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LABELS · 18b3adae-863b-413b-8e36-e3551115db37

KEYTRUDA QLEX

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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
2026-07-31
Captured
2026-09-09T23:37:39.774134+00:00
Current indication reconciliation
Not reconciled

Indications and usage: exact source text

  1. 1 INDICATIONS AND USAGE KEYTRUDA QLEX is a combination of pembrolizumab, a programmed death receptor-1 (PD-1)-blocking antibody, and berahyaluronidase alfa, an endoglycosidase, indicated: Melanoma for the treatment of adult patients with unresectable or metastatic melanoma. ( 1.1 ) for the adjuvant treatment of adult and pediatric patients 12 years and older 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 adult 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 adult patients with metastatic squamous NSCLC. ( 1.2 ) as a single agent for the first-line treatment of adult 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 adult 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 QLEX. ( 1.2 , 2.1 ) for the treatment of adult 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 adult patients with metastatic or with unresectable, recurrent HNSCC. ( 1.4 ) as a single agent for the first-line treatment of adult 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 adult patients with recurrent or metastatic HNSCC with disease progression on or after platinum-containing chemotherapy. ( 1.4 ) Urothelial Cancer in combination with enfortumab vedotin-ejfv, for the treatment of adult patients with locally advanced or metastatic urothelial cancer. ( 1.5 ) as a single agent for the treatment of adult 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. ( 1.5 ) 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). ( 1.5 ) as a single agent for the treatment of adult 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. ( 1.5 ) Microsatellite Instability-High or Mismatch Repair Deficient Cancer for the treatment of adult and pediatric patients 12 years and older 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. ( 1.6 , 2.1 ) Microsatellite Instability-High or Mismatch Repair Deficient Colorectal Cancer (CRC) for the treatment of adult patients with unresectable or metastatic MSI-H or dMMR colorectal cancer (CRC) as determined by an FDA-authorized test. ( 1.7 , 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. ( 1.8 ) 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. ( 1.8 ) Esophageal Cancer for the treatment of adult 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. ( 1.9 , 2.1 ) Cervical Cancer in combination with chemoradiotherapy, for the treatment of adult 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). ( 1.10 ) in combination with chemotherapy, with or without bevacizumab, for the treatment of adult patients with persistent, recurrent, or metastatic cervical cancer whose tumors express PD-L1 (CPS ≥1) as determined by an FDA-authorized test. ( 1.10 , 2.1 ) as a single agent for the treatment of adult 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. ( 1.10 , 2.1 ) Hepatocellular Carcinoma (HCC) for the treatment of adult patients with HCC secondary to hepatitis B who have received prior systemic therapy other than a PD-1/PD-L1-containing regimen. ( 1.11 ) Biliary Tract Cancer (BTC) in combination with gemcitabine and cisplatin, for the treatment of adult patients with locally advanced unresectable or metastatic biliary tract cancer. ( 1.12 ) Merkel Cell Carcinoma (MCC) for the treatment of adult and pediatric patients 12 years and older with recurrent locally advanced or metastatic Merkel cell carcinoma. ( 1.13 ) Renal Cell Carcinoma (RCC) in combination with axitinib, for the first-line treatment of adult patients with advanced RCC. ( 1.14 ) in combination with lenvatinib, for the first-line treatment of adult patients with advanced RCC. ( 1.14 ) for the adjuvant treatment of adult patients with RCC at intermediate-high or high risk of recurrence following nephrectomy, or following nephrectomy and resection of metastatic lesions. ( 1.14 ) 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. ( 1.14 ) Endometrial Carcinoma in combination with carboplatin and paclitaxel, followed by KEYTRUDA QLEX as a single agent, for the treatment of adult patients with primary advanced or recurrent endometrial carcinoma. ( 1.15 ) 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. ( 1.15 , 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. ( 1.15 , 2.1 ) Tumor Mutational Burden-High (TMB-H) Cancer for the treatment of adult and pediatric patients 12 years and older 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 ( 1.16 , 2.1 ) Limitations of Use : The safety and effectiveness of KEYTRUDA QLEX in pediatric patients 12 years and older with TMB-H central nervous system cancers have not been established. Cutaneous Squamous Cell Carcinoma (cSCC) for the treatment of adult patients with recurrent or metastatic cSCC or locally advanced cSCC that is not curable by surgery or radiation. ( 1.17 ) Triple-Negative Breast Cancer (TNBC) for the treatment of adult 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. ( 1.18 ) 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. ( 1.18 , 2.1 ) in combination with chemotherapy, for the treatment of adult patients with locally recurrent unresectable or metastatic TNBC whose tumors express PD-L1 (CPS ≥10) as determined by an FDA-authorized test. ( 1.18 , 2.1 ) Ovarian Cancer 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, and who have received one or two prior systemic treatment regimens. ( 1.19 , 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 QLEX ™ is indicated for the treatment of adult patients with unresectable or metastatic melanoma. KEYTRUDA QLEX is indicated for the adjuvant treatment of adult and pediatric patients 12 years and older with Stage IIB, IIC, or III melanoma following complete resection. 1.2 Non-Small Cell Lung Cancer KEYTRUDA QLEX, in combination with pemetrexed and platinum chemotherapy, is indicated for the first-line treatment of adult patients with metastatic nonsquamous non-small cell lung cancer (NSCLC), with no EGFR or ALK genomic tumor aberrations. KEYTRUDA QLEX, in combination with carboplatin and either paclitaxel or paclitaxel protein-bound, is indicated for the first-line treatment of adult patients with metastatic squamous NSCLC. KEYTRUDA QLEX, as a single agent, is indicated for the first-line treatment of adult 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 QLEX, as a single agent, is indicated for the treatment of adult 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 QLEX. KEYTRUDA QLEX is indicated for the treatment of adult 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 QLEX, 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 QLEX, 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 QLEX 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 QLEX, in combination with platinum and fluorouracil (FU), is indicated for the first-line treatment of adult patients with metastatic or with unresectable, recurrent head and neck squamous cell carcinoma (HNSCC). KEYTRUDA QLEX, as a single agent, is indicated for the first-line treatment of adult 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 QLEX, as a single agent, is indicated for the treatment of adult patients with recurrent or metastatic HNSCC with disease progression on or after platinum-containing chemotherapy. 1.5 Urothelial Cancer KEYTRUDA QLEX, in combination with enfortumab vedotin-ejfv, is indicated for the treatment of adult patients with locally advanced or metastatic urothelial cancer. KEYTRUDA QLEX, as a single agent, is indicated for the treatment of adult 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 QLEX, 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 QLEX, as a single agent, is indicated for the treatment of adult 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. 1.6 Microsatellite Instability-High or Mismatch Repair Deficient Cancer KEYTRUDA QLEX is indicated for the treatment of adult and pediatric patients 12 years and older 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) ] . 1.7 Microsatellite Instability-High or Mismatch Repair Deficient Colorectal Cancer KEYTRUDA QLEX is indicated for the treatment of adult 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) ] . 1.8 Gastric Cancer KEYTRUDA QLEX, 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 QLEX, 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) ] . 1.9 Esophageal Cancer KEYTRUDA QLEX is indicated for the treatment of adult 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) ] . 1.10 Cervical Cancer KEYTRUDA QLEX, in combination with chemoradiotherapy (CRT), is indicated for the treatment of adult 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 QLEX, in combination with chemotherapy, with or without bevacizumab, is indicated for the treatment of adult 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 QLEX, as a single agent, is indicated for the treatment of adult 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) ] . 1.11 Hepatocellular Carcinoma KEYTRUDA QLEX is indicated for the treatment of adult patients with hepatocellular carcinoma (HCC) secondary to hepatitis B who have received prior systemic therapy other than a PD-1/PD-L1-containing regimen. 1.12 Biliary Tract Cancer KEYTRUDA QLEX, in combination with gemcitabine and cisplatin, is indicated for the treatment of adult patients with locally advanced unresectable or metastatic biliary tract cancer (BTC). 1.13 Merkel Cell Carcinoma KEYTRUDA QLEX is indicated for the treatment of adult and pediatric patients 12 years and older with recurrent locally advanced or metastatic Merkel cell carcinoma (MCC). 1.14 Renal Cell Carcinoma KEYTRUDA QLEX, in combination with axitinib, is indicated for the first-line treatment of adult patients with advanced renal cell carcinoma (RCC). KEYTRUDA QLEX, in combination with lenvatinib, is indicated for the first-line treatment of adult patients with advanced RCC. KEYTRUDA QLEX is indicated for the adjuvant treatment of adult 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 QLEX, 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. 1.15 Endometrial Carcinoma KEYTRUDA QLEX, in combination with carboplatin and paclitaxel, followed by KEYTRUDA QLEX as a single agent, is indicated for the treatment of adult patients with primary advanced or recurrent endometrial carcinoma. KEYTRUDA QLEX, 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 QLEX, 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) ] . 1.16 Tumor Mutational Burden-High Cancer KEYTRUDA QLEX is indicated for the treatment of adult and pediatric patients 12 years and older 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 QLEX in pediatric patients 12 years and older with TMB-H central nervous system cancers have not been established. 1.17 Cutaneous Squamous Cell Carcinoma KEYTRUDA QLEX is indicated for the treatment of adult patients with recurrent or metastatic cutaneous squamous cell carcinoma (cSCC) or locally advanced cSCC that is not curable by surgery or radiation. 1.18 Triple-Negative Breast Cancer KEYTRUDA QLEX is indicated for the treatment of adult 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 QLEX, 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 QLEX, in combination with chemotherapy, is indicated for the treatment of adult 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) ] . 1.19 Ovarian Cancer KEYTRUDA QLEX, 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. BLA761467
boxed warning exact
    brand names
    1. KEYTRUDA QLEX
    current indication status
    not_reconciled
    dailymed set url
    https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=097d166f-b73b-41d3-9b37-7653cd2a0c41
    generic names
    1. PEMBROLIZUMAB AND BERAHYALURONIDASE ALFA-PMPH
    id
    18b3adae-863b-413b-8e36-e3551115db37
    indications and usage exact
    1. 1 INDICATIONS AND USAGE KEYTRUDA QLEX is a combination of pembrolizumab, a programmed death receptor-1 (PD-1)-blocking antibody, and berahyaluronidase alfa, an endoglycosidase, indicated: Melanoma for the treatment of adult patients with unresectable or metastatic melanoma. ( 1.1 ) for the adjuvant treatment of adult and pediatric patients 12 years and older 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 adult 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 adult patients with metastatic squamous NSCLC. ( 1.2 ) as a single agent for the first-line treatment of adult 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 adult 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 QLEX. ( 1.2 , 2.1 ) for the treatment of adult 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 adult patients with metastatic or with unresectable, recurrent HNSCC. ( 1.4 ) as a single agent for the first-line treatment of adult 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 adult patients with recurrent or metastatic HNSCC with disease progression on or after platinum-containing chemotherapy. ( 1.4 ) Urothelial Cancer in combination with enfortumab vedotin-ejfv, for the treatment of adult patients with locally advanced or metastatic urothelial cancer. ( 1.5 ) as a single agent for the treatment of adult 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. ( 1.5 ) 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). ( 1.5 ) as a single agent for the treatment of adult 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. ( 1.5 ) Microsatellite Instability-High or Mismatch Repair Deficient Cancer for the treatment of adult and pediatric patients 12 years and older 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. ( 1.6 , 2.1 ) Microsatellite Instability-High or Mismatch Repair Deficient Colorectal Cancer (CRC) for the treatment of adult patients with unresectable or metastatic MSI-H or dMMR colorectal cancer (CRC) as determined by an FDA-authorized test. ( 1.7 , 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. ( 1.8 ) 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. ( 1.8 ) Esophageal Cancer for the treatment of adult 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. ( 1.9 , 2.1 ) Cervical Cancer in combination with chemoradiotherapy, for the treatment of adult 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). ( 1.10 ) in combination with chemotherapy, with or without bevacizumab, for the treatment of adult patients with persistent, recurrent, or metastatic cervical cancer whose tumors express PD-L1 (CPS ≥1) as determined by an FDA-authorized test. ( 1.10 , 2.1 ) as a single agent for the treatment of adult 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. ( 1.10 , 2.1 ) Hepatocellular Carcinoma (HCC) for the treatment of adult patients with HCC secondary to hepatitis B who have received prior systemic therapy other than a PD-1/PD-L1-containing regimen. ( 1.11 ) Biliary Tract Cancer (BTC) in combination with gemcitabine and cisplatin, for the treatment of adult patients with locally advanced unresectable or metastatic biliary tract cancer. ( 1.12 ) Merkel Cell Carcinoma (MCC) for the treatment of adult and pediatric patients 12 years and older with recurrent locally advanced or metastatic Merkel cell carcinoma. ( 1.13 ) Renal Cell Carcinoma (RCC) in combination with axitinib, for the first-line treatment of adult patients with advanced RCC. ( 1.14 ) in combination with lenvatinib, for the first-line treatment of adult patients with advanced RCC. ( 1.14 ) for the adjuvant treatment of adult patients with RCC at intermediate-high or high risk of recurrence following nephrectomy, or following nephrectomy and resection of metastatic lesions. ( 1.14 ) 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. ( 1.14 ) Endometrial Carcinoma in combination with carboplatin and paclitaxel, followed by KEYTRUDA QLEX as a single agent, for the treatment of adult patients with primary advanced or recurrent endometrial carcinoma. ( 1.15 ) 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. ( 1.15 , 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. ( 1.15 , 2.1 ) Tumor Mutational Burden-High (TMB-H) Cancer for the treatment of adult and pediatric patients 12 years and older 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 ( 1.16 , 2.1 ) Limitations of Use : The safety and effectiveness of KEYTRUDA QLEX in pediatric patients 12 years and older with TMB-H central nervous system cancers have not been established. Cutaneous Squamous Cell Carcinoma (cSCC) for the treatment of adult patients with recurrent or metastatic cSCC or locally advanced cSCC that is not curable by surgery or radiation. ( 1.17 ) Triple-Negative Breast Cancer (TNBC) for the treatment of adult 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. ( 1.18 ) 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. ( 1.18 , 2.1 ) in combination with chemotherapy, for the treatment of adult patients with locally recurrent unresectable or metastatic TNBC whose tumors express PD-L1 (CPS ≥10) as determined by an FDA-authorized test. ( 1.18 , 2.1 ) Ovarian Cancer 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, and who have received one or two prior systemic treatment regimens. ( 1.19 , 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 QLEX ™ is indicated for the treatment of adult patients with unresectable or metastatic melanoma. KEYTRUDA QLEX is indicated for the adjuvant treatment of adult and pediatric patients 12 years and older with Stage IIB, IIC, or III melanoma following complete resection. 1.2 Non-Small Cell Lung Cancer KEYTRUDA QLEX, in combination with pemetrexed and platinum chemotherapy, is indicated for the first-line treatment of adult patients with metastatic nonsquamous non-small cell lung cancer (NSCLC), with no EGFR or ALK genomic tumor aberrations. KEYTRUDA QLEX, in combination with carboplatin and either paclitaxel or paclitaxel protein-bound, is indicated for the first-line treatment of adult patients with metastatic squamous NSCLC. KEYTRUDA QLEX, as a single agent, is indicated for the first-line treatment of adult 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 QLEX, as a single agent, is indicated for the treatment of adult 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 QLEX. KEYTRUDA QLEX is indicated for the treatment of adult 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 QLEX, 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 QLEX, 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 QLEX 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 QLEX, in combination with platinum and fluorouracil (FU), is indicated for the first-line treatment of adult patients with metastatic or with unresectable, recurrent head and neck squamous cell carcinoma (HNSCC). KEYTRUDA QLEX, as a single agent, is indicated for the first-line treatment of adult 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 QLEX, as a single agent, is indicated for the treatment of adult patients with recurrent or metastatic HNSCC with disease progression on or after platinum-containing chemotherapy. 1.5 Urothelial Cancer KEYTRUDA QLEX, in combination with enfortumab vedotin-ejfv, is indicated for the treatment of adult patients with locally advanced or metastatic urothelial cancer. KEYTRUDA QLEX, as a single agent, is indicated for the treatment of adult 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 QLEX, 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 QLEX, as a single agent, is indicated for the treatment of adult 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. 1.6 Microsatellite Instability-High or Mismatch Repair Deficient Cancer KEYTRUDA QLEX is indicated for the treatment of adult and pediatric patients 12 years and older 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) ] . 1.7 Microsatellite Instability-High or Mismatch Repair Deficient Colorectal Cancer KEYTRUDA QLEX is indicated for the treatment of adult 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) ] . 1.8 Gastric Cancer KEYTRUDA QLEX, 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 QLEX, 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) ] . 1.9 Esophageal Cancer KEYTRUDA QLEX is indicated for the treatment of adult 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) ] . 1.10 Cervical Cancer KEYTRUDA QLEX, in combination with chemoradiotherapy (CRT), is indicated for the treatment of adult 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 QLEX, in combination with chemotherapy, with or without bevacizumab, is indicated for the treatment of adult 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 QLEX, as a single agent, is indicated for the treatment of adult 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) ] . 1.11 Hepatocellular Carcinoma KEYTRUDA QLEX is indicated for the treatment of adult patients with hepatocellular carcinoma (HCC) secondary to hepatitis B who have received prior systemic therapy other than a PD-1/PD-L1-containing regimen. 1.12 Biliary Tract Cancer KEYTRUDA QLEX, in combination with gemcitabine and cisplatin, is indicated for the treatment of adult patients with locally advanced unresectable or metastatic biliary tract cancer (BTC). 1.13 Merkel Cell Carcinoma KEYTRUDA QLEX is indicated for the treatment of adult and pediatric patients 12 years and older with recurrent locally advanced or metastatic Merkel cell carcinoma (MCC). 1.14 Renal Cell Carcinoma KEYTRUDA QLEX, in combination with axitinib, is indicated for the first-line treatment of adult patients with advanced renal cell carcinoma (RCC). KEYTRUDA QLEX, in combination with lenvatinib, is indicated for the first-line treatment of adult patients with advanced RCC. KEYTRUDA QLEX is indicated for the adjuvant treatment of adult 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 QLEX, 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. 1.15 Endometrial Carcinoma KEYTRUDA QLEX, in combination with carboplatin and paclitaxel, followed by KEYTRUDA QLEX as a single agent, is indicated for the treatment of adult patients with primary advanced or recurrent endometrial carcinoma. KEYTRUDA QLEX, 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 QLEX, 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) ] . 1.16 Tumor Mutational Burden-High Cancer KEYTRUDA QLEX is indicated for the treatment of adult and pediatric patients 12 years and older 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 QLEX in pediatric patients 12 years and older with TMB-H central nervous system cancers have not been established. 1.17 Cutaneous Squamous Cell Carcinoma KEYTRUDA QLEX is indicated for the treatment of adult patients with recurrent or metastatic cutaneous squamous cell carcinoma (cSCC) or locally advanced cSCC that is not curable by surgery or radiation. 1.18 Triple-Negative Breast Cancer KEYTRUDA QLEX is indicated for the treatment of adult 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 QLEX, 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 QLEX, in combination with chemotherapy, is indicated for the treatment of adult 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) ] . 1.19 Ovarian Cancer KEYTRUDA QLEX, 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.
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        1. Active Ingredient
          PEMBROLIZUMAB;BERAHYALURONIDASE ALFA-PMPH
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          1. Prescription

      Source passages and status connections

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      1 INDICATIONS AND USAGE KEYTRUDA QLEX is a combination of pembrolizumab, a programmed death receptor-1 (PD-1)-blocking antibody, and berahyaluronidase alfa, an endoglycosidase, indicated: Melanoma for the treatment of adult patients with unresectable or metastatic melanoma. ( 1.1 ) for the adjuvant treatment of adult and pediatric patients 12 years and older with Stage IIB, IIC, or III melanoma following complete resection. ( 1.1 ) Non-Small Cell Lung Cancer (NSCLC) in
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                                        Passage 14 · unclassified context
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                                          start
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                                          source url
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                                          Source null
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                                          Source null
                                          use intent
                                          unclear
                                          Passage 15 · unclassified context
                                          application numbers
                                          1. BLA761467
                                          brand names
                                          1. KEYTRUDA QLEX
                                          classification reasons
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                                                4. context exact
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                                                6. context exact
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                                                  Passage 18 · unclassified context
                                                  application numbers
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                                                  brand names
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                                                  classification reasons
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                                                                        Passage 26 · unclassified context
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                                                                              Passage 28 · unclassified context
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                                                                                  Non-Small Cell Lung Cancer
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                                                                                  Passage 30 · unclassified context
                                                                                  application numbers
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                                                                                  brand names
                                                                                  1. KEYTRUDA QLEX
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                                                                                  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.
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                                                                                  6. context exact
                                                                                    ( 1.7 , 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
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                                                                                      CRC
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                                                                                    Passage 31 · unclassified context
                                                                                    application numbers
                                                                                    1. BLA761467
                                                                                    brand names
                                                                                    1. KEYTRUDA QLEX
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                                                                                        Passage 32 · unclassified context
                                                                                        application numbers
                                                                                        1. BLA761467
                                                                                        brand names
                                                                                        1. KEYTRUDA QLEX
                                                                                        classification reasons
                                                                                        1. no_unambiguous_positive_indication_predicate
                                                                                        clinical review status
                                                                                        pending
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                                                                                          um-containing chemotherapy, for the first-line treatment of adults with locally advanced unresectable or metastatic HER2-negat
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                                                                                          e treatment of adults with locally advanced unresectable or metastatic HER2-negative gastric or gastroesophageal junction (GEJ) adenocarcinoma whose tumors express
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                                                                                        3. context exact
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                                                                                        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.
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                                                                                            NSCLC
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                                                                                            Non-Small Cell Lung Cancer
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                                                                                            end exclusive
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                                                                                          2. abbreviation
                                                                                            CRC
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                                                                                            Colorectal Cancer
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                                                                                          Passage 33 · unclassified context
                                                                                          application numbers
                                                                                          1. BLA761467
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                                                                                          1. KEYTRUDA QLEX
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                                                                                            Passage 34 · unclassified context
                                                                                            application numbers
                                                                                            1. BLA761467
                                                                                            brand names
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                                                                                            classification reasons
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                                                                                              Passage 35 · unclassified context
                                                                                              application numbers
                                                                                              1. BLA761467
                                                                                              brand names
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                                                                                              classification reasons
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                                                                                                    CRC
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                                                                                                    Colorectal Cancer
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                                                                                                  brand names
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                                                                                                    Passage 37 · unclassified context
                                                                                                    application numbers
                                                                                                    1. BLA761467
                                                                                                    brand names
                                                                                                    1. KEYTRUDA QLEX
                                                                                                    classification reasons
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                                                                                                        Non-Small Cell Lung Cancer
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                                                                                                        CRC
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                                                                                                        Colorectal Cancer
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                                                                                                      Passage 38 · unclassified context
                                                                                                      application numbers
                                                                                                      1. BLA761467
                                                                                                      brand names
                                                                                                      1. KEYTRUDA QLEX
                                                                                                      classification reasons
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                                                                                                      treatment of adult 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. ( 1.10 , 2.1 ) Hepatocellular Carcinoma (HCC) for the treatment of adult patients with HCC secondary to hepatitis B who have received prior systemic therapy other than a PD-1/PD-L1-containing regimen. ( 1.11 ) Biliary Tract Cancer (BTC) in combination with gemcitabine and cisplatin, for the treatment of adult patients with locally advanced unresectable or metastatic biliary tract cancer. ( 1.12 )
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                                                                                                          Non-Small Cell Lung Cancer
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                                                                                                        2. abbreviation
                                                                                                          CRC
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                                                                                                          Colorectal Cancer
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                                                                                                        ( 1.10 , 2.1 ) Hepatocellular Carcinoma (HCC) for the treatment of adult patients with HCC secondary to hepatitis B who have received prior systemic therapy other than a PD-1/PD-L1-containing regimen.
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                                                                                                        tumor histology
                                                                                                        Source null
                                                                                                        use intent
                                                                                                        unclear
                                                                                                        Passage 39 · unclassified context
                                                                                                        application numbers
                                                                                                        1. BLA761467
                                                                                                        brand names
                                                                                                        1. KEYTRUDA QLEX
                                                                                                        classification reasons
                                                                                                        1. no_unambiguous_positive_indication_predicate
                                                                                                        clinical review status
                                                                                                        pending
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                                                                                                        1.10 , 2.1 ) Hepatocellular Carcinoma (HCC) for the treatment of adult patients with HCC secondary to hepatitis B who have received prior systemic therapy other than a PD-1/PD-L1-containing regimen. ( 1.11 ) Biliary Tract Cancer (BTC) in combination with gemcitabine and cisplatin, for the treatment of adult patients with locally advanced unresectable or metastatic biliary tract cancer. ( 1.12 ) Merkel Cell Carcinoma (MCC) for the treatment of adult and pediatric patients 12 years and older with recurrent locally advanced or metastatic Merkel cell carcinoma. ( 1.13 ) Renal Cell Carc
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                                                                                                        generic names
                                                                                                        1. PEMBROLIZUMAB AND BERAHYALURONIDASE ALFA-PMPH
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                                                                                                          stage_or_setting
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                                                                                                        4. context exact
                                                                                                          ( 1.11 ) Biliary Tract Cancer (BTC) in combination with gemcitabine and cisplatin, for the treatment of adult patients with locally advanced unresectable or metastatic biliary tract cancer.
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                                                                                                          regimen
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                                                                                                          in combination with gemcitabine and cisplatin, for the treatment of adult patients with locally advanced unresectable or metastatic biliary tract cancer
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                                                                                                          source defined aliases
                                                                                                          1. abbreviation
                                                                                                            NSCLC
                                                                                                            definition exact
                                                                                                            Non-Small Cell Lung Cancer
                                                                                                            definition span
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                                                                                                            470
                                                                                                            end exclusive
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                                                                                                          2. abbreviation
                                                                                                            CRC
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                                                                                                            Colorectal Cancer
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                                                                                                          ( 1.11 ) Biliary Tract Cancer (BTC) in combination with gemcitabine and cisplatin, for the treatment of adult patients with locally advanced unresectable or metastatic biliary tract cancer.
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                                                                                                          disease stage
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                                                                                                          line
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                                                                                                          Source null
                                                                                                          tumor histology
                                                                                                          Source null
                                                                                                          use intent
                                                                                                          unclear
                                                                                                          Passage 40 · unclassified context
                                                                                                          application numbers
                                                                                                          1. BLA761467
                                                                                                          brand names
                                                                                                          1. KEYTRUDA QLEX
                                                                                                          classification reasons
                                                                                                          1. no_unambiguous_positive_indication_predicate
                                                                                                          clinical review status
                                                                                                          pending
                                                                                                          content role
                                                                                                          unclassified_context
                                                                                                          context span
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                                                                                                          regimen. ( 1.11 ) Biliary Tract Cancer (BTC) in combination with gemcitabine and cisplatin, for the treatment of adult patients with locally advanced unresectable or metastatic biliary tract cancer. ( 1.12 ) Merkel Cell Carcinoma (MCC) for the treatment of adult and pediatric patients 12 years and older with recurrent locally advanced or metastatic Merkel cell carcinoma. ( 1.13 ) Renal Cell Carcinoma (RCC) in combination with axitinib, for the first-line treatment of adult patients with advanced RCC. ( 1.14 ) in combination with lenvatinib, for the first-line treatme
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                                                                                                          extraction review status
                                                                                                          automated_candidate_pending_source_review
                                                                                                          generic names
                                                                                                          1. PEMBROLIZUMAB AND BERAHYALURONIDASE ALFA-PMPH
                                                                                                          id
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                                                                                                            ( 1.12 ) Merkel Cell Carcinoma (MCC) for the treatment of adult and pediatric patients 12 years and older with recurrent lo
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                                                                                                            age
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                                                                                                            not_inferred
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                                                                                                            7394
                                                                                                          2. context exact
                                                                                                            Merkel Cell Carcinoma (MCC) for the treatment of adult and pediatric patients 12 years and older with recurrent locally advanced or metas
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                                                                                                            age
                                                                                                            polarity
                                                                                                            not_inferred
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                                                                                                            7404
                                                                                                          3. context exact
                                                                                                            oma (MCC) for the treatment of adult and pediatric patients 12 years and older with recurrent locally advanced or metastatic Merkel cell c
                                                                                                            kind
                                                                                                            age
                                                                                                            polarity
                                                                                                            not_inferred
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                                                                                                            start
                                                                                                            7423
                                                                                                          4. context exact
                                                                                                            ients 12 years and older with recurrent locally advanced or metastatic Merkel cell carcinoma.
                                                                                                            kind
                                                                                                            biomarker
                                                                                                            polarity
                                                                                                            not_inferred
                                                                                                            span
                                                                                                            end
                                                                                                            7509
                                                                                                            end exclusive
                                                                                                            true
                                                                                                            exact text
                                                                                                            metastatic Merkel cell carcinoma
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                                                                                                            start
                                                                                                            7477
                                                                                                          5. context exact
                                                                                                            ent of adult and pediatric patients 12 years and older with recurrent locally advanced or metastatic Merkel cell carcinoma.
                                                                                                            kind
                                                                                                            stage_or_setting
                                                                                                            polarity
                                                                                                            not_inferred
                                                                                                            span
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                                                                                                            7491
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                                                                                                            exact text
                                                                                                            recurrent locally advanced or metastatic Mer
                                                                                                            label id
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                                                                                                            start
                                                                                                            7447
                                                                                                          regulatory links
                                                                                                            schema version
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                                                                                                            source batch sha256
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                                                                                                            source defined aliases
                                                                                                            1. abbreviation
                                                                                                              NSCLC
                                                                                                              definition exact
                                                                                                              Non-Small Cell Lung Cancer
                                                                                                              definition span
                                                                                                              end
                                                                                                              470
                                                                                                              end exclusive
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                                                                                                              exact text
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                                                                                                              436
                                                                                                            2. abbreviation
                                                                                                              CRC
                                                                                                              definition exact
                                                                                                              Colorectal Cancer
                                                                                                              definition span
                                                                                                              end
                                                                                                              4658
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                                                                                                              true
                                                                                                              exact text
                                                                                                              Colorectal Cancer (CRC)
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                                                                                                              4635
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                                                                                                            7510
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                                                                                                            true
                                                                                                            exact text
                                                                                                            ( 1.12 ) Merkel Cell Carcinoma (MCC) for the treatment of adult and pediatric patients 12 years and older with recurrent locally advanced or metastatic Merkel cell carcinoma.
                                                                                                            label id
                                                                                                            18b3adae-863b-413b-8e36-e3551115db37
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                                                                                                            7336
                                                                                                            source url
                                                                                                            https://api.fda.gov/drug/label.json?search=id%3A%2218b3adae-863b-413b-8e36-e3551115db37%22
                                                                                                            spl effective date
                                                                                                            2026-07-31
                                                                                                            spl set id
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                                                                                                            spl version
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                                                                                                            not_extracted_no_values_inferred_from_mentions
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                                                                                                            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. BLA761467
                                                                                                            brand names
                                                                                                            1. KEYTRUDA QLEX
                                                                                                            classification reasons
                                                                                                            1. no_unambiguous_positive_indication_predicate
                                                                                                            clinical review status
                                                                                                            pending
                                                                                                            content role
                                                                                                            unclassified_context
                                                                                                            context span
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                                                                                                            7842
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                                                                                                            exact text
                                                                                                            ic biliary tract cancer. ( 1.12 ) Merkel Cell Carcinoma (MCC) for the treatment of adult and pediatric patients 12 years and older with recurrent locally advanced or metastatic Merkel cell carcinoma. ( 1.13 ) Renal Cell Carcinoma (RCC) in combination with axitinib, for the first-line treatment of adult patients with advanced RCC. ( 1.14 ) in combination with lenvatinib, for the first-line treatment of adult patients with advanced RCC. ( 1.14 ) for the adjuvant treatment of adult patients with RCC at intermediate-high or high
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                                                                                                            offset unit
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                                                                                                            7311
                                                                                                            current approval status
                                                                                                            not_reconciled
                                                                                                            duplicate text group
                                                                                                            dup-d5e149797849843ba03e
                                                                                                            extraction review status
                                                                                                            automated_candidate_pending_source_review
                                                                                                            generic names
                                                                                                            1. PEMBROLIZUMAB AND BERAHYALURONIDASE ALFA-PMPH
                                                                                                            id
                                                                                                            ind-span-7bc18e4ee09df05a92d0
                                                                                                            label id
                                                                                                            18b3adae-863b-413b-8e36-e3551115db37
                                                                                                            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
                                                                                                              7623
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                                                                                                              true
                                                                                                              exact text
                                                                                                              adult patients
                                                                                                              label id
                                                                                                              18b3adae-863b-413b-8e36-e3551115db37
                                                                                                              offset unit
                                                                                                              unicode_code_points
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                                                                                                              start
                                                                                                              7609
                                                                                                            2. context exact
                                                                                                              itinib, for the first-line treatment of adult patients with advanced RCC.
                                                                                                              kind
                                                                                                              stage_or_setting
                                                                                                              polarity
                                                                                                              not_inferred
                                                                                                              span
                                                                                                              end
                                                                                                              7641
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                                                                                                              true
                                                                                                              exact text
                                                                                                              advanced RCC
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                                                                                                              0
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                                                                                                              start
                                                                                                              7629
                                                                                                            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
                                                                                                              7641
                                                                                                              end exclusive
                                                                                                              true
                                                                                                              exact text
                                                                                                              first-line treatment of adult patients with advanced RCC
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                                                                                                              offset unit
                                                                                                              unicode_code_points
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                                                                                                              7585
                                                                                                            4. context exact
                                                                                                              ( 1.13 ) 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
                                                                                                              7641
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                                                                                                              exact text
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                                                                                                              0
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                                                                                                              start
                                                                                                              7547
                                                                                                            regulatory links
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                                                                                                              source defined aliases
                                                                                                              1. abbreviation
                                                                                                                NSCLC
                                                                                                                definition exact
                                                                                                                Non-Small Cell Lung Cancer
                                                                                                                definition span
                                                                                                                end
                                                                                                                470
                                                                                                                end exclusive
                                                                                                                true
                                                                                                                exact text
                                                                                                                Non-Small Cell Lung Cancer (NSCLC)
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                                                                                                                436
                                                                                                              2. abbreviation
                                                                                                                CRC
                                                                                                                definition exact
                                                                                                                Colorectal Cancer
                                                                                                                definition span
                                                                                                                end
                                                                                                                4658
                                                                                                                end exclusive
                                                                                                                true
                                                                                                                exact text
                                                                                                                Colorectal Cancer (CRC)
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                                                                                                                4635
                                                                                                              source span
                                                                                                              end
                                                                                                              7642
                                                                                                              end exclusive
                                                                                                              true
                                                                                                              exact text
                                                                                                              ( 1.13 ) Renal Cell Carcinoma (RCC) in combination with axitinib, for the first-line treatment of adult patients with advanced RCC.
                                                                                                              label id
                                                                                                              18b3adae-863b-413b-8e36-e3551115db37
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                                                                                                              start
                                                                                                              7511
                                                                                                              source url
                                                                                                              https://api.fda.gov/drug/label.json?search=id%3A%2218b3adae-863b-413b-8e36-e3551115db37%22
                                                                                                              spl effective date
                                                                                                              2026-07-31
                                                                                                              spl set id
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                                                                                                              spl version
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                                                                                                              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. BLA761467
                                                                                                              brand names
                                                                                                              1. KEYTRUDA QLEX
                                                                                                              classification reasons
                                                                                                              1. no_unambiguous_positive_indication_predicate
                                                                                                              clinical review status
                                                                                                              pending
                                                                                                              content role
                                                                                                              unclassified_context
                                                                                                              context span
                                                                                                              end
                                                                                                              7851
                                                                                                              end exclusive
                                                                                                              true
                                                                                                              exact text
                                                                                                              ith recurrent locally advanced or metastatic Merkel cell carcinoma. ( 1.13 ) Renal Cell Carcinoma (RCC) in combination with axitinib, for the first-line treatment of adult patients with advanced RCC. ( 1.14 ) in combination with lenvatinib, for the first-line treatment of adult patients with advanced RCC. ( 1.14 ) for the adjuvant treatment of adult patients with RCC at intermediate-high or high risk of r
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                                                                                                              unicode_code_points
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                                                                                                              0
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                                                                                                              start
                                                                                                              7443
                                                                                                              current approval status
                                                                                                              not_reconciled
                                                                                                              duplicate text group
                                                                                                              dup-10f995e9d9d23b5579ea
                                                                                                              extraction review status
                                                                                                              automated_candidate_pending_source_review
                                                                                                              generic names
                                                                                                              1. PEMBROLIZUMAB AND BERAHYALURONIDASE ALFA-PMPH
                                                                                                              id
                                                                                                              ind-span-285101557759a4e55913
                                                                                                              label id
                                                                                                              18b3adae-863b-413b-8e36-e3551115db37
                                                                                                              positive predicate support span
                                                                                                              Source null
                                                                                                              qualifier mentions
                                                                                                                regulatory links
                                                                                                                  schema version
                                                                                                                  0.1.0
                                                                                                                  source batch sha256
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                                                                                                                  source defined aliases
                                                                                                                  1. abbreviation
                                                                                                                    NSCLC
                                                                                                                    definition exact
                                                                                                                    Non-Small Cell Lung Cancer
                                                                                                                    definition span
                                                                                                                    end
                                                                                                                    470
                                                                                                                    end exclusive
                                                                                                                    true
                                                                                                                    exact text
                                                                                                                    Non-Small Cell Lung Cancer (NSCLC)
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                                                                                                                    offset unit
                                                                                                                    unicode_code_points
                                                                                                                    source array index
                                                                                                                    0
                                                                                                                    source field
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                                                                                                                    source text sha256
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                                                                                                                    start
                                                                                                                    436
                                                                                                                  2. abbreviation
                                                                                                                    CRC
                                                                                                                    definition exact
                                                                                                                    Colorectal Cancer
                                                                                                                    definition span
                                                                                                                    end
                                                                                                                    4658
                                                                                                                    end exclusive
                                                                                                                    true
                                                                                                                    exact text
                                                                                                                    Colorectal Cancer (CRC)
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                                                                                                                    0
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                                                                                                                    4635
                                                                                                                  source span
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                                                                                                                  7651
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                                                                                                                  true
                                                                                                                  exact text
                                                                                                                  ( 1.14 )
                                                                                                                  label id
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                                                                                                                  source field
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                                                                                                                  7643
                                                                                                                  source url
                                                                                                                  https://api.fda.gov/drug/label.json?search=id%3A%2218b3adae-863b-413b-8e36-e3551115db37%22
                                                                                                                  spl effective date
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                                                                                                                  spl set id
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                                                                                                                  spl version
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                                                                                                                  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. BLA761467
                                                                                                                  brand names
                                                                                                                  1. KEYTRUDA QLEX
                                                                                                                  classification reasons
                                                                                                                  1. no_unambiguous_positive_indication_predicate
                                                                                                                  clinical review status
                                                                                                                  pending
                                                                                                                  content role
                                                                                                                  unclassified_context
                                                                                                                  context span
                                                                                                                  end
                                                                                                                  7949
                                                                                                                  end exclusive
                                                                                                                  true
                                                                                                                  exact text
                                                                                                                  rent locally advanced or metastatic Merkel cell carcinoma. ( 1.13 ) Renal Cell Carcinoma (RCC) in combination with axitinib, for the first-line treatment of adult patients with advanced RCC. ( 1.14 ) in combination with lenvatinib, for the first-line treatment of adult patients with advanced RCC. ( 1.14 ) for the adjuvant treatment of adult patients with RCC at intermediate-high or high risk of recurrence following nephrectomy, or following nephrectomy and resection of metastatic lesions. ( 1
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                                                                                                                  7452
                                                                                                                  current approval status
                                                                                                                  not_reconciled
                                                                                                                  duplicate text group
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                                                                                                                  extraction review status
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                                                                                                                  generic names
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                                                                                                                  positive predicate support span
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                                                                                                                  qualifier mentions
                                                                                                                  1. context exact
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                                                                                                                  2. context exact
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                                                                                                                    exact text
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                                                                                                                  4. context exact
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                                                                                                                    regimen
                                                                                                                    polarity
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                                                                                                                    source defined aliases
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                                                                                                                      definition exact
                                                                                                                      Non-Small Cell Lung Cancer
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                                                                                                                      end exclusive
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                                                                                                                    2. abbreviation
                                                                                                                      CRC
                                                                                                                      definition exact
                                                                                                                      Colorectal Cancer
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                                                                                                                    disease stage
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                                                                                                                    limitations
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                                                                                                                    line
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                                                                                                                    prior therapy
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                                                                                                                    regimen
                                                                                                                    Source null
                                                                                                                    tumor histology
                                                                                                                    Source null
                                                                                                                    use intent
                                                                                                                    unclear
                                                                                                                    Passage 44 · unclassified context
                                                                                                                    application numbers
                                                                                                                    1. BLA761467
                                                                                                                    brand names
                                                                                                                    1. KEYTRUDA QLEX
                                                                                                                    classification reasons
                                                                                                                    1. no_unambiguous_positive_indication_predicate
                                                                                                                    clinical review status
                                                                                                                    pending
                                                                                                                    content role
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                                                                                                                    context span
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                                                                                                                    exact text
                                                                                                                    combination with axitinib, for the first-line treatment of adult patients with advanced RCC. ( 1.14 ) in combination with lenvatinib, for the first-line treatment of adult patients with advanced RCC. ( 1.14 ) for the adjuvant treatment of adult patients with RCC at intermediate-high or high risk of recurrence following nephrectomy, or following nephrectomy and resection of metastatic lesions. ( 1.14 ) in
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                                                                                                                    extraction review status
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                                                                                                                    generic names
                                                                                                                    1. PEMBROLIZUMAB AND BERAHYALURONIDASE ALFA-PMPH
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                                                                                                                    positive predicate support span
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                                                                                                                      regulatory links
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                                                                                                                          definition exact
                                                                                                                          Non-Small Cell Lung Cancer
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                                                                                                                          470
                                                                                                                          end exclusive
                                                                                                                          true
                                                                                                                          exact text
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                                                                                                                        2. abbreviation
                                                                                                                          CRC
                                                                                                                          definition exact
                                                                                                                          Colorectal Cancer
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                                                                                                                          4658
                                                                                                                          end exclusive
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                                                                                                                        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 · risk or warning
                                                                                                                        application numbers
                                                                                                                        1. BLA761467
                                                                                                                        brand names
                                                                                                                        1. KEYTRUDA QLEX
                                                                                                                        classification reasons
                                                                                                                        1. risk_or_warning_words_without_positive_predicate
                                                                                                                        clinical review status
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                                                                                                                        exact text
                                                                                                                        on with axitinib, for the first-line treatment of adult patients with advanced RCC. ( 1.14 ) in combination with lenvatinib, for the first-line treatment of adult patients with advanced RCC. ( 1.14 ) for the adjuvant treatment of adult patients with RCC at intermediate-high or high risk of recurrence following nephrectomy, or following nephrectomy and resection of metastatic lesions. ( 1.14 ) 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
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                                                                                                                        extraction review status
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                                                                                                                        generic names
                                                                                                                        1. PEMBROLIZUMAB AND BERAHYALURONIDASE ALFA-PMPH
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                                                                                                                        positive predicate support span
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                                                                                                                        qualifier mentions
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                                                                                                                          7810
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                                                                                                                          exact text
                                                                                                                          adjuvant treatment of adult patients with R
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                                                                                                                            definition exact
                                                                                                                            Non-Small Cell Lung Cancer
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                                                                                                                            end
                                                                                                                            470
                                                                                                                            end exclusive
                                                                                                                            true
                                                                                                                            exact text
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                                                                                                                          2. abbreviation
                                                                                                                            CRC
                                                                                                                            definition exact
                                                                                                                            Colorectal Cancer
                                                                                                                            definition span
                                                                                                                            end
                                                                                                                            4658
                                                                                                                            end exclusive
                                                                                                                            true
                                                                                                                            exact text
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                                                                                                                          source span
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                                                                                                                          end exclusive
                                                                                                                          true
                                                                                                                          exact text
                                                                                                                          for the adjuvant treatment of adult patients with RCC at intermediate-high or high risk of recurrence following nephrectomy, or following nephrectomy and resection of metastatic lesions.
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                                                                                                                          source url
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                                                                                                                          spl effective date
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                                                                                                                          biomarker and test
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                                                                                                                          disease stage
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                                                                                                                          limitations
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                                                                                                                          line
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                                                                                                                          prior therapy
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                                                                                                                              tumor histology
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                                                                                                                              Passage 47 · risk or warning
                                                                                                                              application numbers
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                                                                                                                              brand names
                                                                                                                              1. KEYTRUDA QLEX
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                                                                                                                                  Non-Small Cell Lung Cancer
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                                                                                                                                2. abbreviation
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                                                                                                                                  definition exact
                                                                                                                                  Colorectal Cancer
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                                                                                                                                  4658
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                                                                                                                                Passage 48 · unclassified context
                                                                                                                                application numbers
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                                                                                                                                brand names
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                                                                                                                                  source defined aliases
                                                                                                                                  1. abbreviation
                                                                                                                                    NSCLC
                                                                                                                                    definition exact
                                                                                                                                    Non-Small Cell Lung Cancer
                                                                                                                                    definition span
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                                                                                                                                          spl effective date
                                                                                                                                          2026-07-31
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                                                                                                                                          tumor histology
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                                                                                                                                          use intent
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                                                                                                                                          Passage 52 · limitation of use
                                                                                                                                          application numbers
                                                                                                                                          1. BLA761467
                                                                                                                                          brand names
                                                                                                                                          1. KEYTRUDA QLEX
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                                                                                                                                          generic names
                                                                                                                                          1. PEMBROLIZUMAB AND BERAHYALURONIDASE ALFA-PMPH
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                                                                                                                                          2. context exact
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                                                                                                                                          4. context exact
                                                                                                                                            s of Use : The safety and effectiveness of KEYTRUDA QLEX in pediatric patients 12 years and older with TMB-H central nervous system cancer
                                                                                                                                            kind
                                                                                                                                            age
                                                                                                                                            polarity
                                                                                                                                            not_inferred
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                                                                                                                                          6. context exact
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                                                                                                                                            biomarker
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                                                                                                                                          8. context exact
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                                                                                                                                          10. context exact
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                                                                                                                                              NSCLC
                                                                                                                                              definition exact
                                                                                                                                              Non-Small Cell Lung Cancer
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                                                                                                                                              exact text
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                                                                                                                                              Passage 54 · unclassified context
                                                                                                                                              application numbers
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                                                                                                                                              brand names
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                                                                                                                                                  Non-Small Cell Lung Cancer
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                                                                                                                                                application numbers
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                                                                                                                                                brand names
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                                                                                                                                                    tumor histology
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                                                                                                                                                    use intent
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                                                                                                                                                    Passage 56 · unclassified context
                                                                                                                                                    application numbers
                                                                                                                                                    1. BLA761467
                                                                                                                                                    brand names
                                                                                                                                                    1. KEYTRUDA QLEX
                                                                                                                                                    classification reasons
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                                                                                                                                                      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
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                                                                                                                                                        definition exact
                                                                                                                                                        Non-Small Cell Lung Cancer
                                                                                                                                                        definition span
                                                                                                                                                        end
                                                                                                                                                        470
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                                                                                                                                                        Non-Small Cell Lung Cancer (NSCLC)
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                                                                                                                                                      2. abbreviation
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                                                                                                                                                        Colorectal Cancer
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                                                                                                                                                      regimen
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                                                                                                                                                      tumor histology
                                                                                                                                                      Source null
                                                                                                                                                      use intent
                                                                                                                                                      unclear
                                                                                                                                                      Passage 57 · unclassified context
                                                                                                                                                      application numbers
                                                                                                                                                      1. BLA761467
                                                                                                                                                      brand names
                                                                                                                                                      1. KEYTRUDA QLEX
                                                                                                                                                      classification reasons
                                                                                                                                                      1. no_unambiguous_positive_indication_predicate
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                                                                                                                                                      generic names
                                                                                                                                                      1. PEMBROLIZUMAB AND BERAHYALURONIDASE ALFA-PMPH
                                                                                                                                                      id
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                                                                                                                                                      qualifier mentions
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                                                                                                                                                              ( 1.19 , 2.1 ) 1 This indication is approved under accelerated approval based on tumor response rate and durability of response.
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                                                                                                                                                              Passage 60 · approval contingency
                                                                                                                                                              application numbers
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                                                                                                                                                              brand names
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                                                                                                                                                              t, and who have received one or two prior systemic treatment regimens. ( 1.19 , 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 QLEX ™ is indicated for the treatment of adult patients with unresectable or metastatic melanoma. KEYTRUDA QLEX is indicated for the adjuvant treatment of adult and pediatric pa
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                                                                                                                                                              generic names
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                                                                                                                                                                  2. abbreviation
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                                                                                                                                                                    definition exact
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                                                                                                                                                                  Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trials.
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                                                                                                                                                                  application numbers
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                                                                                                                                                                  brand names
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                                                                                                                                                                  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 QLEX ™ is indicated for the treatment of adult patients with unresectable or metastatic melanoma. KEYTRUDA QLEX is indicated for the adjuvant treatment of adult and pediatric patients 12 years and older with Stage IIB, IIC, or III melanoma following complete resection. 1.2 Non-Small Cell Lung Can
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                                                                                                                                                                  1. PEMBROLIZUMAB AND BERAHYALURONIDASE ALFA-PMPH
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                                                                                                                                                                  3. context exact
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                                                                                                                                                                      exact text
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                                                                                                                                                                    2. abbreviation
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                                                                                                                                                                      definition exact
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                                                                                                                                                                      4658
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                                                                                                                                                                      exact text
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                                                                                                                                                                    1.1 Melanoma KEYTRUDA QLEX ™ is indicated for the treatment of adult patients with unresectable or metastatic melanoma.
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                                                                                                                                                                    application numbers
                                                                                                                                                                    1. BLA761467
                                                                                                                                                                    brand names
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                                                                                                                                                                    exact text
                                                                                                                                                                    on verification and description of clinical benefit in the confirmatory trials. 1.1 Melanoma KEYTRUDA QLEX ™ is indicated for the treatment of adult patients with unresectable or metastatic melanoma. KEYTRUDA QLEX is indicated for the adjuvant treatment of adult and pediatric patients 12 years and older with Stage IIB, IIC, or III melanoma following complete resection. 1.2 Non-Small Cell Lung Cancer KEYTRUDA QLEX, in combination with pemetrexed and platinum chemotherapy, is indicated for the first-line treatment of adult patients with metastatic nonsquamous non-sma
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                                                                                                                                                                    extraction review status
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                                                                                                                                                                    generic names
                                                                                                                                                                    1. PEMBROLIZUMAB AND BERAHYALURONIDASE ALFA-PMPH
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                                                                                                                                                                    2. context exact
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                                                                                                                                                                        definition exact
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                                                                                                                                                                      2. abbreviation
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                                                                                                                                                                      use intent
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                                                                                                                                                                      application numbers
                                                                                                                                                                      1. BLA761467
                                                                                                                                                                      brand names
                                                                                                                                                                      1. KEYTRUDA QLEX
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                                                                                                                                                                      ble or metastatic melanoma. KEYTRUDA QLEX is indicated for the adjuvant treatment of adult and pediatric patients 12 years and older with Stage IIB, IIC, or III melanoma following complete resection. 1.2 Non-Small Cell Lung Cancer KEYTRUDA QLEX, in combination with pemetrexed and platinum chemotherapy, is indicated for the first-line treatment of adult patients with metastatic nonsquamous non-small cell lung cancer (NSCLC), with no EGFR or ALK genomic tumor aberrations. KEYTRUDA QLEX, in combination with carboplatin and either paclitaxel or paclitaxel protein-bound, is indicated for the first-line treatment of adult patients with metastatic squamous NSCLC. KEYTRUDA
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                                                                                                                                                                      generic names
                                                                                                                                                                      1. PEMBROLIZUMAB AND BERAHYALURONIDASE ALFA-PMPH
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                                                                                                                                                                      qualifier mentions
                                                                                                                                                                      1. context exact
                                                                                                                                                                        chemotherapy, is indicated for the first-line treatment of adult patients with metastatic nonsquamous non-small cell lung cancer (NSC
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                                                                                                                                                                      2. context exact
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                                                                                                                                                                      3. context exact
                                                                                                                                                                        tic nonsquamous non-small cell lung cancer (NSCLC), with no EGFR or ALK genomic tumor aberrations.
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                                                                                                                                                                      5. context exact
                                                                                                                                                                        pemetrexed and platinum chemotherapy, is indicated for the first-line treatment of adult patients with metastatic nonsquamous non-small cell lung cancer (NSCLC), with no EGFR or ALK genomic tumor aberrations.
                                                                                                                                                                        kind
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                                                                                                                                                                        exact text
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                                                                                                                                                                      6. context exact
                                                                                                                                                                        1.2 Non-Small Cell Lung Cancer KEYTRUDA QLEX, in combination with pemetrexed and platinum chemotherapy, is indicated for the first-line treatment of adult patients with metastatic nonsquamous non-small cell lung cancer (NSCLC), with no EGFR or ALK genomic tumor aberrations.
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                                                                                                                                                                        in combination with pemetrexed and platinum chemotherapy, is indicated for the first-line treatment of adult patients with metastatic nonsquamous non-small cell lung cancer (NSCLC
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                                                                                                                                                                        1. abbreviation
                                                                                                                                                                          NSCLC
                                                                                                                                                                          definition exact
                                                                                                                                                                          Non-Small Cell Lung Cancer
                                                                                                                                                                          definition span
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                                                                                                                                                                          470
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                                                                                                                                                                        2. abbreviation
                                                                                                                                                                          CRC
                                                                                                                                                                          definition exact
                                                                                                                                                                          Colorectal Cancer
                                                                                                                                                                          definition span
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                                                                                                                                                                          4658
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                                                                                                                                                                        Source null
                                                                                                                                                                        limitations
                                                                                                                                                                        Source null
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                                                                                                                                                                        Source null
                                                                                                                                                                        prior therapy
                                                                                                                                                                        Source null
                                                                                                                                                                        regimen
                                                                                                                                                                        Source null
                                                                                                                                                                        tumor histology
                                                                                                                                                                        Source null
                                                                                                                                                                        use intent
                                                                                                                                                                        tumor_directed_candidate
                                                                                                                                                                        Passage 64 · positive indication candidate
                                                                                                                                                                        application numbers
                                                                                                                                                                        1. BLA761467
                                                                                                                                                                        brand names
                                                                                                                                                                        1. KEYTRUDA QLEX
                                                                                                                                                                        classification reasons
                                                                                                                                                                        1. explicit_positive_indication_predicate
                                                                                                                                                                        2. tumor_or_malignant_hematology_words_in_positive_statement
                                                                                                                                                                        clinical review status
                                                                                                                                                                        pending
                                                                                                                                                                        content role
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                                                                                                                                                                        context span
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                                                                                                                                                                        exact text
                                                                                                                                                                        d and platinum chemotherapy, is indicated for the first-line treatment of adult patients with metastatic nonsquamous non-small cell lung cancer (NSCLC), with no EGFR or ALK genomic tumor aberrations. KEYTRUDA QLEX, in combination with carboplatin and either paclitaxel or paclitaxel protein-bound, is indicated for the first-line treatment of adult patients with metastatic squamous NSCLC. KEYTRUDA QLEX, as a single agent, is indicated for the first-line treatment of adult patients with NSCLC expressing PD-L1 [Tumor Proportion Score (TPS) ≥1%] as determined by an FDA-authorized test [s
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                                                                                                                                                                        extraction review status
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                                                                                                                                                                        generic names
                                                                                                                                                                        1. PEMBROLIZUMAB AND BERAHYALURONIDASE ALFA-PMPH
                                                                                                                                                                        id
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                                                                                                                                                                          kind
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                                                                                                                                                                        3. context exact
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                                                                                                                                                                          kind
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                                                                                                                                                                        4. context exact
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                                                                                                                                                                          kind
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                                                                                                                                                                          exact text
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                                                                                                                                                                        5. context exact
                                                                                                                                                                          KEYTRUDA QLEX, in combination with carboplatin and either paclitaxel or paclitaxel protein-bound, is indicated for the first-line treatment of adult patients with metastatic squamous NSCLC.
                                                                                                                                                                          kind
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                                                                                                                                                                          polarity
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                                                                                                                                                                          exact text
                                                                                                                                                                          in combination with carboplatin and either paclitaxel or paclitaxel protein-bound, is indicated for the first-line treatment of adult patients with metastatic squamous NSCLC
                                                                                                                                                                          label id
                                                                                                                                                                          18b3adae-863b-413b-8e36-e3551115db37
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                                                                                                                                                                          1. abbreviation
                                                                                                                                                                            NSCLC
                                                                                                                                                                            definition exact
                                                                                                                                                                            Non-Small Cell Lung Cancer
                                                                                                                                                                            definition span
                                                                                                                                                                            end
                                                                                                                                                                            470
                                                                                                                                                                            end exclusive
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                                                                                                                                                                            exact text
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                                                                                                                                                                          2. abbreviation
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                                                                                                                                                                            definition exact
                                                                                                                                                                            Colorectal Cancer
                                                                                                                                                                            definition span
                                                                                                                                                                            end
                                                                                                                                                                            4658
                                                                                                                                                                            end exclusive
                                                                                                                                                                            true
                                                                                                                                                                            exact text
                                                                                                                                                                            Colorectal Cancer (CRC)
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                                                                                                                                                                          spl effective date
                                                                                                                                                                          2026-07-31
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                                                                                                                                                                          spl version
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                                                                                                                                                                          Source null
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                                                                                                                                                                          Source null
                                                                                                                                                                          limitations
                                                                                                                                                                          Source null
                                                                                                                                                                          line
                                                                                                                                                                          Source null
                                                                                                                                                                          prior therapy
                                                                                                                                                                          Source null
                                                                                                                                                                          regimen
                                                                                                                                                                          Source null
                                                                                                                                                                          tumor histology
                                                                                                                                                                          Source null
                                                                                                                                                                          use intent
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                                                                                                                                                                          Passage 65 · positive indication candidate
                                                                                                                                                                          application numbers
                                                                                                                                                                          1. BLA761467
                                                                                                                                                                          brand names
                                                                                                                                                                          1. KEYTRUDA QLEX
                                                                                                                                                                          classification reasons
                                                                                                                                                                          1. explicit_positive_indication_predicate
                                                                                                                                                                          2. tumor_or_malignant_hematology_words_in_positive_statement
                                                                                                                                                                          clinical review status
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                                                                                                                                                                          context span
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                                                                                                                                                                          exact text
                                                                                                                                                                          rrations. KEYTRUDA QLEX, in combination with carboplatin and either paclitaxel or paclitaxel protein-bound, is indicated for the first-line treatment of adult patients with metastatic squamous NSCLC. KEYTRUDA QLEX, as a single agent, is indicated for the first-line treatment of adult 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 QLEX, as a single agent, is indicated for the treatment of adult patients with metastatic NSCLC whose tumors express PD-L1 (TPS ≥1%) as determined by an FDA-authorized test [see Dosage and A
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                                                                                                                                                                          generic names
                                                                                                                                                                          1. PEMBROLIZUMAB AND BERAHYALURONIDASE ALFA-PMPH
                                                                                                                                                                          id
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                                                                                                                                                                          exact text
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                                                                                                                                                                          qualifier mentions
                                                                                                                                                                          1. context exact
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                                                                                                                                                                          2. context exact
                                                                                                                                                                            irst-line treatment of adult patients with NSCLC expressing PD-L1 [Tumor Proportion Score (TPS) ≥1%] as determined by an FDA-authorized test [see Dosage and Administ
                                                                                                                                                                            kind
                                                                                                                                                                            biomarker
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                                                                                                                                                                            exact text
                                                                                                                                                                            PD-L1 [Tumor Proportion Score (TPS) ≥1%] as d
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                                                                                                                                                                          3. context exact
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                                                                                                                                                                            kind
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                                                                                                                                                                            exact text
                                                                                                                                                                            EGFR or ALK genomic tumor aberrations
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                                                                                                                                                                          4. context exact
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                                                                                                                                                                            exact text
                                                                                                                                                                            metastatic
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                                                                                                                                                                          5. context exact
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                                                                                                                                                                            metastatic
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                                                                                                                                                                              application numbers
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                                                                                                                                                                                Patients with EGFR or ALK genomic tumor aberrations should have disease progression on FDA-approved therapy for these aberrations prior to receiving KEYTRUDA QLEX.
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                                                                                                                                                                                limitations
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                                                                                                                                                                                line
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                                                                                                                                                                                prior therapy
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                                                                                                                                                                                regimen
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                                                                                                                                                                                tumor histology
                                                                                                                                                                                Source null
                                                                                                                                                                                use intent
                                                                                                                                                                                unclear
                                                                                                                                                                                Passage 68 · positive indication candidate
                                                                                                                                                                                application numbers
                                                                                                                                                                                1. BLA761467
                                                                                                                                                                                brand names
                                                                                                                                                                                1. KEYTRUDA QLEX
                                                                                                                                                                                classification reasons
                                                                                                                                                                                1. explicit_positive_indication_predicate
                                                                                                                                                                                2. tumor_or_malignant_hematology_words_in_positive_statement
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                                                                                                                                                                                r 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 QLEX. KEYTRUDA QLEX is indicated for the treatment of adult 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 QLEX, 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
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                                                                                                                                                                                generic names
                                                                                                                                                                                1. PEMBROLIZUMAB AND BERAHYALURONIDASE ALFA-PMPH
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                                                                                                                                                                                2. context exact
                                                                                                                                                                                  QLEX is indicated for the treatment of adult patients with resectable (tumors ≥4 cm or node positive) NSCLC in combination with platinum-containing chemotherapy as
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                                                                                                                                                                                  1. abbreviation
                                                                                                                                                                                    NSCLC
                                                                                                                                                                                    definition exact
                                                                                                                                                                                    Non-Small Cell Lung Cancer
                                                                                                                                                                                    definition span
                                                                                                                                                                                    end
                                                                                                                                                                                    470
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                                                                                                                                                                                    exact text
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                                                                                                                                                                                  2. abbreviation
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                                                                                                                                                                                    Colorectal Cancer
                                                                                                                                                                                    definition span
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                                                                                                                                                                                  use intent
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                                                                                                                                                                                  Passage 69 · positive indication candidate
                                                                                                                                                                                  application numbers
                                                                                                                                                                                  1. BLA761467
                                                                                                                                                                                  brand names
                                                                                                                                                                                  1. KEYTRUDA QLEX
                                                                                                                                                                                  classification reasons
                                                                                                                                                                                  1. explicit_positive_indication_predicate
                                                                                                                                                                                  2. tumor_or_malignant_hematology_words_in_positive_statement
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                                                                                                                                                                                  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 QLEX, 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 QLEX, in combination with pemetrexed and platinum chemotherapy, is indicated for the first-line treatment of adult patients with unresectable advanced or m
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                                                                                                                                                                                  generic names
                                                                                                                                                                                  1. PEMBROLIZUMAB AND BERAHYALURONIDASE ALFA-PMPH
                                                                                                                                                                                  id
                                                                                                                                                                                  ind-span-e2b46237b005b522f1eb
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                                                                                                                                                                                  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
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                                                                                                                                                                                    exact text
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                                                                                                                                                                                    application numbers
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                                                                                                                                                                                    brand names
                                                                                                                                                                                    1. KEYTRUDA QLEX
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                                                                                                                                                                                    fter surgery. KEYTRUDA QLEX, 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 QLEX, 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 QLEX is indicated for the treatment of adult patients with resectable locally advanced HNSCC whose tumors express PD-L1 [Combined Positive Score (CPS)
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                                                                                                                                                                                    1. PEMBROLIZUMAB AND BERAHYALURONIDASE ALFA-PMPH
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                                                                                                                                                                                      e treatment of adult patients with unresectable advanced or metastatic malignant pleural mesothelioma (MPM).
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                                                                                                                                                                                      dicated for the first-line treatment of adult patients with unresectable advanced or metastatic malignant pleural mesothelioma (MPM).
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                                                                                                                                                                                      pemetrexed and platinum chemotherapy, is indicated for the first-line treatment of adult patients with unresectable advanced or metastatic malignant pleural mesothelioma (MPM).
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                                                                                                                                                                                      1.3 Malignant Pleural Mesothelioma KEYTRUDA QLEX, 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).
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                                                                                                                                                                                      Passage 71 · positive indication candidate
                                                                                                                                                                                      application numbers
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                                                                                                                                                                                      brand names
                                                                                                                                                                                      1. KEYTRUDA QLEX
                                                                                                                                                                                      classification reasons
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                                                                                                                                                                                      X, 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 QLEX 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 QLEX, in combination with platinum and fluorouracil (FU), is indicated for the first-line treatment of adult patients with metastatic or with unresectable, recurrent head and neck squamous c
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                                                                                                                                                                                      current approval status
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                                                                                                                                                                                      duplicate text group
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                                                                                                                                                                                      extraction review status
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                                                                                                                                                                                      generic names
                                                                                                                                                                                      1. PEMBROLIZUMAB AND BERAHYALURONIDASE ALFA-PMPH
                                                                                                                                                                                      id
                                                                                                                                                                                      ind-span-3178b3b94f3d70483aa4
                                                                                                                                                                                      label id
                                                                                                                                                                                      18b3adae-863b-413b-8e36-e3551115db37
                                                                                                                                                                                      positive predicate support span
                                                                                                                                                                                      end
                                                                                                                                                                                      13579
                                                                                                                                                                                      end exclusive
                                                                                                                                                                                      true
                                                                                                                                                                                      exact text
                                                                                                                                                                                      is indicated
                                                                                                                                                                                      label id
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                                                                                                                                                                                      offset unit
                                                                                                                                                                                      unicode_code_points
                                                                                                                                                                                      source array index
                                                                                                                                                                                      0
                                                                                                                                                                                      source field
                                                                                                                                                                                      indications_and_usage_exact
                                                                                                                                                                                      source text sha256
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                                                                                                                                                                                      13567
                                                                                                                                                                                      qualifier mentions
                                                                                                                                                                                      1. context exact
                                                                                                                                                                                        Cell Cancer KEYTRUDA QLEX is indicated for the treatment of adult patients with resectable locally advanced HNSCC whose tumors express
                                                                                                                                                                                        kind
                                                                                                                                                                                        age
                                                                                                                                                                                        polarity
                                                                                                                                                                                        not_inferred
                                                                                                                                                                                        span
                                                                                                                                                                                        end
                                                                                                                                                                                        13615
                                                                                                                                                                                        end exclusive
                                                                                                                                                                                        true
                                                                                                                                                                                        exact text
                                                                                                                                                                                        adult patients
                                                                                                                                                                                        label id
                                                                                                                                                                                        18b3adae-863b-413b-8e36-e3551115db37
                                                                                                                                                                                        offset unit
                                                                                                                                                                                        unicode_code_points
                                                                                                                                                                                        source array index
                                                                                                                                                                                        0
                                                                                                                                                                                        source field
                                                                                                                                                                                        indications_and_usage_exact
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                                                                                                                                                                                        start
                                                                                                                                                                                        13601
                                                                                                                                                                                      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
                                                                                                                                                                                        13721
                                                                                                                                                                                        end exclusive
                                                                                                                                                                                        true
                                                                                                                                                                                        exact text
                                                                                                                                                                                        PD-L1 [Combined Positive Score (CPS) ≥1] as d
                                                                                                                                                                                        label id
                                                                                                                                                                                        18b3adae-863b-413b-8e36-e3551115db37
                                                                                                                                                                                        offset unit
                                                                                                                                                                                        unicode_code_points
                                                                                                                                                                                        source array index
                                                                                                                                                                                        0
                                                                                                                                                                                        source field
                                                                                                                                                                                        indications_and_usage_exact
                                                                                                                                                                                        source text sha256
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                                                                                                                                                                                        start
                                                                                                                                                                                        13676
                                                                                                                                                                                      3. context exact
                                                                                                                                                                                        QLEX 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
                                                                                                                                                                                        13666
                                                                                                                                                                                        end exclusive
                                                                                                                                                                                        true
                                                                                                                                                                                        exact text
                                                                                                                                                                                        resectable locally advanced HNSCC whose tumor
                                                                                                                                                                                        label id
                                                                                                                                                                                        18b3adae-863b-413b-8e36-e3551115db37
                                                                                                                                                                                        offset unit
                                                                                                                                                                                        unicode_code_points
                                                                                                                                                                                        source array index
                                                                                                                                                                                        0
                                                                                                                                                                                        source field
                                                                                                                                                                                        indications_and_usage_exact
                                                                                                                                                                                        source text sha256
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                                                                                                                                                                                        start
                                                                                                                                                                                        13621
                                                                                                                                                                                      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
                                                                                                                                                                                        13840
                                                                                                                                                                                        end exclusive
                                                                                                                                                                                        true
                                                                                                                                                                                        exact text
                                                                                                                                                                                        neoadjuvant treatment
                                                                                                                                                                                        label id
                                                                                                                                                                                        18b3adae-863b-413b-8e36-e3551115db37
                                                                                                                                                                                        offset unit
                                                                                                                                                                                        unicode_code_points
                                                                                                                                                                                        source array index
                                                                                                                                                                                        0
                                                                                                                                                                                        source field
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                                                                                                                                                                                        13819
                                                                                                                                                                                      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
                                                                                                                                                                                        13898
                                                                                                                                                                                        end exclusive
                                                                                                                                                                                        true
                                                                                                                                                                                        exact text
                                                                                                                                                                                        adjuvant treatment in combination with radi
                                                                                                                                                                                        label id
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                                                                                                                                                                                        offset unit
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                                                                                                                                                                                        0
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                                                                                                                                                                                        source text sha256
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                                                                                                                                                                                        start
                                                                                                                                                                                        13855
                                                                                                                                                                                      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
                                                                                                                                                                                        13964
                                                                                                                                                                                        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
                                                                                                                                                                                        18b3adae-863b-413b-8e36-e3551115db37
                                                                                                                                                                                        offset unit
                                                                                                                                                                                        unicode_code_points
                                                                                                                                                                                        source array index
                                                                                                                                                                                        0
                                                                                                                                                                                        source field
                                                                                                                                                                                        indications_and_usage_exact
                                                                                                                                                                                        source text sha256
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                                                                                                                                                                                      regulatory links
                                                                                                                                                                                        schema version
                                                                                                                                                                                        0.1.0
                                                                                                                                                                                        source batch sha256
                                                                                                                                                                                        0dba7a040bbbf460aa9f482c5b67c9f28f75fc9df775ee1e7b345b758f780e07
                                                                                                                                                                                        source defined aliases
                                                                                                                                                                                        1. abbreviation
                                                                                                                                                                                          NSCLC
                                                                                                                                                                                          definition exact
                                                                                                                                                                                          Non-Small Cell Lung Cancer
                                                                                                                                                                                          definition span
                                                                                                                                                                                          end
                                                                                                                                                                                          470
                                                                                                                                                                                          end exclusive
                                                                                                                                                                                          true
                                                                                                                                                                                          exact text
                                                                                                                                                                                          Non-Small Cell Lung Cancer (NSCLC)
                                                                                                                                                                                          label id
                                                                                                                                                                                          18b3adae-863b-413b-8e36-e3551115db37
                                                                                                                                                                                          offset unit
                                                                                                                                                                                          unicode_code_points
                                                                                                                                                                                          source array index
                                                                                                                                                                                          0
                                                                                                                                                                                          source field
                                                                                                                                                                                          indications_and_usage_exact
                                                                                                                                                                                          source text sha256
                                                                                                                                                                                          f7877da6a8663479b5d99b9a05683473e1e1e6f2d38054ea33b4f3839ff112f7
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                                                                                                                                                                                          436
                                                                                                                                                                                        2. abbreviation
                                                                                                                                                                                          CRC
                                                                                                                                                                                          definition exact
                                                                                                                                                                                          Colorectal Cancer
                                                                                                                                                                                          definition span
                                                                                                                                                                                          end
                                                                                                                                                                                          4658
                                                                                                                                                                                          end exclusive
                                                                                                                                                                                          true
                                                                                                                                                                                          exact text
                                                                                                                                                                                          Colorectal Cancer (CRC)
                                                                                                                                                                                          label id
                                                                                                                                                                                          18b3adae-863b-413b-8e36-e3551115db37
                                                                                                                                                                                          offset unit
                                                                                                                                                                                          unicode_code_points
                                                                                                                                                                                          source array index
                                                                                                                                                                                          0
                                                                                                                                                                                          source field
                                                                                                                                                                                          indications_and_usage_exact
                                                                                                                                                                                          source text sha256
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                                                                                                                                                                                          start
                                                                                                                                                                                          4635
                                                                                                                                                                                        source span
                                                                                                                                                                                        end
                                                                                                                                                                                        13965
                                                                                                                                                                                        end exclusive
                                                                                                                                                                                        true
                                                                                                                                                                                        exact text
                                                                                                                                                                                        1.4 Head and Neck Squamous Cell Cancer KEYTRUDA QLEX 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
                                                                                                                                                                                        18b3adae-863b-413b-8e36-e3551115db37
                                                                                                                                                                                        offset unit
                                                                                                                                                                                        unicode_code_points
                                                                                                                                                                                        source array index
                                                                                                                                                                                        0
                                                                                                                                                                                        source field
                                                                                                                                                                                        indications_and_usage_exact
                                                                                                                                                                                        source text sha256
                                                                                                                                                                                        f7877da6a8663479b5d99b9a05683473e1e1e6f2d38054ea33b4f3839ff112f7
                                                                                                                                                                                        start
                                                                                                                                                                                        13514
                                                                                                                                                                                        source url
                                                                                                                                                                                        https://api.fda.gov/drug/label.json?search=id%3A%2218b3adae-863b-413b-8e36-e3551115db37%22
                                                                                                                                                                                        spl effective date
                                                                                                                                                                                        2026-07-31
                                                                                                                                                                                        spl set id
                                                                                                                                                                                        097d166f-b73b-41d3-9b37-7653cd2a0c41
                                                                                                                                                                                        spl version
                                                                                                                                                                                        18
                                                                                                                                                                                        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. BLA761467
                                                                                                                                                                                        brand names
                                                                                                                                                                                        1. KEYTRUDA QLEX
                                                                                                                                                                                        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
                                                                                                                                                                                        14387
                                                                                                                                                                                        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 QLEX, in combination with platinum and fluorouracil (FU), is indicated for the first-line treatment of adult patients with metastatic or with unresectable, recurrent head and neck squamous cell carcinoma (HNSCC). KEYTRUDA QLEX, as a single agent, is indicated for the first-line treatment of adult patients with metastatic or with unresectable, recurrent HNSCC whose tumors express PD-L1 [Combined Positive Score
                                                                                                                                                                                        label id
                                                                                                                                                                                        18b3adae-863b-413b-8e36-e3551115db37
                                                                                                                                                                                        offset unit
                                                                                                                                                                                        unicode_code_points
                                                                                                                                                                                        source array index
                                                                                                                                                                                        0
                                                                                                                                                                                        source field
                                                                                                                                                                                        indications_and_usage_exact
                                                                                                                                                                                        source text sha256
                                                                                                                                                                                        f7877da6a8663479b5d99b9a05683473e1e1e6f2d38054ea33b4f3839ff112f7
                                                                                                                                                                                        start
                                                                                                                                                                                        13766
                                                                                                                                                                                        current approval status
                                                                                                                                                                                        not_reconciled
                                                                                                                                                                                        duplicate text group
                                                                                                                                                                                        dup-82004cca4e86f9e557ce
                                                                                                                                                                                        extraction review status
                                                                                                                                                                                        automated_candidate_pending_source_review
                                                                                                                                                                                        generic names
                                                                                                                                                                                        1. PEMBROLIZUMAB AND BERAHYALURONIDASE ALFA-PMPH
                                                                                                                                                                                        id
                                                                                                                                                                                        ind-span-05e7b2f0a76844c462a3
                                                                                                                                                                                        label id
                                                                                                                                                                                        18b3adae-863b-413b-8e36-e3551115db37
                                                                                                                                                                                        positive predicate support span
                                                                                                                                                                                        end
                                                                                                                                                                                        14045
                                                                                                                                                                                        end exclusive
                                                                                                                                                                                        true
                                                                                                                                                                                        exact text
                                                                                                                                                                                        is indicated
                                                                                                                                                                                        label id
                                                                                                                                                                                        18b3adae-863b-413b-8e36-e3551115db37
                                                                                                                                                                                        offset unit
                                                                                                                                                                                        unicode_code_points
                                                                                                                                                                                        source array index
                                                                                                                                                                                        0
                                                                                                                                                                                        source field
                                                                                                                                                                                        indications_and_usage_exact
                                                                                                                                                                                        source text sha256
                                                                                                                                                                                        f7877da6a8663479b5d99b9a05683473e1e1e6f2d38054ea33b4f3839ff112f7
                                                                                                                                                                                        start
                                                                                                                                                                                        14033
                                                                                                                                                                                        qualifier mentions
                                                                                                                                                                                        1. context exact
                                                                                                                                                                                          rouracil (FU), is indicated for the first-line treatment of adult patients with metastatic or with unresectable, recurrent head and ne
                                                                                                                                                                                          kind
                                                                                                                                                                                          age
                                                                                                                                                                                          polarity
                                                                                                                                                                                          not_inferred
                                                                                                                                                                                          span
                                                                                                                                                                                          end
                                                                                                                                                                                          14092
                                                                                                                                                                                          end exclusive
                                                                                                                                                                                          true
                                                                                                                                                                                          exact text
                                                                                                                                                                                          adult patients
                                                                                                                                                                                          label id
                                                                                                                                                                                          18b3adae-863b-413b-8e36-e3551115db37
                                                                                                                                                                                          offset unit
                                                                                                                                                                                          unicode_code_points
                                                                                                                                                                                          source array index
                                                                                                                                                                                          0
                                                                                                                                                                                          source field
                                                                                                                                                                                          indications_and_usage_exact
                                                                                                                                                                                          source text sha256
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                                                                                                                                                                                          start
                                                                                                                                                                                          14078
                                                                                                                                                                                        2. context exact
                                                                                                                                                                                          dicated for the first-line treatment of adult patients with metastatic or with unresectable, recurrent head and neck squamous cell carcinoma (HNSCC).
                                                                                                                                                                                          kind
                                                                                                                                                                                          biomarker
                                                                                                                                                                                          polarity
                                                                                                                                                                                          not_inferred
                                                                                                                                                                                          span
                                                                                                                                                                                          end
                                                                                                                                                                                          14129
                                                                                                                                                                                          end exclusive
                                                                                                                                                                                          true
                                                                                                                                                                                          exact text
                                                                                                                                                                                          metastatic or with unresectable
                                                                                                                                                                                          label id
                                                                                                                                                                                          18b3adae-863b-413b-8e36-e3551115db37
                                                                                                                                                                                          offset unit
                                                                                                                                                                                          unicode_code_points
                                                                                                                                                                                          source array index
                                                                                                                                                                                          0
                                                                                                                                                                                          source field
                                                                                                                                                                                          indications_and_usage_exact
                                                                                                                                                                                          source text sha256
                                                                                                                                                                                          f7877da6a8663479b5d99b9a05683473e1e1e6f2d38054ea33b4f3839ff112f7
                                                                                                                                                                                          start
                                                                                                                                                                                          14098
                                                                                                                                                                                        3. context exact
                                                                                                                                                                                          dicated for the first-line treatment of adult patients with metastatic or with unresectable, recurrent head and neck squamous cell carcinoma (HNSCC).
                                                                                                                                                                                          kind
                                                                                                                                                                                          stage_or_setting
                                                                                                                                                                                          polarity
                                                                                                                                                                                          not_inferred
                                                                                                                                                                                          span
                                                                                                                                                                                          end
                                                                                                                                                                                          14129
                                                                                                                                                                                          end exclusive
                                                                                                                                                                                          true
                                                                                                                                                                                          exact text
                                                                                                                                                                                          metastatic or with unresectable
                                                                                                                                                                                          label id
                                                                                                                                                                                          18b3adae-863b-413b-8e36-e3551115db37
                                                                                                                                                                                          offset unit
                                                                                                                                                                                          unicode_code_points
                                                                                                                                                                                          source array index
                                                                                                                                                                                          0
                                                                                                                                                                                          source field
                                                                                                                                                                                          indications_and_usage_exact
                                                                                                                                                                                          source text sha256
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                                                                                                                                                                                          start
                                                                                                                                                                                          14098
                                                                                                                                                                                        4. context exact
                                                                                                                                                                                          ent of adult patients with metastatic or with unresectable, recurrent head and neck squamous cell carcinoma (HNSCC).
                                                                                                                                                                                          kind
                                                                                                                                                                                          stage_or_setting
                                                                                                                                                                                          polarity
                                                                                                                                                                                          not_inferred
                                                                                                                                                                                          span
                                                                                                                                                                                          end
                                                                                                                                                                                          14175
                                                                                                                                                                                          end exclusive
                                                                                                                                                                                          true
                                                                                                                                                                                          exact text
                                                                                                                                                                                          recurrent head and neck squamous cell carcin
                                                                                                                                                                                          label id
                                                                                                                                                                                          18b3adae-863b-413b-8e36-e3551115db37
                                                                                                                                                                                          offset unit
                                                                                                                                                                                          unicode_code_points
                                                                                                                                                                                          source array index
                                                                                                                                                                                          0
                                                                                                                                                                                          source field
                                                                                                                                                                                          indications_and_usage_exact
                                                                                                                                                                                          source text sha256
                                                                                                                                                                                          f7877da6a8663479b5d99b9a05683473e1e1e6f2d38054ea33b4f3839ff112f7
                                                                                                                                                                                          start
                                                                                                                                                                                          14131
                                                                                                                                                                                        5. context exact
                                                                                                                                                                                          n with platinum and fluorouracil (FU), is indicated for the first-line treatment of adult patients with metastatic or with unresectable, recurrent head and neck squamous cell carcinoma (HNSCC).
                                                                                                                                                                                          kind
                                                                                                                                                                                          prior_therapy_or_line
                                                                                                                                                                                          polarity
                                                                                                                                                                                          not_inferred
                                                                                                                                                                                          span
                                                                                                                                                                                          end
                                                                                                                                                                                          14186
                                                                                                                                                                                          end exclusive
                                                                                                                                                                                          true
                                                                                                                                                                                          exact text
                                                                                                                                                                                          first-line treatment of adult patients with metastatic or with unresectable, recurrent head and neck squamous cell carcinoma (HNSCC)
                                                                                                                                                                                          label id
                                                                                                                                                                                          18b3adae-863b-413b-8e36-e3551115db37
                                                                                                                                                                                          offset unit
                                                                                                                                                                                          unicode_code_points
                                                                                                                                                                                          source array index
                                                                                                                                                                                          0
                                                                                                                                                                                          source field
                                                                                                                                                                                          indications_and_usage_exact
                                                                                                                                                                                          source text sha256
                                                                                                                                                                                          f7877da6a8663479b5d99b9a05683473e1e1e6f2d38054ea33b4f3839ff112f7
                                                                                                                                                                                          start
                                                                                                                                                                                          14054
                                                                                                                                                                                        6. context exact
                                                                                                                                                                                          KEYTRUDA QLEX, in combination with platinum and fluorouracil (FU), is indicated for the first-line treatment of adult patients with metastatic or with unresectable, recurrent head and neck squamous cell carcinoma (HNSCC).
                                                                                                                                                                                          kind
                                                                                                                                                                                          regimen
                                                                                                                                                                                          polarity
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                                                                                                                                                                                          brand names
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                                                                                                                                                                                            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 QLEX, as a single agent, is indicated for the treatment of adult patients with recurrent or metastatic HNSCC with disease progression on or after platinum-containing chemotherapy. 1.5 Urothelial Cancer KEYTRUDA QLEX, in combination with enfortumab vedotin-ejfv, is indicated for the treatment of adult patients with locally advanced or metastatic urothelial cancer. KEYTRUDA QLEX
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                                                                                                                                                                                            generic names
                                                                                                                                                                                            1. PEMBROLIZUMAB AND BERAHYALURONIDASE ALFA-PMPH
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                                                                                                                                                                                            qualifier mentions
                                                                                                                                                                                            1. context exact
                                                                                                                                                                                              QLEX, as a single agent, is indicated for the treatment of adult patients with recurrent or metastatic HNSCC with disease progression
                                                                                                                                                                                              kind
                                                                                                                                                                                              age
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                                                                                                                                                                                            2. context exact
                                                                                                                                                                                              cated for the treatment of adult patients with recurrent or metastatic HNSCC with disease progression on or after platinum-containing chemotherapy.
                                                                                                                                                                                              kind
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                                                                                                                                                                                            3. context exact
                                                                                                                                                                                              gent, is indicated for the treatment of adult patients with recurrent or metastatic HNSCC with disease progression on or after platinum-containing chemotherapy.
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                                                                                                                                                                                              exact text
                                                                                                                                                                                              recurrent or metastatic HNSCC with disease p
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                                                                                                                                                                                            4. context exact
                                                                                                                                                                                              KEYTRUDA QLEX, as a single agent, is indicated for the treatment of adult patients with recurrent or metastatic HNSCC with disease progression on or after platinum-containing chemotherapy.
                                                                                                                                                                                              kind
                                                                                                                                                                                              regimen
                                                                                                                                                                                              polarity
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                                                                                                                                                                                              span
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                                                                                                                                                                                              14666
                                                                                                                                                                                              end exclusive
                                                                                                                                                                                              true
                                                                                                                                                                                              exact text
                                                                                                                                                                                              as a single agent, is indicated for the treatment of adult patients with recurrent or metastatic HNSCC with disease progression on or after platinum-containing chemotherapy
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                                                                                                                                                                                                NSCLC
                                                                                                                                                                                                definition exact
                                                                                                                                                                                                Non-Small Cell Lung Cancer
                                                                                                                                                                                                definition span
                                                                                                                                                                                                end
                                                                                                                                                                                                470
                                                                                                                                                                                                end exclusive
                                                                                                                                                                                                true
                                                                                                                                                                                                exact text
                                                                                                                                                                                                Non-Small Cell Lung Cancer (NSCLC)
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                                                                                                                                                                                                source array index
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                                                                                                                                                                                              2. abbreviation
                                                                                                                                                                                                CRC
                                                                                                                                                                                                definition exact
                                                                                                                                                                                                Colorectal Cancer
                                                                                                                                                                                                definition span
                                                                                                                                                                                                end
                                                                                                                                                                                                4658
                                                                                                                                                                                                end exclusive
                                                                                                                                                                                                true
                                                                                                                                                                                                exact text
                                                                                                                                                                                                Colorectal Cancer (CRC)
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                                                                                                                                                                                              true
                                                                                                                                                                                              exact text
                                                                                                                                                                                              KEYTRUDA QLEX, as a single agent, is indicated for the treatment of adult patients with recurrent or metastatic HNSCC with disease progression on or after platinum-containing chemotherapy.
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                                                                                                                                                                                              spl effective date
                                                                                                                                                                                              2026-07-31
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                                                                                                                                                                                              structured indication
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                                                                                                                                                                                              approval pathway
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                                                                                                                                                                                              disease stage
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                                                                                                                                                                                              limitations
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                                                                                                                                                                                              line
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                                                                                                                                                                                              prior therapy
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                                                                                                                                                                                              regimen
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                                                                                                                                                                                              tumor histology
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                                                                                                                                                                                              use intent
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                                                                                                                                                                                              Passage 75 · positive indication candidate
                                                                                                                                                                                              application numbers
                                                                                                                                                                                              1. BLA761467
                                                                                                                                                                                              brand names
                                                                                                                                                                                              1. KEYTRUDA QLEX
                                                                                                                                                                                              classification reasons
                                                                                                                                                                                              1. explicit_positive_indication_predicate
                                                                                                                                                                                              2. tumor_or_malignant_hematology_words_in_positive_statement
                                                                                                                                                                                              clinical review status
                                                                                                                                                                                              pending
                                                                                                                                                                                              content role
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                                                                                                                                                                                              exact text
                                                                                                                                                                                              (2.1) ] . KEYTRUDA QLEX, as a single agent, is indicated for the treatment of adult patients with recurrent or metastatic HNSCC with disease progression on or after platinum-containing chemotherapy. 1.5 Urothelial Cancer KEYTRUDA QLEX, in combination with enfortumab vedotin-ejfv, is indicated for the treatment of adult patients with locally advanced or metastatic urothelial cancer. KEYTRUDA QLEX, as a single agent, is indicated for the treatment of adult patients with locally advanced or metastatic urothelial carcinoma: who are not eligible for any platinum-containing chemother
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                                                                                                                                                                                              current approval status
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                                                                                                                                                                                              generic names
                                                                                                                                                                                              1. PEMBROLIZUMAB AND BERAHYALURONIDASE ALFA-PMPH
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                                                                                                                                                                                              end exclusive
                                                                                                                                                                                              true
                                                                                                                                                                                              exact text
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                                                                                                                                                                                              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
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                                                                                                                                                                                                span
                                                                                                                                                                                                end
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                                                                                                                                                                                              2. context exact
                                                                                                                                                                                                or the treatment of adult patients with locally advanced or metastatic urothelial cancer.
                                                                                                                                                                                                kind
                                                                                                                                                                                                biomarker
                                                                                                                                                                                                polarity
                                                                                                                                                                                                not_inferred
                                                                                                                                                                                                span
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                                                                                                                                                                                                14852
                                                                                                                                                                                                end exclusive
                                                                                                                                                                                                true
                                                                                                                                                                                                exact text
                                                                                                                                                                                                metastatic urothelial cancer
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                                                                                                                                                                                                14824
                                                                                                                                                                                              3. context exact
                                                                                                                                                                                                ejfv, is indicated for the treatment of adult patients with locally advanced or metastatic urothelial cancer.
                                                                                                                                                                                                kind
                                                                                                                                                                                                stage_or_setting
                                                                                                                                                                                                polarity
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                                                                                                                                                                                                span
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                                                                                                                                                                                                14852
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                                                                                                                                                                                                true
                                                                                                                                                                                                exact text
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                                                                                                                                                                                              4. context exact
                                                                                                                                                                                                1.5 Urothelial Cancer KEYTRUDA QLEX, in combination with enfortumab vedotin-ejfv, is indicated for the treatment of adult patients with locally advanced or metastatic urothelial cancer.
                                                                                                                                                                                                kind
                                                                                                                                                                                                regimen
                                                                                                                                                                                                polarity
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                                                                                                                                                                                                span
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                                                                                                                                                                                                14852
                                                                                                                                                                                                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
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                                                                                                                                                                                                source defined aliases
                                                                                                                                                                                                1. abbreviation
                                                                                                                                                                                                  NSCLC
                                                                                                                                                                                                  definition exact
                                                                                                                                                                                                  Non-Small Cell Lung Cancer
                                                                                                                                                                                                  definition span
                                                                                                                                                                                                  end
                                                                                                                                                                                                  470
                                                                                                                                                                                                  end exclusive
                                                                                                                                                                                                  true
                                                                                                                                                                                                  exact text
                                                                                                                                                                                                  Non-Small Cell Lung Cancer (NSCLC)
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                                                                                                                                                                                                  offset unit
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                                                                                                                                                                                                  source array index
                                                                                                                                                                                                  0
                                                                                                                                                                                                  source field
                                                                                                                                                                                                  indications_and_usage_exact
                                                                                                                                                                                                  source text sha256
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                                                                                                                                                                                                  436
                                                                                                                                                                                                2. abbreviation
                                                                                                                                                                                                  CRC
                                                                                                                                                                                                  definition exact
                                                                                                                                                                                                  Colorectal Cancer
                                                                                                                                                                                                  definition span
                                                                                                                                                                                                  end
                                                                                                                                                                                                  4658
                                                                                                                                                                                                  end exclusive
                                                                                                                                                                                                  true
                                                                                                                                                                                                  exact text
                                                                                                                                                                                                  Colorectal Cancer (CRC)
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                                                                                                                                                                                                14853
                                                                                                                                                                                                end exclusive
                                                                                                                                                                                                true
                                                                                                                                                                                                exact text
                                                                                                                                                                                                1.5 Urothelial Cancer KEYTRUDA QLEX, in combination with enfortumab vedotin-ejfv, is indicated for the treatment of adult patients with locally advanced or metastatic urothelial cancer.
                                                                                                                                                                                                label id
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                                                                                                                                                                                                source field
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                                                                                                                                                                                                spl effective date
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                                                                                                                                                                                                use intent
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                                                                                                                                                                                                Passage 76 · positive indication candidate
                                                                                                                                                                                                application numbers
                                                                                                                                                                                                1. BLA761467
                                                                                                                                                                                                brand names
                                                                                                                                                                                                1. KEYTRUDA QLEX
                                                                                                                                                                                                classification reasons
                                                                                                                                                                                                1. explicit_positive_indication_predicate
                                                                                                                                                                                                2. tumor_or_malignant_hematology_words_in_positive_statement
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                                                                                                                                                                                                chemotherapy. 1.5 Urothelial Cancer KEYTRUDA QLEX, in combination with enfortumab vedotin-ejfv, is indicated for the treatment of adult patients with locally advanced or metastatic urothelial cancer. KEYTRUDA QLEX, as a single agent, is indicated for the treatment of adult 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 QLEX, 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 m
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                                                                                                                                                                                                generic names
                                                                                                                                                                                                1. PEMBROLIZUMAB AND BERAHYALURONIDASE ALFA-PMPH
                                                                                                                                                                                                id
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                                                                                                                                                                                                  QLEX, as a single agent, is indicated for the treatment of adult patients with locally advanced or metastatic urothelial carcinoma: w
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                                                                                                                                                                                                3. context exact
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                                                                                                                                                                                                  span
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                                                                                                                                                                                                  locally advanced or metastatic urothelial carcinoma
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                                                                                                                                                                                                  15166
                                                                                                                                                                                                5. context exact
                                                                                                                                                                                                  KEYTRUDA QLEX, as a single agent, is indicated for the treatment of adult patients with locally advanced or metastatic urothelial carcinoma: who are not eligible for any platinum-containing chemotherapy, or who have disease progression during or follow
                                                                                                                                                                                                  kind
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                                                                                                                                                                                                  exact text
                                                                                                                                                                                                  as a single agent, is indicated for the treatment of adult patients with locally advanced or metastatic urothelial carcinoma: who are not eligible for any platinum-containing ch
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                                                                                                                                                                                                  1. abbreviation
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                                                                                                                                                                                                  2. abbreviation
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                                                                                                                                                                                                    Colorectal Cancer
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                                                                                                                                                                                                  exact text
                                                                                                                                                                                                  KEYTRUDA QLEX, as a single agent, is indicated for the treatment of adult 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.
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                                                                                                                                                                                                  spl effective date
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                                                                                                                                                                                                  Passage 77 · positive indication candidate
                                                                                                                                                                                                  application numbers
                                                                                                                                                                                                  1. BLA761467
                                                                                                                                                                                                  brand names
                                                                                                                                                                                                  1. KEYTRUDA QLEX
                                                                                                                                                                                                  classification reasons
                                                                                                                                                                                                  1. explicit_positive_indication_predicate
                                                                                                                                                                                                  2. tumor_or_malignant_hematology_words_in_positive_statement
                                                                                                                                                                                                  clinical review status
                                                                                                                                                                                                  pending
                                                                                                                                                                                                  content role
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                                                                                                                                                                                                  context span
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                                                                                                                                                                                                  15675
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                                                                                                                                                                                                  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 QLEX, 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 QLEX, as a single agent, is indicated for the treatment of adult patients with Bacillus Calmette-Guerin (BCG)-unresponsive, high-risk, non-muscle invasive bladder cancer (NMIBC) with carcino
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                                                                                                                                                                                                  generic names
                                                                                                                                                                                                  1. PEMBROLIZUMAB AND BERAHYALURONIDASE ALFA-PMPH
                                                                                                                                                                                                  id
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                                                                                                                                                                                                  qualifier mentions
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                                                                                                                                                                                                    my as adjuvant treatment, is indicated for the treatment of adult patients with muscle invasive bladder cancer (MIBC).
                                                                                                                                                                                                    kind
                                                                                                                                                                                                    age
                                                                                                                                                                                                    polarity
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                                                                                                                                                                                                    span
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                                                                                                                                                                                                    15417
                                                                                                                                                                                                  2. context exact
                                                                                                                                                                                                    TRUDA QLEX, 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
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                                                                                                                                                                                                    span
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                                                                                                                                                                                                    15348
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                                                                                                                                                                                                  3. context exact
                                                                                                                                                                                                    eoadjuvant treatment and then continued after cystectomy as adjuvant treatment, is indicated for the treatment of adult patients with musc
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                                                                                                                                                                                                    stage_or_setting
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                                                                                                                                                                                                    application numbers
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                                                                                                                                                                                                    brand names
                                                                                                                                                                                                    1. KEYTRUDA QLEX
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                                                                                                                                                                                                    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 QLEX, as a single agent, is indicated for the treatment of adult 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. 1.6 Microsatellite Instability-High or Mismatch Repair Deficient Cancer KEYTRUDA QLEX is indicated for the treatment of adult and pediatric patients 12 years and older with unresectable or metastatic
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                                                                                                                                                                                                      QLEX, as a single agent, is indicated for the treatment of adult patients with Bacillus Calmette-Guerin (BCG)-unresponsive, high-risk
                                                                                                                                                                                                      kind
                                                                                                                                                                                                      age
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                                                                                                                                                                                                    2. context exact
                                                                                                                                                                                                      KEYTRUDA QLEX, as a single agent, is indicated for the treatment of adult 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
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                                                                                                                                                                                                      as a single agent, is indicated for the treatment of adult patients with Bacillus Calmette-Guerin (BCG)-unresponsive, high-risk, non-muscle invasive bladder cancer (NMIBC) with
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                                                                                                                                                                                                      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.
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                                                                                                                                                                                                        definition exact
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                                                                                                                                                                                                        definition span
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                                                                                                                                                                                                        Non-Small Cell Lung Cancer (NSCLC)
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                                                                                                                                                                                                      2. abbreviation
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                                                                                                                                                                                                        Colorectal Cancer
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                                                                                                                                                                                                      KEYTRUDA QLEX, as a single agent, is indicated for the treatment of adult 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.
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                                                                                                                                                                                                      Passage 79 · positive indication candidate
                                                                                                                                                                                                      application numbers
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                                                                                                                                                                                                      brand names
                                                                                                                                                                                                      1. KEYTRUDA QLEX
                                                                                                                                                                                                      classification reasons
                                                                                                                                                                                                      1. explicit_positive_indication_predicate
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                                                                                                                                                                                                      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. 1.6 Microsatellite Instability-High or Mismatch Repair Deficient Cancer KEYTRUDA QLEX is indicated for the treatment of adult and pediatric patients 12 years and older 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) ] . 1.7 Microsatellite Instability-High or Mismatch Repair Deficient Colorectal Cancer KEYTRUDA QLEX is indicated for the treatment of adult patients with unresectable or metastatic MSI-H or dMMR colorec
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                                                                                                                                                                                                      generic names
                                                                                                                                                                                                      1. PEMBROLIZUMAB AND BERAHYALURONIDASE ALFA-PMPH
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                                                                                                                                                                                                      qualifier mentions
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                                                                                                                                                                                                        ient Cancer KEYTRUDA QLEX is indicated for the treatment of adult and pediatric patients 12 years and older with unresectable
                                                                                                                                                                                                        kind
                                                                                                                                                                                                        age
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                                                                                                                                                                                                      2. context exact
                                                                                                                                                                                                        r KEYTRUDA QLEX is indicated for the treatment of adult and pediatric patients 12 years and older with unresectable or metastatic microsat
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                                                                                                                                                                                                      3. context exact
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                                                                                                                                                                                                        1. abbreviation
                                                                                                                                                                                                          NSCLC
                                                                                                                                                                                                          definition exact
                                                                                                                                                                                                          Non-Small Cell Lung Cancer
                                                                                                                                                                                                          definition span
                                                                                                                                                                                                          end
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                                                                                                                                                                                                          Non-Small Cell Lung Cancer (NSCLC)
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                                                                                                                                                                                                        2. abbreviation
                                                                                                                                                                                                          CRC
                                                                                                                                                                                                          definition exact
                                                                                                                                                                                                          Colorectal Cancer
                                                                                                                                                                                                          definition span
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                                                                                                                                                                                                          4658
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                                                                                                                                                                                                        1.6 Microsatellite Instability-High or Mismatch Repair Deficient Cancer KEYTRUDA QLEX is indicated for the treatment of adult and pediatric patients 12 years and older 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) ] .
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                                                                                                                                                                                                        spl effective date
                                                                                                                                                                                                        2026-07-31
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                                                                                                                                                                                                        disease stage
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                                                                                                                                                                                                        limitations
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                                                                                                                                                                                                        line
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                                                                                                                                                                                                        prior therapy
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                                                                                                                                                                                                        regimen
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                                                                                                                                                                                                        tumor histology
                                                                                                                                                                                                        Source null
                                                                                                                                                                                                        use intent
                                                                                                                                                                                                        tumor_directed_candidate
                                                                                                                                                                                                        Passage 80 · positive indication candidate
                                                                                                                                                                                                        application numbers
                                                                                                                                                                                                        1. BLA761467
                                                                                                                                                                                                        brand names
                                                                                                                                                                                                        1. KEYTRUDA QLEX
                                                                                                                                                                                                        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
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                                                                                                                                                                                                        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) ] . 1.7 Microsatellite Instability-High or Mismatch Repair Deficient Colorectal Cancer KEYTRUDA QLEX is indicated for the treatment of adult 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) ] . 1.8 Gastric Cancer KEYTRUDA QLEX, in combination with trastuzumab, fluoropyrimidine- and platinum-containing chemotherapy, is indicated for the first-line treatment of adults with locally advanced un
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                                                                                                                                                                                                        generic names
                                                                                                                                                                                                        1. PEMBROLIZUMAB AND BERAHYALURONIDASE ALFA-PMPH
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                                                                                                                                                                                                        ind-span-7d35e99f015a50597656
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                                                                                                                                                                                                        qualifier mentions
                                                                                                                                                                                                        1. context exact
                                                                                                                                                                                                          ctal Cancer KEYTRUDA QLEX is indicated for the treatment of adult patients with unresectable or metastatic MSI-H or dMMR colorectal ca
                                                                                                                                                                                                          kind
                                                                                                                                                                                                          age
                                                                                                                                                                                                          polarity
                                                                                                                                                                                                          not_inferred
                                                                                                                                                                                                          span
                                                                                                                                                                                                          end
                                                                                                                                                                                                          16414
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                                                                                                                                                                                                          adult patients
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                                                                                                                                                                                                          16400
                                                                                                                                                                                                        2. context exact
                                                                                                                                                                                                          ed for the treatment of adult patients with unresectable or metastatic MSI-H or dMMR colorectal cancer (CRC) as determined by an FDA-authorized test [see Dosage an
                                                                                                                                                                                                          kind
                                                                                                                                                                                                          biomarker
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                                                                                                                                                                                                          span
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                                                                                                                                                                                                          16479
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                                                                                                                                                                                                          metastatic MSI-H or dMMR colorectal cancer
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                                                                                                                                                                                                          16436
                                                                                                                                                                                                        3. context exact
                                                                                                                                                                                                          QLEX is indicated for the treatment of adult patients with unresectable or metastatic MSI-H or dMMR colorectal cancer (CRC) as determined by an FDA-authorized test [s
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                                                                                                                                                                                                          source defined aliases
                                                                                                                                                                                                          1. abbreviation
                                                                                                                                                                                                            NSCLC
                                                                                                                                                                                                            definition exact
                                                                                                                                                                                                            Non-Small Cell Lung Cancer
                                                                                                                                                                                                            definition span
                                                                                                                                                                                                            end
                                                                                                                                                                                                            470
                                                                                                                                                                                                            end exclusive
                                                                                                                                                                                                            true
                                                                                                                                                                                                            exact text
                                                                                                                                                                                                            Non-Small Cell Lung Cancer (NSCLC)
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                                                                                                                                                                                                            source field
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                                                                                                                                                                                                          2. abbreviation
                                                                                                                                                                                                            CRC
                                                                                                                                                                                                            definition exact
                                                                                                                                                                                                            Colorectal Cancer
                                                                                                                                                                                                            definition span
                                                                                                                                                                                                            end
                                                                                                                                                                                                            4658
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                                                                                                                                                                                                            true
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                                                                                                                                                                                                            Colorectal Cancer (CRC)
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                                                                                                                                                                                                          1.7 Microsatellite Instability-High or Mismatch Repair Deficient Colorectal Cancer KEYTRUDA QLEX is indicated for the treatment of adult 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) ] .
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                                                                                                                                                                                                          application numbers
                                                                                                                                                                                                          1. BLA761467
                                                                                                                                                                                                          brand names
                                                                                                                                                                                                          1. KEYTRUDA QLEX
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                                                                                                                                                                                                            application numbers
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                                                                                                                                                                                                            brand names
                                                                                                                                                                                                            1. KEYTRUDA QLEX
                                                                                                                                                                                                            classification reasons
                                                                                                                                                                                                            1. explicit_positive_indication_predicate
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                                                                                                                                                                                                            1. PEMBROLIZUMAB AND BERAHYALURONIDASE ALFA-PMPH
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                                                                                                                                                                                                              e treatment of adults with locally advanced unresectable or metastatic HER2-negative gastric or gastroesophageal junction (GEJ) adenocarcinoma whose tumors express
                                                                                                                                                                                                              kind
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                                                                                                                                                                                                              17160
                                                                                                                                                                                                            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) ] .
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                                                                                                                                                                                                              17264
                                                                                                                                                                                                            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
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                                                                                                                                                                                                              exact text
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                                                                                                                                                                                                              17127
                                                                                                                                                                                                            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
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                                                                                                                                                                                                              span
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                                                                                                                                                                                                              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
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                                                                                                                                                                                                              17091
                                                                                                                                                                                                            6. context exact
                                                                                                                                                                                                              KEYTRUDA QLEX, 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
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                                                                                                                                                                                                              span
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                                                                                                                                                                                                              17173
                                                                                                                                                                                                              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
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                                                                                                                                                                                                              1. abbreviation
                                                                                                                                                                                                                NSCLC
                                                                                                                                                                                                                definition exact
                                                                                                                                                                                                                Non-Small Cell Lung Cancer
                                                                                                                                                                                                                definition span
                                                                                                                                                                                                                end
                                                                                                                                                                                                                470
                                                                                                                                                                                                                end exclusive
                                                                                                                                                                                                                true
                                                                                                                                                                                                                exact text
                                                                                                                                                                                                                Non-Small Cell Lung Cancer (NSCLC)
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                                                                                                                                                                                                                436
                                                                                                                                                                                                              2. abbreviation
                                                                                                                                                                                                                CRC
                                                                                                                                                                                                                definition exact
                                                                                                                                                                                                                Colorectal Cancer
                                                                                                                                                                                                                definition span
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                                                                                                                                                                                                                4658
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                                                                                                                                                                                                                true
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                                                                                                                                                                                                                Colorectal Cancer (CRC)
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                                                                                                                                                                                                              exact text
                                                                                                                                                                                                              KEYTRUDA QLEX, 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) ] .
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                                                                                                                                                                                                              source url
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                                                                                                                                                                                                              spl effective date
                                                                                                                                                                                                              2026-07-31
                                                                                                                                                                                                              spl set id
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                                                                                                                                                                                                              spl version
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                                                                                                                                                                                                              structured fields status
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                                                                                                                                                                                                              structured indication
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                                                                                                                                                                                                              approval pathway
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                                                                                                                                                                                                              biomarker and test
                                                                                                                                                                                                              Source null
                                                                                                                                                                                                              disease stage
                                                                                                                                                                                                              Source null
                                                                                                                                                                                                              limitations
                                                                                                                                                                                                              Source null
                                                                                                                                                                                                              line
                                                                                                                                                                                                              Source null
                                                                                                                                                                                                              prior therapy
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                                                                                                                                                                                                              use intent
                                                                                                                                                                                                              tumor_directed_candidate
                                                                                                                                                                                                              Passage 83 · positive indication candidate
                                                                                                                                                                                                              application numbers
                                                                                                                                                                                                              1. BLA761467
                                                                                                                                                                                                              brand names
                                                                                                                                                                                                              1. KEYTRUDA QLEX
                                                                                                                                                                                                              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
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                                                                                                                                                                                                              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) ] . 1.9 Esophageal Cancer KEYTRUDA QLEX is indicated for the treatment of adult 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) ] . 1.10 Cervical Cancer KEYTRUDA QLEX, in combination with chemoradiotherapy (CRT), is indicated for the treatment of adult patients with locally advanced cervical cancer involving the lower third of th
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                                                                                                                                                                                                              extraction review status
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                                                                                                                                                                                                              generic names
                                                                                                                                                                                                              1. PEMBROLIZUMAB AND BERAHYALURONIDASE ALFA-PMPH
                                                                                                                                                                                                              id
                                                                                                                                                                                                              ind-span-91dc0db1c52b554463dc
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                                                                                                                                                                                                              positive predicate support span
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                                                                                                                                                                                                              17409
                                                                                                                                                                                                              end exclusive
                                                                                                                                                                                                              true
                                                                                                                                                                                                              exact text
                                                                                                                                                                                                              is indicated
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                                                                                                                                                                                                              source field
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                                                                                                                                                                                                              17397
                                                                                                                                                                                                              qualifier mentions
                                                                                                                                                                                                              1. context exact
                                                                                                                                                                                                                geal Cancer KEYTRUDA QLEX is indicated for the treatment of adult patients with locally advanced or metastatic esophageal or gastroeso
                                                                                                                                                                                                                kind
                                                                                                                                                                                                                age
                                                                                                                                                                                                                polarity
                                                                                                                                                                                                                not_inferred
                                                                                                                                                                                                                span
                                                                                                                                                                                                                end
                                                                                                                                                                                                                17445
                                                                                                                                                                                                                end exclusive
                                                                                                                                                                                                                true
                                                                                                                                                                                                                exact text
                                                                                                                                                                                                                adult patients
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                                                                                                                                                                                                                0
                                                                                                                                                                                                                source field
                                                                                                                                                                                                                indications_and_usage_exact
                                                                                                                                                                                                                source text sha256
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                                                                                                                                                                                                                start
                                                                                                                                                                                                                17431
                                                                                                                                                                                                              2. context exact
                                                                                                                                                                                                                or the treatment of adult 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
                                                                                                                                                                                                                17514
                                                                                                                                                                                                                end exclusive
                                                                                                                                                                                                                true
                                                                                                                                                                                                                exact text
                                                                                                                                                                                                                metastatic esophageal or gastroesophageal j
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                                                                                                                                                                                                                0
                                                                                                                                                                                                                source field
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                                                                                                                                                                                                                source text sha256
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                                                                                                                                                                                                                start
                                                                                                                                                                                                                17471
                                                                                                                                                                                                              3. 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
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                                                                                                                                                                                                                not_inferred
                                                                                                                                                                                                                span
                                                                                                                                                                                                                end
                                                                                                                                                                                                                17828
                                                                                                                                                                                                                end exclusive
                                                                                                                                                                                                                true
                                                                                                                                                                                                                exact text
                                                                                                                                                                                                                PD-L1 (CPS ≥ 1) as determined by an FDA-autho
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                                                                                                                                                                                                                0
                                                                                                                                                                                                                source field
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                                                                                                                                                                                                                source text sha256
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                                                                                                                                                                                                                start
                                                                                                                                                                                                                17783
                                                                                                                                                                                                              4. 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
                                                                                                                                                                                                                18061
                                                                                                                                                                                                                end exclusive
                                                                                                                                                                                                                true
                                                                                                                                                                                                                exact text
                                                                                                                                                                                                                PD-L1 (CPS ≥10) as determined by an FDA-autho
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                                                                                                                                                                                                                source field
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                                                                                                                                                                                                                source text sha256
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                                                                                                                                                                                                                start
                                                                                                                                                                                                                18016
                                                                                                                                                                                                              5. context exact
                                                                                                                                                                                                                QLEX is indicated for the treatment of adult patients with locally advanced or metastatic esophageal or gastroesophageal junction (GEJ) (tumors with epicenter 1 to 5 cent
                                                                                                                                                                                                                kind
                                                                                                                                                                                                                stage_or_setting
                                                                                                                                                                                                                polarity
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                                                                                                                                                                                                                span
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                                                                                                                                                                                                                17502
                                                                                                                                                                                                                end exclusive
                                                                                                                                                                                                                true
                                                                                                                                                                                                                exact text
                                                                                                                                                                                                                locally advanced or metastatic esophageal or gastro
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                                                                                                                                                                                                                source text sha256
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                                                                                                                                                                                                                start
                                                                                                                                                                                                                17451
                                                                                                                                                                                                              6. 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
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                                                                                                                                                                                                                span
                                                                                                                                                                                                                end
                                                                                                                                                                                                                17854
                                                                                                                                                                                                                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
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                                                                                                                                                                                                                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) ] .
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                                                                                                                                                                                                                regimen
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                                                                                                                                                                                                                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
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                                                                                                                                                                                                                17883
                                                                                                                                                                                                              regulatory links
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                                                                                                                                                                                                                source defined aliases
                                                                                                                                                                                                                1. abbreviation
                                                                                                                                                                                                                  NSCLC
                                                                                                                                                                                                                  definition exact
                                                                                                                                                                                                                  Non-Small Cell Lung Cancer
                                                                                                                                                                                                                  definition span
                                                                                                                                                                                                                  end
                                                                                                                                                                                                                  470
                                                                                                                                                                                                                  end exclusive
                                                                                                                                                                                                                  true
                                                                                                                                                                                                                  exact text
                                                                                                                                                                                                                  Non-Small Cell Lung Cancer (NSCLC)
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                                                                                                                                                                                                                  unicode_code_points
                                                                                                                                                                                                                  source array index
                                                                                                                                                                                                                  0
                                                                                                                                                                                                                  source field
                                                                                                                                                                                                                  indications_and_usage_exact
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                                                                                                                                                                                                                  436
                                                                                                                                                                                                                2. abbreviation
                                                                                                                                                                                                                  CRC
                                                                                                                                                                                                                  definition exact
                                                                                                                                                                                                                  Colorectal Cancer
                                                                                                                                                                                                                  definition span
                                                                                                                                                                                                                  end
                                                                                                                                                                                                                  4658
                                                                                                                                                                                                                  end exclusive
                                                                                                                                                                                                                  true
                                                                                                                                                                                                                  exact text
                                                                                                                                                                                                                  Colorectal Cancer (CRC)
                                                                                                                                                                                                                  label id
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                                                                                                                                                                                                                  unicode_code_points
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                                                                                                                                                                                                                  0
                                                                                                                                                                                                                  source field
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                                                                                                                                                                                                                end exclusive
                                                                                                                                                                                                                true
                                                                                                                                                                                                                exact text
                                                                                                                                                                                                                1.9 Esophageal Cancer KEYTRUDA QLEX is indicated for the treatment of adult 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) ] .
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                                                                                                                                                                                                                17361
                                                                                                                                                                                                                source url
                                                                                                                                                                                                                https://api.fda.gov/drug/label.json?search=id%3A%2218b3adae-863b-413b-8e36-e3551115db37%22
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                                                                                                                                                                                                                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 84 · positive indication candidate
                                                                                                                                                                                                                application numbers
                                                                                                                                                                                                                1. BLA761467
                                                                                                                                                                                                                brand names
                                                                                                                                                                                                                1. KEYTRUDA QLEX
                                                                                                                                                                                                                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
                                                                                                                                                                                                                18672
                                                                                                                                                                                                                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) ] . 1.10 Cervical Cancer KEYTRUDA QLEX, in combination with chemoradiotherapy (CRT), is indicated for the treatment of adult 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 QLEX, in combination with chemotherapy, with or without bevacizumab, is indicated for the treatment of adult patients with persistent, recurrent, or metastatic cervical cancer whose tumors e
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                                                                                                                                                                                                                start
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                                                                                                                                                                                                                current approval status
                                                                                                                                                                                                                not_reconciled
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                                                                                                                                                                                                                extraction review status
                                                                                                                                                                                                                automated_candidate_pending_source_review
                                                                                                                                                                                                                generic names
                                                                                                                                                                                                                1. PEMBROLIZUMAB AND BERAHYALURONIDASE ALFA-PMPH
                                                                                                                                                                                                                id
                                                                                                                                                                                                                ind-span-efed81a7f5307dad866b
                                                                                                                                                                                                                label id
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                                                                                                                                                                                                                positive predicate support span
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                                                                                                                                                                                                                18206
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                                                                                                                                                                                                                true
                                                                                                                                                                                                                exact text
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                                                                                                                                                                                                                18194
                                                                                                                                                                                                                qualifier mentions
                                                                                                                                                                                                                1. context exact
                                                                                                                                                                                                                  chemoradiotherapy (CRT), is indicated for the treatment of adult patients with locally advanced cervical cancer involving the lower t
                                                                                                                                                                                                                  kind
                                                                                                                                                                                                                  age
                                                                                                                                                                                                                  polarity
                                                                                                                                                                                                                  not_inferred
                                                                                                                                                                                                                  span
                                                                                                                                                                                                                  end
                                                                                                                                                                                                                  18242
                                                                                                                                                                                                                  end exclusive
                                                                                                                                                                                                                  true
                                                                                                                                                                                                                  exact text
                                                                                                                                                                                                                  adult patients
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                                                                                                                                                                                                                  source field
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                                                                                                                                                                                                                  start
                                                                                                                                                                                                                  18228
                                                                                                                                                                                                                2. context exact
                                                                                                                                                                                                                  CRT), is indicated for the treatment of adult 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
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                                                                                                                                                                                                                  span
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                                                                                                                                                                                                                  18299
                                                                                                                                                                                                                  end exclusive
                                                                                                                                                                                                                  true
                                                                                                                                                                                                                  exact text
                                                                                                                                                                                                                  locally advanced cervical cancer involving the lowe
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                                                                                                                                                                                                                  0
                                                                                                                                                                                                                  source field
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                                                                                                                                                                                                                  source text sha256
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                                                                                                                                                                                                                  18248
                                                                                                                                                                                                                3. context exact
                                                                                                                                                                                                                  1.10 Cervical Cancer KEYTRUDA QLEX, in combination with chemoradiotherapy (CRT), is indicated for the treatment of adult patients with locally advanced cervical cancer involving the lower third of the vagina, with or without extension to pelvic sidewall, or hydronephrosis/no
                                                                                                                                                                                                                  kind
                                                                                                                                                                                                                  regimen
                                                                                                                                                                                                                  polarity
                                                                                                                                                                                                                  not_inferred
                                                                                                                                                                                                                  span
                                                                                                                                                                                                                  end
                                                                                                                                                                                                                  18328
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                                                                                                                                                                                                                  true
                                                                                                                                                                                                                  exact text
                                                                                                                                                                                                                  in combination with chemoradiotherapy (CRT), is indicated for the treatment of adult patients with locally advanced cervical cancer involving the lower third of the vagina, with o
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                                                                                                                                                                                                                  source field
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                                                                                                                                                                                                                  start
                                                                                                                                                                                                                  18149
                                                                                                                                                                                                                regulatory links
                                                                                                                                                                                                                  schema version
                                                                                                                                                                                                                  0.1.0
                                                                                                                                                                                                                  source batch sha256
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                                                                                                                                                                                                                  source defined aliases
                                                                                                                                                                                                                  1. abbreviation
                                                                                                                                                                                                                    NSCLC
                                                                                                                                                                                                                    definition exact
                                                                                                                                                                                                                    Non-Small Cell Lung Cancer
                                                                                                                                                                                                                    definition span
                                                                                                                                                                                                                    end
                                                                                                                                                                                                                    470
                                                                                                                                                                                                                    end exclusive
                                                                                                                                                                                                                    true
                                                                                                                                                                                                                    exact text
                                                                                                                                                                                                                    Non-Small Cell Lung Cancer (NSCLC)
                                                                                                                                                                                                                    label id
                                                                                                                                                                                                                    18b3adae-863b-413b-8e36-e3551115db37
                                                                                                                                                                                                                    offset unit
                                                                                                                                                                                                                    unicode_code_points
                                                                                                                                                                                                                    source array index
                                                                                                                                                                                                                    0
                                                                                                                                                                                                                    source field
                                                                                                                                                                                                                    indications_and_usage_exact
                                                                                                                                                                                                                    source text sha256
                                                                                                                                                                                                                    f7877da6a8663479b5d99b9a05683473e1e1e6f2d38054ea33b4f3839ff112f7
                                                                                                                                                                                                                    start
                                                                                                                                                                                                                    436
                                                                                                                                                                                                                  2. abbreviation
                                                                                                                                                                                                                    CRC
                                                                                                                                                                                                                    definition exact
                                                                                                                                                                                                                    Colorectal Cancer
                                                                                                                                                                                                                    definition span
                                                                                                                                                                                                                    end
                                                                                                                                                                                                                    4658
                                                                                                                                                                                                                    end exclusive
                                                                                                                                                                                                                    true
                                                                                                                                                                                                                    exact text
                                                                                                                                                                                                                    Colorectal Cancer (CRC)
                                                                                                                                                                                                                    label id
                                                                                                                                                                                                                    18b3adae-863b-413b-8e36-e3551115db37
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                                                                                                                                                                                                                    unicode_code_points
                                                                                                                                                                                                                    source array index
                                                                                                                                                                                                                    0
                                                                                                                                                                                                                    source field
                                                                                                                                                                                                                    indications_and_usage_exact
                                                                                                                                                                                                                    source text sha256
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                                                                                                                                                                                                                    start
                                                                                                                                                                                                                    4635
                                                                                                                                                                                                                  source span
                                                                                                                                                                                                                  end
                                                                                                                                                                                                                  18472
                                                                                                                                                                                                                  end exclusive
                                                                                                                                                                                                                  true
                                                                                                                                                                                                                  exact text
                                                                                                                                                                                                                  1.10 Cervical Cancer KEYTRUDA QLEX, in combination with chemoradiotherapy (CRT), is indicated for the treatment of adult 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
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                                                                                                                                                                                                                  unicode_code_points
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                                                                                                                                                                                                                  0
                                                                                                                                                                                                                  source field
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                                                                                                                                                                                                                  source text sha256
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                                                                                                                                                                                                                  start
                                                                                                                                                                                                                  18113
                                                                                                                                                                                                                  source url
                                                                                                                                                                                                                  https://api.fda.gov/drug/label.json?search=id%3A%2218b3adae-863b-413b-8e36-e3551115db37%22
                                                                                                                                                                                                                  spl effective date
                                                                                                                                                                                                                  2026-07-31
                                                                                                                                                                                                                  spl set id
                                                                                                                                                                                                                  097d166f-b73b-41d3-9b37-7653cd2a0c41
                                                                                                                                                                                                                  spl version
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                                                                                                                                                                                                                  structured indication
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                                                                                                                                                                                                                  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. BLA761467
                                                                                                                                                                                                                  brand names
                                                                                                                                                                                                                  1. KEYTRUDA QLEX
                                                                                                                                                                                                                  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
                                                                                                                                                                                                                  18973
                                                                                                                                                                                                                  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 QLEX, in combination with chemotherapy, with or without bevacizumab, is indicated for the treatment of adult 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 QLEX, as a single agent, is indicated for the treatment of adult patients with recurrent or metastatic cervical cancer with disease progression on or after chemotherapy whose tumors express
                                                                                                                                                                                                                  label id
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                                                                                                                                                                                                                  0
                                                                                                                                                                                                                  source field
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                                                                                                                                                                                                                  source text sha256
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                                                                                                                                                                                                                  start
                                                                                                                                                                                                                  18273
                                                                                                                                                                                                                  current approval status
                                                                                                                                                                                                                  not_reconciled
                                                                                                                                                                                                                  duplicate text group
                                                                                                                                                                                                                  dup-29cdd014fe7900ca1c34
                                                                                                                                                                                                                  extraction review status
                                                                                                                                                                                                                  automated_candidate_pending_source_review
                                                                                                                                                                                                                  generic names
                                                                                                                                                                                                                  1. PEMBROLIZUMAB AND BERAHYALURONIDASE ALFA-PMPH
                                                                                                                                                                                                                  id
                                                                                                                                                                                                                  ind-span-7334881abf8a89619e2e
                                                                                                                                                                                                                  label id
                                                                                                                                                                                                                  18b3adae-863b-413b-8e36-e3551115db37
                                                                                                                                                                                                                  positive predicate support span
                                                                                                                                                                                                                  end
                                                                                                                                                                                                                  18563
                                                                                                                                                                                                                  end exclusive
                                                                                                                                                                                                                  true
                                                                                                                                                                                                                  exact text
                                                                                                                                                                                                                  is indicated
                                                                                                                                                                                                                  label id
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                                                                                                                                                                                                                  offset unit
                                                                                                                                                                                                                  unicode_code_points
                                                                                                                                                                                                                  source array index
                                                                                                                                                                                                                  0
                                                                                                                                                                                                                  source field
                                                                                                                                                                                                                  indications_and_usage_exact
                                                                                                                                                                                                                  source text sha256
                                                                                                                                                                                                                  f7877da6a8663479b5d99b9a05683473e1e1e6f2d38054ea33b4f3839ff112f7
                                                                                                                                                                                                                  start
                                                                                                                                                                                                                  18551
                                                                                                                                                                                                                  qualifier mentions
                                                                                                                                                                                                                  1. context exact
                                                                                                                                                                                                                    h or without bevacizumab, is indicated for the treatment of adult patients with persistent, recurrent, or metastatic cervical cancer w
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                                                                                                                                                                                                                    KEYTRUDA QLEX, in combination with chemotherapy, with or without bevacizumab, is indicated for the treatment of adult patients with persistent, recurrent, or metastatic cervical cancer whose tumors express PD-L1 (CPS ≥1) as determined by an FDA-authorize
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                                                                                                                                                                                                                      NSCLC
                                                                                                                                                                                                                      definition exact
                                                                                                                                                                                                                      Non-Small Cell Lung Cancer
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                                                                                                                                                                                                                      Non-Small Cell Lung Cancer (NSCLC)
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                                                                                                                                                                                                                    2. abbreviation
                                                                                                                                                                                                                      CRC
                                                                                                                                                                                                                      definition exact
                                                                                                                                                                                                                      Colorectal Cancer
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                                                                                                                                                                                                                    KEYTRUDA QLEX, in combination with chemotherapy, with or without bevacizumab, is indicated for the treatment of adult 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) ].
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                                                                                                                                                                                                                    spl effective date
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                                                                                                                                                                                                                    use intent
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                                                                                                                                                                                                                    Passage 86 · positive indication candidate
                                                                                                                                                                                                                    application numbers
                                                                                                                                                                                                                    1. BLA761467
                                                                                                                                                                                                                    brand names
                                                                                                                                                                                                                    1. KEYTRUDA QLEX
                                                                                                                                                                                                                    classification reasons
                                                                                                                                                                                                                    1. explicit_positive_indication_predicate
                                                                                                                                                                                                                    2. tumor_or_malignant_hematology_words_in_positive_statement
                                                                                                                                                                                                                    clinical review status
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                                                                                                                                                                                                                    eatment of adult 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 QLEX, as a single agent, is indicated for the treatment of adult 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) ] . 1.11 Hepatocellular Carcinoma KEYTRUDA QLEX is indicated for the treatment of adult patients with hepatocellular carcinoma (HCC) secondary to hepatitis B who have received prior systemic therapy othe
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                                                                                                                                                                                                                    1. PEMBROLIZUMAB AND BERAHYALURONIDASE ALFA-PMPH
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                                                                                                                                                                                                                      QLEX, as a single agent, is indicated for the treatment of adult patients with recurrent or metastatic cervical cancer with disease p
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                                                                                                                                                                                                                      kind
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                                                                                                                                                                                                                      18862
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                                                                                                                                                                                                                      KEYTRUDA QLEX, as a single agent, is indicated for the treatment of adult 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 tes
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                                                                                                                                                                                                                      source defined aliases
                                                                                                                                                                                                                      1. abbreviation
                                                                                                                                                                                                                        NSCLC
                                                                                                                                                                                                                        definition exact
                                                                                                                                                                                                                        Non-Small Cell Lung Cancer
                                                                                                                                                                                                                        definition span
                                                                                                                                                                                                                        end
                                                                                                                                                                                                                        470
                                                                                                                                                                                                                        end exclusive
                                                                                                                                                                                                                        true
                                                                                                                                                                                                                        exact text
                                                                                                                                                                                                                        Non-Small Cell Lung Cancer (NSCLC)
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                                                                                                                                                                                                                      2. abbreviation
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                                                                                                                                                                                                                        Colorectal Cancer
                                                                                                                                                                                                                        definition span
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                                                                                                                                                                                                                        4658
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                                                                                                                                                                                                                        Colorectal Cancer (CRC)
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                                                                                                                                                                                                                        source field
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                                                                                                                                                                                                                      KEYTRUDA QLEX, as a single agent, is indicated for the treatment of adult 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) ] .
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                                                                                                                                                                                                                      18774
                                                                                                                                                                                                                      source url
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                                                                                                                                                                                                                      spl effective date
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                                                                                                                                                                                                                      Source null
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                                                                                                                                                                                                                      Source null
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                                                                                                                                                                                                                      Source null
                                                                                                                                                                                                                      line
                                                                                                                                                                                                                      Source null
                                                                                                                                                                                                                      prior therapy
                                                                                                                                                                                                                      Source null
                                                                                                                                                                                                                      regimen
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                                                                                                                                                                                                                      tumor histology
                                                                                                                                                                                                                      Source null
                                                                                                                                                                                                                      use intent
                                                                                                                                                                                                                      tumor_directed_candidate
                                                                                                                                                                                                                      Passage 87 · positive indication candidate
                                                                                                                                                                                                                      application numbers
                                                                                                                                                                                                                      1. BLA761467
                                                                                                                                                                                                                      brand names
                                                                                                                                                                                                                      1. KEYTRUDA QLEX
                                                                                                                                                                                                                      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
                                                                                                                                                                                                                      19507
                                                                                                                                                                                                                      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) ] . 1.11 Hepatocellular Carcinoma KEYTRUDA QLEX is indicated for the treatment of adult patients with hepatocellular carcinoma (HCC) secondary to hepatitis B who have received prior systemic therapy other than a PD-1/PD-L1-containing regimen. 1.12 Biliary Tract Cancer KEYTRUDA QLEX, in combination with gemcitabine and cisplatin, is indicated for the treatment of adult patients with locally advanced unresectable or metastatic biliary tract
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                                                                                                                                                                                                                      source field
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                                                                                                                                                                                                                      current approval status
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                                                                                                                                                                                                                      extraction review status
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                                                                                                                                                                                                                      generic names
                                                                                                                                                                                                                      1. PEMBROLIZUMAB AND BERAHYALURONIDASE ALFA-PMPH
                                                                                                                                                                                                                      id
                                                                                                                                                                                                                      ind-span-42f2a07afb93c6cc1ca3
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                                                                                                                                                                                                                      18b3adae-863b-413b-8e36-e3551115db37
                                                                                                                                                                                                                      positive predicate support span
                                                                                                                                                                                                                      end
                                                                                                                                                                                                                      19125
                                                                                                                                                                                                                      end exclusive
                                                                                                                                                                                                                      true
                                                                                                                                                                                                                      exact text
                                                                                                                                                                                                                      is indicated
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                                                                                                                                                                                                                      unicode_code_points
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                                                                                                                                                                                                                      source field
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                                                                                                                                                                                                                      19113
                                                                                                                                                                                                                      qualifier mentions
                                                                                                                                                                                                                      1. context exact
                                                                                                                                                                                                                        r Carcinoma KEYTRUDA QLEX is indicated for the treatment of adult patients with hepatocellular carcinoma (HCC) secondary to hepatitis
                                                                                                                                                                                                                        kind
                                                                                                                                                                                                                        age
                                                                                                                                                                                                                        polarity
                                                                                                                                                                                                                        not_inferred
                                                                                                                                                                                                                        span
                                                                                                                                                                                                                        end
                                                                                                                                                                                                                        19161
                                                                                                                                                                                                                        end exclusive
                                                                                                                                                                                                                        true
                                                                                                                                                                                                                        exact text
                                                                                                                                                                                                                        adult patients
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                                                                                                                                                                                                                        source field
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                                                                                                                                                                                                                        start
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                                                                                                                                                                                                                      2. context exact
                                                                                                                                                                                                                        who have received prior systemic therapy other than a PD-1/PD-L1-containing regimen.
                                                                                                                                                                                                                        kind
                                                                                                                                                                                                                        biomarker
                                                                                                                                                                                                                        polarity
                                                                                                                                                                                                                        not_inferred
                                                                                                                                                                                                                        span
                                                                                                                                                                                                                        end
                                                                                                                                                                                                                        19306
                                                                                                                                                                                                                        end exclusive
                                                                                                                                                                                                                        true
                                                                                                                                                                                                                        exact text
                                                                                                                                                                                                                        PD-L1-containing regimen
                                                                                                                                                                                                                        label id
                                                                                                                                                                                                                        18b3adae-863b-413b-8e36-e3551115db37
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                                                                                                                                                                                                                        unicode_code_points
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                                                                                                                                                                                                                        source field
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                                                                                                                                                                                                                        start
                                                                                                                                                                                                                        19282
                                                                                                                                                                                                                      3. 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
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                                                                                                                                                                                                                        not_inferred
                                                                                                                                                                                                                        span
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                                                                                                                                                                                                                        19306
                                                                                                                                                                                                                        end exclusive
                                                                                                                                                                                                                        true
                                                                                                                                                                                                                        exact text
                                                                                                                                                                                                                        who have received prior systemic therapy other than a PD-1/PD-L1-containing regimen
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                                                                                                                                                                                                                      regulatory links
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                                                                                                                                                                                                                        source defined aliases
                                                                                                                                                                                                                        1. abbreviation
                                                                                                                                                                                                                          NSCLC
                                                                                                                                                                                                                          definition exact
                                                                                                                                                                                                                          Non-Small Cell Lung Cancer
                                                                                                                                                                                                                          definition span
                                                                                                                                                                                                                          end
                                                                                                                                                                                                                          470
                                                                                                                                                                                                                          end exclusive
                                                                                                                                                                                                                          true
                                                                                                                                                                                                                          exact text
                                                                                                                                                                                                                          Non-Small Cell Lung Cancer (NSCLC)
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                                                                                                                                                                                                                          offset unit
                                                                                                                                                                                                                          unicode_code_points
                                                                                                                                                                                                                          source array index
                                                                                                                                                                                                                          0
                                                                                                                                                                                                                          source field
                                                                                                                                                                                                                          indications_and_usage_exact
                                                                                                                                                                                                                          source text sha256
                                                                                                                                                                                                                          f7877da6a8663479b5d99b9a05683473e1e1e6f2d38054ea33b4f3839ff112f7
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                                                                                                                                                                                                                        2. abbreviation
                                                                                                                                                                                                                          CRC
                                                                                                                                                                                                                          definition exact
                                                                                                                                                                                                                          Colorectal Cancer
                                                                                                                                                                                                                          definition span
                                                                                                                                                                                                                          end
                                                                                                                                                                                                                          4658
                                                                                                                                                                                                                          end exclusive
                                                                                                                                                                                                                          true
                                                                                                                                                                                                                          exact text
                                                                                                                                                                                                                          Colorectal Cancer (CRC)
                                                                                                                                                                                                                          label id
                                                                                                                                                                                                                          18b3adae-863b-413b-8e36-e3551115db37
                                                                                                                                                                                                                          offset unit
                                                                                                                                                                                                                          unicode_code_points
                                                                                                                                                                                                                          source array index
                                                                                                                                                                                                                          0
                                                                                                                                                                                                                          source field
                                                                                                                                                                                                                          indications_and_usage_exact
                                                                                                                                                                                                                          source text sha256
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                                                                                                                                                                                                                          4635
                                                                                                                                                                                                                        source span
                                                                                                                                                                                                                        end
                                                                                                                                                                                                                        19307
                                                                                                                                                                                                                        end exclusive
                                                                                                                                                                                                                        true
                                                                                                                                                                                                                        exact text
                                                                                                                                                                                                                        1.11 Hepatocellular Carcinoma KEYTRUDA QLEX is indicated for the treatment of adult 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
                                                                                                                                                                                                                        18b3adae-863b-413b-8e36-e3551115db37
                                                                                                                                                                                                                        offset unit
                                                                                                                                                                                                                        unicode_code_points
                                                                                                                                                                                                                        source array index
                                                                                                                                                                                                                        0
                                                                                                                                                                                                                        source field
                                                                                                                                                                                                                        indications_and_usage_exact
                                                                                                                                                                                                                        source text sha256
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                                                                                                                                                                                                                        start
                                                                                                                                                                                                                        19069
                                                                                                                                                                                                                        source url
                                                                                                                                                                                                                        https://api.fda.gov/drug/label.json?search=id%3A%2218b3adae-863b-413b-8e36-e3551115db37%22
                                                                                                                                                                                                                        spl effective date
                                                                                                                                                                                                                        2026-07-31
                                                                                                                                                                                                                        spl set id
                                                                                                                                                                                                                        097d166f-b73b-41d3-9b37-7653cd2a0c41
                                                                                                                                                                                                                        spl version
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                                                                                                                                                                                                                        structured fields status
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                                                                                                                                                                                                                        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. BLA761467
                                                                                                                                                                                                                        brand names
                                                                                                                                                                                                                        1. KEYTRUDA QLEX
                                                                                                                                                                                                                        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
                                                                                                                                                                                                                        19721
                                                                                                                                                                                                                        end exclusive
                                                                                                                                                                                                                        true
                                                                                                                                                                                                                        exact text
                                                                                                                                                                                                                        QLEX is indicated for the treatment of adult patients with hepatocellular carcinoma (HCC) secondary to hepatitis B who have received prior systemic therapy other than a PD-1/PD-L1-containing regimen. 1.12 Biliary Tract Cancer KEYTRUDA QLEX, in combination with gemcitabine and cisplatin, is indicated for the treatment of adult patients with locally advanced unresectable or metastatic biliary tract cancer (BTC). 1.13 Merkel Cell Carcinoma KEYTRUDA QLEX is indicated for the treatment of adult and pediatric patients 12 years and older with recurrent locally advanced or metastatic Merkel cell carcinoma (MCC). 1
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                                                                                                                                                                                                                        0
                                                                                                                                                                                                                        source field
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                                                                                                                                                                                                                        start
                                                                                                                                                                                                                        19108
                                                                                                                                                                                                                        current approval status
                                                                                                                                                                                                                        not_reconciled
                                                                                                                                                                                                                        duplicate text group
                                                                                                                                                                                                                        dup-5d4253d0138072de1cb1
                                                                                                                                                                                                                        extraction review status
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                                                                                                                                                                                                                        generic names
                                                                                                                                                                                                                        1. PEMBROLIZUMAB AND BERAHYALURONIDASE ALFA-PMPH
                                                                                                                                                                                                                        id
                                                                                                                                                                                                                        ind-span-50bde6b764730bfa3d9c
                                                                                                                                                                                                                        label id
                                                                                                                                                                                                                        18b3adae-863b-413b-8e36-e3551115db37
                                                                                                                                                                                                                        positive predicate support span
                                                                                                                                                                                                                        end
                                                                                                                                                                                                                        19408
                                                                                                                                                                                                                        end exclusive
                                                                                                                                                                                                                        true
                                                                                                                                                                                                                        exact text
                                                                                                                                                                                                                        is indicated
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                                                                                                                                                                                                                        unicode_code_points
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                                                                                                                                                                                                                        0
                                                                                                                                                                                                                        source field
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                                                                                                                                                                                                                        start
                                                                                                                                                                                                                        19396
                                                                                                                                                                                                                        qualifier mentions
                                                                                                                                                                                                                        1. context exact
                                                                                                                                                                                                                          emcitabine and cisplatin, is indicated for the treatment of adult patients with locally advanced unresectable or metastatic biliary tr
                                                                                                                                                                                                                          kind
                                                                                                                                                                                                                          age
                                                                                                                                                                                                                          polarity
                                                                                                                                                                                                                          not_inferred
                                                                                                                                                                                                                          span
                                                                                                                                                                                                                          end
                                                                                                                                                                                                                          19444
                                                                                                                                                                                                                          end exclusive
                                                                                                                                                                                                                          true
                                                                                                                                                                                                                          exact text
                                                                                                                                                                                                                          adult patients
                                                                                                                                                                                                                          label id
                                                                                                                                                                                                                          18b3adae-863b-413b-8e36-e3551115db37
                                                                                                                                                                                                                          offset unit
                                                                                                                                                                                                                          unicode_code_points
                                                                                                                                                                                                                          source array index
                                                                                                                                                                                                                          0
                                                                                                                                                                                                                          source field
                                                                                                                                                                                                                          indications_and_usage_exact
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                                                                                                                                                                                                                          f7877da6a8663479b5d99b9a05683473e1e1e6f2d38054ea33b4f3839ff112f7
                                                                                                                                                                                                                          start
                                                                                                                                                                                                                          19430
                                                                                                                                                                                                                        2. context exact
                                                                                                                                                                                                                          ent of adult patients with locally advanced unresectable or metastatic biliary tract cancer (BTC).
                                                                                                                                                                                                                          kind
                                                                                                                                                                                                                          biomarker
                                                                                                                                                                                                                          polarity
                                                                                                                                                                                                                          not_inferred
                                                                                                                                                                                                                          span
                                                                                                                                                                                                                          end
                                                                                                                                                                                                                          19520
                                                                                                                                                                                                                          end exclusive
                                                                                                                                                                                                                          true
                                                                                                                                                                                                                          exact text
                                                                                                                                                                                                                          metastatic biliary tract cancer (BTC)
                                                                                                                                                                                                                          label id
                                                                                                                                                                                                                          18b3adae-863b-413b-8e36-e3551115db37
                                                                                                                                                                                                                          offset unit
                                                                                                                                                                                                                          unicode_code_points
                                                                                                                                                                                                                          source array index
                                                                                                                                                                                                                          0
                                                                                                                                                                                                                          source field
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                                                                                                                                                                                                                          start
                                                                                                                                                                                                                          19483
                                                                                                                                                                                                                        3. context exact
                                                                                                                                                                                                                          atin, is indicated for the treatment of adult patients with locally advanced unresectable or metastatic biliary tract cancer (BTC).
                                                                                                                                                                                                                          kind
                                                                                                                                                                                                                          stage_or_setting
                                                                                                                                                                                                                          polarity
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                                                                                                                                                                                                                          span
                                                                                                                                                                                                                          end
                                                                                                                                                                                                                          19501
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                                                                                                                                                                                                                          true
                                                                                                                                                                                                                          exact text
                                                                                                                                                                                                                          locally advanced unresectable or metastatic biliary
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                                                                                                                                                                                                                          1.12 Biliary Tract Cancer KEYTRUDA QLEX, in combination with gemcitabine and cisplatin, is indicated for the treatment of adult patients with locally advanced unresectable or metastatic biliary tract cancer (BTC).
                                                                                                                                                                                                                          kind
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                                                                                                                                                                                                                          in combination with gemcitabine and cisplatin, is indicated for the treatment of adult patients with locally advanced unresectable or metastatic biliary tract cancer (BTC)
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                                                                                                                                                                                                                          source defined aliases
                                                                                                                                                                                                                          1. abbreviation
                                                                                                                                                                                                                            NSCLC
                                                                                                                                                                                                                            definition exact
                                                                                                                                                                                                                            Non-Small Cell Lung Cancer
                                                                                                                                                                                                                            definition span
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                                                                                                                                                                                                                          2. abbreviation
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                                                                                                                                                                                                                          1.12 Biliary Tract Cancer KEYTRUDA QLEX, in combination with gemcitabine and cisplatin, is indicated for the treatment of adult patients with locally advanced unresectable or metastatic biliary tract cancer (BTC).
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                                                                                                                                                                                                                          structured indication
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                                                                                                                                                                                                                          Source null
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                                                                                                                                                                                                                          Source null
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                                                                                                                                                                                                                          use intent
                                                                                                                                                                                                                          tumor_directed_candidate
                                                                                                                                                                                                                          Passage 89 · positive indication candidate
                                                                                                                                                                                                                          application numbers
                                                                                                                                                                                                                          1. BLA761467
                                                                                                                                                                                                                          brand names
                                                                                                                                                                                                                          1. KEYTRUDA QLEX
                                                                                                                                                                                                                          classification reasons
                                                                                                                                                                                                                          1. explicit_positive_indication_predicate
                                                                                                                                                                                                                          2. tumor_or_malignant_hematology_words_in_positive_statement
                                                                                                                                                                                                                          clinical review status
                                                                                                                                                                                                                          pending
                                                                                                                                                                                                                          content role
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                                                                                                                                                                                                                          ract Cancer KEYTRUDA QLEX, in combination with gemcitabine and cisplatin, is indicated for the treatment of adult patients with locally advanced unresectable or metastatic biliary tract cancer (BTC). 1.13 Merkel Cell Carcinoma KEYTRUDA QLEX is indicated for the treatment of adult and pediatric patients 12 years and older with recurrent locally advanced or metastatic Merkel cell carcinoma (MCC). 1.14 Renal Cell Carcinoma KEYTRUDA QLEX, in combination with axitinib, is indicated for the first-line treatment of adult patients with advanced renal cell carcinoma (RCC). KEYTRUDA QLEX, in combinat
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                                                                                                                                                                                                                          extraction review status
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                                                                                                                                                                                                                          generic names
                                                                                                                                                                                                                          1. PEMBROLIZUMAB AND BERAHYALURONIDASE ALFA-PMPH
                                                                                                                                                                                                                          id
                                                                                                                                                                                                                          ind-span-1ccc3b1e08c79ceac564
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                                                                                                                                                                                                                          positive predicate support span
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                                                                                                                                                                                                                          exact text
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                                                                                                                                                                                                                          qualifier mentions
                                                                                                                                                                                                                          1. context exact
                                                                                                                                                                                                                            l Carcinoma KEYTRUDA QLEX is indicated for the treatment of adult and pediatric patients 12 years and older with recurrent lo
                                                                                                                                                                                                                            kind
                                                                                                                                                                                                                            age
                                                                                                                                                                                                                            polarity
                                                                                                                                                                                                                            not_inferred
                                                                                                                                                                                                                            span
                                                                                                                                                                                                                            end
                                                                                                                                                                                                                            19602
                                                                                                                                                                                                                            end exclusive
                                                                                                                                                                                                                            true
                                                                                                                                                                                                                            exact text
                                                                                                                                                                                                                            adult
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                                                                                                                                                                                                                            19597
                                                                                                                                                                                                                          2. context exact
                                                                                                                                                                                                                            a KEYTRUDA QLEX is indicated for the treatment of adult and pediatric patients 12 years and older with recurrent locally advanced or metas
                                                                                                                                                                                                                            kind
                                                                                                                                                                                                                            age
                                                                                                                                                                                                                            polarity
                                                                                                                                                                                                                            not_inferred
                                                                                                                                                                                                                            span
                                                                                                                                                                                                                            end
                                                                                                                                                                                                                            19625
                                                                                                                                                                                                                            end exclusive
                                                                                                                                                                                                                            true
                                                                                                                                                                                                                            exact text
                                                                                                                                                                                                                            pediatric patients
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                                                                                                                                                                                                                            19607
                                                                                                                                                                                                                          3. context exact
                                                                                                                                                                                                                            indicated for the treatment of adult and pediatric patients 12 years and older with recurrent locally advanced or metastatic Merkel cell c
                                                                                                                                                                                                                            kind
                                                                                                                                                                                                                            age
                                                                                                                                                                                                                            polarity
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                                                                                                                                                                                                                            span
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                                                                                                                                                                                                                            19644
                                                                                                                                                                                                                            end exclusive
                                                                                                                                                                                                                            true
                                                                                                                                                                                                                            exact text
                                                                                                                                                                                                                            12 years and older
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                                                                                                                                                                                                                            19626
                                                                                                                                                                                                                          4. context exact
                                                                                                                                                                                                                            ients 12 years and older with recurrent locally advanced or metastatic Merkel cell carcinoma (MCC).
                                                                                                                                                                                                                            kind
                                                                                                                                                                                                                            biomarker
                                                                                                                                                                                                                            polarity
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                                                                                                                                                                                                                            span
                                                                                                                                                                                                                            end
                                                                                                                                                                                                                            19718
                                                                                                                                                                                                                            end exclusive
                                                                                                                                                                                                                            true
                                                                                                                                                                                                                            exact text
                                                                                                                                                                                                                            metastatic Merkel cell carcinoma (MCC)
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                                                                                                                                                                                                                            19680
                                                                                                                                                                                                                          5. context exact
                                                                                                                                                                                                                            ent of adult and pediatric patients 12 years and older with recurrent locally advanced or metastatic Merkel cell carcinoma (MCC).
                                                                                                                                                                                                                            kind
                                                                                                                                                                                                                            stage_or_setting
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                                                                                                                                                                                                                            true
                                                                                                                                                                                                                            exact text
                                                                                                                                                                                                                            recurrent locally advanced or metastatic Mer
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                                                                                                                                                                                                                            source defined aliases
                                                                                                                                                                                                                            1. abbreviation
                                                                                                                                                                                                                              NSCLC
                                                                                                                                                                                                                              definition exact
                                                                                                                                                                                                                              Non-Small Cell Lung Cancer
                                                                                                                                                                                                                              definition span
                                                                                                                                                                                                                              end
                                                                                                                                                                                                                              470
                                                                                                                                                                                                                              end exclusive
                                                                                                                                                                                                                              true
                                                                                                                                                                                                                              exact text
                                                                                                                                                                                                                              Non-Small Cell Lung Cancer (NSCLC)
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                                                                                                                                                                                                                              source field
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                                                                                                                                                                                                                              436
                                                                                                                                                                                                                            2. abbreviation
                                                                                                                                                                                                                              CRC
                                                                                                                                                                                                                              definition exact
                                                                                                                                                                                                                              Colorectal Cancer
                                                                                                                                                                                                                              definition span
                                                                                                                                                                                                                              end
                                                                                                                                                                                                                              4658
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                                                                                                                                                                                                                              true
                                                                                                                                                                                                                              exact text
                                                                                                                                                                                                                              Colorectal Cancer (CRC)
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                                                                                                                                                                                                                            exact text
                                                                                                                                                                                                                            1.13 Merkel Cell Carcinoma KEYTRUDA QLEX is indicated for the treatment of adult and pediatric patients 12 years and older with recurrent locally advanced or metastatic Merkel cell carcinoma (MCC).
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                                                                                                                                                                                                                            Source null
                                                                                                                                                                                                                            limitations
                                                                                                                                                                                                                            Source null
                                                                                                                                                                                                                            line
                                                                                                                                                                                                                            Source null
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                                                                                                                                                                                                                            use intent
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                                                                                                                                                                                                                            application numbers
                                                                                                                                                                                                                            1. BLA761467
                                                                                                                                                                                                                            brand names
                                                                                                                                                                                                                            1. KEYTRUDA QLEX
                                                                                                                                                                                                                            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
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                                                                                                                                                                                                                            true
                                                                                                                                                                                                                            exact text
                                                                                                                                                                                                                            . 1.13 Merkel Cell Carcinoma KEYTRUDA QLEX is indicated for the treatment of adult and pediatric patients 12 years and older with recurrent locally advanced or metastatic Merkel cell carcinoma (MCC). 1.14 Renal Cell Carcinoma KEYTRUDA QLEX, in combination with axitinib, is indicated for the first-line treatment of adult patients with advanced renal cell carcinoma (RCC). KEYTRUDA QLEX, in combination with lenvatinib, is indicated for the first-line treatment of adult patients with advanced RCC. KEYTRUDA QLEX is indicated for the adjuvant treatment of adult patients w
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                                                                                                                                                                                                                            generic names
                                                                                                                                                                                                                            1. PEMBROLIZUMAB AND BERAHYALURONIDASE ALFA-PMPH
                                                                                                                                                                                                                            id
                                                                                                                                                                                                                            ind-span-b2c0f9800d417d6b3f8a
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                                                                                                                                                                                                                            exact text
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                                                                                                                                                                                                                            19791
                                                                                                                                                                                                                            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
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                                                                                                                                                                                                                              span
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                                                                                                                                                                                                                              exact text
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                                                                                                                                                                                                                              19836
                                                                                                                                                                                                                            2. context exact
                                                                                                                                                                                                                              dicated for the first-line treatment of adult patients with advanced renal cell carcinoma (RCC).
                                                                                                                                                                                                                              kind
                                                                                                                                                                                                                              stage_or_setting
                                                                                                                                                                                                                              polarity
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                                                                                                                                                                                                                              span
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                                                                                                                                                                                                                              end exclusive
                                                                                                                                                                                                                              true
                                                                                                                                                                                                                              exact text
                                                                                                                                                                                                                              advanced renal cell carcinoma (RCC)
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                                                                                                                                                                                                                              start
                                                                                                                                                                                                                              19856
                                                                                                                                                                                                                            3. context exact
                                                                                                                                                                                                                              DA QLEX, 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
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                                                                                                                                                                                                                              19891
                                                                                                                                                                                                                              end exclusive
                                                                                                                                                                                                                              true
                                                                                                                                                                                                                              exact text
                                                                                                                                                                                                                              first-line treatment of adult patients with advanced renal cell carcinoma (RCC)
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                                                                                                                                                                                                                              19812
                                                                                                                                                                                                                            4. context exact
                                                                                                                                                                                                                              1.14 Renal Cell Carcinoma KEYTRUDA QLEX, 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
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                                                                                                                                                                                                                              19891
                                                                                                                                                                                                                              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)
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                                                                                                                                                                                                                              source defined aliases
                                                                                                                                                                                                                              1. abbreviation
                                                                                                                                                                                                                                NSCLC
                                                                                                                                                                                                                                definition exact
                                                                                                                                                                                                                                Non-Small Cell Lung Cancer
                                                                                                                                                                                                                                definition span
                                                                                                                                                                                                                                end
                                                                                                                                                                                                                                470
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                                                                                                                                                                                                                                Non-Small Cell Lung Cancer (NSCLC)
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                                                                                                                                                                                                                                436
                                                                                                                                                                                                                              2. abbreviation
                                                                                                                                                                                                                                CRC
                                                                                                                                                                                                                                definition exact
                                                                                                                                                                                                                                Colorectal Cancer
                                                                                                                                                                                                                                definition span
                                                                                                                                                                                                                                end
                                                                                                                                                                                                                                4658
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                                                                                                                                                                                                                                true
                                                                                                                                                                                                                                exact text
                                                                                                                                                                                                                                Colorectal Cancer (CRC)
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                                                                                                                                                                                                                                4635
                                                                                                                                                                                                                              source span
                                                                                                                                                                                                                              end
                                                                                                                                                                                                                              19892
                                                                                                                                                                                                                              end exclusive
                                                                                                                                                                                                                              true
                                                                                                                                                                                                                              exact text
                                                                                                                                                                                                                              1.14 Renal Cell Carcinoma KEYTRUDA QLEX, in combination with axitinib, is indicated for the first-line treatment of adult patients with advanced renal cell carcinoma (RCC).
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                                                                                                                                                                                                                              spl effective date
                                                                                                                                                                                                                              2026-07-31
                                                                                                                                                                                                                              spl set id
                                                                                                                                                                                                                              097d166f-b73b-41d3-9b37-7653cd2a0c41
                                                                                                                                                                                                                              spl version
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                                                                                                                                                                                                                              structured fields status
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                                                                                                                                                                                                                              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
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                                                                                                                                                                                                                              tumor histology
                                                                                                                                                                                                                              Source null
                                                                                                                                                                                                                              use intent
                                                                                                                                                                                                                              tumor_directed_candidate
                                                                                                                                                                                                                              Passage 91 · positive indication candidate
                                                                                                                                                                                                                              application numbers
                                                                                                                                                                                                                              1. BLA761467
                                                                                                                                                                                                                              brand names
                                                                                                                                                                                                                              1. KEYTRUDA QLEX
                                                                                                                                                                                                                              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
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                                                                                                                                                                                                                              20218
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                                                                                                                                                                                                                              exact text
                                                                                                                                                                                                                              rkel cell carcinoma (MCC). 1.14 Renal Cell Carcinoma KEYTRUDA QLEX, in combination with axitinib, is indicated for the first-line treatment of adult patients with advanced renal cell carcinoma (RCC). KEYTRUDA QLEX, in combination with lenvatinib, is indicated for the first-line treatment of adult patients with advanced RCC. KEYTRUDA QLEX is indicated for the adjuvant treatment of adult patients with RCC at intermediate-high or high risk of recurrence following nephrectomy, or following nephrectomy and resection of metas
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                                                                                                                                                                                                                              start
                                                                                                                                                                                                                              19693
                                                                                                                                                                                                                              current approval status
                                                                                                                                                                                                                              not_reconciled
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                                                                                                                                                                                                                              generic names
                                                                                                                                                                                                                              1. PEMBROLIZUMAB AND BERAHYALURONIDASE ALFA-PMPH
                                                                                                                                                                                                                              id
                                                                                                                                                                                                                              ind-span-29897cc7dca25429ae3c
                                                                                                                                                                                                                              label id
                                                                                                                                                                                                                              18b3adae-863b-413b-8e36-e3551115db37
                                                                                                                                                                                                                              positive predicate support span
                                                                                                                                                                                                                              end
                                                                                                                                                                                                                              19952
                                                                                                                                                                                                                              end exclusive
                                                                                                                                                                                                                              true
                                                                                                                                                                                                                              exact text
                                                                                                                                                                                                                              is indicated
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                                                                                                                                                                                                                              19940
                                                                                                                                                                                                                              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
                                                                                                                                                                                                                                19999
                                                                                                                                                                                                                                end exclusive
                                                                                                                                                                                                                                true
                                                                                                                                                                                                                                exact text
                                                                                                                                                                                                                                adult patients
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                                                                                                                                                                                                                                source field
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                                                                                                                                                                                                                                start
                                                                                                                                                                                                                                19985
                                                                                                                                                                                                                              2. context exact
                                                                                                                                                                                                                                dicated for the first-line treatment of adult patients with advanced RCC.
                                                                                                                                                                                                                                kind
                                                                                                                                                                                                                                stage_or_setting
                                                                                                                                                                                                                                polarity
                                                                                                                                                                                                                                not_inferred
                                                                                                                                                                                                                                span
                                                                                                                                                                                                                                end
                                                                                                                                                                                                                                20017
                                                                                                                                                                                                                                end exclusive
                                                                                                                                                                                                                                true
                                                                                                                                                                                                                                exact text
                                                                                                                                                                                                                                advanced RCC
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                                                                                                                                                                                                                                0
                                                                                                                                                                                                                                source field
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                                                                                                                                                                                                                                start
                                                                                                                                                                                                                                20005
                                                                                                                                                                                                                              3. context exact
                                                                                                                                                                                                                                QLEX, 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
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                                                                                                                                                                                                                                20017
                                                                                                                                                                                                                                end exclusive
                                                                                                                                                                                                                                true
                                                                                                                                                                                                                                exact text
                                                                                                                                                                                                                                first-line treatment of adult patients with advanced RCC
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                                                                                                                                                                                                                                start
                                                                                                                                                                                                                                19961
                                                                                                                                                                                                                              4. context exact
                                                                                                                                                                                                                                KEYTRUDA QLEX, in combination with lenvatinib, is indicated for the first-line treatment of adult patients with advanced RCC.
                                                                                                                                                                                                                                kind
                                                                                                                                                                                                                                regimen
                                                                                                                                                                                                                                polarity
                                                                                                                                                                                                                                not_inferred
                                                                                                                                                                                                                                span
                                                                                                                                                                                                                                end
                                                                                                                                                                                                                                20017
                                                                                                                                                                                                                                end exclusive
                                                                                                                                                                                                                                true
                                                                                                                                                                                                                                exact text
                                                                                                                                                                                                                                in combination with lenvatinib, is indicated for the first-line treatment of adult patients with advanced RCC
                                                                                                                                                                                                                                label id
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                                                                                                                                                                                                                                source defined aliases
                                                                                                                                                                                                                                1. abbreviation
                                                                                                                                                                                                                                  NSCLC
                                                                                                                                                                                                                                  definition exact
                                                                                                                                                                                                                                  Non-Small Cell Lung Cancer
                                                                                                                                                                                                                                  definition span
                                                                                                                                                                                                                                  end
                                                                                                                                                                                                                                  470
                                                                                                                                                                                                                                  end exclusive
                                                                                                                                                                                                                                  true
                                                                                                                                                                                                                                  exact text
                                                                                                                                                                                                                                  Non-Small Cell Lung Cancer (NSCLC)
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                                                                                                                                                                                                                                KEYTRUDA QLEX, in combination with lenvatinib, is indicated for the first-line treatment of adult patients with advanced RCC.
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                                                                                                                                                                                                                                application numbers
                                                                                                                                                                                                                                1. BLA761467
                                                                                                                                                                                                                                brand names
                                                                                                                                                                                                                                1. KEYTRUDA QLEX
                                                                                                                                                                                                                                classification reasons
                                                                                                                                                                                                                                1. explicit_positive_indication_predicate
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                                                                                                                                                                                                                                content role
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                                                                                                                                                                                                                                ine treatment of adult patients with advanced renal cell carcinoma (RCC). KEYTRUDA QLEX, in combination with lenvatinib, is indicated for the first-line treatment of adult patients with advanced RCC. KEYTRUDA QLEX is indicated for the adjuvant treatment of adult 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 QLEX, 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 f
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                                                                                                                                                                                                                                generic names
                                                                                                                                                                                                                                1. PEMBROLIZUMAB AND BERAHYALURONIDASE ALFA-PMPH
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                                                                                                                                                                                                                                  KEYTRUDA QLEX is indicated for the adjuvant treatment of adult patients with RCC at intermediate-high or high risk of recurrence fo
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                                                                                                                                                                                                                                  metastatic lesions [see Clinical Studies (1
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                                                                                                                                                                                                                                  KEYTRUDA QLEX is indicated for the adjuvant treatment of adult patients with RCC at intermediate-high or high risk of recurrence following
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                                                                                                                                                                                                                                  metastatic lesions [see Clinical Studies (14
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                                                                                                                                                                                                                                  1. abbreviation
                                                                                                                                                                                                                                    NSCLC
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                                                                                                                                                                                                                                    Non-Small Cell Lung Cancer
                                                                                                                                                                                                                                    definition span
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                                                                                                                                                                                                                                    Colorectal Cancer
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                                                                                                                                                                                                                                  exact text
                                                                                                                                                                                                                                  KEYTRUDA QLEX is indicated for the adjuvant treatment of adult 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) ] .
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                                                                                                                                                                                                                                  spl effective date
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                                                                                                                                                                                                                                  use intent
                                                                                                                                                                                                                                  non_oncology_or_unclear_candidate
                                                                                                                                                                                                                                  Passage 93 · positive indication candidate
                                                                                                                                                                                                                                  application numbers
                                                                                                                                                                                                                                  1. BLA761467
                                                                                                                                                                                                                                  brand names
                                                                                                                                                                                                                                  1. KEYTRUDA QLEX
                                                                                                                                                                                                                                  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
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                                                                                                                                                                                                                                  context span
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                                                                                                                                                                                                                                  20748
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                                                                                                                                                                                                                                  exact text
                                                                                                                                                                                                                                  atment of adult 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 QLEX, 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. 1.15 Endometrial Carcinoma KEYTRUDA QLEX, in combination with carboplatin and paclitaxel, followed by KEYTRUDA QLEX as a single agent, is indicated for the treatment of adult patients with primary ad
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                                                                                                                                                                                                                                  generic names
                                                                                                                                                                                                                                  1. PEMBROLIZUMAB AND BERAHYALURONIDASE ALFA-PMPH
                                                                                                                                                                                                                                  id
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                                                                                                                                                                                                                                  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
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                                                                                                                                                                                                                                    adult patients
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                                                                                                                                                                                                                                    20356
                                                                                                                                                                                                                                  2. context exact
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                                                                                                                                                                                                                                    20529
                                                                                                                                                                                                                                  3. context exact
                                                                                                                                                                                                                                    QLEX, 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
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                                                                                                                                                                                                                                    20334
                                                                                                                                                                                                                                  4. context exact
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                                                                                                                                                                                                                                    20529
                                                                                                                                                                                                                                  5. context exact
                                                                                                                                                                                                                                    KEYTRUDA QLEX, 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
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                                                                                                                                                                                                                                    span
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                                                                                                                                                                                                                                    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
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                                                                                                                                                                                                                                    20281
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                                                                                                                                                                                                                                      definition exact
                                                                                                                                                                                                                                      Non-Small Cell Lung Cancer
                                                                                                                                                                                                                                      definition span
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                                                                                                                                                                                                                                    2. abbreviation
                                                                                                                                                                                                                                      CRC
                                                                                                                                                                                                                                      definition exact
                                                                                                                                                                                                                                      Colorectal Cancer
                                                                                                                                                                                                                                      definition span
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                                                                                                                                                                                                                                    true
                                                                                                                                                                                                                                    exact text
                                                                                                                                                                                                                                    KEYTRUDA QLEX, 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.
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                                                                                                                                                                                                                                    approval pathway
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                                                                                                                                                                                                                                    disease stage
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                                                                                                                                                                                                                                    limitations
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                                                                                                                                                                                                                                    line
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                                                                                                                                                                                                                                    use intent
                                                                                                                                                                                                                                    non_oncology_or_unclear_candidate
                                                                                                                                                                                                                                    Passage 94 · positive indication candidate
                                                                                                                                                                                                                                    application numbers
                                                                                                                                                                                                                                    1. BLA761467
                                                                                                                                                                                                                                    brand names
                                                                                                                                                                                                                                    1. KEYTRUDA QLEX
                                                                                                                                                                                                                                    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
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                                                                                                                                                                                                                                    end exclusive
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                                                                                                                                                                                                                                    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. 1.15 Endometrial Carcinoma KEYTRUDA QLEX, in combination with carboplatin and paclitaxel, followed by KEYTRUDA QLEX as a single agent, is indicated for the treatment of adult patients with primary advanced or recurrent endometrial carcinoma. KEYTRUDA QLEX, 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 determine
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                                                                                                                                                                                                                                    current approval status
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                                                                                                                                                                                                                                    extraction review status
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                                                                                                                                                                                                                                    generic names
                                                                                                                                                                                                                                    1. PEMBROLIZUMAB AND BERAHYALURONIDASE ALFA-PMPH
                                                                                                                                                                                                                                    id
                                                                                                                                                                                                                                    ind-span-78971f602fb4e1b0bc36
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                                                                                                                                                                                                                                    positive predicate support span
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                                                                                                                                                                                                                                    true
                                                                                                                                                                                                                                    exact text
                                                                                                                                                                                                                                    is indicated
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                                                                                                                                                                                                                                    qualifier mentions
                                                                                                                                                                                                                                    1. context exact
                                                                                                                                                                                                                                      A QLEX 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
                                                                                                                                                                                                                                      20732
                                                                                                                                                                                                                                      end exclusive
                                                                                                                                                                                                                                      true
                                                                                                                                                                                                                                      exact text
                                                                                                                                                                                                                                      adult patients
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                                                                                                                                                                                                                                      start
                                                                                                                                                                                                                                      20718
                                                                                                                                                                                                                                    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
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                                                                                                                                                                                                                                      20789
                                                                                                                                                                                                                                      end exclusive
                                                                                                                                                                                                                                      true
                                                                                                                                                                                                                                      exact text
                                                                                                                                                                                                                                      advanced or recurrent endometrial carcinoma
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                                                                                                                                                                                                                                      20746
                                                                                                                                                                                                                                    3. context exact
                                                                                                                                                                                                                                      1.15 Endometrial Carcinoma KEYTRUDA QLEX, in combination with carboplatin and paclitaxel, followed by KEYTRUDA QLEX as a single agent, is indicated for the treatment of adult patients with primary advanced or recurrent endometrial carcinoma.
                                                                                                                                                                                                                                      kind
                                                                                                                                                                                                                                      regimen
                                                                                                                                                                                                                                      polarity
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                                                                                                                                                                                                                                      span
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                                                                                                                                                                                                                                      20770
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                                                                                                                                                                                                                                      true
                                                                                                                                                                                                                                      exact text
                                                                                                                                                                                                                                      in combination with carboplatin and paclitaxel, followed by KEYTRUDA QLEX as a single agent, is indicated for the treatment of adult patients with primary advanced or recurrent en
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                                                                                                                                                                                                                                      source defined aliases
                                                                                                                                                                                                                                      1. abbreviation
                                                                                                                                                                                                                                        NSCLC
                                                                                                                                                                                                                                        definition exact
                                                                                                                                                                                                                                        Non-Small Cell Lung Cancer
                                                                                                                                                                                                                                        definition span
                                                                                                                                                                                                                                        end
                                                                                                                                                                                                                                        470
                                                                                                                                                                                                                                        end exclusive
                                                                                                                                                                                                                                        true
                                                                                                                                                                                                                                        exact text
                                                                                                                                                                                                                                        Non-Small Cell Lung Cancer (NSCLC)
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                                                                                                                                                                                                                                        source field
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                                                                                                                                                                                                                                        436
                                                                                                                                                                                                                                      2. abbreviation
                                                                                                                                                                                                                                        CRC
                                                                                                                                                                                                                                        definition exact
                                                                                                                                                                                                                                        Colorectal Cancer
                                                                                                                                                                                                                                        definition span
                                                                                                                                                                                                                                        end
                                                                                                                                                                                                                                        4658
                                                                                                                                                                                                                                        end exclusive
                                                                                                                                                                                                                                        true
                                                                                                                                                                                                                                        exact text
                                                                                                                                                                                                                                        Colorectal Cancer (CRC)
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                                                                                                                                                                                                                                      source span
                                                                                                                                                                                                                                      end
                                                                                                                                                                                                                                      20790
                                                                                                                                                                                                                                      end exclusive
                                                                                                                                                                                                                                      true
                                                                                                                                                                                                                                      exact text
                                                                                                                                                                                                                                      1.15 Endometrial Carcinoma KEYTRUDA QLEX, in combination with carboplatin and paclitaxel, followed by KEYTRUDA QLEX as a single agent, is indicated for the treatment of adult patients with primary advanced or recurrent endometrial carcinoma.
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                                                                                                                                                                                                                                      20549
                                                                                                                                                                                                                                      source url
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                                                                                                                                                                                                                                      spl effective date
                                                                                                                                                                                                                                      2026-07-31
                                                                                                                                                                                                                                      spl set id
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                                                                                                                                                                                                                                      approval pathway
                                                                                                                                                                                                                                      Source null
                                                                                                                                                                                                                                      biomarker and test
                                                                                                                                                                                                                                      Source null
                                                                                                                                                                                                                                      disease stage
                                                                                                                                                                                                                                      Source null
                                                                                                                                                                                                                                      limitations
                                                                                                                                                                                                                                      Source null
                                                                                                                                                                                                                                      line
                                                                                                                                                                                                                                      Source null
                                                                                                                                                                                                                                      prior therapy
                                                                                                                                                                                                                                      Source null
                                                                                                                                                                                                                                      regimen
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                                                                                                                                                                                                                                      tumor histology
                                                                                                                                                                                                                                      Source null
                                                                                                                                                                                                                                      use intent
                                                                                                                                                                                                                                      tumor_directed_candidate
                                                                                                                                                                                                                                      Passage 95 · positive indication candidate
                                                                                                                                                                                                                                      application numbers
                                                                                                                                                                                                                                      1. BLA761467
                                                                                                                                                                                                                                      brand names
                                                                                                                                                                                                                                      1. KEYTRUDA QLEX
                                                                                                                                                                                                                                      classification reasons
                                                                                                                                                                                                                                      1. explicit_positive_indication_predicate
                                                                                                                                                                                                                                      2. tumor_or_malignant_hematology_words_in_positive_statement
                                                                                                                                                                                                                                      clinical review status
                                                                                                                                                                                                                                      pending
                                                                                                                                                                                                                                      content role
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                                                                                                                                                                                                                                      context span
                                                                                                                                                                                                                                      end
                                                                                                                                                                                                                                      21393
                                                                                                                                                                                                                                      end exclusive
                                                                                                                                                                                                                                      true
                                                                                                                                                                                                                                      exact text
                                                                                                                                                                                                                                      in combination with carboplatin and paclitaxel, followed by KEYTRUDA QLEX as a single agent, is indicated for the treatment of adult patients with primary advanced or recurrent endometrial carcinoma. KEYTRUDA QLEX, 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 QLEX, 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
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                                                                                                                                                                                                                                      generic names
                                                                                                                                                                                                                                      1. PEMBROLIZUMAB AND BERAHYALURONIDASE ALFA-PMPH
                                                                                                                                                                                                                                      id
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                                                                                                                                                                                                                                      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
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                                                                                                                                                                                                                                        exact text
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                                                                                                                                                                                                                                      2. context exact
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                                                                                                                                                                                                                                        kind
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                                                                                                                                                                                                                                        span
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                                                                                                                                                                                                                                        exact text
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                                                                                                                                                                                                                                        20972
                                                                                                                                                                                                                                      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
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                                                                                                                                                                                                                                        exact text
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                                                                                                                                                                                                                                        kind
                                                                                                                                                                                                                                        prior_therapy_or_line
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                                                                                                                                                                                                                                        span
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                                                                                                                                                                                                                                        true
                                                                                                                                                                                                                                        exact text
                                                                                                                                                                                                                                        prior systemic therapy in any setting and are not candidates for curative surgery or radiation [see Dosage and Administration (2
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                                                                                                                                                                                                                                      5. context exact
                                                                                                                                                                                                                                        KEYTRUDA QLEX, 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
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                                                                                                                                                                                                                                        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
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                                                                                                                                                                                                                                        source defined aliases
                                                                                                                                                                                                                                        1. abbreviation
                                                                                                                                                                                                                                          NSCLC
                                                                                                                                                                                                                                          definition exact
                                                                                                                                                                                                                                          Non-Small Cell Lung Cancer
                                                                                                                                                                                                                                          definition span
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                                                                                                                                                                                                                                          Non-Small Cell Lung Cancer (NSCLC)
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                                                                                                                                                                                                                                        2. abbreviation
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                                                                                                                                                                                                                                          definition exact
                                                                                                                                                                                                                                          Colorectal Cancer
                                                                                                                                                                                                                                          definition span
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                                                                                                                                                                                                                                        true
                                                                                                                                                                                                                                        exact text
                                                                                                                                                                                                                                        KEYTRUDA QLEX, 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) ] .
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                                                                                                                                                                                                                                        source url
                                                                                                                                                                                                                                        https://api.fda.gov/drug/label.json?search=id%3A%2218b3adae-863b-413b-8e36-e3551115db37%22
                                                                                                                                                                                                                                        spl effective date
                                                                                                                                                                                                                                        2026-07-31
                                                                                                                                                                                                                                        spl set id
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                                                                                                                                                                                                                                        spl version
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                                                                                                                                                                                                                                        structured fields status
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                                                                                                                                                                                                                                        structured indication
                                                                                                                                                                                                                                        age
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                                                                                                                                                                                                                                        Source null
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                                                                                                                                                                                                                                        Source null
                                                                                                                                                                                                                                        disease stage
                                                                                                                                                                                                                                        Source null
                                                                                                                                                                                                                                        limitations
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                                                                                                                                                                                                                                        line
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                                                                                                                                                                                                                                        Source null
                                                                                                                                                                                                                                        regimen
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                                                                                                                                                                                                                                        tumor histology
                                                                                                                                                                                                                                        Source null
                                                                                                                                                                                                                                        use intent
                                                                                                                                                                                                                                        tumor_directed_candidate
                                                                                                                                                                                                                                        Passage 96 · positive indication candidate
                                                                                                                                                                                                                                        application numbers
                                                                                                                                                                                                                                        1. BLA761467
                                                                                                                                                                                                                                        brand names
                                                                                                                                                                                                                                        1. KEYTRUDA QLEX
                                                                                                                                                                                                                                        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
                                                                                                                                                                                                                                        21751
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                                                                                                                                                                                                                                        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 QLEX, 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) ] . 1.16 Tumor Mutational Burden-High Cancer KEYTRUDA QLEX is indicated for the treatment of adult and pediatric patients 12 years and older with unresectable or metastatic tumor mutational burden-high (
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                                                                                                                                                                                                                                        generic names
                                                                                                                                                                                                                                        1. PEMBROLIZUMAB AND BERAHYALURONIDASE ALFA-PMPH
                                                                                                                                                                                                                                        id
                                                                                                                                                                                                                                        ind-span-d62aba3c095192eb0dd3
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                                                                                                                                                                                                                                        positive predicate support span
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                                                                                                                                                                                                                                        true
                                                                                                                                                                                                                                        exact text
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                                                                                                                                                                                                                                        21228
                                                                                                                                                                                                                                        qualifier mentions
                                                                                                                                                                                                                                        1. context exact
                                                                                                                                                                                                                                          QLEX, 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
                                                                                                                                                                                                                                          21276
                                                                                                                                                                                                                                          end exclusive
                                                                                                                                                                                                                                          true
                                                                                                                                                                                                                                          exact text
                                                                                                                                                                                                                                          adult patients
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                                                                                                                                                                                                                                          0
                                                                                                                                                                                                                                          source field
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                                                                                                                                                                                                                                          start
                                                                                                                                                                                                                                          21262
                                                                                                                                                                                                                                        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
                                                                                                                                                                                                                                          21334
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                                                                                                                                                                                                                                          true
                                                                                                                                                                                                                                          exact text
                                                                                                                                                                                                                                          MSI-H or dMMR
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                                                                                                                                                                                                                                          18b3adae-863b-413b-8e36-e3551115db37
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                                                                                                                                                                                                                                          unicode_code_points
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                                                                                                                                                                                                                                          source field
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                                                                                                                                                                                                                                          21321
                                                                                                                                                                                                                                        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
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                                                                                                                                                                                                                                          span
                                                                                                                                                                                                                                          end
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                                                                                                                                                                                                                                          end exclusive
                                                                                                                                                                                                                                          true
                                                                                                                                                                                                                                          exact text
                                                                                                                                                                                                                                          advanced endometrial carcinoma that is MSI-
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                                                                                                                                                                                                                                        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) ] .
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                                                                                                                                                                                                                                          prior systemic therapy in any setting and are not candidates for curative surgery or radiation [see Dosage and Administration (2
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                                                                                                                                                                                                                                        5. context exact
                                                                                                                                                                                                                                          KEYTRUDA QLEX, 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
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                                                                                                                                                                                                                                          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
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                                                                                                                                                                                                                                            NSCLC
                                                                                                                                                                                                                                            definition exact
                                                                                                                                                                                                                                            Non-Small Cell Lung Cancer
                                                                                                                                                                                                                                            definition span
                                                                                                                                                                                                                                            end
                                                                                                                                                                                                                                            470
                                                                                                                                                                                                                                            end exclusive
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                                                                                                                                                                                                                                            Non-Small Cell Lung Cancer (NSCLC)
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                                                                                                                                                                                                                                          2. abbreviation
                                                                                                                                                                                                                                            CRC
                                                                                                                                                                                                                                            definition exact
                                                                                                                                                                                                                                            Colorectal Cancer
                                                                                                                                                                                                                                            definition span
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                                                                                                                                                                                                                                          end exclusive
                                                                                                                                                                                                                                          true
                                                                                                                                                                                                                                          exact text
                                                                                                                                                                                                                                          KEYTRUDA QLEX, 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) ] .
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                                                                                                                                                                                                                                          source url
                                                                                                                                                                                                                                          https://api.fda.gov/drug/label.json?search=id%3A%2218b3adae-863b-413b-8e36-e3551115db37%22
                                                                                                                                                                                                                                          spl effective date
                                                                                                                                                                                                                                          2026-07-31
                                                                                                                                                                                                                                          spl set id
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                                                                                                                                                                                                                                          spl version
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                                                                                                                                                                                                                                          structured fields status
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                                                                                                                                                                                                                                          structured indication
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                                                                                                                                                                                                                                          approval pathway
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                                                                                                                                                                                                                                          biomarker and test
                                                                                                                                                                                                                                          Source null
                                                                                                                                                                                                                                          disease stage
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                                                                                                                                                                                                                                          limitations
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                                                                                                                                                                                                                                          line
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                                                                                                                                                                                                                                          tumor histology
                                                                                                                                                                                                                                          Source null
                                                                                                                                                                                                                                          use intent
                                                                                                                                                                                                                                          tumor_directed_candidate
                                                                                                                                                                                                                                          Passage 97 · positive indication candidate
                                                                                                                                                                                                                                          application numbers
                                                                                                                                                                                                                                          1. BLA761467
                                                                                                                                                                                                                                          brand names
                                                                                                                                                                                                                                          1. KEYTRUDA QLEX
                                                                                                                                                                                                                                          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
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                                                                                                                                                                                                                                          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) ] . 1.16 Tumor Mutational Burden-High Cancer KEYTRUDA QLEX is indicated for the treatment of adult and pediatric patients 12 years and older 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
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                                                                                                                                                                                                                                          current approval status
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                                                                                                                                                                                                                                          extraction review status
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                                                                                                                                                                                                                                          generic names
                                                                                                                                                                                                                                          1. PEMBROLIZUMAB AND BERAHYALURONIDASE ALFA-PMPH
                                                                                                                                                                                                                                          id
                                                                                                                                                                                                                                          ind-span-fcd072a8ae34719198ad
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                                                                                                                                                                                                                                          positive predicate support span
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                                                                                                                                                                                                                                          true
                                                                                                                                                                                                                                          exact text
                                                                                                                                                                                                                                          is indicated
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                                                                                                                                                                                                                                          21607
                                                                                                                                                                                                                                          qualifier mentions
                                                                                                                                                                                                                                          1. context exact
                                                                                                                                                                                                                                            High Cancer KEYTRUDA QLEX is indicated for the treatment of adult and pediatric patients 12 years and older with unresectable
                                                                                                                                                                                                                                            kind
                                                                                                                                                                                                                                            age
                                                                                                                                                                                                                                            polarity
                                                                                                                                                                                                                                            not_inferred
                                                                                                                                                                                                                                            span
                                                                                                                                                                                                                                            end
                                                                                                                                                                                                                                            21646
                                                                                                                                                                                                                                            end exclusive
                                                                                                                                                                                                                                            true
                                                                                                                                                                                                                                            exact text
                                                                                                                                                                                                                                            adult
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                                                                                                                                                                                                                                            start
                                                                                                                                                                                                                                            21641
                                                                                                                                                                                                                                          2. context exact
                                                                                                                                                                                                                                            r KEYTRUDA QLEX is indicated for the treatment of adult and pediatric patients 12 years and older with unresectable or metastatic tumor mu
                                                                                                                                                                                                                                            kind
                                                                                                                                                                                                                                            age
                                                                                                                                                                                                                                            polarity
                                                                                                                                                                                                                                            not_inferred
                                                                                                                                                                                                                                            span
                                                                                                                                                                                                                                            end
                                                                                                                                                                                                                                            21669
                                                                                                                                                                                                                                            end exclusive
                                                                                                                                                                                                                                            true
                                                                                                                                                                                                                                            exact text
                                                                                                                                                                                                                                            pediatric patients
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                                                                                                                                                                                                                                            21651
                                                                                                                                                                                                                                          3. context exact
                                                                                                                                                                                                                                            indicated for the treatment of adult and pediatric patients 12 years and older with unresectable or metastatic tumor mutational burden-hig
                                                                                                                                                                                                                                            kind
                                                                                                                                                                                                                                            age
                                                                                                                                                                                                                                            polarity
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                                                                                                                                                                                                                                            span
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                                                                                                                                                                                                                                            end exclusive
                                                                                                                                                                                                                                            true
                                                                                                                                                                                                                                            exact text
                                                                                                                                                                                                                                            12 years and older
                                                                                                                                                                                                                                            label id
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                                                                                                                                                                                                                                            source field
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                                                                                                                                                                                                                                            21670
                                                                                                                                                                                                                                          4. context exact
                                                                                                                                                                                                                                            pediatric patients 12 years and older 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
                                                                                                                                                                                                                                            21753
                                                                                                                                                                                                                                            end exclusive
                                                                                                                                                                                                                                            true
                                                                                                                                                                                                                                            exact text
                                                                                                                                                                                                                                            metastatic tumor mutational burden-high (TM
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                                                                                                                                                                                                                                            21710
                                                                                                                                                                                                                                          5. context exact
                                                                                                                                                                                                                                            ent of adult and pediatric patients 12 years and older with unresectable or metastatic tumor mutational burden-high (TMB-H) [≥10 mutations/megabase (mut/Mb)] solid tum
                                                                                                                                                                                                                                            kind
                                                                                                                                                                                                                                            stage_or_setting
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                                                                                                                                                                                                                                            end exclusive
                                                                                                                                                                                                                                            true
                                                                                                                                                                                                                                            exact text
                                                                                                                                                                                                                                            unresectable or metastatic tumor mutational bur
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                                                                                                                                                                                                                                            21694
                                                                                                                                                                                                                                          6. context exact
                                                                                                                                                                                                                                            and Administration (2.1) ] , that have progressed following prior treatment and who have no satisfactory alternative treatment options .
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                                                                                                                                                                                                                                            prior_therapy_or_line
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                                                                                                                                                                                                                                            true
                                                                                                                                                                                                                                            exact text
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                                                                                                                                                                                                                                            21918
                                                                                                                                                                                                                                          regulatory links
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                                                                                                                                                                                                                                            source defined aliases
                                                                                                                                                                                                                                            1. abbreviation
                                                                                                                                                                                                                                              NSCLC
                                                                                                                                                                                                                                              definition exact
                                                                                                                                                                                                                                              Non-Small Cell Lung Cancer
                                                                                                                                                                                                                                              definition span
                                                                                                                                                                                                                                              end
                                                                                                                                                                                                                                              470
                                                                                                                                                                                                                                              end exclusive
                                                                                                                                                                                                                                              true
                                                                                                                                                                                                                                              exact text
                                                                                                                                                                                                                                              Non-Small Cell Lung Cancer (NSCLC)
                                                                                                                                                                                                                                              label id
                                                                                                                                                                                                                                              18b3adae-863b-413b-8e36-e3551115db37
                                                                                                                                                                                                                                              offset unit
                                                                                                                                                                                                                                              unicode_code_points
                                                                                                                                                                                                                                              source array index
                                                                                                                                                                                                                                              0
                                                                                                                                                                                                                                              source field
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                                                                                                                                                                                                                                              source text sha256
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                                                                                                                                                                                                                                              start
                                                                                                                                                                                                                                              436
                                                                                                                                                                                                                                            2. abbreviation
                                                                                                                                                                                                                                              CRC
                                                                                                                                                                                                                                              definition exact
                                                                                                                                                                                                                                              Colorectal Cancer
                                                                                                                                                                                                                                              definition span
                                                                                                                                                                                                                                              end
                                                                                                                                                                                                                                              4658
                                                                                                                                                                                                                                              end exclusive
                                                                                                                                                                                                                                              true
                                                                                                                                                                                                                                              exact text
                                                                                                                                                                                                                                              Colorectal Cancer (CRC)
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                                                                                                                                                                                                                                              source array index
                                                                                                                                                                                                                                              0
                                                                                                                                                                                                                                              source field
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                                                                                                                                                                                                                                            source span
                                                                                                                                                                                                                                            end
                                                                                                                                                                                                                                            21994
                                                                                                                                                                                                                                            end exclusive
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                                                                                                                                                                                                                                            1.16 Tumor Mutational Burden-High Cancer KEYTRUDA QLEX is indicated for the treatment of adult and pediatric patients 12 years and older 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 .
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                                                                                                                                                                                                                                            id 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
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                                                                                                                                                                                                                                                    brand names
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                                                                                                                                                                                                                                                      Limitations of Use : The safety and effectiveness of KEYTRUDA QLEX in pediatric patients 12 years and older with TMB-H central nervous system cancers have not been established.
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                                                                                                                                                                                                                                                      application numbers
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                                                                                                                                                                                                                                                      brand names
                                                                                                                                                                                                                                                      1. KEYTRUDA QLEX
                                                                                                                                                                                                                                                      classification reasons
                                                                                                                                                                                                                                                      1. explicit_positive_indication_predicate
                                                                                                                                                                                                                                                      2. tumor_or_malignant_hematology_words_in_positive_statement
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                                                                                                                                                                                                                                                      e confirmatory trials. Limitations of Use : The safety and effectiveness of KEYTRUDA QLEX in pediatric patients 12 years and older with TMB-H central nervous system cancers have not been established. 1.17 Cutaneous Squamous Cell Carcinoma KEYTRUDA QLEX is indicated for the treatment of adult patients with recurrent or metastatic cutaneous squamous cell carcinoma (cSCC) or locally advanced cSCC that is not curable by surgery or radiation. 1.18 Triple-Negative Breast Cancer KEYTRUDA QLEX is indicated for the treatment of adult patients with high-risk early-stage triple-negative breast cancer (TNBC) in combination with chemotherapy as n
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                                                                                                                                                                                                                                                      1. PEMBROLIZUMAB AND BERAHYALURONIDASE ALFA-PMPH
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                                                                                                                                                                                                                                                        l Carcinoma KEYTRUDA QLEX is indicated for the treatment of adult patients with recurrent or metastatic cutaneous squamous cell carcin
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                                                                                                                                                                                                                                                      2. context exact
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                                                                                                                                                                                                                                                        22619
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                                                                                                                                                                                                                                                        true
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                                                                                                                                                                                                                                                        recurrent or metastatic cutaneous squamous c
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                                                                                                                                                                                                                                                      4. context exact
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                                                                                                                                                                                                                                                        source defined aliases
                                                                                                                                                                                                                                                        1. abbreviation
                                                                                                                                                                                                                                                          NSCLC
                                                                                                                                                                                                                                                          definition exact
                                                                                                                                                                                                                                                          Non-Small Cell Lung Cancer
                                                                                                                                                                                                                                                          definition span
                                                                                                                                                                                                                                                          end
                                                                                                                                                                                                                                                          470
                                                                                                                                                                                                                                                          end exclusive
                                                                                                                                                                                                                                                          true
                                                                                                                                                                                                                                                          exact text
                                                                                                                                                                                                                                                          Non-Small Cell Lung Cancer (NSCLC)
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                                                                                                                                                                                                                                                        2. abbreviation
                                                                                                                                                                                                                                                          CRC
                                                                                                                                                                                                                                                          definition exact
                                                                                                                                                                                                                                                          Colorectal Cancer
                                                                                                                                                                                                                                                          definition span
                                                                                                                                                                                                                                                          end
                                                                                                                                                                                                                                                          4658
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                                                                                                                                                                                                                                                          true
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                                                                                                                                                                                                                                                          Colorectal Cancer (CRC)
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                                                                                                                                                                                                                                                        1.17 Cutaneous Squamous Cell Carcinoma KEYTRUDA QLEX is indicated for the treatment of adult patients with recurrent or metastatic cutaneous squamous cell carcinoma (cSCC) or locally advanced cSCC that is not curable by surgery or radiation.
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                                                                                                                                                                                                                                                        limitations
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                                                                                                                                                                                                                                                        Source null
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                                                                                                                                                                                                                                                        Source null
                                                                                                                                                                                                                                                        tumor histology
                                                                                                                                                                                                                                                        Source null
                                                                                                                                                                                                                                                        use intent
                                                                                                                                                                                                                                                        tumor_directed_candidate
                                                                                                                                                                                                                                                        Passage 102 · positive indication candidate
                                                                                                                                                                                                                                                        application numbers
                                                                                                                                                                                                                                                        1. BLA761467
                                                                                                                                                                                                                                                        brand names
                                                                                                                                                                                                                                                        1. KEYTRUDA QLEX
                                                                                                                                                                                                                                                        classification reasons
                                                                                                                                                                                                                                                        1. explicit_positive_indication_predicate
                                                                                                                                                                                                                                                        2. tumor_or_malignant_hematology_words_in_positive_statement
                                                                                                                                                                                                                                                        clinical review status
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                                                                                                                                                                                                                                                        content role
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                                                                                                                                                                                                                                                        23192
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                                                                                                                                                                                                                                                        TRUDA QLEX is indicated for the treatment of adult patients with recurrent or metastatic cutaneous squamous cell carcinoma (cSCC) or locally advanced cSCC that is not curable by surgery or radiation. 1.18 Triple-Negative Breast Cancer KEYTRUDA QLEX is indicated for the treatment of adult 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 QLEX, 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 P
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                                                                                                                                                                                                                                                          1. abbreviation
                                                                                                                                                                                                                                                            NSCLC
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                                                                                                                                                                                                                                                            Non-Small Cell Lung Cancer
                                                                                                                                                                                                                                                            definition span
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                                                                                                                                                                                                                                                            Colorectal Cancer
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                                                                                                                                                                                                                                                          1.18 Triple-Negative Breast Cancer KEYTRUDA QLEX is indicated for the treatment of adult 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.
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                                                                                                                                                                                                                                                          application numbers
                                                                                                                                                                                                                                                          1. BLA761467
                                                                                                                                                                                                                                                          brand names
                                                                                                                                                                                                                                                          1. KEYTRUDA QLEX
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                                                                                                                                                                                                                                                          generic names
                                                                                                                                                                                                                                                          1. PEMBROLIZUMAB AND BERAHYALURONIDASE ALFA-PMPH
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                                                                                                                                                                                                                                                          qualifier mentions
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                                                                                                                                                                                                                                                            ovitecan-hziy, is indicated for the first-line treatment of adult patients with unresectable locally advanced or metastatic TNBC whose
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                                                                                                                                                                                                                                                          2. context exact
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                                                                                                                                                                                                                                                            brand names
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                                                                                                                                                                                                                                                              use intent
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                                                                                                                                                                                                                                                              Passage 105 · positive indication candidate
                                                                                                                                                                                                                                                              application numbers
                                                                                                                                                                                                                                                              1. BLA761467
                                                                                                                                                                                                                                                              brand names
                                                                                                                                                                                                                                                              1. KEYTRUDA QLEX
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                                                                                                                                                                                                                                                              2. tumor_or_malignant_hematology_words_in_positive_statement
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                                                                                                                                                                                                                                                              reatment of adult 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) ] . 1.19 Ovarian Cancer KEYTRUDA QLEX, 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.
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                                                                                                                                                                                                                                                              1. PEMBROLIZUMAB AND BERAHYALURONIDASE ALFA-PMPH
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                                                                                                                                                                                                                                                              4. context exact
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                                                                                                                                                                                                                                                                1.19 Ovarian Cancer KEYTRUDA QLEX, 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.
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                                                                                                                                                                                                                                                                spl effective date
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                                                                                                                                                                                                                                                                Preserved source evidence · Not medical advice