                                                                                                                                                                                                                                    brand names
                                                                                                                                                                                                                                                                                    1. KEYTRUDA
                                                                                                                                                                                                                                                                                    classification reasons
                                                                                                                                                                                                                                                                                    1. explicit_positive_indication_predicate
                                                                                                                                                                                                                                                                                    2. tumor_or_malignant_hematology_words_in_positive_statement
                                                                                                                                                                                                                                                                                    clinical review status
                                                                                                                                                                                                                                                                                    pending
                                                                                                                                                                                                                                                                                    content role
                                                                                                                                                                                                                                                                                    positive_indication_candidate
                                                                                                                                                                                                                                                                                    context span
                                                                                                                                                                                                                                                                                    end
                                                                                                                                                                                                                                                                                    24246
                                                                                                                                                                                                                                                                                    end exclusive
                                                                                                                                                                                                                                                                                    true
                                                                                                                                                                                                                                                                                    exact text
                                                                                                                                                                                                                                                                                    treatment of adult patients with unresectable locally advanced or metastatic TNBC whose tumors express PD-L1 (CPS ≥10) as determined by an FDA-authorized test [see Dosage and Administration (2.1) ] . KEYTRUDA, in combination with chemotherapy, is indicated for the treatment of patients with locally recurrent unresectable or metastatic TNBC whose tumors express PD-L1 (CPS ≥10) as determined by an FDA-authorized test [see Dosage and Administration (2.1) ] . 1.21 Ovarian Cancer KEYTRUDA, in combination with paclitaxel, with or without bevacizumab, is indicated for the treatment of adult patients with platinum-resistant epithelial ovarian, fallopian tube,
                                                                                                                                                                                                                                                                                    label id
                                                                                                                                                                                                                                                                                    228e1e3f-d207-481f-8e14-9fdcbd0470e9
                                                                                                                                                                                                                                                                                    offset unit
                                                                                                                                                                                                                                                                                    unicode_code_points
                                                                                                                                                                                                                                                                                    source array index
                                                                                                                                                                                                                                                                                    0
                                                                                                                                                                                                                                                                                    source field
                                                                                                                                                                                                                                                                                    indications_and_usage_exact
                                                                                                                                                                                                                                                                                    source text sha256
                                                                                                                                                                                                                                                                                    e526ba14c91f10737e6d3331fe23a6219f58c0eca6380bfce9bd78b573fea912
                                                                                                                                                                                                                                                                                    start
                                                                                                                                                                                                                                                                                    23587
                                                                                                                                                                                                                                                                                    current approval status
                                                                                                                                                                                                                                                                                    not_reconciled
                                                                                                                                                                                                                                                                                    duplicate text group
                                                                                                                                                                                                                                                                                    dup-b3bbef1b232f49863201
                                                                                                                                                                                                                                                                                    extraction review status
                                                                                                                                                                                                                                                                                    automated_candidate_pending_source_review
                                                                                                                                                                                                                                                                                    generic names
                                                                                                                                                                                                                                                                                    1. PEMBROLIZUMAB
                                                                                                                                                                                                                                                                                    id
                                                                                                                                                                                                                                                                                    ind-span-289b7897fb92ab1e941b
                                                                                                                                                                                                                                                                                    label id
                                                                                                                                                                                                                                                                                    228e1e3f-d207-481f-8e14-9fdcbd0470e9
                                                                                                                                                                                                                                                                                    positive predicate support span
                                                                                                                                                                                                                                                                                    end
                                                                                                                                                                                                                                                                                    23843
                                                                                                                                                                                                                                                                                    end exclusive
                                                                                                                                                                                                                                                                                    true
                                                                                                                                                                                                                                                                                    exact text
                                                                                                                                                                                                                                                                                    is indicated
                                                                                                                                                                                                                                                                                    label id
                                                                                                                                                                                                                                                                                    228e1e3f-d207-481f-8e14-9fdcbd0470e9
                                                                                                                                                                                                                                                                                    offset unit
                                                                                                                                                                                                                                                                                    unicode_code_points
                                                                                                                                                                                                                                                                                    source array index
                                                                                                                                                                                                                                                                                    0
                                                                                                                                                                                                                                                                                    source field
                                                                                                                                                                                                                                                                                    indications_and_usage_exact
                                                                                                                                                                                                                                                                                    source text sha256
                                                                                                                                                                                                                                                                                    e526ba14c91f10737e6d3331fe23a6219f58c0eca6380bfce9bd78b573fea912
                                                                                                                                                                                                                                                                                    start
                                                                                                                                                                                                                                                                                    23831
                                                                                                                                                                                                                                                                                    qualifier mentions
                                                                                                                                                                                                                                                                                    1. context exact
                                                                                                                                                                                                                                                                                      reatment of patients with locally recurrent unresectable or metastatic TNBC whose tumors express PD-L1 (CPS ≥10) as determined by an FDA-authorized test [see Dosag
                                                                                                                                                                                                                                                                                      kind
                                                                                                                                                                                                                                                                                      biomarker
                                                                                                                                                                                                                                                                                      polarity
                                                                                                                                                                                                                                                                                      not_inferred
                                                                                                                                                                                                                                                                                      span
                                                                                                                                                                                                                                                                                      end
                                                                                                                                                                                                                                                                                      23956
                                                                                                                                                                                                                                                                                      end exclusive
                                                                                                                                                                                                                                                                                      true
                                                                                                                                                                                                                                                                                      exact text
                                                                                                                                                                                                                                                                                      metastatic TNBC whose tumors express PD-L1
                                                                                                                                                                                                                                                                                      label id
                                                                                                                                                                                                                                                                                      228e1e3f-d207-481f-8e14-9fdcbd0470e9
                                                                                                                                                                                                                                                                                      offset unit
                                                                                                                                                                                                                                                                                      unicode_code_points
                                                                                                                                                                                                                                                                                      source array index
                                                                                                                                                                                                                                                                                      0
                                                                                                                                                                                                                                                                                      source field
                                                                                                                                                                                                                                                                                      indications_and_usage_exact
                                                                                                                                                                                                                                                                                      source text sha256
                                                                                                                                                                                                                                                                                      e526ba14c91f10737e6d3331fe23a6219f58c0eca6380bfce9bd78b573fea912
                                                                                                                                                                                                                                                                                      start
                                                                                                                                                                                                                                                                                      23913
                                                                                                                                                                                                                                                                                    2. context exact
                                                                                                                                                                                                                                                                                      py, is indicated for the treatment of patients with locally recurrent unresectable or metastatic TNBC whose tumors express PD-L1 (CPS ≥10) as determined by an FDA-a
                                                                                                                                                                                                                                                                                      kind
                                                                                                                                                                                                                                                                                      stage_or_setting
                                                                                                                                                                                                                                                                                      polarity
                                                                                                                                                                                                                                                                                      not_inferred
                                                                                                                                                                                                                                                                                      span
                                                                                                                                                                                                                                                                                      end
                                                                                                                                                                                                                                                                                      23931
                                                                                                                                                                                                                                                                                      end exclusive
                                                                                                                                                                                                                                                                                      true
                                                                                                                                                                                                                                                                                      exact text
                                                                                                                                                                                                                                                                                      recurrent unresectable or metastatic TNBC wh
                                                                                                                                                                                                                                                                                      label id
                                                                                                                                                                                                                                                                                      228e1e3f-d207-481f-8e14-9fdcbd0470e9
                                                                                                                                                                                                                                                                                      offset unit
                                                                                                                                                                                                                                                                                      unicode_code_points
                                                                                                                                                                                                                                                                                      source array index
                                                                                                                                                                                                                                                                                      0
                                                                                                                                                                                                                                                                                      source field
                                                                                                                                                                                                                                                                                      indications_and_usage_exact
                                                                                                                                                                                                                                                                                      source text sha256
                                                                                                                                                                                                                                                                                      e526ba14c91f10737e6d3331fe23a6219f58c0eca6380bfce9bd78b573fea912
                                                                                                                                                                                                                                                                                      start
                                                                                                                                                                                                                                                                                      23887
                                                                                                                                                                                                                                                                                    3. context exact
                                                                                                                                                                                                                                                                                      KEYTRUDA, in combination with chemotherapy, is indicated for the treatment of patients with locally recurrent unresectable or metastatic TNBC whose tumors express PD-L1 (CPS ≥10) as determined by an FDA-authorized test [see Dosage and Administration
                                                                                                                                                                                                                                                                                      kind
                                                                                                                                                                                                                                                                                      regimen
                                                                                                                                                                                                                                                                                      polarity
                                                                                                                                                                                                                                                                                      not_inferred
                                                                                                                                                                                                                                                                                      span
                                                                                                                                                                                                                                                                                      end
                                                                                                                                                                                                                                                                                      23976
                                                                                                                                                                                                                                                                                      end exclusive
                                                                                                                                                                                                                                                                                      true
                                                                                                                                                                                                                                                                                      exact text
                                                                                                                                                                                                                                                                                      in combination with chemotherapy, is indicated for the treatment of patients with locally recurrent unresectable or metastatic TNBC whose tumors express PD-L1 (CPS ≥10) as determi
                                                                                                                                                                                                                                                                                      label id
                                                                                                                                                                                                                                                                                      228e1e3f-d207-481f-8e14-9fdcbd0470e9
                                                                                                                                                                                                                                                                                      offset unit
                                                                                                                                                                                                                                                                                      unicode_code_points
                                                                                                                                                                                                                                                                                      source array index
                                                                                                                                                                                                                                                                                      0
                                                                                                                                                                                                                                                                                      source field
                                                                                                                                                                                                                                                                                      indications_and_usage_exact
                                                                                                                                                                                                                                                                                      source text sha256
                                                                                                                                                                                                                                                                                      e526ba14c91f10737e6d3331fe23a6219f58c0eca6380bfce9bd78b573fea912
                                                                                                                                                                                                                                                                                      start
                                                                                                                                                                                                                                                                                      23797
                                                                                                                                                                                                                                                                                    regulatory links
                                                                                                                                                                                                                                                                                      schema version
                                                                                                                                                                                                                                                                                      0.1.0
                                                                                                                                                                                                                                                                                      source batch sha256
                                                                                                                                                                                                                                                                                      fc39a8c5cf96bf95ca20b85578140167b66b2741f7d9217f500d9ba0847ac058
                                                                                                                                                                                                                                                                                      source defined aliases
                                                                                                                                                                                                                                                                                      1. abbreviation
                                                                                                                                                                                                                                                                                        NSCLC
                                                                                                                                                                                                                                                                                        definition exact
                                                                                                                                                                                                                                                                                        Non-Small Cell Lung Cancer
                                                                                                                                                                                                                                                                                        definition span
                                                                                                                                                                                                                                                                                        end
                                                                                                                                                                                                                                                                                        380
                                                                                                                                                                                                                                                                                        end exclusive
                                                                                                                                                                                                                                                                                        true
                                                                                                                                                                                                                                                                                        exact text
                                                                                                                                                                                                                                                                                        Non-Small Cell Lung Cancer (NSCLC)
                                                                                                                                                                                                                                                                                        label id
                                                                                                                                                                                                                                                                                        228e1e3f-d207-481f-8e14-9fdcbd0470e9
                                                                                                                                                                                                                                                                                        offset unit
                                                                                                                                                                                                                                                                                        unicode_code_points
                                                                                                                                                                                                                                                                                        source array index
                                                                                                                                                                                                                                                                                        0
                                                                                                                                                                                                                                                                                        source field
                                                                                                                                                                                                                                                                                        indications_and_usage_exact
                                                                                                                                                                                                                                                                                        source text sha256
                                                                                                                                                                                                                                                                                        e526ba14c91f10737e6d3331fe23a6219f58c0eca6380bfce9bd78b573fea912
                                                                                                                                                                                                                                                                                        start
                                                                                                                                                                                                                                                                                        346
                                                                                                                                                                                                                                                                                      2. abbreviation
                                                                                                                                                                                                                                                                                        CRC
                                                                                                                                                                                                                                                                                        definition exact
                                                                                                                                                                                                                                                                                        Colorectal Cancer
                                                                                                                                                                                                                                                                                        definition span
                                                                                                                                                                                                                                                                                        end
                                                                                                                                                                                                                                                                                        5042
                                                                                                                                                                                                                                                                                        end exclusive
                                                                                                                                                                                                                                                                                        true
                                                                                                                                                                                                                                                                                        exact text
                                                                                                                                                                                                                                                                                        Colorectal Cancer (CRC)
                                                                                                                                                                                                                                                                                        label id
                                                                                                                                                                                                                                                                                        228e1e3f-d207-481f-8e14-9fdcbd0470e9
                                                                                                                                                                                                                                                                                        offset unit
                                                                                                                                                                                                                                                                                        unicode_code_points
                                                                                                                                                                                                                                                                                        source array index
                                                                                                                                                                                                                                                                                        0
                                                                                                                                                                                                                                                                                        source field
                                                                                                                                                                                                                                                                                        indications_and_usage_exact
                                                                                                                                                                                                                                                                                        source text sha256
                                                                                                                                                                                                                                                                                        e526ba14c91f10737e6d3331fe23a6219f58c0eca6380bfce9bd78b573fea912
                                                                                                                                                                                                                                                                                        start
                                                                                                                                                                                                                                                                                        5019
                                                                                                                                                                                                                                                                                      source span
                                                                                                                                                                                                                                                                                      end
                                                                                                                                                                                                                                                                                      24046
                                                                                                                                                                                                                                                                                      end exclusive
                                                                                                                                                                                                                                                                                      true
                                                                                                                                                                                                                                                                                      exact text
                                                                                                                                                                                                                                                                                      KEYTRUDA, in combination with chemotherapy, is indicated for the treatment of patients with locally recurrent unresectable or metastatic TNBC whose tumors express PD-L1 (CPS ≥10) as determined by an FDA-authorized test [see Dosage and Administration (2.1) ] .
                                                                                                                                                                                                                                                                                      label id
                                                                                                                                                                                                                                                                                      228e1e3f-d207-481f-8e14-9fdcbd0470e9
                                                                                                                                                                                                                                                                                      offset unit
                                                                                                                                                                                                                                                                                      unicode_code_points
                                                                                                                                                                                                                                                                                      source array index
                                                                                                                                                                                                                                                                                      0
                                                                                                                                                                                                                                                                                      source field
                                                                                                                                                                                                                                                                                      indications_and_usage_exact
                                                                                                                                                                                                                                                                                      source text sha256
                                                                                                                                                                                                                                                                                      e526ba14c91f10737e6d3331fe23a6219f58c0eca6380bfce9bd78b573fea912
                                                                                                                                                                                                                                                                                      start
                                                                                                                                                                                                                                                                                      23787
                                                                                                                                                                                                                                                                                      source url
                                                                                                                                                                                                                                                                                      https://api.fda.gov/drug/label.json?search=id%3A%22228e1e3f-d207-481f-8e14-9fdcbd0470e9%22
                                                                                                                                                                                                                                                                                      spl effective date
                                                                                                                                                                                                                                                                                      2026-07-10
                                                                                                                                                                                                                                                                                      spl set id
                                                                                                                                                                                                                                                                                      9333c79b-d487-4538-a9f0-71b91a02b287
                                                                                                                                                                                                                                                                                      spl version
                                                                                                                                                                                                                                                                                      228
                                                                                                                                                                                                                                                                                      structured fields status
                                                                                                                                                                                                                                                                                      not_extracted_no_values_inferred_from_mentions
                                                                                                                                                                                                                                                                                      structured indication
                                                                                                                                                                                                                                                                                      age
                                                                                                                                                                                                                                                                                      Source null
                                                                                                                                                                                                                                                                                      approval pathway
                                                                                                                                                                                                                                                                                      Source null
                                                                                                                                                                                                                                                                                      biomarker and test
                                                                                                                                                                                                                                                                                      Source null
                                                                                                                                                                                                                                                                                      disease stage
                                                                                                                                                                                                                                                                                      Source null
                                                                                                                                                                                                                                                                                      limitations
                                                                                                                                                                                                                                                                                      Source null
                                                                                                                                                                                                                                                                                      line
                                                                                                                                                                                                                                                                                      Source null
                                                                                                                                                                                                                                                                                      prior therapy
                                                                                                                                                                                                                                                                                      Source null
                                                                                                                                                                                                                                                                                      regimen
                                                                                                                                                                                                                                                                                      Source null
                                                                                                                                                                                                                                                                                      tumor histology
                                                                                                                                                                                                                                                                                      Source null
                                                                                                                                                                                                                                                                                      use intent
                                                                                                                                                                                                                                                                                      tumor_directed_candidate
                                                                                                                                                                                                                                                                                      Passage 114 · positive indication candidate
                                                                                                                                                                                                                                                                                      application numbers
                                                                                                                                                                                                                                                                                      1. BLA125514
                                                                                                                                                                                                                                                                                      brand names
                                                                                                                                                                                                                                                                                      1. KEYTRUDA
                                                                                                                                                                                                                                                                                      classification reasons
                                                                                                                                                                                                                                                                                      1. explicit_positive_indication_predicate
                                                                                                                                                                                                                                                                                      2. tumor_or_malignant_hematology_words_in_positive_statement
                                                                                                                                                                                                                                                                                      clinical review status
                                                                                                                                                                                                                                                                                      pending
                                                                                                                                                                                                                                                                                      content role
                                                                                                                                                                                                                                                                                      positive_indication_candidate
                                                                                                                                                                                                                                                                                      context span
                                                                                                                                                                                                                                                                                      end
                                                                                                                                                                                                                                                                                      24463
                                                                                                                                                                                                                                                                                      end exclusive
                                                                                                                                                                                                                                                                                      true
                                                                                                                                                                                                                                                                                      exact text
                                                                                                                                                                                                                                                                                      the treatment of patients with locally recurrent unresectable or metastatic TNBC whose tumors express PD-L1 (CPS ≥10) as determined by an FDA-authorized test [see Dosage and Administration (2.1) ] . 1.21 Ovarian Cancer KEYTRUDA, in combination with paclitaxel, with or without bevacizumab, is indicated for the treatment of adult patients with platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal carcinoma whose tumors express PD-L1 (CPS ≥1) as determined by an FDA-authorized test [see Dosage and Administration (2.1) ] , and who have received one or two prior systemic treatment regimens.
                                                                                                                                                                                                                                                                                      label id
                                                                                                                                                                                                                                                                                      228e1e3f-d207-481f-8e14-9fdcbd0470e9
                                                                                                                                                                                                                                                                                      offset unit
                                                                                                                                                                                                                                                                                      unicode_code_points
                                                                                                                                                                                                                                                                                      source array index
                                                                                                                                                                                                                                                                                      0
                                                                                                                                                                                                                                                                                      source field
                                                                                                                                                                                                                                                                                      indications_and_usage_exact
                                                                                                                                                                                                                                                                                      source text sha256
                                                                                                                                                                                                                                                                                      e526ba14c91f10737e6d3331fe23a6219f58c0eca6380bfce9bd78b573fea912
                                                                                                                                                                                                                                                                                      start
                                                                                                                                                                                                                                                                                      23847
                                                                                                                                                                                                                                                                                      current approval status
                                                                                                                                                                                                                                                                                      not_reconciled
                                                                                                                                                                                                                                                                                      duplicate text group
                                                                                                                                                                                                                                                                                      dup-23a354a6a6cf1acd694b
                                                                                                                                                                                                                                                                                      extraction review status
                                                                                                                                                                                                                                                                                      automated_candidate_pending_source_review
                                                                                                                                                                                                                                                                                      generic names
                                                                                                                                                                                                                                                                                      1. PEMBROLIZUMAB
                                                                                                                                                                                                                                                                                      id
                                                                                                                                                                                                                                                                                      ind-span-a067a20864334271e82b
                                                                                                                                                                                                                                                                                      label id
                                                                                                                                                                                                                                                                                      228e1e3f-d207-481f-8e14-9fdcbd0470e9
                                                                                                                                                                                                                                                                                      positive predicate support span
                                                                                                                                                                                                                                                                                      end
                                                                                                                                                                                                                                                                                      24150
                                                                                                                                                                                                                                                                                      end exclusive
                                                                                                                                                                                                                                                                                      true
                                                                                                                                                                                                                                                                                      exact text
                                                                                                                                                                                                                                                                                      is indicated
                                                                                                                                                                                                                                                                                      label id
                                                                                                                                                                                                                                                                                      228e1e3f-d207-481f-8e14-9fdcbd0470e9
                                                                                                                                                                                                                                                                                      offset unit
                                                                                                                                                                                                                                                                                      unicode_code_points
                                                                                                                                                                                                                                                                                      source array index
                                                                                                                                                                                                                                                                                      0
                                                                                                                                                                                                                                                                                      source field
                                                                                                                                                                                                                                                                                      indications_and_usage_exact
                                                                                                                                                                                                                                                                                      source text sha256
                                                                                                                                                                                                                                                                                      e526ba14c91f10737e6d3331fe23a6219f58c0eca6380bfce9bd78b573fea912
                                                                                                                                                                                                                                                                                      start
                                                                                                                                                                                                                                                                                      24138
                                                                                                                                                                                                                                                                                      qualifier mentions
                                                                                                                                                                                                                                                                                      1. context exact
                                                                                                                                                                                                                                                                                        h or without bevacizumab, is indicated for the treatment of adult patients with platinum-resistant epithelial ovarian, fallopian tube,
                                                                                                                                                                                                                                                                                        kind
                                                                                                                                                                                                                                                                                        age
                                                                                                                                                                                                                                                                                        polarity
                                                                                                                                                                                                                                                                                        not_inferred
                                                                                                                                                                                                                                                                                        span
                                                                                                                                                                                                                                                                                        end
                                                                                                                                                                                                                                                                                        24186
                                                                                                                                                                                                                                                                                        end exclusive
                                                                                                                                                                                                                                                                                        true
                                                                                                                                                                                                                                                                                        exact text
                                                                                                                                                                                                                                                                                        adult patients
                                                                                                                                                                                                                                                                                        label id
                                                                                                                                                                                                                                                                                        228e1e3f-d207-481f-8e14-9fdcbd0470e9
                                                                                                                                                                                                                                                                                        offset unit
                                                                                                                                                                                                                                                                                        unicode_code_points
                                                                                                                                                                                                                                                                                        source array index
                                                                                                                                                                                                                                                                                        0
                                                                                                                                                                                                                                                                                        source field
                                                                                                                                                                                                                                                                                        indications_and_usage_exact
                                                                                                                                                                                                                                                                                        source text sha256
                                                                                                                                                                                                                                                                                        e526ba14c91f10737e6d3331fe23a6219f58c0eca6380bfce9bd78b573fea912
                                                                                                                                                                                                                                                                                        start
                                                                                                                                                                                                                                                                                        24172
                                                                                                                                                                                                                                                                                      2. context exact
                                                                                                                                                                                                                                                                                        tube, or primary peritoneal carcinoma whose tumors express PD-L1 (CPS ≥1) as determined by an FDA-authorized test [see Dosage and Administration (2.1) ] , and who h
                                                                                                                                                                                                                                                                                        kind
                                                                                                                                                                                                                                                                                        biomarker
                                                                                                                                                                                                                                                                                        polarity
                                                                                                                                                                                                                                                                                        not_inferred
                                                                                                                                                                                                                                                                                        span
                                                                                                                                                                                                                                                                                        end
                                                                                                                                                                                                                                                                                        24345
                                                                                                                                                                                                                                                                                        end exclusive
                                                                                                                                                                                                                                                                                        true
                                                                                                                                                                                                                                                                                        exact text
                                                                                                                                                                                                                                                                                        PD-L1 (CPS ≥1) as determined by an FDA-author
                                                                                                                                                                                                                                                                                        label id
                                                                                                                                                                                                                                                                                        228e1e3f-d207-481f-8e14-9fdcbd0470e9
                                                                                                                                                                                                                                                                                        offset unit
                                                                                                                                                                                                                                                                                        unicode_code_points
                                                                                                                                                                                                                                                                                        source array index
                                                                                                                                                                                                                                                                                        0
                                                                                                                                                                                                                                                                                        source field
                                                                                                                                                                                                                                                                                        indications_and_usage_exact
                                                                                                                                                                                                                                                                                        source text sha256
                                                                                                                                                                                                                                                                                        e526ba14c91f10737e6d3331fe23a6219f58c0eca6380bfce9bd78b573fea912
                                                                                                                                                                                                                                                                                        start
                                                                                                                                                                                                                                                                                        24300
                                                                                                                                                                                                                                                                                      3. context exact
                                                                                                                                                                                                                                                                                        uthorized test [see Dosage and Administration (2.1) ] , and who have received one or two prior systemic treatment regimens.
                                                                                                                                                                                                                                                                                        kind
                                                                                                                                                                                                                                                                                        prior_therapy_or_line
                                                                                                                                                                                                                                                                                        polarity
                                                                                                                                                                                                                                                                                        not_inferred
                                                                                                                                                                                                                                                                                        span
                                                                                                                                                                                                                                                                                        end
                                                                                                                                                                                                                                                                                        24462
                                                                                                                                                                                                                                                                                        end exclusive
                                                                                                                                                                                                                                                                                        true
                                                                                                                                                                                                                                                                                        exact text
                                                                                                                                                                                                                                                                                        who have received one or two prior systemic treatment regimens
                                                                                                                                                                                                                                                                                        label id
                                                                                                                                                                                                                                                                                        228e1e3f-d207-481f-8e14-9fdcbd0470e9
                                                                                                                                                                                                                                                                                        offset unit
                                                                                                                                                                                                                                                                                        unicode_code_points
                                                                                                                                                                                                                                                                                        source array index
                                                                                                                                                                                                                                                                                        0
                                                                                                                                                                                                                                                                                        source field
                                                                                                                                                                                                                                                                                        indications_and_usage_exact
                                                                                                                                                                                                                                                                                        source text sha256
                                                                                                                                                                                                                                                                                        e526ba14c91f10737e6d3331fe23a6219f58c0eca6380bfce9bd78b573fea912
                                                                                                                                                                                                                                                                                        start
                                                                                                                                                                                                                                                                                        24400
                                                                                                                                                                                                                                                                                      4. context exact
                                                                                                                                                                                                                                                                                        1.21 Ovarian Cancer KEYTRUDA, in combination with paclitaxel, with or without bevacizumab, is indicated for the treatment of adult patients with platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal carcinoma whose tumors express PD-L1 (CPS ≥1) a
                                                                                                                                                                                                                                                                                        kind
                                                                                                                                                                                                                                                                                        regimen
                                                                                                                                                                                                                                                                                        polarity
                                                                                                                                                                                                                                                                                        not_inferred
                                                                                                                                                                                                                                                                                        span
                                                                                                                                                                                                                                                                                        end
                                                                                                                                                                                                                                                                                        24256
                                                                                                                                                                                                                                                                                        end exclusive
                                                                                                                                                                                                                                                                                        true
                                                                                                                                                                                                                                                                                        exact text
                                                                                                                                                                                                                                                                                        in combination with paclitaxel, with or without bevacizumab, is indicated for the treatment of adult patients with platinum-resistant epithelial ovarian, fallopian tube, or primar
                                                                                                                                                                                                                                                                                        label id
                                                                                                                                                                                                                                                                                        228e1e3f-d207-481f-8e14-9fdcbd0470e9
                                                                                                                                                                                                                                                                                        offset unit
                                                                                                                                                                                                                                                                                        unicode_code_points
                                                                                                                                                                                                                                                                                        source array index
                                                                                                                                                                                                                                                                                        0
                                                                                                                                                                                                                                                                                        source field
                                                                                                                                                                                                                                                                                        indications_and_usage_exact
                                                                                                                                                                                                                                                                                        source text sha256
                                                                                                                                                                                                                                                                                        e526ba14c91f10737e6d3331fe23a6219f58c0eca6380bfce9bd78b573fea912
                                                                                                                                                                                                                                                                                        start
                                                                                                                                                                                                                                                                                        24077
                                                                                                                                                                                                                                                                                      regulatory links
                                                                                                                                                                                                                                                                                        schema version
                                                                                                                                                                                                                                                                                        0.1.0
                                                                                                                                                                                                                                                                                        source batch sha256
                                                                                                                                                                                                                                                                                        fc39a8c5cf96bf95ca20b85578140167b66b2741f7d9217f500d9ba0847ac058
                                                                                                                                                                                                                                                                                        source defined aliases
                                                                                                                                                                                                                                                                                        1. abbreviation
                                                                                                                                                                                                                                                                                          NSCLC
                                                                                                                                                                                                                                                                                          definition exact
                                                                                                                                                                                                                                                                                          Non-Small Cell Lung Cancer
                                                                                                                                                                                                                                                                                          definition span
                                                                                                                                                                                                                                                                                          end
                                                                                                                                                                                                                                                                                          380
                                                                                                                                                                                                                                                                                          end exclusive
                                                                                                                                                                                                                                                                                          true
                                                                                                                                                                                                                                                                                          exact text
                                                                                                                                                                                                                                                                                          Non-Small Cell Lung Cancer (NSCLC)
                                                                                                                                                                                                                                                                                          label id
                                                                                                                                                                                                                                                                                          228e1e3f-d207-481f-8e14-9fdcbd0470e9
                                                                                                                                                                                                                                                                                          offset unit
                                                                                                                                                                                                                                                                                          unicode_code_points
                                                                                                                                                                                                                                                                                          source array index
                                                                                                                                                                                                                                                                                          0
                                                                                                                                                                                                                                                                                          source field
                                                                                                                                                                                                                                                                                          indications_and_usage_exact
                                                                                                                                                                                                                                                                                          source text sha256
                                                                                                                                                                                                                                                                                          e526ba14c91f10737e6d3331fe23a6219f58c0eca6380bfce9bd78b573fea912
                                                                                                                                                                                                                                                                                          start
                                                                                                                                                                                                                                                                                          346
                                                                                                                                                                                                                                                                                        2. abbreviation
                                                                                                                                                                                                                                                                                          CRC
                                                                                                                                                                                                                                                                                          definition exact
                                                                                                                                                                                                                                                                                          Colorectal Cancer
                                                                                                                                                                                                                                                                                          definition span
                                                                                                                                                                                                                                                                                          end
                                                                                                                                                                                                                                                                                          5042
                                                                                                                                                                                                                                                                                          end exclusive
                                                                                                                                                                                                                                                                                          true
                                                                                                                                                                                                                                                                                          exact text
                                                                                                                                                                                                                                                                                          Colorectal Cancer (CRC)
                                                                                                                                                                                                                                                                                          label id
                                                                                                                                                                                                                                                                                          228e1e3f-d207-481f-8e14-9fdcbd0470e9
                                                                                                                                                                                                                                                                                          offset unit
                                                                                                                                                                                                                                                                                          unicode_code_points
                                                                                                                                                                                                                                                                                          source array index
                                                                                                                                                                                                                                                                                          0
                                                                                                                                                                                                                                                                                          source field
                                                                                                                                                                                                                                                                                          indications_and_usage_exact
                                                                                                                                                                                                                                                                                          source text sha256
                                                                                                                                                                                                                                                                                          e526ba14c91f10737e6d3331fe23a6219f58c0eca6380bfce9bd78b573fea912
                                                                                                                                                                                                                                                                                          start
                                                                                                                                                                                                                                                                                          5019
                                                                                                                                                                                                                                                                                        source span
                                                                                                                                                                                                                                                                                        end
                                                                                                                                                                                                                                                                                        24463
                                                                                                                                                                                                                                                                                        end exclusive
                                                                                                                                                                                                                                                                                        true
                                                                                                                                                                                                                                                                                        exact text
                                                                                                                                                                                                                                                                                        1.21 Ovarian Cancer KEYTRUDA, in combination with paclitaxel, with or without bevacizumab, is indicated for the treatment of adult patients with platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal carcinoma whose tumors express PD-L1 (CPS ≥1) as determined by an FDA-authorized test [see Dosage and Administration (2.1) ] , and who have received one or two prior systemic treatment regimens.
                                                                                                                                                                                                                                                                                        label id
                                                                                                                                                                                                                                                                                        228e1e3f-d207-481f-8e14-9fdcbd0470e9
                                                                                                                                                                                                                                                                                        offset unit
                                                                                                                                                                                                                                                                                        unicode_code_points
                                                                                                                                                                                                                                                                                        source array index
                                                                                                                                                                                                                                                                                        0
                                                                                                                                                                                                                                                                                        source field
                                                                                                                                                                                                                                                                                        indications_and_usage_exact
                                                                                                                                                                                                                                                                                        source text sha256
                                                                                                                                                                                                                                                                                        e526ba14c91f10737e6d3331fe23a6219f58c0eca6380bfce9bd78b573fea912
                                                                                                                                                                                                                                                                                        start
                                                                                                                                                                                                                                                                                        24047
                                                                                                                                                                                                                                                                                        source url
                                                                                                                                                                                                                                                                                        https://api.fda.gov/drug/label.json?search=id%3A%22228e1e3f-d207-481f-8e14-9fdcbd0470e9%22
                                                                                                                                                                                                                                                                                        spl effective date
                                                                                                                                                                                                                                                                                        2026-07-10
                                                                                                                                                                                                                                                                                        spl set id
                                                                                                                                                                                                                                                                                        9333c79b-d487-4538-a9f0-71b91a02b287
                                                                                                                                                                                                                                                                                        spl version
                                                                                                                                                                                                                                                                                        228
                                                                                                                                                                                                                                                                                        structured fields status
                                                                                                                                                                                                                                                                                        not_extracted_no_values_inferred_from_mentions
                                                                                                                                                                                                                                                                                        structured indication
                                                                                                                                                                                                                                                                                        age
                                                                                                                                                                                                                                                                                        Source null
                                                                                                                                                                                                                                                                                        approval pathway
                                                                                                                                                                                                                                                                                        Source null
                                                                                                                                                                                                                                                                                        biomarker and test
                                                                                                                                                                                                                                                                                        Source null
                                                                                                                                                                                                                                                                                        disease stage
                                                                                                                                                                                                                                                                                        Source null
                                                                                                                                                                                                                                                                                        limitations
                                                                                                                                                                                                                                                                                        Source null
                                                                                                                                                                                                                                                                                        line
                                                                                                                                                                                                                                                                                        Source null
                                                                                                                                                                                                                                                                                        prior therapy
                                                                                                                                                                                                                                                                                        Source null
                                                                                                                                                                                                                                                                                        regimen
                                                                                                                                                                                                                                                                                        Source null
                                                                                                                                                                                                                                                                                        tumor histology
                                                                                                                                                                                                                                                                                        Source null
                                                                                                                                                                                                                                                                                        use intent
                                                                                                                                                                                                                                                                                        tumor_directed_candidate

                                                                                                                                                                                                                                                                                        Preserved source evidence · Not medical advice