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LABELS · 1fce9e6a-6a7c-4fc0-a3a4-a0099f7bd2ce

OPDIVO

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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
2026-08-12
Captured
2026-09-09T23:37:42.544548+00:00
Current indication reconciliation
Not reconciled

Indications and usage: exact source text

  1. 1 INDICATIONS AND USAGE OPDIVO is a programmed death receptor-1 (PD-1)-blocking antibody indicated for the treatment of: Melanoma • adult and pediatric (12 years and older) patients with unresectable or metastatic melanoma, as a single agent or in combination with ipilimumab. (1.1) • for the adjuvant treatment of adult and pediatric patients 12 years and older with completely resected Stage IIB, Stage IIC, Stage III, or Stage IV melanoma. (1.2) Non-Small Cell Lung Cancer (NSCLC) • adult patients with resectable (tumors ≥4 cm or node positive) non-small cell lung cancer in the neoadjuvant setting, in combination with platinum-doublet chemotherapy. (1.3) • adult patients with resectable (tumors ≥4 cm or node positive) non-small cell lung cancer and no known EGFR mutations or ALK rearrangements, for neoadjuvant treatment, in combination with platinum-doublet chemotherapy, followed by single-agent OPDIVO as adjuvant treatment after surgery. (1.4) • adult patients with metastatic non-small cell lung cancer expressing PD‑L1 (≥1%) as determined by an FDA-authorized test, with no EGFR or ALK genomic tumor aberrations, as first-line treatment in combination with ipilimumab. (1.5) • adult patients with metastatic or recurrent non-small cell lung cancer with no EGFR or ALK genomic tumor aberrations as first-line treatment, in combination with ipilimumab and 2 cycles of platinum-doublet chemotherapy. (1.5) • adult patients with metastatic non-small cell lung cancer and progression on or after platinum-based chemotherapy. Patients with EGFR or ALK genomic tumor aberrations should have disease progression on FDA-approved therapy for these aberrations prior to receiving OPDIVO. (1.5) Malignant Pleural Mesothelioma • adult patients with unresectable malignant pleural mesothelioma, as first-line treatment in combination with ipilimumab. (1.6) Renal Cell Carcinoma (RCC) • adult patients with intermediate or poor risk advanced renal cell carcinoma, as a first-line treatment in combination with ipilimumab. (1.7) • adult patients with advanced renal cell carcinoma, as a first-line treatment in combination with cabozantinib. (1.7) • adult patients with advanced renal cell carcinoma who have received prior anti-angiogenic therapy. (1.7) Classical Hodgkin Lymphoma (cHL) • adult and pediatric (12 years and older) patients with previously untreated, Stage III or IV classical Hodgkin lymphoma in combination with doxorubicin, vinblastine, and dacarbazine (AVD). (1.8) • adult patients with classical Hodgkin lymphoma that has relapsed or progressed after: (1.8) • autologous hematopoietic stem cell transplantation (HSCT) and brentuximab vedotin, or • 3 or more lines of systemic therapy that includes autologous HSCT. Squamous Cell Carcinoma of the Head and Neck (SCCHN) • adult patients with recurrent or metastatic squamous cell carcinoma of the head and neck with disease progression on or after a platinum-based therapy. (1.9) Urothelial Carcinoma • adjuvant treatment of adult patients with urothelial carcinoma (UC) who are at high risk of recurrence after undergoing radical resection of UC. (1.10) • adult patients with unresectable or metastatic urothelial carcinoma, as first-line treatment in combination with cisplatin and gemcitabine. (1.10) • adult patients with locally advanced or metastatic urothelial carcinoma who: • have disease progression during or following platinum-containing chemotherapy. • have disease progression within 12 months of neoadjuvant or adjuvant treatment with platinum-containing chemotherapy. (1.10) Colorectal Cancer • adult and pediatric (12 years and older) patients with unresectable or metastatic microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) colorectal cancer (CRC) in combination with ipilimumab. (1.11) • adult and pediatric (12 years and older) patients with microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) metastatic colorectal cancer that has progressed following treatment with a fluoropyrimidine, oxaliplatin, and irinotecan. ( 1.11 ) Hepatocellular Carcinoma (HCC) • adult patients with unresectable or metastatic hepatocellular carcinoma (HCC), as a first-line treatment in combination with ipilimumab. (1.12) • in combination with ipilimumab in adult patients with unresectable or metastatic HCC who have been previously treated with sorafenib. ( 1.12 ) Esophageal Cancer • adult patients with completely resected esophageal or gastroesophageal junction cancer with residual pathologic disease, who have received neoadjuvant chemoradiotherapy (CRT). (1.13) • adult patients with unresectable advanced or metastatic esophageal squamous cell carcinoma as first-line treatment in combination with fluoropyrimidine- and platinum‑containing chemotherapy whose tumors express PD-L1 (≥1). (1.13) • adult patients with unresectable advanced or metastatic esophageal squamous cell carcinoma as first-line treatment in combination with ipilimumab whose tumors express PD-L1 (≥1). (1.13) • adult patients with unresectable advanced, recurrent or metastatic esophageal squamous cell carcinoma (ESCC) after prior fluoropyrimidine- and platinum-based chemotherapy. (1.13) Gastric Cancer, Gastroesophageal Junction Cancer, and Esophageal Adenocarcinoma • adult patients with advanced or metastatic gastric cancer, gastroesophageal junction cancer, and esophageal adenocarcinoma whose tumors express PD-L1 (≥1) in combination with fluoropyrimidine- and platinum-containing chemotherapy. (1.14) 1.1 Unresectable or Metastatic Melanoma OPDIVO, as a single agent or in combination with ipilimumab, is indicated for the treatment of adult and pediatric patients 12 years and older with unresectable or metastatic melanoma. 1.2 Adjuvant Treatment of Melanoma OPDIVO is indicated for the adjuvant treatment of adult and pediatric patients 12 years and older with completely resected Stage IIB, Stage IIC, Stage III, or Stage IV melanoma. 1.3 Neoadjuvant Treatment of Resectable Non-Small Cell Lung Cancer OPDIVO, in combination with platinum-doublet chemotherapy, is indicated as neoadjuvant treatment of adult patients with resectable (tumors ≥4 cm or node positive) non-small cell lung cancer (NSCLC). 1.4 Neoadjuvant and Adjuvant Treatment of Resectable Non-Small Cell Lung Cancer OPDIVO, in combination with platinum-doublet chemotherapy, is indicated for the neoadjuvant treatment of adult patients with resectable (tumors ≥4 cm or node positive) NSCLC and no known epidermal growth factor receptor (EGFR) mutations or anaplastic lymphoma kinase (ALK) rearrangements, followed by single-agent OPDIVO as adjuvant treatment after surgery. 1.5 Metastatic Non-Small Cell Lung Cancer • OPDIVO, in combination with ipilimumab, is indicated for the first-line treatment of adult patients with metastatic NSCLC whose tumors express PD-L1 (≥1%) as determined by an FDA-authorized test [see Dosage and Administration (2.1) ] , with no EGFR or ALK genomic tumor aberrations. • OPDIVO, in combination with ipilimumab and 2 cycles of platinum-doublet chemotherapy, is indicated for the first-line treatment of adult patients with metastatic or recurrent NSCLC, with no EGFR or ALK genomic tumor aberrations. • OPDIVO is indicated for the treatment of adult patients with metastatic NSCLC with progression on or after platinum-based chemotherapy. Patients with EGFR or ALK genomic tumor aberrations should have disease progression on FDA-approved therapy for these aberrations prior to receiving OPDIVO. 1.6 Malignant Pleural Mesothelioma OPDIVO, in combination with ipilimumab, is indicated for the first-line treatment of adult patients with unresectable malignant pleural mesothelioma. 1.7 Advanced Renal Cell Carcinoma • OPDIVO, in combination with ipilimumab, is indicated for the first-line treatment of adult patients with intermediate or poor risk advanced RCC. • OPDIVO, in combination with cabozantinib, is indicated for the first-line treatment of adult patients with advanced RCC. • OPDIVO, as a single agent, is indicated for the treatment of adult patients with advanced renal cell carcinoma (RCC) who have received prior anti-angiogenic therapy. 1.8 Classical Hodgkin Lymphoma • OPDIVO, in combination with doxorubicin, vinblastine, and dacarbazine (AVD), is indicated for the treatment of adult and pediatric patients 12 years and older with previously untreated, Stage III or IV classical Hodgkin lymphoma (cHL). • OPDIVO, as a single agent, is indicated for the treatment of adult patients with classical Hodgkin lymphoma (cHL) that has relapsed or progressed after: • autologous hematopoietic stem cell transplantation (HSCT) and brentuximab vedotin, or • 3 or more lines of systemic therapy that includes autologous HSCT. 1.9 Squamous Cell Carcinoma of the Head and Neck OPDIVO is indicated for the treatment of adult patients with recurrent or metastatic squamous cell carcinoma of the head and neck (SCCHN) with disease progression on or after platinum-based therapy. 1.10 Urothelial Carcinoma OPDIVO is indicated for the adjuvant treatment of adult patients with urothelial carcinoma (UC) who are at high risk of recurrence after undergoing radical resection of UC [see Clinical Studies (14.10) ] . OPDIVO, in combination with cisplatin and gemcitabine, is indicated for the first-line treatment of adult patients with unresectable or metastatic urothelial carcinoma. OPDIVO is indicated for the treatment of adult patients with locally advanced or metastatic urothelial carcinoma who: • have disease progression during or following platinum-containing chemotherapy. • have disease progression within 12 months of neoadjuvant or adjuvant treatment with platinum-containing chemotherapy. 1.11 Microsatellite Instability-High or Mismatch Repair Deficient Metastatic Colorectal Cancer • OPDIVO, in combination with ipilimumab, 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) colorectal cancer (CRC) . • OPDIVO, as a single agent, is indicated for the treatment of adult and pediatric patients 12 years and older with microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) metastatic colorectal cancer (CRC) that has progressed following treatment with a fluoropyrimidine, oxaliplatin, and irinotecan. 1.12 Hepatocellular Carcinoma • OPDIVO, in combination with ipilimumab, is indicated for the first-line treatment of adult patients with unresectable or metastatic hepatocellular carcinoma (HCC). • OPDIVO, in combination with ipilimumab, is indicated for the treatment of adult patients with unresectable or metastatic HCC who have been previously treated with sorafenib. 1.13 Esophageal Cancer • OPDIVO is indicated for the adjuvant treatment of completely resected esophageal or gastroesophageal junction cancer with residual pathologic disease in adult patients who have received neoadjuvant chemoradiotherapy (CRT). • OPDIVO, in combination with fluoropyrimidine- and platinum-containing chemotherapy, is indicated for the first-line treatment of adult patients with unresectable advanced or metastatic esophageal squamous cell carcinoma (ESCC) whose tumors express PD-L1 (≥1) [see Dosage and Administration (2.1) ] . • OPDIVO, in combination with ipilimumab, is indicated for the first-line treatment of adult patients with unresectable advanced or metastatic esophageal squamous cell carcinoma (ESCC) whose tumors express PD-L1 (≥1) [see Dosage and Administration (2.1) ] . • OPDIVO is indicated for the treatment of adult patients with unresectable advanced, recurrent or metastatic esophageal squamous cell carcinoma (ESCC) after prior fluoropyrimidine- and platinum-based chemotherapy. 1.14 Gastric Cancer, Gastroesophageal Junction Cancer, and Esophageal Adenocarcinoma OPDIVO, in combination with fluoropyrimidine- and platinum-containing chemotherapy, is indicated for the treatment of adult patients with advanced or metastatic gastric cancer, gastroesophageal junction cancer, and esophageal adenocarcinoma whose tumors express PD-L1 (≥1) [see Dosage and Administration (2.1) ] .
Full extracted label fields
application numbers
  1. BLA125554
boxed warning exact
    brand names
    1. OPDIVO
    current indication status
    not_reconciled
    dailymed set url
    https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=f570b9c4-6846-4de2-abfa-4d0a4ae4e394
    generic names
    1. NIVOLUMAB
    id
    1fce9e6a-6a7c-4fc0-a3a4-a0099f7bd2ce
    indications and usage exact
    1. 1 INDICATIONS AND USAGE OPDIVO is a programmed death receptor-1 (PD-1)-blocking antibody indicated for the treatment of: Melanoma • adult and pediatric (12 years and older) patients with unresectable or metastatic melanoma, as a single agent or in combination with ipilimumab. (1.1) • for the adjuvant treatment of adult and pediatric patients 12 years and older with completely resected Stage IIB, Stage IIC, Stage III, or Stage IV melanoma. (1.2) Non-Small Cell Lung Cancer (NSCLC) • adult patients with resectable (tumors ≥4 cm or node positive) non-small cell lung cancer in the neoadjuvant setting, in combination with platinum-doublet chemotherapy. (1.3) • adult patients with resectable (tumors ≥4 cm or node positive) non-small cell lung cancer and no known EGFR mutations or ALK rearrangements, for neoadjuvant treatment, in combination with platinum-doublet chemotherapy, followed by single-agent OPDIVO as adjuvant treatment after surgery. (1.4) • adult patients with metastatic non-small cell lung cancer expressing PD‑L1 (≥1%) as determined by an FDA-authorized test, with no EGFR or ALK genomic tumor aberrations, as first-line treatment in combination with ipilimumab. (1.5) • adult patients with metastatic or recurrent non-small cell lung cancer with no EGFR or ALK genomic tumor aberrations as first-line treatment, in combination with ipilimumab and 2 cycles of platinum-doublet chemotherapy. (1.5) • adult patients with metastatic non-small cell lung cancer and progression on or after platinum-based chemotherapy. Patients with EGFR or ALK genomic tumor aberrations should have disease progression on FDA-approved therapy for these aberrations prior to receiving OPDIVO. (1.5) Malignant Pleural Mesothelioma • adult patients with unresectable malignant pleural mesothelioma, as first-line treatment in combination with ipilimumab. (1.6) Renal Cell Carcinoma (RCC) • adult patients with intermediate or poor risk advanced renal cell carcinoma, as a first-line treatment in combination with ipilimumab. (1.7) • adult patients with advanced renal cell carcinoma, as a first-line treatment in combination with cabozantinib. (1.7) • adult patients with advanced renal cell carcinoma who have received prior anti-angiogenic therapy. (1.7) Classical Hodgkin Lymphoma (cHL) • adult and pediatric (12 years and older) patients with previously untreated, Stage III or IV classical Hodgkin lymphoma in combination with doxorubicin, vinblastine, and dacarbazine (AVD). (1.8) • adult patients with classical Hodgkin lymphoma that has relapsed or progressed after: (1.8) • autologous hematopoietic stem cell transplantation (HSCT) and brentuximab vedotin, or • 3 or more lines of systemic therapy that includes autologous HSCT. Squamous Cell Carcinoma of the Head and Neck (SCCHN) • adult patients with recurrent or metastatic squamous cell carcinoma of the head and neck with disease progression on or after a platinum-based therapy. (1.9) Urothelial Carcinoma • adjuvant treatment of adult patients with urothelial carcinoma (UC) who are at high risk of recurrence after undergoing radical resection of UC. (1.10) • adult patients with unresectable or metastatic urothelial carcinoma, as first-line treatment in combination with cisplatin and gemcitabine. (1.10) • adult patients with locally advanced or metastatic urothelial carcinoma who: • have disease progression during or following platinum-containing chemotherapy. • have disease progression within 12 months of neoadjuvant or adjuvant treatment with platinum-containing chemotherapy. (1.10) Colorectal Cancer • adult and pediatric (12 years and older) patients with unresectable or metastatic microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) colorectal cancer (CRC) in combination with ipilimumab. (1.11) • adult and pediatric (12 years and older) patients with microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) metastatic colorectal cancer that has progressed following treatment with a fluoropyrimidine, oxaliplatin, and irinotecan. ( 1.11 ) Hepatocellular Carcinoma (HCC) • adult patients with unresectable or metastatic hepatocellular carcinoma (HCC), as a first-line treatment in combination with ipilimumab. (1.12) • in combination with ipilimumab in adult patients with unresectable or metastatic HCC who have been previously treated with sorafenib. ( 1.12 ) Esophageal Cancer • adult patients with completely resected esophageal or gastroesophageal junction cancer with residual pathologic disease, who have received neoadjuvant chemoradiotherapy (CRT). (1.13) • adult patients with unresectable advanced or metastatic esophageal squamous cell carcinoma as first-line treatment in combination with fluoropyrimidine- and platinum‑containing chemotherapy whose tumors express PD-L1 (≥1). (1.13) • adult patients with unresectable advanced or metastatic esophageal squamous cell carcinoma as first-line treatment in combination with ipilimumab whose tumors express PD-L1 (≥1). (1.13) • adult patients with unresectable advanced, recurrent or metastatic esophageal squamous cell carcinoma (ESCC) after prior fluoropyrimidine- and platinum-based chemotherapy. (1.13) Gastric Cancer, Gastroesophageal Junction Cancer, and Esophageal Adenocarcinoma • adult patients with advanced or metastatic gastric cancer, gastroesophageal junction cancer, and esophageal adenocarcinoma whose tumors express PD-L1 (≥1) in combination with fluoropyrimidine- and platinum-containing chemotherapy. (1.14) 1.1 Unresectable or Metastatic Melanoma OPDIVO, as a single agent or in combination with ipilimumab, is indicated for the treatment of adult and pediatric patients 12 years and older with unresectable or metastatic melanoma. 1.2 Adjuvant Treatment of Melanoma OPDIVO is indicated for the adjuvant treatment of adult and pediatric patients 12 years and older with completely resected Stage IIB, Stage IIC, Stage III, or Stage IV melanoma. 1.3 Neoadjuvant Treatment of Resectable Non-Small Cell Lung Cancer OPDIVO, in combination with platinum-doublet chemotherapy, is indicated as neoadjuvant treatment of adult patients with resectable (tumors ≥4 cm or node positive) non-small cell lung cancer (NSCLC). 1.4 Neoadjuvant and Adjuvant Treatment of Resectable Non-Small Cell Lung Cancer OPDIVO, in combination with platinum-doublet chemotherapy, is indicated for the neoadjuvant treatment of adult patients with resectable (tumors ≥4 cm or node positive) NSCLC and no known epidermal growth factor receptor (EGFR) mutations or anaplastic lymphoma kinase (ALK) rearrangements, followed by single-agent OPDIVO as adjuvant treatment after surgery. 1.5 Metastatic Non-Small Cell Lung Cancer • OPDIVO, in combination with ipilimumab, is indicated for the first-line treatment of adult patients with metastatic NSCLC whose tumors express PD-L1 (≥1%) as determined by an FDA-authorized test [see Dosage and Administration (2.1) ] , with no EGFR or ALK genomic tumor aberrations. • OPDIVO, in combination with ipilimumab and 2 cycles of platinum-doublet chemotherapy, is indicated for the first-line treatment of adult patients with metastatic or recurrent NSCLC, with no EGFR or ALK genomic tumor aberrations. • OPDIVO is indicated for the treatment of adult patients with metastatic NSCLC with progression on or after platinum-based chemotherapy. Patients with EGFR or ALK genomic tumor aberrations should have disease progression on FDA-approved therapy for these aberrations prior to receiving OPDIVO. 1.6 Malignant Pleural Mesothelioma OPDIVO, in combination with ipilimumab, is indicated for the first-line treatment of adult patients with unresectable malignant pleural mesothelioma. 1.7 Advanced Renal Cell Carcinoma • OPDIVO, in combination with ipilimumab, is indicated for the first-line treatment of adult patients with intermediate or poor risk advanced RCC. • OPDIVO, in combination with cabozantinib, is indicated for the first-line treatment of adult patients with advanced RCC. • OPDIVO, as a single agent, is indicated for the treatment of adult patients with advanced renal cell carcinoma (RCC) who have received prior anti-angiogenic therapy. 1.8 Classical Hodgkin Lymphoma • OPDIVO, in combination with doxorubicin, vinblastine, and dacarbazine (AVD), is indicated for the treatment of adult and pediatric patients 12 years and older with previously untreated, Stage III or IV classical Hodgkin lymphoma (cHL). • OPDIVO, as a single agent, is indicated for the treatment of adult patients with classical Hodgkin lymphoma (cHL) that has relapsed or progressed after: • autologous hematopoietic stem cell transplantation (HSCT) and brentuximab vedotin, or • 3 or more lines of systemic therapy that includes autologous HSCT. 1.9 Squamous Cell Carcinoma of the Head and Neck OPDIVO is indicated for the treatment of adult patients with recurrent or metastatic squamous cell carcinoma of the head and neck (SCCHN) with disease progression on or after platinum-based therapy. 1.10 Urothelial Carcinoma OPDIVO is indicated for the adjuvant treatment of adult patients with urothelial carcinoma (UC) who are at high risk of recurrence after undergoing radical resection of UC [see Clinical Studies (14.10) ] . OPDIVO, in combination with cisplatin and gemcitabine, is indicated for the first-line treatment of adult patients with unresectable or metastatic urothelial carcinoma. OPDIVO is indicated for the treatment of adult patients with locally advanced or metastatic urothelial carcinoma who: • have disease progression during or following platinum-containing chemotherapy. • have disease progression within 12 months of neoadjuvant or adjuvant treatment with platinum-containing chemotherapy. 1.11 Microsatellite Instability-High or Mismatch Repair Deficient Metastatic Colorectal Cancer • OPDIVO, in combination with ipilimumab, 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) colorectal cancer (CRC) . • OPDIVO, as a single agent, is indicated for the treatment of adult and pediatric patients 12 years and older with microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) metastatic colorectal cancer (CRC) that has progressed following treatment with a fluoropyrimidine, oxaliplatin, and irinotecan. 1.12 Hepatocellular Carcinoma • OPDIVO, in combination with ipilimumab, is indicated for the first-line treatment of adult patients with unresectable or metastatic hepatocellular carcinoma (HCC). • OPDIVO, in combination with ipilimumab, is indicated for the treatment of adult patients with unresectable or metastatic HCC who have been previously treated with sorafenib. 1.13 Esophageal Cancer • OPDIVO is indicated for the adjuvant treatment of completely resected esophageal or gastroesophageal junction cancer with residual pathologic disease in adult patients who have received neoadjuvant chemoradiotherapy (CRT). • OPDIVO, in combination with fluoropyrimidine- and platinum-containing chemotherapy, is indicated for the first-line treatment of adult patients with unresectable advanced or metastatic esophageal squamous cell carcinoma (ESCC) whose tumors express PD-L1 (≥1) [see Dosage and Administration (2.1) ] . • OPDIVO, in combination with ipilimumab, is indicated for the first-line treatment of adult patients with unresectable advanced or metastatic esophageal squamous cell carcinoma (ESCC) whose tumors express PD-L1 (≥1) [see Dosage and Administration (2.1) ] . • OPDIVO is indicated for the treatment of adult patients with unresectable advanced, recurrent or metastatic esophageal squamous cell carcinoma (ESCC) after prior fluoropyrimidine- and platinum-based chemotherapy. 1.14 Gastric Cancer, Gastroesophageal Junction Cancer, and Esophageal Adenocarcinoma OPDIVO, in combination with fluoropyrimidine- and platinum-containing chemotherapy, is indicated for the treatment of adult patients with advanced or metastatic gastric cancer, gastroesophageal junction cancer, and esophageal adenocarcinoma whose tumors express PD-L1 (≥1) [see Dosage and Administration (2.1) ] .
    indications and usage tables exact
      is original packager
      1. true
      manufacturer names
      1. E.R. Squibb & Sons, L.L.C.
      matched search terms
      1. cancer
      2. carcinoma
      3. lymphoma
      4. melanoma
      5. tumor
      6. tumors
      7. malignant
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      1. 0003-3772-11
      2. 0003-3774-12
      3. 0003-3734-13
      4. 0003-3756-14
      product ndcs
      1. 0003-3734
      2. 0003-3772
      3. 0003-3774
      4. 0003-3756
      product types
      1. HUMAN PRESCRIPTION DRUG
      recent major changes exact
      1. Indications and Usage (1) 3/2026 Dosage and Administration (2) 3/2026 Warnings and Precautions (5) 5/2026
      record type
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      routes
      1. INTRAVENOUS
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      disclaimer
      Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. We may limit or otherwise restrict your access to the API in line with our Terms of Service.
      last updated
      2026-09-09
      results
      limit
      100
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      830
      sha256
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      url
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      source url
      https://api.fda.gov/drug/label.json?search=id%3A%221fce9e6a-6a7c-4fc0-a3a4-a0099f7bd2ce%22
      spl effective date
      2026-08-12
      spl effective time
      20260812
      spl set id
      f570b9c4-6846-4de2-abfa-4d0a4ae4e394
      spl version
      68
      substance names
      1. NIVOLUMAB
      uniis
      1. 31YO63LBSN
      verification flags
      1. oncology_keyword_candidate_not_clinically_classified
      2. spl_text_not_verified_identical_to_latest_approved_label
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      4. fda_label_posted_after_spl_effective_date_requires_version_review
      Drugs@FDA application source records
      1. application number
        BLA125554
        payload
        all indexed label documents
        1. Appl No
          125554
          Application Docs Date
          2016-05-17 00:00:00
          Application Docs ID
          18936
          Application Docs Title
          0
          Application Docs Type ID
          2
          Submission No
          19
          Submission Type
          SUPPL
        2. Appl No
          125554
          Application Docs Date
          2014-12-22 00:00:00
          Application Docs ID
          39991
          Application Docs Title
          0
          Application Docs Type ID
          2
          Submission No
          1
          Submission Type
          ORIG
        3. Appl No
          125554
          Application Docs Date
          2015-11-25 00:00:00
          Application Docs ID
          39992
          Application Docs Title
          0
          Application Docs Type ID
          2
          Submission No
          1
          Submission Type
          SUPPL
        4. Appl No
          125554
          Application Docs Date
          2015-10-09 00:00:00
          Application Docs ID
          39993
          Application Docs Title
          0
          Application Docs Type ID
          2
          Submission No
          5
          Submission Type
          SUPPL
        5. Appl No
          125554
          Application Docs Date
          2015-11-23 00:00:00
          Application Docs ID
          39994
          Application Docs Title
          0
          Application Docs Type ID
          2
          Submission No
          12
          Submission Type
          SUPPL
        6. Appl No
          125554
          Application Docs Date
          2016-09-28 00:00:00
          Application Docs ID
          45403
          Application Docs Title
          0
          Application Docs Type ID
          2
          Submission No
          18
          Submission Type
          SUPPL
        7. Appl No
          125554
          Application Docs Date
          2016-09-28 00:00:00
          Application Docs ID
          45404
          Application Docs Title
          0
          Application Docs Type ID
          2
          Submission No
          17
          Submission Type
          SUPPL
        8. Appl No
          125554
          Application Docs Date
          2016-10-06 00:00:00
          Application Docs ID
          45501
          Application Docs Title
          0
          Application Docs Type ID
          2
          Submission No
          16
          Submission Type
          SUPPL
        9. Appl No
          125554
          Application Docs Date
          2015-10-01 00:00:00
          Application Docs ID
          45518
          Application Docs Title
          0
          Application Docs Type ID
          2
          Submission No
          2
          Submission Type
          SUPPL
        10. Appl No
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          Submission No
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        11. Appl No
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          Submission No
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        application number
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        1. Appl No
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        Appl No
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        Sponsor Name
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        products
        1. Active Ingredient
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          Reference Standard
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      Source passages and status connections

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                                    Passage 11 · unclassified context
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                                        Passage 12 · unclassified context
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                                          Passage 13 · unclassified context
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                                              Passage 14 · unclassified context
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                                                Passage 15 · unclassified context
                                                application numbers
                                                1. BLA125554
                                                brand names
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                                                      (1.5) Malignant Pleural Mesothelioma
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                                                        • adult patients with unresectable malignant pleural mesothelioma, as first-
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                                                      4. context exact
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                                                        regimen
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                                                          colorectal cancer
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                                                          3760
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                                                          true
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                                                          colorectal cancer (CRC)
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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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                                                            (1.6) Renal Cell Carcinoma (RCC)
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                                                            Passage 19 · unclassified context
                                                            application numbers
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                                                            brand names
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                                                                                Passage 26 · unclassified context
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                                                                                                    Passage 32 · unclassified context
                                                                                                    application numbers
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                                                                                                    brand names
                                                                                                    1. OPDIVO
                                                                                                    classification reasons
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                                                                                                        Passage 33 · risk or warning
                                                                                                        application numbers
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                                                                                                        brand names
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                                                                                                        classification reasons
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                                                                                                                      Passage 38 · unclassified context
                                                                                                                      application numbers
                                                                                                                      1. BLA125554
                                                                                                                      brand names
                                                                                                                      1. OPDIVO
                                                                                                                      classification reasons
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                                                                                                                          Passage 39 · unclassified context
                                                                                                                          application numbers
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                                                                                                                          brand names
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                                                                                                                            Passage 40 · unclassified context
                                                                                                                            application numbers
                                                                                                                            1. BLA125554
                                                                                                                            brand names
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                                                                                                                                tumor histology
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                                                                                                                                Passage 41 · unclassified context
                                                                                                                                application numbers
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                                                                                                                                brand names
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                                                                                                                                4. context exact
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                                                                                                                                5. context exact
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                                                                                                                                6. context exact
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                                                                                                                                  exact text
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                                                                                                                                7. context exact
                                                                                                                                  or mismatch repair deficient (dMMR) colorectal cancer (CRC) in combination with ipilimumab.
                                                                                                                                  kind
                                                                                                                                  regimen
                                                                                                                                  polarity
                                                                                                                                  not_inferred
                                                                                                                                  span
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                                                                                                                                  3791
                                                                                                                                  end exclusive
                                                                                                                                  true
                                                                                                                                  exact text
                                                                                                                                  in combination with ipilimumab
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                                                                                                                                regulatory links
                                                                                                                                  schema version
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                                                                                                                                  source defined aliases
                                                                                                                                  1. abbreviation
                                                                                                                                    NSCLC
                                                                                                                                    definition exact
                                                                                                                                    Non-Small Cell Lung Cancer
                                                                                                                                    definition span
                                                                                                                                    end
                                                                                                                                    483
                                                                                                                                    end exclusive
                                                                                                                                    true
                                                                                                                                    exact text
                                                                                                                                    Non-Small Cell Lung Cancer (NSCLC)
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                                                                                                                                  2. abbreviation
                                                                                                                                    CRC
                                                                                                                                    definition exact
                                                                                                                                    colorectal cancer
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                                                                                                                                    3760
                                                                                                                                    end exclusive
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                                                                                                                                    exact text
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                                                                                                                                  exact text
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                                                                                                                                  spl effective date
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                                                                                                                                  disease stage
                                                                                                                                  Source null
                                                                                                                                  limitations
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                                                                                                                                  line
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                                                                                                                                  regimen
                                                                                                                                  Source null
                                                                                                                                  tumor histology
                                                                                                                                  Source null
                                                                                                                                  use intent
                                                                                                                                  unclear
                                                                                                                                  Passage 42 · unclassified context
                                                                                                                                  application numbers
                                                                                                                                  1. BLA125554
                                                                                                                                  brand names
                                                                                                                                  1. OPDIVO
                                                                                                                                  classification reasons
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                                                                                                                                  clinical review status
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                                                                                                                                  atric (12 years and older) patients with unresectable or metastatic microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) colorectal cancer (CRC) in combination with ipilimumab. (1.11) • adult and pediatric (12 years and older) patients with microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) metastatic colorectal cancer that has progressed following treatme
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                                                                                                                                      source defined aliases
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                                                                                                                                        definition exact
                                                                                                                                        Non-Small Cell Lung Cancer
                                                                                                                                        definition span
                                                                                                                                        end
                                                                                                                                        483
                                                                                                                                        end exclusive
                                                                                                                                        true
                                                                                                                                        exact text
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                                                                                                                                      2. abbreviation
                                                                                                                                        CRC
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                                                                                                                                        colorectal cancer
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                                                                                                                                        3760
                                                                                                                                        end exclusive
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                                                                                                                                        exact text
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                                                                                                                                      end exclusive
                                                                                                                                      true
                                                                                                                                      exact text
                                                                                                                                      (1.11)
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                                                                                                                                      approval pathway
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                                                                                                                                      tumor histology
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                                                                                                                                      Passage 43 · unclassified context
                                                                                                                                      application numbers
                                                                                                                                      1. BLA125554
                                                                                                                                      brand names
                                                                                                                                      1. OPDIVO
                                                                                                                                      classification reasons
                                                                                                                                      1. no_unambiguous_positive_indication_predicate
                                                                                                                                      clinical review status
                                                                                                                                      pending
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                                                                                                                                      12 years and older) patients with unresectable or metastatic microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) colorectal cancer (CRC) in combination with ipilimumab. (1.11) • adult and pediatric (12 years and older) patients with microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) metastatic colorectal cancer that has progressed following treatment with a fluoropyrimidine, oxaliplatin, and irinotecan. ( 1.11 ) Hepatocellular Carcinoma (HCC) • adult patients with unresectable or metastatic hepatocellular carcinoma (HCC), as a first-line treatment in combination with ipilimumab. (1.12) • in combinat
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                                                                                                                                      qualifier mentions
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                                                                                                                                        kind
                                                                                                                                        age
                                                                                                                                        polarity
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                                                                                                                                      4. context exact
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                                                                                                                                        exact text
                                                                                                                                        MSI-H) or mismatch repair deficient (dMMR) me
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                                                                                                                                      5. context exact
                                                                                                                                        nstability-high (MSI-H) or mismatch repair deficient (dMMR) metastatic colorectal cancer that has progressed following treatment with a fluoropyrimidine, oxaliplatin
                                                                                                                                        kind
                                                                                                                                        stage_or_setting
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                                                                                                                                        exact text
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                                                                                                                                      regulatory links
                                                                                                                                        schema version
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                                                                                                                                        source defined aliases
                                                                                                                                        1. abbreviation
                                                                                                                                          NSCLC
                                                                                                                                          definition exact
                                                                                                                                          Non-Small Cell Lung Cancer
                                                                                                                                          definition span
                                                                                                                                          end
                                                                                                                                          483
                                                                                                                                          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
                                                                                                                                          3760
                                                                                                                                          end exclusive
                                                                                                                                          true
                                                                                                                                          exact text
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                                                                                                                                        end exclusive
                                                                                                                                        true
                                                                                                                                        exact text
                                                                                                                                        • adult and pediatric (12 years and older) patients with microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) metastatic colorectal cancer that has progressed following treatment with a fluoropyrimidine, oxaliplatin, and irinotecan.
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                                                                                                                                        source url
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                                                                                                                                        spl effective date
                                                                                                                                        2026-08-12
                                                                                                                                        spl set id
                                                                                                                                        f570b9c4-6846-4de2-abfa-4d0a4ae4e394
                                                                                                                                        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
                                                                                                                                        unclear
                                                                                                                                        Passage 44 · unclassified context
                                                                                                                                        application numbers
                                                                                                                                        1. BLA125554
                                                                                                                                        brand names
                                                                                                                                        1. OPDIVO
                                                                                                                                        classification reasons
                                                                                                                                        1. no_unambiguous_positive_indication_predicate
                                                                                                                                        clinical review status
                                                                                                                                        pending
                                                                                                                                        content role
                                                                                                                                        unclassified_context
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                                                                                                                                        4295
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                                                                                                                                        true
                                                                                                                                        exact text
                                                                                                                                        microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) metastatic colorectal cancer that has progressed following treatment with a fluoropyrimidine, oxaliplatin, and irinotecan. ( 1.11 ) Hepatocellular Carcinoma (HCC) • adult patients with unresectable or metastatic hepatocellular carcinoma (HCC), as a first-line treatment in combination with ipilimumab. (1.12) • in combination with ipilimumab in adult patients wi
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                                                                                                                                        current approval status
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                                                                                                                                        extraction review status
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                                                                                                                                        positive predicate support span
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                                                                                                                                        qualifier mentions
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                                                                                                                                            schema version
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                                                                                                                                            source defined aliases
                                                                                                                                            1. abbreviation
                                                                                                                                              NSCLC
                                                                                                                                              definition exact
                                                                                                                                              Non-Small Cell Lung Cancer
                                                                                                                                              definition span
                                                                                                                                              end
                                                                                                                                              483
                                                                                                                                              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
                                                                                                                                              3760
                                                                                                                                              end exclusive
                                                                                                                                              true
                                                                                                                                              exact text
                                                                                                                                              colorectal cancer (CRC)
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                                                                                                                                            4095
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                                                                                                                                            true
                                                                                                                                            exact text
                                                                                                                                            ( 1.11 ) Hepatocellular Carcinoma (HCC)
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                                                                                                                                            source url
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                                                                                                                                            spl effective date
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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
                                                                                                                                            unclear
                                                                                                                                            Passage 45 · unclassified context
                                                                                                                                            application numbers
                                                                                                                                            1. BLA125554
                                                                                                                                            brand names
                                                                                                                                            1. OPDIVO
                                                                                                                                            classification reasons
                                                                                                                                            1. no_unambiguous_positive_indication_predicate
                                                                                                                                            clinical review status
                                                                                                                                            pending
                                                                                                                                            content role
                                                                                                                                            unclassified_context
                                                                                                                                            context span
                                                                                                                                            end
                                                                                                                                            4434
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                                                                                                                                            true
                                                                                                                                            exact text
                                                                                                                                            or mismatch repair deficient (dMMR) metastatic colorectal cancer that has progressed following treatment with a fluoropyrimidine, oxaliplatin, and irinotecan. ( 1.11 ) Hepatocellular Carcinoma (HCC) • adult patients with unresectable or metastatic hepatocellular carcinoma (HCC), as a first-line treatment in combination with ipilimumab. (1.12) • in combination with ipilimumab in adult patients with unresectable or metastatic HCC who have been previously treated with sorafenib. ( 1.12 ) Esophageal Cancer • adult patients with complet
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                                                                                                                                            current approval status
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                                                                                                                                            extraction review status
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                                                                                                                                            generic names
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                                                                                                                                            label id
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                                                                                                                                            positive predicate support span
                                                                                                                                            Source null
                                                                                                                                            qualifier mentions
                                                                                                                                            1. context exact
                                                                                                                                              • adult patients with unresectable or metastatic hepatocellular carcinoma (H
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                                                                                                                                              polarity
                                                                                                                                              not_inferred
                                                                                                                                              span
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                                                                                                                                              true
                                                                                                                                              exact text
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                                                                                                                                              source field
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                                                                                                                                            2. context exact
                                                                                                                                              • adult patients with unresectable or metastatic hepatocellular carcinoma (HCC), as a first-line treatment in combination with ipilimumab.
                                                                                                                                              kind
                                                                                                                                              biomarker
                                                                                                                                              polarity
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                                                                                                                                              span
                                                                                                                                              end
                                                                                                                                              4175
                                                                                                                                              end exclusive
                                                                                                                                              true
                                                                                                                                              exact text
                                                                                                                                              metastatic hepatocellular carcinoma (HCC)
                                                                                                                                              label id
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                                                                                                                                              source field
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                                                                                                                                              source text sha256
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                                                                                                                                              4134
                                                                                                                                            3. context exact
                                                                                                                                              • adult patients with unresectable or metastatic hepatocellular carcinoma (HCC), as a first-line treatment in combination with ip
                                                                                                                                              kind
                                                                                                                                              stage_or_setting
                                                                                                                                              polarity
                                                                                                                                              not_inferred
                                                                                                                                              span
                                                                                                                                              end
                                                                                                                                              4165
                                                                                                                                              end exclusive
                                                                                                                                              true
                                                                                                                                              exact text
                                                                                                                                              unresectable or metastatic hepatocellular carci
                                                                                                                                              label id
                                                                                                                                              1fce9e6a-6a7c-4fc0-a3a4-a0099f7bd2ce
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                                                                                                                                                              Passage 51 · unclassified context
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                                                                                                                                                              1. BLA125554
                                                                                                                                                              brand names
                                                                                                                                                              1. OPDIVO
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                                                                                                                                                              6. context exact
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                                                                                                                                                                exact text
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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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                                                                                                                                                                exact text
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                                                                                                                                                                approval pathway
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                                                                                                                                                                biomarker and test
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                                                                                                                                                                limitations
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                                                                                                                                                                prior therapy
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                                                                                                                                                                regimen
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                                                                                                                                                                tumor histology
                                                                                                                                                                Source null
                                                                                                                                                                use intent
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                                                                                                                                                                Passage 52 · unclassified context
                                                                                                                                                                application numbers
                                                                                                                                                                1. BLA125554
                                                                                                                                                                brand names
                                                                                                                                                                1. OPDIVO
                                                                                                                                                                classification reasons
                                                                                                                                                                1. no_unambiguous_positive_indication_predicate
                                                                                                                                                                clinical review status
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                                                                                                                                                                exact text
                                                                                                                                                                esectable advanced or metastatic esophageal squamous cell carcinoma as first-line treatment in combination with fluoropyrimidine- and platinum‑containing chemotherapy whose tumors express PD-L1 (≥1). (1.13) • adult patients with unresectable advanced or metastatic esophageal squamous cell carcinoma as first-line treatment in combination with ipilimumab whose tumors express PD-L1 (≥1). (1.13) • adult pat
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                                                                                                                                                                    2. abbreviation
                                                                                                                                                                      CRC
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                                                                                                                                                                    spl effective date
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                                                                                                                                                                    spl set id
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                                                                                                                                                                    approval pathway
                                                                                                                                                                    Source null
                                                                                                                                                                    biomarker and test
                                                                                                                                                                    Source null
                                                                                                                                                                    disease stage
                                                                                                                                                                    Source null
                                                                                                                                                                    limitations
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                                                                                                                                                                    line
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                                                                                                                                                                    prior therapy
                                                                                                                                                                    Source null
                                                                                                                                                                    regimen
                                                                                                                                                                    Source null
                                                                                                                                                                    tumor histology
                                                                                                                                                                    Source null
                                                                                                                                                                    use intent
                                                                                                                                                                    unclear
                                                                                                                                                                    Passage 53 · unclassified context
                                                                                                                                                                    application numbers
                                                                                                                                                                    1. BLA125554
                                                                                                                                                                    brand names
                                                                                                                                                                    1. OPDIVO
                                                                                                                                                                    classification reasons
                                                                                                                                                                    1. no_unambiguous_positive_indication_predicate
                                                                                                                                                                    clinical review status
                                                                                                                                                                    pending
                                                                                                                                                                    content role
                                                                                                                                                                    unclassified_context
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                                                                                                                                                                    exact text
                                                                                                                                                                    le advanced or metastatic esophageal squamous cell carcinoma as first-line treatment in combination with fluoropyrimidine- and platinum‑containing chemotherapy whose tumors express PD-L1 (≥1). (1.13) • adult patients with unresectable advanced or metastatic esophageal squamous cell carcinoma as first-line treatment in combination with ipilimumab whose tumors express PD-L1 (≥1). (1.13) • adult patients with unresectable advanced, recurrent or metastatic esophageal squamous cell carcinoma (ESCC) after prior fluoropyrimidine- and platinum-based chemotherapy. (1.13) Gastric Can
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                                                                                                                                                                    current approval status
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                                                                                                                                                                    extraction review status
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                                                                                                                                                                    generic names
                                                                                                                                                                    1. NIVOLUMAB
                                                                                                                                                                    id
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                                                                                                                                                                    label id
                                                                                                                                                                    1fce9e6a-6a7c-4fc0-a3a4-a0099f7bd2ce
                                                                                                                                                                    positive predicate support span
                                                                                                                                                                    Source null
                                                                                                                                                                    qualifier mentions
                                                                                                                                                                    1. context exact
                                                                                                                                                                      • adult patients with unresectable advanced or metastatic esophageal squamou
                                                                                                                                                                      kind
                                                                                                                                                                      age
                                                                                                                                                                      polarity
                                                                                                                                                                      not_inferred
                                                                                                                                                                      span
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                                                                                                                                                                      4838
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                                                                                                                                                                      true
                                                                                                                                                                      exact text
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                                                                                                                                                                      Passage 54 · unclassified context
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                                                                                                                                                                          application numbers
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                                                                                                                                                                          brand names
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                                                                                                                                                                          2. context exact
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                                                                                                                                                                            exact text
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                                                                                                                                                                          3. context exact
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                                                                                                                                                                            stage_or_setting
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                                                                                                                                                                            5053
                                                                                                                                                                            end exclusive
                                                                                                                                                                            true
                                                                                                                                                                            exact text
                                                                                                                                                                            unresectable advanced
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                                                                                                                                                                          4. context exact
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                                                                                                                                                                            kind
                                                                                                                                                                            stage_or_setting
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                                                                                                                                                                            exact text
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                                                                                                                                                                            2. abbreviation
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                                                                                                                                                                            • adult patients with unresectable advanced, recurrent or metastatic esophageal squamous cell carcinoma (ESCC) after prior fluoropyrimidine- and platinum-based chemotherapy.
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                                                                                                                                                                            prior therapy
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                                                                                                                                                                            Passage 56 · unclassified context
                                                                                                                                                                            application numbers
                                                                                                                                                                            1. BLA125554
                                                                                                                                                                            brand names
                                                                                                                                                                            1. OPDIVO
                                                                                                                                                                            classification reasons
                                                                                                                                                                            1. no_unambiguous_positive_indication_predicate
                                                                                                                                                                            clinical review status
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                                                                                                                                                                            xpress PD-L1 (≥1). (1.13) • adult patients with unresectable advanced, recurrent or metastatic esophageal squamous cell carcinoma (ESCC) after prior fluoropyrimidine- and platinum-based chemotherapy. (1.13) Gastric Cancer, Gastroesophageal Junction Cancer, and Esophageal Adenocarcinoma • adult patients with advanced or metastatic gastric cancer, gastroesophageal junction cancer, and esophageal adenocarcinoma whose tumors express PD-L1 (≥1) in combination with fluoropyrimidine- and
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                                                                                                                                                                            generic names
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                                                                                                                                                                                1. abbreviation
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                                                                                                                                                                                  definition exact
                                                                                                                                                                                  Non-Small Cell Lung Cancer
                                                                                                                                                                                  definition span
                                                                                                                                                                                  end
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                                                                                                                                                                                  exact text
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                                                                                                                                                                                2. abbreviation
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                                                                                                                                                                                  end
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                                                                                                                                                                                (1.13) Gastric Cancer, Gastroesophageal Junction Cancer, and Esophageal Adenocarcinoma
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                                                                                                                                                                                prior therapy
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                                                                                                                                                                                Passage 57 · unclassified context
                                                                                                                                                                                application numbers
                                                                                                                                                                                1. BLA125554
                                                                                                                                                                                brand names
                                                                                                                                                                                1. OPDIVO
                                                                                                                                                                                classification reasons
                                                                                                                                                                                1. no_unambiguous_positive_indication_predicate
                                                                                                                                                                                clinical review status
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                                                                                                                                                                                astatic esophageal squamous cell carcinoma (ESCC) after prior fluoropyrimidine- and platinum-based chemotherapy. (1.13) Gastric Cancer, Gastroesophageal Junction Cancer, and Esophageal Adenocarcinoma • adult patients with advanced or metastatic gastric cancer, gastroesophageal junction cancer, and esophageal adenocarcinoma whose tumors express PD-L1 (≥1) in combination with fluoropyrimidine- and platinum-containing chemotherapy. (1.14) 1.1 Unresectable or Metastatic Melanoma OPDIVO, as a single agent or in combination with ipilimumab, is indicated for the treatment of adult and pediatric patients 12 years and older with unre
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                                                                                                                                                                                generic names
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                                                                                                                                                                                qualifier mentions
                                                                                                                                                                                1. context exact
                                                                                                                                                                                  • adult patients with advanced or metastatic gastric cancer, gastroesophagea
                                                                                                                                                                                  kind
                                                                                                                                                                                  age
                                                                                                                                                                                  polarity
                                                                                                                                                                                  not_inferred
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                                                                                                                                                                                2. context exact
                                                                                                                                                                                  • adult patients with advanced or metastatic gastric cancer, gastroesophageal junction cancer, and esophageal adenocarc
                                                                                                                                                                                  kind
                                                                                                                                                                                  biomarker
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                                                                                                                                                                                  exact text
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                                                                                                                                                                                  5305
                                                                                                                                                                                3. context exact
                                                                                                                                                                                  cancer, and esophageal adenocarcinoma whose tumors express PD-L1 (≥1) in combination with fluoropyrimidine- and platinum-containing chemotherapy.
                                                                                                                                                                                  kind
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                                                                                                                                                                                  polarity
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                                                                                                                                                                                  5462
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                                                                                                                                                                                  exact text
                                                                                                                                                                                  PD-L1 (≥1) in combination with fluoropyrimidi
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                                                                                                                                                                                4. context exact
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                                                                                                                                                                                  stage_or_setting
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                                                                                                                                                                                  true
                                                                                                                                                                                  exact text
                                                                                                                                                                                  advanced or metastatic gastric cancer
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                                                                                                                                                                                5. context exact
                                                                                                                                                                                  d esophageal adenocarcinoma whose tumors express PD-L1 (≥1) in combination with fluoropyrimidine- and platinum-containing chemotherapy.
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                                                                                                                                                                                  regimen
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                                                                                                                                                                                  exact text
                                                                                                                                                                                  in combination with fluoropyrimidine- and platinum-containing chemotherapy
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                                                                                                                                                                                  source defined aliases
                                                                                                                                                                                  1. abbreviation
                                                                                                                                                                                    NSCLC
                                                                                                                                                                                    definition exact
                                                                                                                                                                                    Non-Small Cell Lung Cancer
                                                                                                                                                                                    definition span
                                                                                                                                                                                    end
                                                                                                                                                                                    483
                                                                                                                                                                                    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
                                                                                                                                                                                    3760
                                                                                                                                                                                    end exclusive
                                                                                                                                                                                    true
                                                                                                                                                                                    exact text
                                                                                                                                                                                    colorectal cancer (CRC)
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                                                                                                                                                                                  true
                                                                                                                                                                                  exact text
                                                                                                                                                                                  • adult patients with advanced or metastatic gastric cancer, gastroesophageal junction cancer, and esophageal adenocarcinoma whose tumors express PD-L1 (≥1) in combination with fluoropyrimidine- and platinum-containing chemotherapy.
                                                                                                                                                                                  label id
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                                                                                                                                                                                  spl effective date
                                                                                                                                                                                  2026-08-12
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                                                                                                                                                                                  limitations
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                                                                                                                                                                                  prior therapy
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                                                                                                                                                                                  regimen
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                                                                                                                                                                                  tumor histology
                                                                                                                                                                                  Source null
                                                                                                                                                                                  use intent
                                                                                                                                                                                  unclear
                                                                                                                                                                                  Passage 58 · unclassified context
                                                                                                                                                                                  application numbers
                                                                                                                                                                                  1. BLA125554
                                                                                                                                                                                  brand names
                                                                                                                                                                                  1. OPDIVO
                                                                                                                                                                                  classification reasons
                                                                                                                                                                                  1. no_unambiguous_positive_indication_predicate
                                                                                                                                                                                  clinical review status
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                                                                                                                                                                                  metastatic gastric cancer, gastroesophageal junction cancer, and esophageal adenocarcinoma whose tumors express PD-L1 (≥1) in combination with fluoropyrimidine- and platinum-containing chemotherapy. (1.14) 1.1 Unresectable or Metastatic Melanoma OPDIVO, as a single agent or in combination with ipilimumab, is indicated for the treatment of adult and pediatric patients 12 years and older with unresectabl
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                                                                                                                                                                                  extraction review status
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                                                                                                                                                                                  generic names
                                                                                                                                                                                  1. NIVOLUMAB
                                                                                                                                                                                  id
                                                                                                                                                                                  ind-span-ed453d4eb7b276213908
                                                                                                                                                                                  label id
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                                                                                                                                                                                  qualifier mentions
                                                                                                                                                                                    regulatory links
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                                                                                                                                                                                        definition exact
                                                                                                                                                                                        Non-Small Cell Lung Cancer
                                                                                                                                                                                        definition span
                                                                                                                                                                                        end
                                                                                                                                                                                        483
                                                                                                                                                                                        end exclusive
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                                                                                                                                                                                        exact text
                                                                                                                                                                                        Non-Small Cell Lung Cancer (NSCLC)
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                                                                                                                                                                                        source field
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                                                                                                                                                                                        source text sha256
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                                                                                                                                                                                      2. abbreviation
                                                                                                                                                                                        CRC
                                                                                                                                                                                        definition exact
                                                                                                                                                                                        colorectal cancer
                                                                                                                                                                                        definition span
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                                                                                                                                                                                        3760
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                                                                                                                                                                                        exact text
                                                                                                                                                                                        colorectal cancer (CRC)
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                                                                                                                                                                                      5510
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                                                                                                                                                                                      exact text
                                                                                                                                                                                      (1.14)
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                                                                                                                                                                                      source url
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                                                                                                                                                                                      spl effective date
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                                                                                                                                                                                      spl set id
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                                                                                                                                                                                      spl version
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                                                                                                                                                                                      Source null
                                                                                                                                                                                      biomarker and test
                                                                                                                                                                                      Source null
                                                                                                                                                                                      disease stage
                                                                                                                                                                                      Source null
                                                                                                                                                                                      limitations
                                                                                                                                                                                      Source null
                                                                                                                                                                                      line
                                                                                                                                                                                      Source null
                                                                                                                                                                                      prior therapy
                                                                                                                                                                                      Source null
                                                                                                                                                                                      regimen
                                                                                                                                                                                      Source null
                                                                                                                                                                                      tumor histology
                                                                                                                                                                                      Source null
                                                                                                                                                                                      use intent
                                                                                                                                                                                      unclear
                                                                                                                                                                                      Passage 59 · positive indication candidate
                                                                                                                                                                                      application numbers
                                                                                                                                                                                      1. BLA125554
                                                                                                                                                                                      brand names
                                                                                                                                                                                      1. OPDIVO
                                                                                                                                                                                      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
                                                                                                                                                                                      5935
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                                                                                                                                                                                      true
                                                                                                                                                                                      exact text
                                                                                                                                                                                      atic gastric cancer, gastroesophageal junction cancer, and esophageal adenocarcinoma whose tumors express PD-L1 (≥1) in combination with fluoropyrimidine- and platinum-containing chemotherapy. (1.14) 1.1 Unresectable or Metastatic Melanoma OPDIVO, as a single agent or in combination with ipilimumab, is indicated for the treatment of adult and pediatric patients 12 years and older with unresectable or metastatic melanoma. 1.2 Adjuvant Treatment of Melanoma OPDIVO is indicated for the adjuvant treatment of adult and pediatric patients 12 years and older with completely resected Stage IIB, Stage IIC, Stage III, or Stage
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                                                                                                                                                                                      source text sha256
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                                                                                                                                                                                      current approval status
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                                                                                                                                                                                      duplicate text group
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                                                                                                                                                                                      extraction review status
                                                                                                                                                                                      automated_candidate_pending_source_review
                                                                                                                                                                                      generic names
                                                                                                                                                                                      1. NIVOLUMAB
                                                                                                                                                                                      id
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                                                                                                                                                                                      label id
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                                                                                                                                                                                      true
                                                                                                                                                                                      exact text
                                                                                                                                                                                      is indicated
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                                                                                                                                                                                      qualifier mentions
                                                                                                                                                                                      1. context exact
                                                                                                                                                                                        bination with ipilimumab, is indicated for the treatment of adult and pediatric patients 12 years and older with unresectable
                                                                                                                                                                                        kind
                                                                                                                                                                                        age
                                                                                                                                                                                        polarity
                                                                                                                                                                                        not_inferred
                                                                                                                                                                                        span
                                                                                                                                                                                        end
                                                                                                                                                                                        5651
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                                                                                                                                                                                        true
                                                                                                                                                                                        exact text
                                                                                                                                                                                        adult
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                                                                                                                                                                                        0
                                                                                                                                                                                        source field
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                                                                                                                                                                                        source text sha256
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                                                                                                                                                                                        5646
                                                                                                                                                                                      2. context exact
                                                                                                                                                                                        ith ipilimumab, is indicated for the treatment of adult and pediatric patients 12 years and older with unresectable or metastatic melanoma
                                                                                                                                                                                        kind
                                                                                                                                                                                        age
                                                                                                                                                                                        polarity
                                                                                                                                                                                        not_inferred
                                                                                                                                                                                        span
                                                                                                                                                                                        end
                                                                                                                                                                                        5674
                                                                                                                                                                                        end exclusive
                                                                                                                                                                                        true
                                                                                                                                                                                        exact text
                                                                                                                                                                                        pediatric patients
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                                                                                                                                                                                        source array index
                                                                                                                                                                                        0
                                                                                                                                                                                        source field
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                                                                                                                                                                                        source text sha256
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                                                                                                                                                                                        5656
                                                                                                                                                                                      3. context exact
                                                                                                                                                                                        indicated for the treatment of adult and pediatric patients 12 years and older with unresectable or metastatic melanoma.
                                                                                                                                                                                        kind
                                                                                                                                                                                        age
                                                                                                                                                                                        polarity
                                                                                                                                                                                        not_inferred
                                                                                                                                                                                        span
                                                                                                                                                                                        end
                                                                                                                                                                                        5693
                                                                                                                                                                                        end exclusive
                                                                                                                                                                                        true
                                                                                                                                                                                        exact text
                                                                                                                                                                                        12 years and older
                                                                                                                                                                                        label id
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                                                                                                                                                                                        offset unit
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                                                                                                                                                                                        source array index
                                                                                                                                                                                        0
                                                                                                                                                                                        source field
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                                                                                                                                                                                        source text sha256
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                                                                                                                                                                                        start
                                                                                                                                                                                        5675
                                                                                                                                                                                      4. context exact
                                                                                                                                                                                        1.1 Unresectable or Metastatic Melanoma OPDIVO, as a single agent or in combination with ipilimumab, is in
                                                                                                                                                                                        kind
                                                                                                                                                                                        biomarker
                                                                                                                                                                                        polarity
                                                                                                                                                                                        not_inferred
                                                                                                                                                                                        span
                                                                                                                                                                                        end
                                                                                                                                                                                        5557
                                                                                                                                                                                        end exclusive
                                                                                                                                                                                        true
                                                                                                                                                                                        exact text
                                                                                                                                                                                        Metastatic Melanoma OPDIVO
                                                                                                                                                                                        label id
                                                                                                                                                                                        1fce9e6a-6a7c-4fc0-a3a4-a0099f7bd2ce
                                                                                                                                                                                        offset unit
                                                                                                                                                                                        unicode_code_points
                                                                                                                                                                                        source array index
                                                                                                                                                                                        0
                                                                                                                                                                                        source field
                                                                                                                                                                                        indications_and_usage_exact
                                                                                                                                                                                        source text sha256
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                                                                                                                                                                                        start
                                                                                                                                                                                        5531
                                                                                                                                                                                      5. context exact
                                                                                                                                                                                        pediatric patients 12 years and older with unresectable or metastatic melanoma.
                                                                                                                                                                                        kind
                                                                                                                                                                                        biomarker
                                                                                                                                                                                        polarity
                                                                                                                                                                                        not_inferred
                                                                                                                                                                                        span
                                                                                                                                                                                        end
                                                                                                                                                                                        5734
                                                                                                                                                                                        end exclusive
                                                                                                                                                                                        true
                                                                                                                                                                                        exact text
                                                                                                                                                                                        metastatic melanoma
                                                                                                                                                                                        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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                                                                                                                                                                                        start
                                                                                                                                                                                        5715
                                                                                                                                                                                      6. context exact
                                                                                                                                                                                        1.1 Unresectable or Metastatic Melanoma OPDIVO, as a single agent or in combination with ipilimumab, is in
                                                                                                                                                                                        kind
                                                                                                                                                                                        stage_or_setting
                                                                                                                                                                                        polarity
                                                                                                                                                                                        not_inferred
                                                                                                                                                                                        span
                                                                                                                                                                                        end
                                                                                                                                                                                        5557
                                                                                                                                                                                        end exclusive
                                                                                                                                                                                        true
                                                                                                                                                                                        exact text
                                                                                                                                                                                        Unresectable or Metastatic Melanoma OPDIVO
                                                                                                                                                                                        label id
                                                                                                                                                                                        1fce9e6a-6a7c-4fc0-a3a4-a0099f7bd2ce
                                                                                                                                                                                        offset unit
                                                                                                                                                                                        unicode_code_points
                                                                                                                                                                                        source array index
                                                                                                                                                                                        0
                                                                                                                                                                                        source field
                                                                                                                                                                                        indications_and_usage_exact
                                                                                                                                                                                        source text sha256
                                                                                                                                                                                        26eb0583e63f8a27943a9a4f86da103eb1299c470279d992a424213286c89343
                                                                                                                                                                                        start
                                                                                                                                                                                        5515
                                                                                                                                                                                      7. context exact
                                                                                                                                                                                        ent of adult and pediatric patients 12 years and older with unresectable or metastatic melanoma.
                                                                                                                                                                                        kind
                                                                                                                                                                                        stage_or_setting
                                                                                                                                                                                        polarity
                                                                                                                                                                                        not_inferred
                                                                                                                                                                                        span
                                                                                                                                                                                        end
                                                                                                                                                                                        5734
                                                                                                                                                                                        end exclusive
                                                                                                                                                                                        true
                                                                                                                                                                                        exact text
                                                                                                                                                                                        unresectable or metastatic melanoma
                                                                                                                                                                                        label id
                                                                                                                                                                                        1fce9e6a-6a7c-4fc0-a3a4-a0099f7bd2ce
                                                                                                                                                                                        offset unit
                                                                                                                                                                                        unicode_code_points
                                                                                                                                                                                        source array index
                                                                                                                                                                                        0
                                                                                                                                                                                        source field
                                                                                                                                                                                        indications_and_usage_exact
                                                                                                                                                                                        source text sha256
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                                                                                                                                                                                        start
                                                                                                                                                                                        5699
                                                                                                                                                                                      8. context exact
                                                                                                                                                                                        1.1 Unresectable or Metastatic Melanoma OPDIVO, as a single agent or in combination with ipilimumab, is indicated for the treatment of adult and pediatric patients 12 years and older with unresectable or metastatic melanoma.
                                                                                                                                                                                        kind
                                                                                                                                                                                        regimen
                                                                                                                                                                                        polarity
                                                                                                                                                                                        not_inferred
                                                                                                                                                                                        span
                                                                                                                                                                                        end
                                                                                                                                                                                        5734
                                                                                                                                                                                        end exclusive
                                                                                                                                                                                        true
                                                                                                                                                                                        exact text
                                                                                                                                                                                        as a single agent or in combination with ipilimumab, is indicated for the treatment of adult and pediatric patients 12 years and older with unresectable or metastatic melanoma
                                                                                                                                                                                        label id
                                                                                                                                                                                        1fce9e6a-6a7c-4fc0-a3a4-a0099f7bd2ce
                                                                                                                                                                                        offset unit
                                                                                                                                                                                        unicode_code_points
                                                                                                                                                                                        source array index
                                                                                                                                                                                        0
                                                                                                                                                                                        source field
                                                                                                                                                                                        indications_and_usage_exact
                                                                                                                                                                                        source text sha256
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                                                                                                                                                                                        5559
                                                                                                                                                                                      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
                                                                                                                                                                                          483
                                                                                                                                                                                          end exclusive
                                                                                                                                                                                          true
                                                                                                                                                                                          exact text
                                                                                                                                                                                          Non-Small Cell Lung Cancer (NSCLC)
                                                                                                                                                                                          label id
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                                                                                                                                                                                          source array index
                                                                                                                                                                                          0
                                                                                                                                                                                          source field
                                                                                                                                                                                          indications_and_usage_exact
                                                                                                                                                                                          source text sha256
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                                                                                                                                                                                          start
                                                                                                                                                                                          449
                                                                                                                                                                                        2. abbreviation
                                                                                                                                                                                          CRC
                                                                                                                                                                                          definition exact
                                                                                                                                                                                          colorectal cancer
                                                                                                                                                                                          definition span
                                                                                                                                                                                          end
                                                                                                                                                                                          3760
                                                                                                                                                                                          end exclusive
                                                                                                                                                                                          true
                                                                                                                                                                                          exact text
                                                                                                                                                                                          colorectal cancer (CRC)
                                                                                                                                                                                          label id
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                                                                                                                                                                                          source array index
                                                                                                                                                                                          0
                                                                                                                                                                                          source field
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                                                                                                                                                                                          source text sha256
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                                                                                                                                                                                          3737
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                                                                                                                                                                                        tatic Melanoma OPDIVO, as a single agent or in combination with ipilimumab, is indicated for the treatment of adult and pediatric patients 12 years and older with unresectable or metastatic melanoma. 1.2 Adjuvant Treatment of Melanoma OPDIVO is indicated for the adjuvant treatment of adult and pediatric patients 12 years and older with completely resected Stage IIB, Stage IIC, Stage III, or Stage IV melanoma. 1.3 Neoadjuvant Treatment of Resectable Non-Small Cell Lung Cancer OPDIVO, in combination with platinum-doublet chemotherapy, is indicated as neoadjuvant treatment of adult patients with resectable (
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                                                                                                                                                                                          application numbers
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                                                                                                                                                                                          brand names
                                                                                                                                                                                          1. OPDIVO
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                                                                                                                                                                                          Treatment of Melanoma OPDIVO is indicated for the adjuvant treatment of adult and pediatric patients 12 years and older with completely resected Stage IIB, Stage IIC, Stage III, or Stage IV melanoma. 1.3 Neoadjuvant Treatment of Resectable Non-Small Cell Lung Cancer OPDIVO, in combination with platinum-doublet chemotherapy, is indicated as neoadjuvant treatment of adult patients with resectable (tumors ≥4 cm or node positive) non-small cell lung cancer (NSCLC). 1.4 Neoadjuvant and Adjuvant Treatment of Resectable Non-Small Cell Lung Cancer OPDIVO, in combination with platinum-doublet chemotherapy, is indicated for the neoadjuvant treatment of adult patients
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                                                                                                                                                                                                brand names
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                                                                                                                                                                                                wth factor receptor (EGFR) mutations or anaplastic lymphoma kinase (ALK) rearrangements, followed by single-agent OPDIVO as adjuvant treatment after surgery. 1.5 Metastatic Non-Small Cell Lung Cancer • OPDIVO, in combination with ipilimumab, is indicated for the first-line treatment of adult patients with metastatic NSCLC whose tumors express PD-L1 (≥1%) as determined by an FDA-authorized test [see Dosage and Administration (2.1) ] , with no EGFR or ALK genomic tumor aberrations. • OPDIVO, in combination with ipilimumab and 2 cycles of platinum-doublet chemotherapy, is indicated for the first-line treatment of adult patients with metastatic or recurrent NSCLC, with no EGFR or
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                                                                                                                                                                                                  use intent
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                                                                                                                                                                                                  Passage 65 · positive indication candidate
                                                                                                                                                                                                  application numbers
                                                                                                                                                                                                  1. BLA125554
                                                                                                                                                                                                  brand names
                                                                                                                                                                                                  1. OPDIVO
                                                                                                                                                                                                  classification reasons
                                                                                                                                                                                                  1. explicit_positive_indication_predicate
                                                                                                                                                                                                  2. tumor_or_malignant_hematology_words_in_positive_statement
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                                                                                                                                                                                                  f adult patients with metastatic NSCLC whose tumors express PD-L1 (≥1%) as determined by an FDA-authorized test [see Dosage and Administration (2.1) ] , with no EGFR or ALK genomic tumor aberrations. • OPDIVO, in combination with ipilimumab and 2 cycles of platinum-doublet chemotherapy, is indicated for the first-line treatment of adult patients with metastatic or recurrent NSCLC, with no EGFR or ALK genomic tumor aberrations. • OPDIVO is indicated for the treatment of adult patients with metastatic NSCLC with progression on or after platinum-based chemotherapy. Patients with EGFR or ALK genomic tumor aberrations should ha
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                                                                                                                                                                                                    adult patients with metastatic or recurrent NSCLC, with no EGFR or ALK genomic tumor aberrations.
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                                                                                                                                                                                                  5. context exact
                                                                                                                                                                                                    cles of platinum-doublet chemotherapy, is indicated for the first-line treatment of adult patients with metastatic or recurrent NSCLC, with no EGFR or ALK genomic tumor aberrations.
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                                                                                                                                                                                                    exact text
                                                                                                                                                                                                    first-line treatment of adult patients with metastatic or recurrent NSCLC, with no EGFR or ALK genomic tumor aberrations
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                                                                                                                                                                                                  6. context exact
                                                                                                                                                                                                    • OPDIVO, in combination with ipilimumab and 2 cycles of platinum-doublet chemotherapy, is indicated for the first-line treatment of adult patients with metastatic or recurrent NSCLC, with no EGFR or ALK genomic tumor aberrations.
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                                                                                                                                                                                                    in combination with ipilimumab and 2 cycles of platinum-doublet chemotherapy, is indicated for the first-line treatment of adult patients with metastatic or recurrent NSCLC, with
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                                                                                                                                                                                                    1. abbreviation
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                                                                                                                                                                                                      Non-Small Cell Lung Cancer
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                                                                                                                                                                                                    2. abbreviation
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                                                                                                                                                                                                      colorectal cancer
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                                                                                                                                                                                                    • OPDIVO, in combination with ipilimumab and 2 cycles of platinum-doublet chemotherapy, is indicated for the first-line treatment of adult patients with metastatic or recurrent NSCLC, with no EGFR or ALK genomic tumor aberrations.
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                                                                                                                                                                                                    use intent
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                                                                                                                                                                                                    Passage 66 · positive indication candidate
                                                                                                                                                                                                    application numbers
                                                                                                                                                                                                    1. BLA125554
                                                                                                                                                                                                    brand names
                                                                                                                                                                                                    1. OPDIVO
                                                                                                                                                                                                    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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                                                                                                                                                                                                    exact text
                                                                                                                                                                                                    pilimumab and 2 cycles of platinum-doublet chemotherapy, is indicated for the first-line treatment of adult patients with metastatic or recurrent NSCLC, with no EGFR or ALK genomic tumor aberrations. • OPDIVO is indicated for the treatment of adult patients with metastatic NSCLC with progression on or after platinum-based chemotherapy. Patients with EGFR or ALK genomic tumor aberrations should have disease progression on FDA-approved therapy for these aberrations prior to receiving OPDIVO. 1.6 Malignant Pleural Mesothelioma OPDIVO,
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                                                                                                                                                                                                    generic names
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                                                                                                                                                                                                    id
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                                                                                                                                                                                                    qualifier mentions
                                                                                                                                                                                                    1. context exact
                                                                                                                                                                                                      • OPDIVO is indicated for the treatment of adult patients with metastatic NSCLC with progression on or after platinum
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                                                                                                                                                                                                      age
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                                                                                                                                                                                                    2. context exact
                                                                                                                                                                                                      PDIVO is indicated for the treatment of adult patients with metastatic NSCLC with progression on or after platinum-based chemotherapy.
                                                                                                                                                                                                      kind
                                                                                                                                                                                                      biomarker
                                                                                                                                                                                                      polarity
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                                                                                                                                                                                                      span
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                                                                                                                                                                                                      7317
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                                                                                                                                                                                                      exact text
                                                                                                                                                                                                      metastatic NSCLC with progression on or aft
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                                                                                                                                                                                                    3. context exact
                                                                                                                                                                                                      PDIVO is indicated for the treatment of adult patients with metastatic NSCLC with progression on or after platinum-based chemotherapy.
                                                                                                                                                                                                      kind
                                                                                                                                                                                                      stage_or_setting
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                                                                                                                                                                                                      span
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                                                                                                                                                                                                      7319
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                                                                                                                                                                                                      exact text
                                                                                                                                                                                                      metastatic NSCLC with progression on or after
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                                                                                                                                                                                                      source defined aliases
                                                                                                                                                                                                      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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                                                                                                                                                                                                        colorectal cancer (CRC)
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                                                                                                                                                                                                      • OPDIVO is indicated for the treatment of adult patients with metastatic NSCLC with progression on or after platinum-based chemotherapy.
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                                                                                                                                                                                                      Source null
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                                                                                                                                                                                                      prior therapy
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                                                                                                                                                                                                      Source null
                                                                                                                                                                                                      use intent
                                                                                                                                                                                                      tumor_directed_candidate
                                                                                                                                                                                                      Passage 67 · unclassified context
                                                                                                                                                                                                      application numbers
                                                                                                                                                                                                      1. BLA125554
                                                                                                                                                                                                      brand names
                                                                                                                                                                                                      1. OPDIVO
                                                                                                                                                                                                      classification reasons
                                                                                                                                                                                                      1. no_unambiguous_positive_indication_predicate
                                                                                                                                                                                                      clinical review status
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                                                                                                                                                                                                      content role
                                                                                                                                                                                                      unclassified_context
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                                                                                                                                                                                                      current NSCLC, with no EGFR or ALK genomic tumor aberrations. • OPDIVO is indicated for the treatment of adult patients with metastatic NSCLC with progression on or after platinum-based chemotherapy. Patients with EGFR or ALK genomic tumor aberrations should have disease progression on FDA-approved therapy for these aberrations prior to receiving OPDIVO. 1.6 Malignant Pleural Mesothelioma OPDIVO, in combination with ipilimumab, is indicated for the first-line treatment of adult patients with unresectable malignant pleural mesothelioma. 1.7 Advanced R
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                                                                                                                                                                                                      extraction review status
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                                                                                                                                                                                                      generic names
                                                                                                                                                                                                      1. NIVOLUMAB
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                                                                                                                                                                                                      qualifier mentions
                                                                                                                                                                                                      1. context exact
                                                                                                                                                                                                        Patients with EGFR or ALK genomic tumor aberrations should have disease progression on FDA-approved therapy for these
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                                                                                                                                                                                                        biomarker
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                                                                                                                                                                                                        EGFR or ALK genomic tumor aberrations should
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                                                                                                                                                                                                        source defined aliases
                                                                                                                                                                                                        1. abbreviation
                                                                                                                                                                                                          NSCLC
                                                                                                                                                                                                          definition exact
                                                                                                                                                                                                          Non-Small Cell Lung Cancer
                                                                                                                                                                                                          definition span
                                                                                                                                                                                                          end
                                                                                                                                                                                                          483
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                                                                                                                                                                                                          exact text
                                                                                                                                                                                                          Non-Small Cell Lung Cancer (NSCLC)
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                                                                                                                                                                                                        2. abbreviation
                                                                                                                                                                                                          CRC
                                                                                                                                                                                                          definition exact
                                                                                                                                                                                                          colorectal cancer
                                                                                                                                                                                                          definition span
                                                                                                                                                                                                          end
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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 OPDIVO.
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                                                                                                                                                                                                        Source null
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                                                                                                                                                                                                        Source null
                                                                                                                                                                                                        disease stage
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                                                                                                                                                                                                        Source null
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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. BLA125554
                                                                                                                                                                                                        brand names
                                                                                                                                                                                                        1. OPDIVO
                                                                                                                                                                                                        classification reasons
                                                                                                                                                                                                        1. explicit_positive_indication_predicate
                                                                                                                                                                                                        2. no_tumor_directed_keyword_in_positive_statement
                                                                                                                                                                                                        clinical review status
                                                                                                                                                                                                        pending
                                                                                                                                                                                                        content role
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                                                                                                                                                                                                        context span
                                                                                                                                                                                                        end
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                                                                                                                                                                                                        exact text
                                                                                                                                                                                                        n on or after platinum-based chemotherapy. Patients with EGFR or ALK genomic tumor aberrations should have disease progression on FDA-approved therapy for these aberrations prior to receiving OPDIVO. 1.6 Malignant Pleural Mesothelioma OPDIVO, in combination with ipilimumab, is indicated for the first-line treatment of adult patients with unresectable malignant pleural mesothelioma. 1.7 Advanced Renal Cell Carcinoma • OPDIVO, in combination with ipilimumab, is indicated for the first-line treatment of adult patients with intermediate or poor risk advanced RCC. • OPDIVO, in combi
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                                                                                                                                                                                                        generic names
                                                                                                                                                                                                        1. NIVOLUMAB
                                                                                                                                                                                                        id
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                                                                                                                                                                                                        label id
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                                                                                                                                                                                                        exact text
                                                                                                                                                                                                        is indicated
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                                                                                                                                                                                                        qualifier mentions
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                                                                                                                                                                                                          th ipilimumab, is indicated for the first-line treatment of adult patients with unresectable malignant pleural mesothelioma.
                                                                                                                                                                                                          kind
                                                                                                                                                                                                          age
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                                                                                                                                                                                                          span
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                                                                                                                                                                                                          adult patients
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                                                                                                                                                                                                        2. context exact
                                                                                                                                                                                                          dicated for the first-line treatment of adult patients with unresectable malignant pleural mesothelioma.
                                                                                                                                                                                                          kind
                                                                                                                                                                                                          stage_or_setting
                                                                                                                                                                                                          polarity
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                                                                                                                                                                                                          span
                                                                                                                                                                                                          end
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                                                                                                                                                                                                          true
                                                                                                                                                                                                          exact text
                                                                                                                                                                                                          unresectable malignant pleural mesothelioma
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                                                                                                                                                                                                        3. context exact
                                                                                                                                                                                                          PDIVO, in combination with ipilimumab, is indicated for the first-line treatment of adult patients with unresectable malignant pleural mesothelioma.
                                                                                                                                                                                                          kind
                                                                                                                                                                                                          prior_therapy_or_line
                                                                                                                                                                                                          polarity
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                                                                                                                                                                                                          span
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                                                                                                                                                                                                          true
                                                                                                                                                                                                          exact text
                                                                                                                                                                                                          first-line treatment of adult patients with unresectable malignant pleural mesothelioma
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                                                                                                                                                                                                        4. context exact
                                                                                                                                                                                                          1.6 Malignant Pleural Mesothelioma OPDIVO, in combination with ipilimumab, is indicated for the first-line treatment of adult patients with unresectable malignant pleural mesothelioma.
                                                                                                                                                                                                          kind
                                                                                                                                                                                                          regimen
                                                                                                                                                                                                          polarity
                                                                                                                                                                                                          not_inferred
                                                                                                                                                                                                          span
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                                                                                                                                                                                                          exact text
                                                                                                                                                                                                          in combination with ipilimumab, is indicated for the first-line treatment of adult patients with unresectable malignant pleural mesothelioma
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                                                                                                                                                                                                          source defined aliases
                                                                                                                                                                                                          1. abbreviation
                                                                                                                                                                                                            NSCLC
                                                                                                                                                                                                            definition exact
                                                                                                                                                                                                            Non-Small Cell Lung Cancer
                                                                                                                                                                                                            definition span
                                                                                                                                                                                                            end
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                                                                                                                                                                                                          1.6 Malignant Pleural Mesothelioma OPDIVO, in combination with ipilimumab, is indicated for the first-line treatment of adult patients with unresectable malignant pleural mesothelioma.
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                                                                                                                                                                                                          brand names
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                                                                                                                                                                                                            application numbers
                                                                                                                                                                                                            1. BLA125554
                                                                                                                                                                                                            brand names
                                                                                                                                                                                                            1. OPDIVO
                                                                                                                                                                                                            classification reasons
                                                                                                                                                                                                            1. explicit_positive_indication_predicate
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                                                                                                                                                                                                            al Mesothelioma OPDIVO, in combination with ipilimumab, is indicated for the first-line treatment of adult patients with unresectable malignant pleural mesothelioma. 1.7 Advanced Renal Cell Carcinoma • OPDIVO, in combination with ipilimumab, is indicated for the first-line treatment of adult patients with intermediate or poor risk advanced RCC. • OPDIVO, in combination with cabozantinib, is indicated for the first-line treatment of adult patients with advanced RCC. • OPDIVO, as a single agent, is indicated for the treatment of adult patient
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                                                                                                                                                                                                              PDIVO, in combination with ipilimumab, is indicated for the first-line treatment of adult patients with intermediate or poor risk advanced RCC.
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                                                                                                                                                                                                            4. context exact
                                                                                                                                                                                                              • OPDIVO, in combination with ipilimumab, is indicated for the first-line treatment of adult patients with intermediate or poor risk advanced RCC.
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                                                                                                                                                                                                              in combination with ipilimumab, is indicated for the first-line treatment of adult patients with intermediate or poor risk advanced RCC
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                                                                                                                                                                                                              2. abbreviation
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                                                                                                                                                                                                              • OPDIVO, in combination with ipilimumab, is indicated for the first-line treatment of adult patients with intermediate or poor risk advanced RCC.
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                                                                                                                                                                                                              application numbers
                                                                                                                                                                                                              1. BLA125554
                                                                                                                                                                                                              brand names
                                                                                                                                                                                                              1. OPDIVO
                                                                                                                                                                                                              classification reasons
                                                                                                                                                                                                              1. explicit_positive_indication_predicate
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                                                                                                                                                                                                              ural mesothelioma. 1.7 Advanced Renal Cell Carcinoma • OPDIVO, in combination with ipilimumab, is indicated for the first-line treatment of adult patients with intermediate or poor risk advanced RCC. • OPDIVO, in combination with cabozantinib, is indicated for the first-line treatment of adult patients with advanced RCC. • OPDIVO, as a single agent, is indicated for the treatment of adult patients with advanced renal cell carcinoma (RCC) who have received prior anti-angiogenic therapy. 1.8 Classical Hodgkin Lymphoma
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                                                                                                                                                                                                                cabozantinib, is indicated for the first-line treatment of adult patients with advanced RCC.
                                                                                                                                                                                                                kind
                                                                                                                                                                                                                age
                                                                                                                                                                                                                polarity
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                                                                                                                                                                                                                kind
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                                                                                                                                                                                                                span
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                                                                                                                                                                                                                advanced RCC
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                                                                                                                                                                                                              3. context exact
                                                                                                                                                                                                                IVO, in combination with cabozantinib, is indicated for the first-line treatment of adult patients with advanced RCC.
                                                                                                                                                                                                                kind
                                                                                                                                                                                                                prior_therapy_or_line
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                                                                                                                                                                                                                first-line treatment of adult patients with advanced RCC
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                                                                                                                                                                                                                • OPDIVO, in combination with cabozantinib, is indicated for the first-line treatment of adult patients with advanced RCC.
                                                                                                                                                                                                                kind
                                                                                                                                                                                                                regimen
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                                                                                                                                                                                                                exact text
                                                                                                                                                                                                                in combination with cabozantinib, is indicated for the first-line treatment of adult patients with advanced RCC
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                                                                                                                                                                                                                1. abbreviation
                                                                                                                                                                                                                  NSCLC
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                                                                                                                                                                                                                  Non-Small Cell Lung Cancer
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                                                                                                                                                                                                                • OPDIVO, in combination with cabozantinib, is indicated for the first-line treatment of adult patients with advanced RCC.
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                                                                                                                                                                                                                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
                                                                                                                                                                                                                non_oncology_or_unclear_candidate
                                                                                                                                                                                                                Passage 72 · positive indication candidate
                                                                                                                                                                                                                application numbers
                                                                                                                                                                                                                1. BLA125554
                                                                                                                                                                                                                brand names
                                                                                                                                                                                                                1. OPDIVO
                                                                                                                                                                                                                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
                                                                                                                                                                                                                8362
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                                                                                                                                                                                                                exact text
                                                                                                                                                                                                                ine treatment of adult patients with intermediate or poor risk advanced RCC. • OPDIVO, in combination with cabozantinib, is indicated for the first-line treatment of adult patients with advanced RCC. • OPDIVO, as a single agent, is indicated for the treatment of adult patients with advanced renal cell carcinoma (RCC) who have received prior anti-angiogenic therapy. 1.8 Classical Hodgkin Lymphoma • OPDIVO, in combination with doxorubicin, vinblastine, and dacarbazine (AVD), is indicated for the treatment of adult and pediatric patients 12 years and older with pr
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                                                                                                                                                                                                                generic names
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                                                                                                                                                                                                                id
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                                                                                                                                                                                                                exact text
                                                                                                                                                                                                                is indicated
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                                                                                                                                                                                                                qualifier mentions
                                                                                                                                                                                                                1. context exact
                                                                                                                                                                                                                  PDIVO, as a single agent, is indicated for the treatment of adult patients with advanced renal cell carcinoma (RCC) who have received
                                                                                                                                                                                                                  kind
                                                                                                                                                                                                                  age
                                                                                                                                                                                                                  polarity
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                                                                                                                                                                                                                  exact text
                                                                                                                                                                                                                  adult patients
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                                                                                                                                                                                                                  8058
                                                                                                                                                                                                                2. context exact
                                                                                                                                                                                                                  gent, is indicated for the treatment of adult patients with advanced renal cell carcinoma (RCC) who have received prior anti-angiogenic therapy.
                                                                                                                                                                                                                  kind
                                                                                                                                                                                                                  stage_or_setting
                                                                                                                                                                                                                  polarity
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                                                                                                                                                                                                                  span
                                                                                                                                                                                                                  end
                                                                                                                                                                                                                  8121
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                                                                                                                                                                                                                  true
                                                                                                                                                                                                                  exact text
                                                                                                                                                                                                                  advanced renal cell carcinoma (RCC) who hav
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                                                                                                                                                                                                                  8078
                                                                                                                                                                                                                3. context exact
                                                                                                                                                                                                                  of adult patients with advanced renal cell carcinoma (RCC) who have received prior anti-angiogenic therapy.
                                                                                                                                                                                                                  kind
                                                                                                                                                                                                                  prior_therapy_or_line
                                                                                                                                                                                                                  polarity
                                                                                                                                                                                                                  not_inferred
                                                                                                                                                                                                                  span
                                                                                                                                                                                                                  end
                                                                                                                                                                                                                  8161
                                                                                                                                                                                                                  end exclusive
                                                                                                                                                                                                                  true
                                                                                                                                                                                                                  exact text
                                                                                                                                                                                                                  who have received prior anti-angiogenic therapy
                                                                                                                                                                                                                  label id
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                                                                                                                                                                                                                  8114
                                                                                                                                                                                                                4. context exact
                                                                                                                                                                                                                  • OPDIVO, as a single agent, is indicated for the treatment of adult patients with advanced renal cell carcinoma (RCC) who have received prior anti-angiogenic therapy.
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                                                                                                                                                                                                                  exact text
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                                                                                                                                                                                                                  • OPDIVO, as a single agent, is indicated for the treatment of adult patients with advanced renal cell carcinoma (RCC) who have received prior anti-angiogenic therapy.
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                                                                                                                                                                                                                  application numbers
                                                                                                                                                                                                                  1. BLA125554
                                                                                                                                                                                                                  brand names
                                                                                                                                                                                                                  1. OPDIVO
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                                                                                                                                                                                                                  1. no_unambiguous_positive_indication_predicate
                                                                                                                                                                                                                  clinical review status
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                                                                                                                                                                                                                        definition span
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                                                                                                                                                                                                                      2. abbreviation
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                                                                                                                                                                                                                      Passage 74 · positive indication candidate
                                                                                                                                                                                                                      application numbers
                                                                                                                                                                                                                      1. BLA125554
                                                                                                                                                                                                                      brand names
                                                                                                                                                                                                                      1. OPDIVO
                                                                                                                                                                                                                      classification reasons
                                                                                                                                                                                                                      1. explicit_positive_indication_predicate
                                                                                                                                                                                                                      2. tumor_or_malignant_hematology_words_in_positive_statement
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                                                                                                                                                                                                                      exact text
                                                                                                                                                                                                                      • OPDIVO, as a single agent, is indicated for the treatment of adult patients with advanced renal cell carcinoma (RCC) who have received prior anti-angiogenic therapy. 1.8 Classical Hodgkin Lymphoma • OPDIVO, in combination with doxorubicin, vinblastine, and dacarbazine (AVD), is indicated for the treatment of adult and pediatric patients 12 years and older with previously untreated, Stage III or IV classical Hodgkin lymphoma (cHL). • OPDIVO, as a single agent, is indicated for the treatment of adult patients with classical Hodgkin lymphoma (cHL) that has relapsed or progressed after: • autologous hematopoietic stem cell transpl
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                                                                                                                                                                                                                        e, and dacarbazine (AVD), is indicated for the treatment of adult and pediatric patients 12 years and older with previously u
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                                                                                                                                                                                                                      2. context exact
                                                                                                                                                                                                                        arbazine (AVD), is indicated for the treatment of adult and pediatric patients 12 years and older with previously untreated, Stage III or
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                                                                                                                                                                                                                      3. context exact
                                                                                                                                                                                                                        indicated for the treatment of adult and pediatric patients 12 years and older with previously untreated, Stage III or IV classical Hodgki
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                                                                                                                                                                                                                      4. context exact
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                                                                                                                                                                                                                        prior_therapy_or_line
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                                                                                                                                                                                                                        exact text
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                                                                                                                                                                                                                      5. context exact
                                                                                                                                                                                                                        • OPDIVO, in combination with doxorubicin, vinblastine, and dacarbazine (AVD), is indicated for the treatment of adult and pediatric patients 12 years and older with previously untreated, Stage III or IV classical Hodgkin lymphoma (cHL).
                                                                                                                                                                                                                        kind
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                                                                                                                                                                                                                        exact text
                                                                                                                                                                                                                        in combination with doxorubicin, vinblastine, and dacarbazine (AVD), is indicated for the treatment of adult and pediatric patients 12 years and older with previously untreated, S
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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
                                                                                                                                                                                                                          CRC
                                                                                                                                                                                                                          definition exact
                                                                                                                                                                                                                          colorectal cancer
                                                                                                                                                                                                                          definition span
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                                                                                                                                                                                                                        • OPDIVO, in combination with doxorubicin, vinblastine, and dacarbazine (AVD), is indicated for the treatment of adult and pediatric patients 12 years and older with previously untreated, Stage III or IV classical Hodgkin lymphoma (cHL).
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                                                                                                                                                                                                                        source url
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                                                                                                                                                                                                                        spl effective date
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                                                                                                                                                                                                                        Source null
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                                                                                                                                                                                                                        Source null
                                                                                                                                                                                                                        disease stage
                                                                                                                                                                                                                        Source null
                                                                                                                                                                                                                        limitations
                                                                                                                                                                                                                        Source null
                                                                                                                                                                                                                        line
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                                                                                                                                                                                                                        regimen
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                                                                                                                                                                                                                        tumor histology
                                                                                                                                                                                                                        Source null
                                                                                                                                                                                                                        use intent
                                                                                                                                                                                                                        tumor_directed_candidate
                                                                                                                                                                                                                        Passage 75 · positive indication candidate
                                                                                                                                                                                                                        application numbers
                                                                                                                                                                                                                        1. BLA125554
                                                                                                                                                                                                                        brand names
                                                                                                                                                                                                                        1. OPDIVO
                                                                                                                                                                                                                        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
                                                                                                                                                                                                                        8786
                                                                                                                                                                                                                        end exclusive
                                                                                                                                                                                                                        true
                                                                                                                                                                                                                        exact text
                                                                                                                                                                                                                        cin, vinblastine, and dacarbazine (AVD), is indicated for the treatment of adult and pediatric patients 12 years and older with previously untreated, Stage III or IV classical Hodgkin lymphoma (cHL). • OPDIVO, as a single agent, is indicated for the treatment of adult patients with classical Hodgkin lymphoma (cHL) that has relapsed or progressed after: • autologous hematopoietic stem cell transplantation (HSCT) and brentuximab vedotin, or • 3 or more lines of systemic therapy that includes autologous HSCT. 1.9 Squamous Cell Carcinoma of the Head an
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                                                                                                                                                                                                                        extraction review status
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                                                                                                                                                                                                                        generic names
                                                                                                                                                                                                                        1. NIVOLUMAB
                                                                                                                                                                                                                        id
                                                                                                                                                                                                                        ind-span-b2fab8f571eb5166f6e1
                                                                                                                                                                                                                        label id
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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
                                                                                                                                                                                                                          PDIVO, as a single agent, is indicated for the treatment of adult patients with classical Hodgkin lymphoma (cHL) that has relapsed or
                                                                                                                                                                                                                          kind
                                                                                                                                                                                                                          age
                                                                                                                                                                                                                          polarity
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                                                                                                                                                                                                                          true
                                                                                                                                                                                                                          exact text
                                                                                                                                                                                                                          adult patients
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                                                                                                                                                                                                                        2. context exact
                                                                                                                                                                                                                          ult patients with classical Hodgkin lymphoma (cHL) that has relapsed or progressed after:
                                                                                                                                                                                                                          kind
                                                                                                                                                                                                                          stage_or_setting
                                                                                                                                                                                                                          polarity
                                                                                                                                                                                                                          not_inferred
                                                                                                                                                                                                                          span
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                                                                                                                                                                                                                          true
                                                                                                                                                                                                                          exact text
                                                                                                                                                                                                                          relapsed or progressed after:
                                                                                                                                                                                                                          label id
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                                                                                                                                                                                                                        3. context exact
                                                                                                                                                                                                                          • OPDIVO, as a single agent, is indicated for the treatment of adult patients with classical Hodgkin lymphoma (cHL) that has relapsed or progressed after:
                                                                                                                                                                                                                          kind
                                                                                                                                                                                                                          regimen
                                                                                                                                                                                                                          polarity
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                                                                                                                                                                                                                          span
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                                                                                                                                                                                                                          8586
                                                                                                                                                                                                                          end exclusive
                                                                                                                                                                                                                          true
                                                                                                                                                                                                                          exact text
                                                                                                                                                                                                                          as a single agent, is indicated for the treatment of adult patients with classical Hodgkin lymphoma (cHL) that has relapsed or progressed after:
                                                                                                                                                                                                                          label id
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                                                                                                                                                                                                                          source defined aliases
                                                                                                                                                                                                                          1. abbreviation
                                                                                                                                                                                                                            NSCLC
                                                                                                                                                                                                                            definition exact
                                                                                                                                                                                                                            Non-Small Cell Lung Cancer
                                                                                                                                                                                                                            definition span
                                                                                                                                                                                                                            end
                                                                                                                                                                                                                            483
                                                                                                                                                                                                                            end exclusive
                                                                                                                                                                                                                            true
                                                                                                                                                                                                                            exact text
                                                                                                                                                                                                                            Non-Small Cell Lung Cancer (NSCLC)
                                                                                                                                                                                                                            label id
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                                                                                                                                                                                                                          2. abbreviation
                                                                                                                                                                                                                            CRC
                                                                                                                                                                                                                            definition exact
                                                                                                                                                                                                                            colorectal cancer
                                                                                                                                                                                                                            definition span
                                                                                                                                                                                                                            end
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                                                                                                                                                                                                                            true
                                                                                                                                                                                                                            exact text
                                                                                                                                                                                                                            colorectal cancer (CRC)
                                                                                                                                                                                                                            label id
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                                                                                                                                                                                                                            unicode_code_points
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                                                                                                                                                                                                                          end exclusive
                                                                                                                                                                                                                          true
                                                                                                                                                                                                                          exact text
                                                                                                                                                                                                                          • OPDIVO, as a single agent, is indicated for the treatment of adult patients with classical Hodgkin lymphoma (cHL) that has relapsed or progressed after:
                                                                                                                                                                                                                          label id
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                                                                                                                                                                                                                          source url
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                                                                                                                                                                                                                          spl effective date
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                                                                                                                                                                                                                          spl set id
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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 76 · unclassified context
                                                                                                                                                                                                                          application numbers
                                                                                                                                                                                                                          1. BLA125554
                                                                                                                                                                                                                          brand names
                                                                                                                                                                                                                          1. OPDIVO
                                                                                                                                                                                                                          classification reasons
                                                                                                                                                                                                                          1. no_unambiguous_positive_indication_predicate
                                                                                                                                                                                                                          clinical review status
                                                                                                                                                                                                                          pending
                                                                                                                                                                                                                          content role
                                                                                                                                                                                                                          unclassified_context
                                                                                                                                                                                                                          context span
                                                                                                                                                                                                                          end
                                                                                                                                                                                                                          8874
                                                                                                                                                                                                                          end exclusive
                                                                                                                                                                                                                          true
                                                                                                                                                                                                                          exact text
                                                                                                                                                                                                                          III or IV classical Hodgkin lymphoma (cHL). • OPDIVO, as a single agent, is indicated for the treatment of adult patients with classical Hodgkin lymphoma (cHL) that has relapsed or progressed after: • autologous hematopoietic stem cell transplantation (HSCT) and brentuximab vedotin, or • 3 or more lines of systemic therapy that includes autologous HSCT. 1.9 Squamous Cell Carcinoma of the Head and Neck OPDIVO is indicated for the treatment of adult patients with recurrent or metasta
                                                                                                                                                                                                                          label id
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                                                                                                                                                                                                                          current approval status
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                                                                                                                                                                                                                          extraction review status
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                                                                                                                                                                                                                          generic names
                                                                                                                                                                                                                          1. NIVOLUMAB
                                                                                                                                                                                                                          id
                                                                                                                                                                                                                          ind-span-27b5b182b33614d782e2
                                                                                                                                                                                                                          label id
                                                                                                                                                                                                                          1fce9e6a-6a7c-4fc0-a3a4-a0099f7bd2ce
                                                                                                                                                                                                                          positive predicate support span
                                                                                                                                                                                                                          Source null
                                                                                                                                                                                                                          qualifier mentions
                                                                                                                                                                                                                            regulatory links
                                                                                                                                                                                                                              schema version
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                                                                                                                                                                                                                              fc39a8c5cf96bf95ca20b85578140167b66b2741f7d9217f500d9ba0847ac058
                                                                                                                                                                                                                              source defined aliases
                                                                                                                                                                                                                              1. abbreviation
                                                                                                                                                                                                                                NSCLC
                                                                                                                                                                                                                                definition exact
                                                                                                                                                                                                                                Non-Small Cell Lung Cancer
                                                                                                                                                                                                                                definition span
                                                                                                                                                                                                                                end
                                                                                                                                                                                                                                483
                                                                                                                                                                                                                                end exclusive
                                                                                                                                                                                                                                true
                                                                                                                                                                                                                                exact text
                                                                                                                                                                                                                                Non-Small Cell Lung Cancer (NSCLC)
                                                                                                                                                                                                                                label id
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                                                                                                                                                                                                                                unicode_code_points
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                                                                                                                                                                                                                                0
                                                                                                                                                                                                                                source field
                                                                                                                                                                                                                                indications_and_usage_exact
                                                                                                                                                                                                                                source text sha256
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                                                                                                                                                                                                                              2. abbreviation
                                                                                                                                                                                                                                CRC
                                                                                                                                                                                                                                definition exact
                                                                                                                                                                                                                                colorectal cancer
                                                                                                                                                                                                                                definition span
                                                                                                                                                                                                                                end
                                                                                                                                                                                                                                3760
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                                                                                                                                                                                                                                true
                                                                                                                                                                                                                                exact text
                                                                                                                                                                                                                                colorectal cancer (CRC)
                                                                                                                                                                                                                                label id
                                                                                                                                                                                                                                1fce9e6a-6a7c-4fc0-a3a4-a0099f7bd2ce
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                                                                                                                                                                                                                                source field
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                                                                                                                                                                                                                                source text sha256
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                                                                                                                                                                                                                              source span
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                                                                                                                                                                                                                              end exclusive
                                                                                                                                                                                                                              true
                                                                                                                                                                                                                              exact text
                                                                                                                                                                                                                              • autologous hematopoietic stem cell transplantation (HSCT) and brentuximab vedotin, or
                                                                                                                                                                                                                              label id
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                                                                                                                                                                                                                              application numbers
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                                                                                                                                                                                                                              brand names
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                                                                                                                                                                                                                                  • 3 or more lines of systemic therapy that includes autologous HSCT.
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                                                                                                                                                                                                                                  application numbers
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                                                                                                                                                                                                                                  brand names
                                                                                                                                                                                                                                  1. OPDIVO
                                                                                                                                                                                                                                  classification reasons
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                                                                                                                                                                                                                                  HL) that has relapsed or progressed after: • autologous hematopoietic stem cell transplantation (HSCT) and brentuximab vedotin, or • 3 or more lines of systemic therapy that includes autologous HSCT. 1.9 Squamous Cell Carcinoma of the Head and Neck OPDIVO is indicated for the treatment of adult patients with recurrent or metastatic squamous cell carcinoma of the head and neck (SCCHN) with disease progression on or after platinum-based therapy. 1.10 Urothelial Carcinoma OPDIVO is indicated for the adjuvant treatment of adult patients with urothelial carcinoma (UC) who are at high risk of recurrence after undergoing radical resection of UC [
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                                                                                                                                                                                                                                    1. abbreviation
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                                                                                                                                                                                                                                      definition exact
                                                                                                                                                                                                                                      Non-Small Cell Lung Cancer
                                                                                                                                                                                                                                      definition span
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                                                                                                                                                                                                                                      exact text
                                                                                                                                                                                                                                      Non-Small Cell Lung Cancer (NSCLC)
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                                                                                                                                                                                                                                    2. abbreviation
                                                                                                                                                                                                                                      CRC
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                                                                                                                                                                                                                                      definition span
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                                                                                                                                                                                                                                      exact text
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                                                                                                                                                                                                                                    1.9 Squamous Cell Carcinoma of the Head and Neck OPDIVO is indicated for the treatment of adult patients with recurrent or metastatic squamous cell carcinoma of the head and neck (SCCHN) with disease progression on or after platinum-based therapy.
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                                                                                                                                                                                                                                    spl effective date
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                                                                                                                                                                                                                                    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
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                                                                                                                                                                                                                                    Passage 79 · positive indication candidate
                                                                                                                                                                                                                                    application numbers
                                                                                                                                                                                                                                    1. BLA125554
                                                                                                                                                                                                                                    brand names
                                                                                                                                                                                                                                    1. OPDIVO
                                                                                                                                                                                                                                    classification reasons
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                                                                                                                                                                                                                                    OPDIVO is indicated for the treatment of adult patients with recurrent or metastatic squamous cell carcinoma of the head and neck (SCCHN) with disease progression on or after platinum-based therapy. 1.10 Urothelial Carcinoma OPDIVO is indicated for the adjuvant treatment of adult patients with urothelial carcinoma (UC) who are at high risk of recurrence after undergoing radical resection of UC [see Clinical Studies (14.10) ] . OPDIVO, in combination with cisplatin and gemcitabine, is indicated for the first-line treatment of adult patients with unresectable or metastatic urothelial carcinoma. OPDIVO is indicated for the tr
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                                                                                                                                                                                                                                      1.10 Urothelial Carcinoma OPDIVO is indicated for the adjuvant treatment of adult patients with urothelial carcinoma (UC) who are at high risk of recurrence after undergoing radical resection of UC [see Clinical Studies (14.10) ] .
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                                                                                                                                                                                                                                      application numbers
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                                                                                                                                                                                                                                      brand names
                                                                                                                                                                                                                                      1. OPDIVO
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                                                                                                                                                                                                                                      is indicated for the adjuvant treatment of adult patients with urothelial carcinoma (UC) who are at high risk of recurrence after undergoing radical resection of UC [see Clinical Studies (14.10) ] . OPDIVO, in combination with cisplatin and gemcitabine, is indicated for the first-line treatment of adult patients with unresectable or metastatic urothelial carcinoma. OPDIVO is indicated for the treatment of adult patients with locally advanced or metastatic urothelial carcinoma who: • have disease progression during or following platinum-containing chemotherapy.
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                                                                                                                                                                                                                                        d gemcitabine, is indicated for the first-line treatment of adult patients with unresectable or metastatic urothelial carcinoma.
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                                                                                                                                                                                                                                        first-line treatment of adult patients with unresectable or metastatic urothelial carcinoma.
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                                                                                                                                                                                                                                        first-line treatment of adult patients with unresectable or metastatic urothelial carcinoma
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                                                                                                                                                                                                                                        in combination with cisplatin and gemcitabine, is indicated for the first-line treatment of adult patients with unresectable or metastatic urothelial carcinoma
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                                                                                                                                                                                                                                          end
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                                                                                                                                                                                                                                          colorectal cancer
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                                                                                                                                                                                                                                              Passage 83 · unclassified context
                                                                                                                                                                                                                                              application numbers
                                                                                                                                                                                                                                              1. BLA125554
                                                                                                                                                                                                                                              brand names
                                                                                                                                                                                                                                              1. OPDIVO
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                                                                                                                                                                                                                                              clinical review status
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                                                                                                                                                                                                                                              OPDIVO is indicated for the treatment of adult patients with locally advanced or metastatic urothelial carcinoma who: • have disease progression during or following platinum-containing chemotherapy. • have disease progression within 12 months of neoadjuvant or adjuvant treatment with platinum-containing chemotherapy. 1.11 Microsatellite Instability-High or Mismatch Repair Deficient Metastatic Colorectal Cancer • OPDIVO, in combination with ipilimumab, is indicated for the treatment of adult and pediatric patients
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                                                                                                                                                                                                                                                source defined aliases
                                                                                                                                                                                                                                                1. abbreviation
                                                                                                                                                                                                                                                  NSCLC
                                                                                                                                                                                                                                                  definition exact
                                                                                                                                                                                                                                                  Non-Small Cell Lung Cancer
                                                                                                                                                                                                                                                  definition span
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                                                                                                                                                                                                                                                  483
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                                                                                                                                                                                                                                                use intent
                                                                                                                                                                                                                                                unclear
                                                                                                                                                                                                                                                Passage 84 · unclassified context
                                                                                                                                                                                                                                                application numbers
                                                                                                                                                                                                                                                1. BLA125554
                                                                                                                                                                                                                                                brand names
                                                                                                                                                                                                                                                1. OPDIVO
                                                                                                                                                                                                                                                classification reasons
                                                                                                                                                                                                                                                1. no_unambiguous_positive_indication_predicate
                                                                                                                                                                                                                                                clinical review status
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                                                                                                                                                                                                                                                  source defined aliases
                                                                                                                                                                                                                                                  1. abbreviation
                                                                                                                                                                                                                                                    NSCLC
                                                                                                                                                                                                                                                    definition exact
                                                                                                                                                                                                                                                    Non-Small Cell Lung Cancer
                                                                                                                                                                                                                                                    definition span
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                                                                                                                                                                                                                                                    483
                                                                                                                                                                                                                                                    end exclusive
                                                                                                                                                                                                                                                    true
                                                                                                                                                                                                                                                    exact text
                                                                                                                                                                                                                                                    Non-Small Cell Lung Cancer (NSCLC)
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                                                                                                                                                                                                                                                  2. abbreviation
                                                                                                                                                                                                                                                    CRC
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                                                                                                                                                                                                                                                    colorectal cancer
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                                                                                                                                                                                                                                                  exact text
                                                                                                                                                                                                                                                  1.11 Microsatellite Instability-High or Mismatch Repair Deficient Metastatic Colorectal Cancer
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                                                                                                                                                                                                                                                  use intent
                                                                                                                                                                                                                                                  unclear
                                                                                                                                                                                                                                                  Passage 85 · positive indication candidate
                                                                                                                                                                                                                                                  application numbers
                                                                                                                                                                                                                                                  1. BLA125554
                                                                                                                                                                                                                                                  brand names
                                                                                                                                                                                                                                                  1. OPDIVO
                                                                                                                                                                                                                                                  classification reasons
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                                                                                                                                                                                                                                                  2. tumor_or_malignant_hematology_words_in_positive_statement
                                                                                                                                                                                                                                                  clinical review status
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                                                                                                                                                                                                                                                  10264
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                                                                                                                                                                                                                                                  exact text
                                                                                                                                                                                                                                                  progression within 12 months of neoadjuvant or adjuvant treatment with platinum-containing chemotherapy. 1.11 Microsatellite Instability-High or Mismatch Repair Deficient Metastatic Colorectal Cancer • OPDIVO, in combination with ipilimumab, 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) colorectal cancer (CRC) . • OPDIVO, as a single agent, is indicated for the treatment of adult and pediatric patients 12 years and older with microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) metasta
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                                                                                                                                                                                                                                                  generic names
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                                                                                                                                                                                                                                                  id
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                                                                                                                                                                                                                                                  label id
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                                                                                                                                                                                                                                                  offset unit
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                                                                                                                                                                                                                                                  source field
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                                                                                                                                                                                                                                                  start
                                                                                                                                                                                                                                                  9849
                                                                                                                                                                                                                                                  qualifier mentions
                                                                                                                                                                                                                                                  1. context exact
                                                                                                                                                                                                                                                    bination with ipilimumab, is indicated for the treatment of adult and pediatric patients 12 years and older with unresectable
                                                                                                                                                                                                                                                    kind
                                                                                                                                                                                                                                                    age
                                                                                                                                                                                                                                                    polarity
                                                                                                                                                                                                                                                    not_inferred
                                                                                                                                                                                                                                                    span
                                                                                                                                                                                                                                                    end
                                                                                                                                                                                                                                                    9888
                                                                                                                                                                                                                                                    end exclusive
                                                                                                                                                                                                                                                    true
                                                                                                                                                                                                                                                    exact text
                                                                                                                                                                                                                                                    adult
                                                                                                                                                                                                                                                    label id
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                                                                                                                                                                                                                                                    offset unit
                                                                                                                                                                                                                                                    unicode_code_points
                                                                                                                                                                                                                                                    source array index
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                                                                                                                                                                                                                                                    source field
                                                                                                                                                                                                                                                    indications_and_usage_exact
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                                                                                                                                                                                                                                                    start
                                                                                                                                                                                                                                                    9883
                                                                                                                                                                                                                                                  2. context exact
                                                                                                                                                                                                                                                    ith ipilimumab, is indicated for the treatment of adult and pediatric patients 12 years and older with unresectable or metastatic microsat
                                                                                                                                                                                                                                                    kind
                                                                                                                                                                                                                                                    age
                                                                                                                                                                                                                                                    polarity
                                                                                                                                                                                                                                                    not_inferred
                                                                                                                                                                                                                                                    span
                                                                                                                                                                                                                                                    end
                                                                                                                                                                                                                                                    9911
                                                                                                                                                                                                                                                    end exclusive
                                                                                                                                                                                                                                                    true
                                                                                                                                                                                                                                                    exact text
                                                                                                                                                                                                                                                    pediatric patients
                                                                                                                                                                                                                                                    label id
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                                                                                                                                                                                                                                                    unicode_code_points
                                                                                                                                                                                                                                                    source array index
                                                                                                                                                                                                                                                    0
                                                                                                                                                                                                                                                    source field
                                                                                                                                                                                                                                                    indications_and_usage_exact
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                                                                                                                                                                                                                                                    start
                                                                                                                                                                                                                                                    9893
                                                                                                                                                                                                                                                  3. context exact
                                                                                                                                                                                                                                                    indicated for the treatment of adult and pediatric patients 12 years and older with unresectable or metastatic microsatellite instability-
                                                                                                                                                                                                                                                    kind
                                                                                                                                                                                                                                                    age
                                                                                                                                                                                                                                                    polarity
                                                                                                                                                                                                                                                    not_inferred
                                                                                                                                                                                                                                                    span
                                                                                                                                                                                                                                                    end
                                                                                                                                                                                                                                                    9930
                                                                                                                                                                                                                                                    end exclusive
                                                                                                                                                                                                                                                    true
                                                                                                                                                                                                                                                    exact text
                                                                                                                                                                                                                                                    12 years and older
                                                                                                                                                                                                                                                    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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                                                                                                                                                                                                                                                    start
                                                                                                                                                                                                                                                    9912
                                                                                                                                                                                                                                                  4. context exact
                                                                                                                                                                                                                                                    pediatric patients 12 years and older with unresectable or metastatic microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) colorectal cance
                                                                                                                                                                                                                                                    kind
                                                                                                                                                                                                                                                    biomarker
                                                                                                                                                                                                                                                    polarity
                                                                                                                                                                                                                                                    not_inferred
                                                                                                                                                                                                                                                    span
                                                                                                                                                                                                                                                    end
                                                                                                                                                                                                                                                    9995
                                                                                                                                                                                                                                                    end exclusive
                                                                                                                                                                                                                                                    true
                                                                                                                                                                                                                                                    exact text
                                                                                                                                                                                                                                                    metastatic microsatellite instability-high
                                                                                                                                                                                                                                                    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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                                                                                                                                                                                                                                                    start
                                                                                                                                                                                                                                                    9952
                                                                                                                                                                                                                                                  5. context exact
                                                                                                                                                                                                                                                    unresectable or metastatic microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) colorectal cancer (CRC) .
                                                                                                                                                                                                                                                    kind
                                                                                                                                                                                                                                                    biomarker
                                                                                                                                                                                                                                                    polarity
                                                                                                                                                                                                                                                    not_inferred
                                                                                                                                                                                                                                                    span
                                                                                                                                                                                                                                                    end
                                                                                                                                                                                                                                                    10041
                                                                                                                                                                                                                                                    end exclusive
                                                                                                                                                                                                                                                    true
                                                                                                                                                                                                                                                    exact text
                                                                                                                                                                                                                                                    MSI-H) or mismatch repair deficient (dMMR) co
                                                                                                                                                                                                                                                    label id
                                                                                                                                                                                                                                                    1fce9e6a-6a7c-4fc0-a3a4-a0099f7bd2ce
                                                                                                                                                                                                                                                    offset unit
                                                                                                                                                                                                                                                    unicode_code_points
                                                                                                                                                                                                                                                    source array index
                                                                                                                                                                                                                                                    0
                                                                                                                                                                                                                                                    source field
                                                                                                                                                                                                                                                    indications_and_usage_exact
                                                                                                                                                                                                                                                    source text sha256
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                                                                                                                                                                                                                                                    start
                                                                                                                                                                                                                                                    9996
                                                                                                                                                                                                                                                  6. context exact
                                                                                                                                                                                                                                                    ent of adult and pediatric patients 12 years and older with unresectable or metastatic microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) colo
                                                                                                                                                                                                                                                    kind
                                                                                                                                                                                                                                                    stage_or_setting
                                                                                                                                                                                                                                                    polarity
                                                                                                                                                                                                                                                    not_inferred
                                                                                                                                                                                                                                                    span
                                                                                                                                                                                                                                                    end
                                                                                                                                                                                                                                                    9983
                                                                                                                                                                                                                                                    end exclusive
                                                                                                                                                                                                                                                    true
                                                                                                                                                                                                                                                    exact text
                                                                                                                                                                                                                                                    unresectable or metastatic microsatellite insta
                                                                                                                                                                                                                                                    label id
                                                                                                                                                                                                                                                    1fce9e6a-6a7c-4fc0-a3a4-a0099f7bd2ce
                                                                                                                                                                                                                                                    offset unit
                                                                                                                                                                                                                                                    unicode_code_points
                                                                                                                                                                                                                                                    source array index
                                                                                                                                                                                                                                                    0
                                                                                                                                                                                                                                                    source field
                                                                                                                                                                                                                                                    indications_and_usage_exact
                                                                                                                                                                                                                                                    source text sha256
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                                                                                                                                                                                                                                                    start
                                                                                                                                                                                                                                                    9936
                                                                                                                                                                                                                                                  7. context exact
                                                                                                                                                                                                                                                    • OPDIVO, in combination with ipilimumab, 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) colorectal cancer
                                                                                                                                                                                                                                                    kind
                                                                                                                                                                                                                                                    regimen
                                                                                                                                                                                                                                                    polarity
                                                                                                                                                                                                                                                    not_inferred
                                                                                                                                                                                                                                                    span
                                                                                                                                                                                                                                                    end
                                                                                                                                                                                                                                                    9996
                                                                                                                                                                                                                                                    end exclusive
                                                                                                                                                                                                                                                    true
                                                                                                                                                                                                                                                    exact text
                                                                                                                                                                                                                                                    in combination with ipilimumab, is indicated for the treatment of adult and pediatric patients 12 years and older with unresectable or metastatic microsatellite instability-high (
                                                                                                                                                                                                                                                    label id
                                                                                                                                                                                                                                                    1fce9e6a-6a7c-4fc0-a3a4-a0099f7bd2ce
                                                                                                                                                                                                                                                    offset unit
                                                                                                                                                                                                                                                    unicode_code_points
                                                                                                                                                                                                                                                    source array index
                                                                                                                                                                                                                                                    0
                                                                                                                                                                                                                                                    source field
                                                                                                                                                                                                                                                    indications_and_usage_exact
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                                                                                                                                                                                                                                                    start
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                                                                                                                                                                                                                                                  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
                                                                                                                                                                                                                                                      483
                                                                                                                                                                                                                                                      end exclusive
                                                                                                                                                                                                                                                      true
                                                                                                                                                                                                                                                      exact text
                                                                                                                                                                                                                                                      Non-Small Cell Lung Cancer (NSCLC)
                                                                                                                                                                                                                                                      label id
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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
                                                                                                                                                                                                                                                      449
                                                                                                                                                                                                                                                    2. abbreviation
                                                                                                                                                                                                                                                      CRC
                                                                                                                                                                                                                                                      definition exact
                                                                                                                                                                                                                                                      colorectal cancer
                                                                                                                                                                                                                                                      definition span
                                                                                                                                                                                                                                                      end
                                                                                                                                                                                                                                                      3760
                                                                                                                                                                                                                                                      end exclusive
                                                                                                                                                                                                                                                      true
                                                                                                                                                                                                                                                      exact text
                                                                                                                                                                                                                                                      colorectal cancer (CRC)
                                                                                                                                                                                                                                                      label id
                                                                                                                                                                                                                                                      1fce9e6a-6a7c-4fc0-a3a4-a0099f7bd2ce
                                                                                                                                                                                                                                                      offset unit
                                                                                                                                                                                                                                                      unicode_code_points
                                                                                                                                                                                                                                                      source array index
                                                                                                                                                                                                                                                      0
                                                                                                                                                                                                                                                      source field
                                                                                                                                                                                                                                                      indications_and_usage_exact
                                                                                                                                                                                                                                                      source text sha256
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                                                                                                                                                                                                                                                      start
                                                                                                                                                                                                                                                      3737
                                                                                                                                                                                                                                                    source span
                                                                                                                                                                                                                                                    end
                                                                                                                                                                                                                                                    10064
                                                                                                                                                                                                                                                    end exclusive
                                                                                                                                                                                                                                                    true
                                                                                                                                                                                                                                                    exact text
                                                                                                                                                                                                                                                    • OPDIVO, in combination with ipilimumab, 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) colorectal cancer (CRC) .
                                                                                                                                                                                                                                                    label id
                                                                                                                                                                                                                                                    1fce9e6a-6a7c-4fc0-a3a4-a0099f7bd2ce
                                                                                                                                                                                                                                                    offset unit
                                                                                                                                                                                                                                                    unicode_code_points
                                                                                                                                                                                                                                                    source array index
                                                                                                                                                                                                                                                    0
                                                                                                                                                                                                                                                    source field
                                                                                                                                                                                                                                                    indications_and_usage_exact
                                                                                                                                                                                                                                                    source text sha256
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                                                                                                                                                                                                                                                    start
                                                                                                                                                                                                                                                    9807
                                                                                                                                                                                                                                                    source url
                                                                                                                                                                                                                                                    https://api.fda.gov/drug/label.json?search=id%3A%221fce9e6a-6a7c-4fc0-a3a4-a0099f7bd2ce%22
                                                                                                                                                                                                                                                    spl effective date
                                                                                                                                                                                                                                                    2026-08-12
                                                                                                                                                                                                                                                    spl set id
                                                                                                                                                                                                                                                    f570b9c4-6846-4de2-abfa-4d0a4ae4e394
                                                                                                                                                                                                                                                    spl version
                                                                                                                                                                                                                                                    68
                                                                                                                                                                                                                                                    structured fields status
                                                                                                                                                                                                                                                    not_extracted_no_values_inferred_from_mentions
                                                                                                                                                                                                                                                    structured indication
                                                                                                                                                                                                                                                    age
                                                                                                                                                                                                                                                    Source null
                                                                                                                                                                                                                                                    approval pathway
                                                                                                                                                                                                                                                    Source null
                                                                                                                                                                                                                                                    biomarker and test
                                                                                                                                                                                                                                                    Source null
                                                                                                                                                                                                                                                    disease stage
                                                                                                                                                                                                                                                    Source null
                                                                                                                                                                                                                                                    limitations
                                                                                                                                                                                                                                                    Source null
                                                                                                                                                                                                                                                    line
                                                                                                                                                                                                                                                    Source null
                                                                                                                                                                                                                                                    prior therapy
                                                                                                                                                                                                                                                    Source null
                                                                                                                                                                                                                                                    regimen
                                                                                                                                                                                                                                                    Source null
                                                                                                                                                                                                                                                    tumor histology
                                                                                                                                                                                                                                                    Source null
                                                                                                                                                                                                                                                    use intent
                                                                                                                                                                                                                                                    tumor_directed_candidate
                                                                                                                                                                                                                                                    Passage 86 · positive indication candidate
                                                                                                                                                                                                                                                    application numbers
                                                                                                                                                                                                                                                    1. BLA125554
                                                                                                                                                                                                                                                    brand names
                                                                                                                                                                                                                                                    1. OPDIVO
                                                                                                                                                                                                                                                    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
                                                                                                                                                                                                                                                    10585
                                                                                                                                                                                                                                                    end exclusive
                                                                                                                                                                                                                                                    true
                                                                                                                                                                                                                                                    exact text
                                                                                                                                                                                                                                                    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) colorectal cancer (CRC) . • OPDIVO, as a single agent, is indicated for the treatment of adult and pediatric patients 12 years and older with microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) metastatic colorectal cancer (CRC) that has progressed following treatment with a fluoropyrimidine, oxaliplatin, and irinotecan. 1.12 Hepatocellular Carcinoma • OPDIVO, in combination with ipilimumab, is indicated for the first-line treatment of adult patients with unresectable or metastatic hepatocellular carcinoma (HCC). • O
                                                                                                                                                                                                                                                    label id
                                                                                                                                                                                                                                                    1fce9e6a-6a7c-4fc0-a3a4-a0099f7bd2ce
                                                                                                                                                                                                                                                    offset unit
                                                                                                                                                                                                                                                    unicode_code_points
                                                                                                                                                                                                                                                    source array index
                                                                                                                                                                                                                                                    0
                                                                                                                                                                                                                                                    source field
                                                                                                                                                                                                                                                    indications_and_usage_exact
                                                                                                                                                                                                                                                    source text sha256
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                                                                                                                                                                                                                                                    start
                                                                                                                                                                                                                                                    9865
                                                                                                                                                                                                                                                    current approval status
                                                                                                                                                                                                                                                    not_reconciled
                                                                                                                                                                                                                                                    duplicate text group
                                                                                                                                                                                                                                                    dup-ad9c5dab2b4a3bd34b5f
                                                                                                                                                                                                                                                    extraction review status
                                                                                                                                                                                                                                                    automated_candidate_pending_source_review
                                                                                                                                                                                                                                                    generic names
                                                                                                                                                                                                                                                    1. NIVOLUMAB
                                                                                                                                                                                                                                                    id
                                                                                                                                                                                                                                                    ind-span-c792b5d70a7b8803741d
                                                                                                                                                                                                                                                    label id
                                                                                                                                                                                                                                                    1fce9e6a-6a7c-4fc0-a3a4-a0099f7bd2ce
                                                                                                                                                                                                                                                    positive predicate support span
                                                                                                                                                                                                                                                    end
                                                                                                                                                                                                                                                    10106
                                                                                                                                                                                                                                                    end exclusive
                                                                                                                                                                                                                                                    true
                                                                                                                                                                                                                                                    exact text
                                                                                                                                                                                                                                                    is indicated
                                                                                                                                                                                                                                                    label id
                                                                                                                                                                                                                                                    1fce9e6a-6a7c-4fc0-a3a4-a0099f7bd2ce
                                                                                                                                                                                                                                                    offset unit
                                                                                                                                                                                                                                                    unicode_code_points
                                                                                                                                                                                                                                                    source array index
                                                                                                                                                                                                                                                    0
                                                                                                                                                                                                                                                    source field
                                                                                                                                                                                                                                                    indications_and_usage_exact
                                                                                                                                                                                                                                                    source text sha256
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                                                                                                                                                                                                                                                    start
                                                                                                                                                                                                                                                    10094
                                                                                                                                                                                                                                                    qualifier mentions
                                                                                                                                                                                                                                                    1. context exact
                                                                                                                                                                                                                                                      PDIVO, as a single agent, is indicated for the treatment of adult and pediatric patients 12 years and older with microsatelli
                                                                                                                                                                                                                                                      kind
                                                                                                                                                                                                                                                      age
                                                                                                                                                                                                                                                      polarity
                                                                                                                                                                                                                                                      not_inferred
                                                                                                                                                                                                                                                      span
                                                                                                                                                                                                                                                      end
                                                                                                                                                                                                                                                      10133
                                                                                                                                                                                                                                                      end exclusive
                                                                                                                                                                                                                                                      true
                                                                                                                                                                                                                                                      exact text
                                                                                                                                                                                                                                                      adult
                                                                                                                                                                                                                                                      label id
                                                                                                                                                                                                                                                      1fce9e6a-6a7c-4fc0-a3a4-a0099f7bd2ce
                                                                                                                                                                                                                                                      offset unit
                                                                                                                                                                                                                                                      unicode_code_points
                                                                                                                                                                                                                                                      source array index
                                                                                                                                                                                                                                                      0
                                                                                                                                                                                                                                                      source field
                                                                                                                                                                                                                                                      indications_and_usage_exact
                                                                                                                                                                                                                                                      source text sha256
                                                                                                                                                                                                                                                      26eb0583e63f8a27943a9a4f86da103eb1299c470279d992a424213286c89343
                                                                                                                                                                                                                                                      start
                                                                                                                                                                                                                                                      10128
                                                                                                                                                                                                                                                    2. context exact
                                                                                                                                                                                                                                                      a single agent, is indicated for the treatment of adult and pediatric patients 12 years and older with microsatellite instability-high (MS
                                                                                                                                                                                                                                                      kind
                                                                                                                                                                                                                                                      age
                                                                                                                                                                                                                                                      polarity
                                                                                                                                                                                                                                                      not_inferred
                                                                                                                                                                                                                                                      span
                                                                                                                                                                                                                                                      end
                                                                                                                                                                                                                                                      10156
                                                                                                                                                                                                                                                      end exclusive
                                                                                                                                                                                                                                                      true
                                                                                                                                                                                                                                                      exact text
                                                                                                                                                                                                                                                      pediatric patients
                                                                                                                                                                                                                                                      label id
                                                                                                                                                                                                                                                      1fce9e6a-6a7c-4fc0-a3a4-a0099f7bd2ce
                                                                                                                                                                                                                                                      offset unit
                                                                                                                                                                                                                                                      unicode_code_points
                                                                                                                                                                                                                                                      source array index
                                                                                                                                                                                                                                                      0
                                                                                                                                                                                                                                                      source field
                                                                                                                                                                                                                                                      indications_and_usage_exact
                                                                                                                                                                                                                                                      source text sha256
                                                                                                                                                                                                                                                      26eb0583e63f8a27943a9a4f86da103eb1299c470279d992a424213286c89343
                                                                                                                                                                                                                                                      start
                                                                                                                                                                                                                                                      10138
                                                                                                                                                                                                                                                    3. context exact
                                                                                                                                                                                                                                                      indicated for the treatment of adult and pediatric patients 12 years and older with microsatellite instability-high (MSI-H) or mismatch re
                                                                                                                                                                                                                                                      kind
                                                                                                                                                                                                                                                      age
                                                                                                                                                                                                                                                      polarity
                                                                                                                                                                                                                                                      not_inferred
                                                                                                                                                                                                                                                      span
                                                                                                                                                                                                                                                      end
                                                                                                                                                                                                                                                      10175
                                                                                                                                                                                                                                                      end exclusive
                                                                                                                                                                                                                                                      true
                                                                                                                                                                                                                                                      exact text
                                                                                                                                                                                                                                                      12 years and older
                                                                                                                                                                                                                                                      label id
                                                                                                                                                                                                                                                      1fce9e6a-6a7c-4fc0-a3a4-a0099f7bd2ce
                                                                                                                                                                                                                                                      offset unit
                                                                                                                                                                                                                                                      unicode_code_points
                                                                                                                                                                                                                                                      source array index
                                                                                                                                                                                                                                                      0
                                                                                                                                                                                                                                                      source field
                                                                                                                                                                                                                                                      indications_and_usage_exact
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                                                                                                                                                                                                                                                      start
                                                                                                                                                                                                                                                      10157
                                                                                                                                                                                                                                                    4. context exact
                                                                                                                                                                                                                                                      ts 12 years and older with microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) metastatic colorectal cancer (CRC) that has progressed followi
                                                                                                                                                                                                                                                      kind
                                                                                                                                                                                                                                                      biomarker
                                                                                                                                                                                                                                                      polarity
                                                                                                                                                                                                                                                      not_inferred
                                                                                                                                                                                                                                                      span
                                                                                                                                                                                                                                                      end
                                                                                                                                                                                                                                                      10259
                                                                                                                                                                                                                                                      end exclusive
                                                                                                                                                                                                                                                      true
                                                                                                                                                                                                                                                      exact text
                                                                                                                                                                                                                                                      MSI-H) or mismatch repair deficient (dMMR) me
                                                                                                                                                                                                                                                      label id
                                                                                                                                                                                                                                                      1fce9e6a-6a7c-4fc0-a3a4-a0099f7bd2ce
                                                                                                                                                                                                                                                      offset unit
                                                                                                                                                                                                                                                      unicode_code_points
                                                                                                                                                                                                                                                      source array index
                                                                                                                                                                                                                                                      0
                                                                                                                                                                                                                                                      source field
                                                                                                                                                                                                                                                      indications_and_usage_exact
                                                                                                                                                                                                                                                      source text sha256
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                                                                                                                                                                                                                                                      start
                                                                                                                                                                                                                                                      10214
                                                                                                                                                                                                                                                    5. context exact
                                                                                                                                                                                                                                                      nstability-high (MSI-H) or mismatch repair deficient (dMMR) metastatic colorectal cancer (CRC) that has progressed following treatment with a fluoropyrimidine, oxali
                                                                                                                                                                                                                                                      kind
                                                                                                                                                                                                                                                      stage_or_setting
                                                                                                                                                                                                                                                      polarity
                                                                                                                                                                                                                                                      not_inferred
                                                                                                                                                                                                                                                      span
                                                                                                                                                                                                                                                      end
                                                                                                                                                                                                                                                      10302
                                                                                                                                                                                                                                                      end exclusive
                                                                                                                                                                                                                                                      true
                                                                                                                                                                                                                                                      exact text
                                                                                                                                                                                                                                                      metastatic colorectal cancer (CRC) that has p
                                                                                                                                                                                                                                                      label id
                                                                                                                                                                                                                                                      1fce9e6a-6a7c-4fc0-a3a4-a0099f7bd2ce
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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
                                                                                                                                                                                                                                                      10257
                                                                                                                                                                                                                                                    6. context exact
                                                                                                                                                                                                                                                      • OPDIVO, as a single agent, is indicated for the treatment of adult and pediatric patients 12 years and older with microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) metastatic colorectal cancer (CRC) that has progressed
                                                                                                                                                                                                                                                      kind
                                                                                                                                                                                                                                                      regimen
                                                                                                                                                                                                                                                      polarity
                                                                                                                                                                                                                                                      not_inferred
                                                                                                                                                                                                                                                      span
                                                                                                                                                                                                                                                      end
                                                                                                                                                                                                                                                      10252
                                                                                                                                                                                                                                                      end exclusive
                                                                                                                                                                                                                                                      true
                                                                                                                                                                                                                                                      exact text
                                                                                                                                                                                                                                                      as a single agent, is indicated for the treatment of adult and pediatric patients 12 years and older with microsatellite instability-high (MSI-H) or mismatch repair deficient (d
                                                                                                                                                                                                                                                      label id
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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
                                                                                                                                                                                                                                                      10075
                                                                                                                                                                                                                                                    regulatory links
                                                                                                                                                                                                                                                    1. candidate source span
                                                                                                                                                                                                                                                      end
                                                                                                                                                                                                                                                      10385
                                                                                                                                                                                                                                                      end exclusive
                                                                                                                                                                                                                                                      true
                                                                                                                                                                                                                                                      exact text
                                                                                                                                                                                                                                                      • OPDIVO, as a single agent, is indicated for the treatment of adult and pediatric patients 12 years and older with microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) metastatic colorectal cancer (CRC) that has progressed following treatment with a fluoropyrimidine, oxaliplatin, and irinotecan.
                                                                                                                                                                                                                                                      label id
                                                                                                                                                                                                                                                      1fce9e6a-6a7c-4fc0-a3a4-a0099f7bd2ce
                                                                                                                                                                                                                                                      offset unit
                                                                                                                                                                                                                                                      unicode_code_points
                                                                                                                                                                                                                                                      source array index
                                                                                                                                                                                                                                                      0
                                                                                                                                                                                                                                                      source field
                                                                                                                                                                                                                                                      indications_and_usage_exact
                                                                                                                                                                                                                                                      source text sha256
                                                                                                                                                                                                                                                      26eb0583e63f8a27943a9a4f86da103eb1299c470279d992a424213286c89343
                                                                                                                                                                                                                                                      start
                                                                                                                                                                                                                                                      10065
                                                                                                                                                                                                                                                      fda indication exact
                                                                                                                                                                                                                                                      For the treatment of adult and pediatric patients 12 years and older with microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) metastatic colorectal cancer (CRC) that has progressed following treatment with a fluoropyrimidine, oxaliplatin, and irinotecan
                                                                                                                                                                                                                                                      fda source row index
                                                                                                                                                                                                                                                      15
                                                                                                                                                                                                                                                      fda source sha256
                                                                                                                                                                                                                                                      91f921503728c2afb0ec500d9c6034553e0b81d5af260a20c5478686c1127a7e
                                                                                                                                                                                                                                                      fda status record id
                                                                                                                                                                                                                                                      fda-aa-57a457367471d7ab21dc
                                                                                                                                                                                                                                                      interpretation
                                                                                                                                                                                                                                                      Source wording correspondence to a dated FDA status row; current approval not certified
                                                                                                                                                                                                                                                      match method
                                                                                                                                                                                                                                                      whole_indication_literal_normalized_substring
                                                                                                                                                                                                                                                      matching review status
                                                                                                                                                                                                                                                      source_comparison_only_clinical_review_pending
                                                                                                                                                                                                                                                      scope relationship
                                                                                                                                                                                                                                                      whole_fda_indication_text_present
                                                                                                                                                                                                                                                      status category
                                                                                                                                                                                                                                                      verified_clinical_benefit
                                                                                                                                                                                                                                                      status event date
                                                                                                                                                                                                                                                      2025-04-08
                                                                                                                                                                                                                                                      supporting anchor spans
                                                                                                                                                                                                                                                      schema version
                                                                                                                                                                                                                                                      0.1.0
                                                                                                                                                                                                                                                      source batch sha256
                                                                                                                                                                                                                                                      fc39a8c5cf96bf95ca20b85578140167b66b2741f7d9217f500d9ba0847ac058
                                                                                                                                                                                                                                                      source defined aliases
                                                                                                                                                                                                                                                      1. abbreviation
                                                                                                                                                                                                                                                        NSCLC
                                                                                                                                                                                                                                                        definition exact
                                                                                                                                                                                                                                                        Non-Small Cell Lung Cancer
                                                                                                                                                                                                                                                        definition span
                                                                                                                                                                                                                                                        end
                                                                                                                                                                                                                                                        483
                                                                                                                                                                                                                                                        end exclusive
                                                                                                                                                                                                                                                        true
                                                                                                                                                                                                                                                        exact text
                                                                                                                                                                                                                                                        Non-Small Cell Lung Cancer (NSCLC)
                                                                                                                                                                                                                                                        label id
                                                                                                                                                                                                                                                        1fce9e6a-6a7c-4fc0-a3a4-a0099f7bd2ce
                                                                                                                                                                                                                                                        offset unit
                                                                                                                                                                                                                                                        unicode_code_points
                                                                                                                                                                                                                                                        source array index
                                                                                                                                                                                                                                                        0
                                                                                                                                                                                                                                                        source field
                                                                                                                                                                                                                                                        indications_and_usage_exact
                                                                                                                                                                                                                                                        source text sha256
                                                                                                                                                                                                                                                        26eb0583e63f8a27943a9a4f86da103eb1299c470279d992a424213286c89343
                                                                                                                                                                                                                                                        start
                                                                                                                                                                                                                                                        449
                                                                                                                                                                                                                                                      2. abbreviation
                                                                                                                                                                                                                                                        CRC
                                                                                                                                                                                                                                                        definition exact
                                                                                                                                                                                                                                                        colorectal cancer
                                                                                                                                                                                                                                                        definition span
                                                                                                                                                                                                                                                        end
                                                                                                                                                                                                                                                        3760
                                                                                                                                                                                                                                                        end exclusive
                                                                                                                                                                                                                                                        true
                                                                                                                                                                                                                                                        exact text
                                                                                                                                                                                                                                                        colorectal cancer (CRC)
                                                                                                                                                                                                                                                        label id
                                                                                                                                                                                                                                                        1fce9e6a-6a7c-4fc0-a3a4-a0099f7bd2ce
                                                                                                                                                                                                                                                        offset unit
                                                                                                                                                                                                                                                        unicode_code_points
                                                                                                                                                                                                                                                        source array index
                                                                                                                                                                                                                                                        0
                                                                                                                                                                                                                                                        source field
                                                                                                                                                                                                                                                        indications_and_usage_exact
                                                                                                                                                                                                                                                        source text sha256
                                                                                                                                                                                                                                                        26eb0583e63f8a27943a9a4f86da103eb1299c470279d992a424213286c89343
                                                                                                                                                                                                                                                        start
                                                                                                                                                                                                                                                        3737
                                                                                                                                                                                                                                                      source span
                                                                                                                                                                                                                                                      end
                                                                                                                                                                                                                                                      10385
                                                                                                                                                                                                                                                      end exclusive
                                                                                                                                                                                                                                                      true
                                                                                                                                                                                                                                                      exact text
                                                                                                                                                                                                                                                      • OPDIVO, as a single agent, is indicated for the treatment of adult and pediatric patients 12 years and older with microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) metastatic colorectal cancer (CRC) that has progressed following treatment with a fluoropyrimidine, oxaliplatin, and irinotecan.
                                                                                                                                                                                                                                                      label id
                                                                                                                                                                                                                                                      1fce9e6a-6a7c-4fc0-a3a4-a0099f7bd2ce
                                                                                                                                                                                                                                                      offset unit
                                                                                                                                                                                                                                                      unicode_code_points
                                                                                                                                                                                                                                                      source array index
                                                                                                                                                                                                                                                      0
                                                                                                                                                                                                                                                      source field
                                                                                                                                                                                                                                                      indications_and_usage_exact
                                                                                                                                                                                                                                                      source text sha256
                                                                                                                                                                                                                                                      26eb0583e63f8a27943a9a4f86da103eb1299c470279d992a424213286c89343
                                                                                                                                                                                                                                                      start
                                                                                                                                                                                                                                                      10065
                                                                                                                                                                                                                                                      source url
                                                                                                                                                                                                                                                      https://api.fda.gov/drug/label.json?search=id%3A%221fce9e6a-6a7c-4fc0-a3a4-a0099f7bd2ce%22
                                                                                                                                                                                                                                                      spl effective date
                                                                                                                                                                                                                                                      2026-08-12
                                                                                                                                                                                                                                                      spl set id
                                                                                                                                                                                                                                                      f570b9c4-6846-4de2-abfa-4d0a4ae4e394
                                                                                                                                                                                                                                                      spl version
                                                                                                                                                                                                                                                      68
                                                                                                                                                                                                                                                      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

                                                                                                                                                                                                                                                      Read indication-specific status → · whole_fda_indication_text_present

                                                                                                                                                                                                                                                      Passage 87 · unclassified context
                                                                                                                                                                                                                                                      application numbers
                                                                                                                                                                                                                                                      1. BLA125554
                                                                                                                                                                                                                                                      brand names
                                                                                                                                                                                                                                                      1. OPDIVO
                                                                                                                                                                                                                                                      classification reasons
                                                                                                                                                                                                                                                      1. no_unambiguous_positive_indication_predicate
                                                                                                                                                                                                                                                      clinical review status
                                                                                                                                                                                                                                                      pending
                                                                                                                                                                                                                                                      content role
                                                                                                                                                                                                                                                      unclassified_context
                                                                                                                                                                                                                                                      context span
                                                                                                                                                                                                                                                      end
                                                                                                                                                                                                                                                      10615
                                                                                                                                                                                                                                                      end exclusive
                                                                                                                                                                                                                                                      true
                                                                                                                                                                                                                                                      exact text
                                                                                                                                                                                                                                                      satellite instability-high (MSI-H) or mismatch repair deficient (dMMR) metastatic colorectal cancer (CRC) that has progressed following treatment with a fluoropyrimidine, oxaliplatin, and irinotecan. 1.12 Hepatocellular Carcinoma • OPDIVO, in combination with ipilimumab, is indicated for the first-line treatment of adult patients with unresectable or metastatic hepatocellular carcinoma (HCC). • OPDIVO, in combination with ipi
                                                                                                                                                                                                                                                      label id
                                                                                                                                                                                                                                                      1fce9e6a-6a7c-4fc0-a3a4-a0099f7bd2ce
                                                                                                                                                                                                                                                      offset unit
                                                                                                                                                                                                                                                      unicode_code_points
                                                                                                                                                                                                                                                      source array index
                                                                                                                                                                                                                                                      0
                                                                                                                                                                                                                                                      source field
                                                                                                                                                                                                                                                      indications_and_usage_exact
                                                                                                                                                                                                                                                      source text sha256
                                                                                                                                                                                                                                                      26eb0583e63f8a27943a9a4f86da103eb1299c470279d992a424213286c89343
                                                                                                                                                                                                                                                      start
                                                                                                                                                                                                                                                      10186
                                                                                                                                                                                                                                                      current approval status
                                                                                                                                                                                                                                                      not_reconciled
                                                                                                                                                                                                                                                      duplicate text group
                                                                                                                                                                                                                                                      dup-9c0028b336730511cfa2
                                                                                                                                                                                                                                                      extraction review status
                                                                                                                                                                                                                                                      automated_candidate_pending_source_review
                                                                                                                                                                                                                                                      generic names
                                                                                                                                                                                                                                                      1. NIVOLUMAB
                                                                                                                                                                                                                                                      id
                                                                                                                                                                                                                                                      ind-span-ed865accef7264fc69c8
                                                                                                                                                                                                                                                      label id
                                                                                                                                                                                                                                                      1fce9e6a-6a7c-4fc0-a3a4-a0099f7bd2ce
                                                                                                                                                                                                                                                      positive predicate support span
                                                                                                                                                                                                                                                      Source null
                                                                                                                                                                                                                                                      qualifier mentions
                                                                                                                                                                                                                                                        regulatory links
                                                                                                                                                                                                                                                          schema version
                                                                                                                                                                                                                                                          0.1.0
                                                                                                                                                                                                                                                          source batch sha256
                                                                                                                                                                                                                                                          fc39a8c5cf96bf95ca20b85578140167b66b2741f7d9217f500d9ba0847ac058
                                                                                                                                                                                                                                                          source defined aliases
                                                                                                                                                                                                                                                          1. abbreviation
                                                                                                                                                                                                                                                            NSCLC
                                                                                                                                                                                                                                                            definition exact
                                                                                                                                                                                                                                                            Non-Small Cell Lung Cancer
                                                                                                                                                                                                                                                            definition span
                                                                                                                                                                                                                                                            end
                                                                                                                                                                                                                                                            483
                                                                                                                                                                                                                                                            end exclusive
                                                                                                                                                                                                                                                            true
                                                                                                                                                                                                                                                            exact text
                                                                                                                                                                                                                                                            Non-Small Cell Lung Cancer (NSCLC)
                                                                                                                                                                                                                                                            label id
                                                                                                                                                                                                                                                            1fce9e6a-6a7c-4fc0-a3a4-a0099f7bd2ce
                                                                                                                                                                                                                                                            offset unit
                                                                                                                                                                                                                                                            unicode_code_points
                                                                                                                                                                                                                                                            source array index
                                                                                                                                                                                                                                                            0
                                                                                                                                                                                                                                                            source field
                                                                                                                                                                                                                                                            indications_and_usage_exact
                                                                                                                                                                                                                                                            source text sha256
                                                                                                                                                                                                                                                            26eb0583e63f8a27943a9a4f86da103eb1299c470279d992a424213286c89343
                                                                                                                                                                                                                                                            start
                                                                                                                                                                                                                                                            449
                                                                                                                                                                                                                                                          2. abbreviation
                                                                                                                                                                                                                                                            CRC
                                                                                                                                                                                                                                                            definition exact
                                                                                                                                                                                                                                                            colorectal cancer
                                                                                                                                                                                                                                                            definition span
                                                                                                                                                                                                                                                            end
                                                                                                                                                                                                                                                            3760
                                                                                                                                                                                                                                                            end exclusive
                                                                                                                                                                                                                                                            true
                                                                                                                                                                                                                                                            exact text
                                                                                                                                                                                                                                                            colorectal cancer (CRC)
                                                                                                                                                                                                                                                            label id
                                                                                                                                                                                                                                                            1fce9e6a-6a7c-4fc0-a3a4-a0099f7bd2ce
                                                                                                                                                                                                                                                            offset unit
                                                                                                                                                                                                                                                            unicode_code_points
                                                                                                                                                                                                                                                            source array index
                                                                                                                                                                                                                                                            0
                                                                                                                                                                                                                                                            source field
                                                                                                                                                                                                                                                            indications_and_usage_exact
                                                                                                                                                                                                                                                            source text sha256
                                                                                                                                                                                                                                                            26eb0583e63f8a27943a9a4f86da103eb1299c470279d992a424213286c89343
                                                                                                                                                                                                                                                            start
                                                                                                                                                                                                                                                            3737
                                                                                                                                                                                                                                                          source span
                                                                                                                                                                                                                                                          end
                                                                                                                                                                                                                                                          10415
                                                                                                                                                                                                                                                          end exclusive
                                                                                                                                                                                                                                                          true
                                                                                                                                                                                                                                                          exact text
                                                                                                                                                                                                                                                          1.12 Hepatocellular Carcinoma
                                                                                                                                                                                                                                                          label id
                                                                                                                                                                                                                                                          1fce9e6a-6a7c-4fc0-a3a4-a0099f7bd2ce
                                                                                                                                                                                                                                                          offset unit
                                                                                                                                                                                                                                                          unicode_code_points
                                                                                                                                                                                                                                                          source array index
                                                                                                                                                                                                                                                          0
                                                                                                                                                                                                                                                          source field
                                                                                                                                                                                                                                                          indications_and_usage_exact
                                                                                                                                                                                                                                                          source text sha256
                                                                                                                                                                                                                                                          26eb0583e63f8a27943a9a4f86da103eb1299c470279d992a424213286c89343
                                                                                                                                                                                                                                                          start
                                                                                                                                                                                                                                                          10386
                                                                                                                                                                                                                                                          source url
                                                                                                                                                                                                                                                          https://api.fda.gov/drug/label.json?search=id%3A%221fce9e6a-6a7c-4fc0-a3a4-a0099f7bd2ce%22
                                                                                                                                                                                                                                                          spl effective date
                                                                                                                                                                                                                                                          2026-08-12
                                                                                                                                                                                                                                                          spl set id
                                                                                                                                                                                                                                                          f570b9c4-6846-4de2-abfa-4d0a4ae4e394
                                                                                                                                                                                                                                                          spl version
                                                                                                                                                                                                                                                          68
                                                                                                                                                                                                                                                          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 88 · positive indication candidate
                                                                                                                                                                                                                                                          application numbers
                                                                                                                                                                                                                                                          1. BLA125554
                                                                                                                                                                                                                                                          brand names
                                                                                                                                                                                                                                                          1. OPDIVO
                                                                                                                                                                                                                                                          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
                                                                                                                                                                                                                                                          10781
                                                                                                                                                                                                                                                          end exclusive
                                                                                                                                                                                                                                                          true
                                                                                                                                                                                                                                                          exact text
                                                                                                                                                                                                                                                          I-H) or mismatch repair deficient (dMMR) metastatic colorectal cancer (CRC) that has progressed following treatment with a fluoropyrimidine, oxaliplatin, and irinotecan. 1.12 Hepatocellular Carcinoma • OPDIVO, in combination with ipilimumab, is indicated for the first-line treatment of adult patients with unresectable or metastatic hepatocellular carcinoma (HCC). • OPDIVO, in combination with ipilimumab, is indicated for the treatment of adult patients with unresectable or metastatic HCC who have been previously treated with sorafenib. 1.13 Esophageal Cancer
                                                                                                                                                                                                                                                          label id
                                                                                                                                                                                                                                                          1fce9e6a-6a7c-4fc0-a3a4-a0099f7bd2ce
                                                                                                                                                                                                                                                          offset unit
                                                                                                                                                                                                                                                          unicode_code_points
                                                                                                                                                                                                                                                          source array index
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                                                                                                                                                                                                                                                          exact text
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                                                                                                                                                                                                                                                          qualifier mentions
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                                                                                                                                                                                                                                                            th ipilimumab, is indicated for the first-line treatment of adult patients with unresectable or metastatic hepatocellular carcinoma (H
                                                                                                                                                                                                                                                            kind
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                                                                                                                                                                                                                                                          2. context exact
                                                                                                                                                                                                                                                            first-line treatment of adult patients with unresectable or metastatic hepatocellular carcinoma (HCC).
                                                                                                                                                                                                                                                            kind
                                                                                                                                                                                                                                                            biomarker
                                                                                                                                                                                                                                                            polarity
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                                                                                                                                                                                                                                                            true
                                                                                                                                                                                                                                                            exact text
                                                                                                                                                                                                                                                            metastatic hepatocellular carcinoma (HCC)
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                                                                                                                                                                                                                                                          3. context exact
                                                                                                                                                                                                                                                            dicated for the first-line treatment of adult patients with unresectable or metastatic hepatocellular carcinoma (HCC).
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                                                                                                                                                                                                                                                            stage_or_setting
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                                                                                                                                                                                                                                                            span
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                                                                                                                                                                                                                                                            10570
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                                                                                                                                                                                                                                                            true
                                                                                                                                                                                                                                                            exact text
                                                                                                                                                                                                                                                            unresectable or metastatic hepatocellular carci
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                                                                                                                                                                                                                                                          4. context exact
                                                                                                                                                                                                                                                            PDIVO, in combination with ipilimumab, is indicated for the first-line treatment of adult patients with unresectable or metastatic hepatocellular carcinoma (HCC).
                                                                                                                                                                                                                                                            kind
                                                                                                                                                                                                                                                            prior_therapy_or_line
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                                                                                                                                                                                                                                                            10580
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                                                                                                                                                                                                                                                            true
                                                                                                                                                                                                                                                            exact text
                                                                                                                                                                                                                                                            first-line treatment of adult patients with unresectable or metastatic hepatocellular carcinoma (HCC)
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                                                                                                                                                                                                                                                          5. context exact
                                                                                                                                                                                                                                                            • OPDIVO, in combination with ipilimumab, is indicated for the first-line treatment of adult patients with unresectable or metastatic hepatocellular carcinoma (HCC).
                                                                                                                                                                                                                                                            kind
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                                                                                                                                                                                                                                                            span
                                                                                                                                                                                                                                                            end
                                                                                                                                                                                                                                                            10580
                                                                                                                                                                                                                                                            end exclusive
                                                                                                                                                                                                                                                            true
                                                                                                                                                                                                                                                            exact text
                                                                                                                                                                                                                                                            in combination with ipilimumab, is indicated for the first-line treatment of adult patients with unresectable or metastatic hepatocellular carcinoma (HCC)
                                                                                                                                                                                                                                                            label id
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                                                                                                                                                                                                                                                            source defined aliases
                                                                                                                                                                                                                                                            1. abbreviation
                                                                                                                                                                                                                                                              NSCLC
                                                                                                                                                                                                                                                              definition exact
                                                                                                                                                                                                                                                              Non-Small Cell Lung Cancer
                                                                                                                                                                                                                                                              definition span
                                                                                                                                                                                                                                                              end
                                                                                                                                                                                                                                                              483
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                                                                                                                                                                                                                                                              true
                                                                                                                                                                                                                                                              exact text
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                                                                                                                                                                                                                                                            2. abbreviation
                                                                                                                                                                                                                                                              CRC
                                                                                                                                                                                                                                                              definition exact
                                                                                                                                                                                                                                                              colorectal cancer
                                                                                                                                                                                                                                                              definition span
                                                                                                                                                                                                                                                              end
                                                                                                                                                                                                                                                              3760
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                                                                                                                                                                                                                                                              true
                                                                                                                                                                                                                                                              exact text
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                                                                                                                                                                                                                                                              source field
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                                                                                                                                                                                                                                                            10581
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                                                                                                                                                                                                                                                            true
                                                                                                                                                                                                                                                            exact text
                                                                                                                                                                                                                                                            • OPDIVO, in combination with ipilimumab, is indicated for the first-line treatment of adult patients with unresectable or metastatic hepatocellular carcinoma (HCC).
                                                                                                                                                                                                                                                            label id
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                                                                                                                                                                                                                                                            source url
                                                                                                                                                                                                                                                            https://api.fda.gov/drug/label.json?search=id%3A%221fce9e6a-6a7c-4fc0-a3a4-a0099f7bd2ce%22
                                                                                                                                                                                                                                                            spl effective date
                                                                                                                                                                                                                                                            2026-08-12
                                                                                                                                                                                                                                                            spl set id
                                                                                                                                                                                                                                                            f570b9c4-6846-4de2-abfa-4d0a4ae4e394
                                                                                                                                                                                                                                                            spl version
                                                                                                                                                                                                                                                            68
                                                                                                                                                                                                                                                            structured fields status
                                                                                                                                                                                                                                                            not_extracted_no_values_inferred_from_mentions
                                                                                                                                                                                                                                                            structured indication
                                                                                                                                                                                                                                                            age
                                                                                                                                                                                                                                                            Source null
                                                                                                                                                                                                                                                            approval pathway
                                                                                                                                                                                                                                                            Source null
                                                                                                                                                                                                                                                            biomarker and test
                                                                                                                                                                                                                                                            Source null
                                                                                                                                                                                                                                                            disease stage
                                                                                                                                                                                                                                                            Source null
                                                                                                                                                                                                                                                            limitations
                                                                                                                                                                                                                                                            Source null
                                                                                                                                                                                                                                                            line
                                                                                                                                                                                                                                                            Source null
                                                                                                                                                                                                                                                            prior therapy
                                                                                                                                                                                                                                                            Source null
                                                                                                                                                                                                                                                            regimen
                                                                                                                                                                                                                                                            Source null
                                                                                                                                                                                                                                                            tumor histology
                                                                                                                                                                                                                                                            Source null
                                                                                                                                                                                                                                                            use intent
                                                                                                                                                                                                                                                            tumor_directed_candidate
                                                                                                                                                                                                                                                            Passage 89 · positive indication candidate
                                                                                                                                                                                                                                                            application numbers
                                                                                                                                                                                                                                                            1. BLA125554
                                                                                                                                                                                                                                                            brand names
                                                                                                                                                                                                                                                            1. OPDIVO
                                                                                                                                                                                                                                                            classification reasons
                                                                                                                                                                                                                                                            1. explicit_positive_indication_predicate
                                                                                                                                                                                                                                                            2. no_tumor_directed_keyword_in_positive_statement
                                                                                                                                                                                                                                                            clinical review status
                                                                                                                                                                                                                                                            pending
                                                                                                                                                                                                                                                            content role
                                                                                                                                                                                                                                                            positive_indication_candidate
                                                                                                                                                                                                                                                            context span
                                                                                                                                                                                                                                                            end
                                                                                                                                                                                                                                                            10957
                                                                                                                                                                                                                                                            end exclusive
                                                                                                                                                                                                                                                            true
                                                                                                                                                                                                                                                            exact text
                                                                                                                                                                                                                                                            an. 1.12 Hepatocellular Carcinoma • OPDIVO, in combination with ipilimumab, is indicated for the first-line treatment of adult patients with unresectable or metastatic hepatocellular carcinoma (HCC). • OPDIVO, in combination with ipilimumab, is indicated for the treatment of adult patients with unresectable or metastatic HCC who have been previously treated with sorafenib. 1.13 Esophageal Cancer • OPDIVO is indicated for the adjuvant treatment of completely resected esophageal or gastroesophageal junction cancer with residual pathologic disease in adult patients who ha
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                                                                                                                                                                                                                                                            current approval status
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                                                                                                                                                                                                                                                            extraction review status
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                                                                                                                                                                                                                                                            generic names
                                                                                                                                                                                                                                                            1. NIVOLUMAB
                                                                                                                                                                                                                                                            id
                                                                                                                                                                                                                                                            ind-span-eb9bc9248b3fb94a1150
                                                                                                                                                                                                                                                            label id
                                                                                                                                                                                                                                                            1fce9e6a-6a7c-4fc0-a3a4-a0099f7bd2ce
                                                                                                                                                                                                                                                            positive predicate support span
                                                                                                                                                                                                                                                            end
                                                                                                                                                                                                                                                            10636
                                                                                                                                                                                                                                                            end exclusive
                                                                                                                                                                                                                                                            true
                                                                                                                                                                                                                                                            exact text
                                                                                                                                                                                                                                                            is indicated
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                                                                                                                                                                                                                                                            0
                                                                                                                                                                                                                                                            source field
                                                                                                                                                                                                                                                            indications_and_usage_exact
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                                                                                                                                                                                                                                                            10624
                                                                                                                                                                                                                                                            qualifier mentions
                                                                                                                                                                                                                                                            1. context exact
                                                                                                                                                                                                                                                              bination with ipilimumab, is indicated for the treatment of adult patients with unresectable or metastatic HCC who have been previousl
                                                                                                                                                                                                                                                              kind
                                                                                                                                                                                                                                                              age
                                                                                                                                                                                                                                                              polarity
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                                                                                                                                                                                                                                                              span
                                                                                                                                                                                                                                                              end
                                                                                                                                                                                                                                                              10672
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                                                                                                                                                                                                                                                              true
                                                                                                                                                                                                                                                              exact text
                                                                                                                                                                                                                                                              adult patients
                                                                                                                                                                                                                                                              label id
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                                                                                                                                                                                                                                                              unicode_code_points
                                                                                                                                                                                                                                                              source array index
                                                                                                                                                                                                                                                              0
                                                                                                                                                                                                                                                              source field
                                                                                                                                                                                                                                                              indications_and_usage_exact
                                                                                                                                                                                                                                                              source text sha256
                                                                                                                                                                                                                                                              26eb0583e63f8a27943a9a4f86da103eb1299c470279d992a424213286c89343
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                                                                                                                                                                                                                                                            2. context exact
                                                                                                                                                                                                                                                              ed for the treatment of adult patients with unresectable or metastatic HCC who have been previously treated with sorafenib.
                                                                                                                                                                                                                                                              kind
                                                                                                                                                                                                                                                              biomarker
                                                                                                                                                                                                                                                              polarity
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                                                                                                                                                                                                                                                              span
                                                                                                                                                                                                                                                              end
                                                                                                                                                                                                                                                              10737
                                                                                                                                                                                                                                                              end exclusive
                                                                                                                                                                                                                                                              true
                                                                                                                                                                                                                                                              exact text
                                                                                                                                                                                                                                                              metastatic HCC who have been previously tre
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                                                                                                                                                                                                                                                              source array index
                                                                                                                                                                                                                                                              0
                                                                                                                                                                                                                                                              source field
                                                                                                                                                                                                                                                              indications_and_usage_exact
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                                                                                                                                                                                                                                                            3. context exact
                                                                                                                                                                                                                                                              umab, is indicated for the treatment of adult patients with unresectable or metastatic HCC who have been previously treated with sorafenib.
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                                                                                                                                                                                                                                                              stage_or_setting
                                                                                                                                                                                                                                                              polarity
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                                                                                                                                                                                                                                                              end
                                                                                                                                                                                                                                                              10725
                                                                                                                                                                                                                                                              end exclusive
                                                                                                                                                                                                                                                              true
                                                                                                                                                                                                                                                              exact text
                                                                                                                                                                                                                                                              unresectable or metastatic HCC who have been pr
                                                                                                                                                                                                                                                              label id
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                                                                                                                                                                                                                                                              0
                                                                                                                                                                                                                                                              source field
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                                                                                                                                                                                                                                                              10678
                                                                                                                                                                                                                                                            4. context exact
                                                                                                                                                                                                                                                              patients with unresectable or metastatic HCC who have been previously treated with sorafenib.
                                                                                                                                                                                                                                                              kind
                                                                                                                                                                                                                                                              prior_therapy_or_line
                                                                                                                                                                                                                                                              polarity
                                                                                                                                                                                                                                                              not_inferred
                                                                                                                                                                                                                                                              span
                                                                                                                                                                                                                                                              end
                                                                                                                                                                                                                                                              10756
                                                                                                                                                                                                                                                              end exclusive
                                                                                                                                                                                                                                                              true
                                                                                                                                                                                                                                                              exact text
                                                                                                                                                                                                                                                              previously treated with sorafenib
                                                                                                                                                                                                                                                              label id
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                                                                                                                                                                                                                                                              exact text
                                                                                                                                                                                                                                                              • OPDIVO, in combination with ipilimumab, is indicated for the treatment of adult patients with unresectable or metastatic HCC who have been previously treated with sorafenib.
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                                                                                                                                                                                                                                                              brand names
                                                                                                                                                                                                                                                              1. OPDIVO
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                                                                                                                                                                                                                                                              exact text
                                                                                                                                                                                                                                                              llular carcinoma (HCC). • OPDIVO, in combination with ipilimumab, is indicated for the treatment of adult patients with unresectable or metastatic HCC who have been previously treated with sorafenib. 1.13 Esophageal Cancer • OPDIVO is indicated for the adjuvant treatment of completely resected esophageal or gastroesophageal junction cancer with residual pathologic disease in adult patients who have received neoadjuvant
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                                                                                                                                                                                                                                                                    Non-Small Cell Lung Cancer
                                                                                                                                                                                                                                                                    definition span
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                                                                                                                                                                                                                                                                    483
                                                                                                                                                                                                                                                                    end exclusive
                                                                                                                                                                                                                                                                    true
                                                                                                                                                                                                                                                                    exact text
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                                                                                                                                                                                                                                                                  2. abbreviation
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                                                                                                                                                                                                                                                                    3760
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                                                                                                                                                                                                                                                                  exact text
                                                                                                                                                                                                                                                                  1.13 Esophageal Cancer
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                                                                                                                                                                                                                                                                  use intent
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                                                                                                                                                                                                                                                                  Passage 91 · positive indication candidate
                                                                                                                                                                                                                                                                  application numbers
                                                                                                                                                                                                                                                                  1. BLA125554
                                                                                                                                                                                                                                                                  brand names
                                                                                                                                                                                                                                                                  1. OPDIVO
                                                                                                                                                                                                                                                                  classification reasons
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                                                                                                                                                                                                                                                                  2. tumor_or_malignant_hematology_words_in_positive_statement
                                                                                                                                                                                                                                                                  clinical review status
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                                                                                                                                                                                                                                                                  11205
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                                                                                                                                                                                                                                                                  exact text
                                                                                                                                                                                                                                                                  • OPDIVO, in combination with ipilimumab, is indicated for the treatment of adult patients with unresectable or metastatic HCC who have been previously treated with sorafenib. 1.13 Esophageal Cancer • OPDIVO is indicated for the adjuvant treatment of completely resected esophageal or gastroesophageal junction cancer with residual pathologic disease in adult patients who have received neoadjuvant chemoradiotherapy (CRT). • OPDIVO, in combination with fluoropyrimidine- and platinum-containing chemotherapy, is indicated for the first-line treatment of adult patients with unresectable advanced or metastatic esophageal s
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                                                                                                                                                                                                                                                                  true
                                                                                                                                                                                                                                                                  exact text
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                                                                                                                                                                                                                                                                  qualifier mentions
                                                                                                                                                                                                                                                                  1. context exact
                                                                                                                                                                                                                                                                    phageal junction cancer with residual pathologic disease in adult patients who have received neoadjuvant chemoradiotherapy (CRT).
                                                                                                                                                                                                                                                                    kind
                                                                                                                                                                                                                                                                    age
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                                                                                                                                                                                                                                                                    10950
                                                                                                                                                                                                                                                                    end exclusive
                                                                                                                                                                                                                                                                    true
                                                                                                                                                                                                                                                                    exact text
                                                                                                                                                                                                                                                                    adult patients
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                                                                                                                                                                                                                                                                  2. context exact
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                                                                                                                                                                                                                                                                    10854
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                                                                                                                                                                                                                                                                    true
                                                                                                                                                                                                                                                                    exact text
                                                                                                                                                                                                                                                                    adjuvant treatment of completely resected e
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                                                                                                                                                                                                                                                                  3. context exact
                                                                                                                                                                                                                                                                    dual pathologic disease in adult patients who have received neoadjuvant chemoradiotherapy (CRT).
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                                                                                                                                                                                                                                                                    stage_or_setting
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                                                                                                                                                                                                                                                                    exact text
                                                                                                                                                                                                                                                                    neoadjuvant chemoradiotherapy (CRT)
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                                                                                                                                                                                                                                                                      Non-Small Cell Lung Cancer
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                                                                                                                                                                                                                                                                    2. abbreviation
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                                                                                                                                                                                                                                                                    • OPDIVO is indicated for the adjuvant treatment of completely resected esophageal or gastroesophageal junction cancer with residual pathologic disease in adult patients who have received neoadjuvant chemoradiotherapy (CRT).
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                                                                                                                                                                                                                                                                    Passage 92 · positive indication candidate
                                                                                                                                                                                                                                                                    application numbers
                                                                                                                                                                                                                                                                    1. BLA125554
                                                                                                                                                                                                                                                                    brand names
                                                                                                                                                                                                                                                                    1. OPDIVO
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                                                                                                                                                                                                                                                                    the adjuvant treatment of completely resected esophageal or gastroesophageal junction cancer with residual pathologic disease in adult patients who have received neoadjuvant chemoradiotherapy (CRT). • OPDIVO, in combination with fluoropyrimidine- and platinum-containing chemotherapy, is indicated for the first-line treatment of adult patients with unresectable advanced or metastatic esophageal squamous cell carcinoma (ESCC) whose tumors express PD-L1 (≥1) [see Dosage and Administration (2.1) ] . • OPDIVO, in combination with ipilimumab, is indicated for the first-line treatment of adult patients with unresectable advanced or metastatic esophageal squamous cell carcinoma (ESCC) whose tumors e
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                                                                                                                                                                                                                                                                    qualifier mentions
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                                                                                                                                                                                                                                                                    5. context exact
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                                                                                                                                                                                                                                                                      in combination with fluoropyrimidine- and platinum-containing chemotherapy, is indicated for the first-line treatment of adult patients with unresectable advanced or metastatic es
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                                                                                                                                                                                                                                                                      1. abbreviation
                                                                                                                                                                                                                                                                        NSCLC
                                                                                                                                                                                                                                                                        definition exact
                                                                                                                                                                                                                                                                        Non-Small Cell Lung Cancer
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                                                                                                                                                                                                                                                                        483
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                                                                                                                                                                                                                                                                        exact text
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                                                                                                                                                                                                                                                                      2. abbreviation
                                                                                                                                                                                                                                                                        CRC
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                                                                                                                                                                                                                                                                        colorectal cancer
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                                                                                                                                                                                                                                                                        3760
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                                                                                                                                                                                                                                                                        true
                                                                                                                                                                                                                                                                        exact text
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                                                                                                                                                                                                                                                                      true
                                                                                                                                                                                                                                                                      exact text
                                                                                                                                                                                                                                                                      • OPDIVO, in combination with fluoropyrimidine- and platinum-containing chemotherapy, is indicated for the first-line treatment of adult patients with unresectable advanced or metastatic esophageal squamous cell carcinoma (ESCC) whose tumors express PD-L1 (≥1) [see Dosage and Administration (2.1) ] .
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                                                                                                                                                                                                                                                                      brand names
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                                                                                                                                                                                                                                                                      qualifier mentions
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                                                                                                                                                                                                                                                                      3. context exact
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                                                                                                                                                                                                                                                                        exact text
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                                                                                                                                                                                                                                                                      4. context exact
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                                                                                                                                                                                                                                                                      5. context exact
                                                                                                                                                                                                                                                                        PDIVO, in combination with ipilimumab, is indicated for the first-line treatment of adult patients with unresectable advanced or metastatic esophageal squamous cell carcinoma (ESCC) whose tumors express PD-L1 (≥1) [see Dosage and Administration (2.1) ] .
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                                                                                                                                                                                                                                                                        exact text
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                                                                                                                                                                                                                                                                      6. context exact
                                                                                                                                                                                                                                                                        • OPDIVO, in combination with ipilimumab, is indicated for the first-line treatment of adult patients with unresectable advanced or metastatic esophageal squamous cell carcinoma (ESCC) whose tumors express PD-L1 (≥1) [see Dosage and Administration (
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                                                                                                                                                                                                                                                                        true
                                                                                                                                                                                                                                                                        exact text
                                                                                                                                                                                                                                                                        in combination with ipilimumab, is indicated for the first-line treatment of adult patients with unresectable advanced or metastatic esophageal squamous cell carcinoma (ESCC) whos
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                                                                                                                                                                                                                                                                          Non-Small Cell Lung Cancer
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                                                                                                                                                                                                                                                                        2. abbreviation
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                                                                                                                                                                                                                                                                        11565
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                                                                                                                                                                                                                                                                        true
                                                                                                                                                                                                                                                                        exact text
                                                                                                                                                                                                                                                                        • OPDIVO, in combination with ipilimumab, is indicated for the first-line treatment of adult patients with unresectable advanced or metastatic esophageal squamous cell carcinoma (ESCC) whose tumors express PD-L1 (≥1) [see Dosage and Administration (2.1) ] .
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                                                                                                                                                                                                                                                                        biomarker and test
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                                                                                                                                                                                                                                                                        disease stage
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                                                                                                                                                                                                                                                                        tumor histology
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                                                                                                                                                                                                                                                                        use intent
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                                                                                                                                                                                                                                                                        Passage 94 · positive indication candidate
                                                                                                                                                                                                                                                                        application numbers
                                                                                                                                                                                                                                                                        1. BLA125554
                                                                                                                                                                                                                                                                        brand names
                                                                                                                                                                                                                                                                        1. OPDIVO
                                                                                                                                                                                                                                                                        classification reasons
                                                                                                                                                                                                                                                                        1. explicit_positive_indication_predicate
                                                                                                                                                                                                                                                                        2. tumor_or_malignant_hematology_words_in_positive_statement
                                                                                                                                                                                                                                                                        clinical review status
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                                                                                                                                                                                                                                                                        11980
                                                                                                                                                                                                                                                                        end exclusive
                                                                                                                                                                                                                                                                        true
                                                                                                                                                                                                                                                                        exact text
                                                                                                                                                                                                                                                                        the first-line treatment of adult patients with unresectable advanced or metastatic esophageal squamous cell carcinoma (ESCC) whose tumors express PD-L1 (≥1) [see Dosage and Administration (2.1) ] . • OPDIVO is indicated for the treatment of adult patients with unresectable advanced, recurrent or metastatic esophageal squamous cell carcinoma (ESCC) after prior fluoropyrimidine- and platinum-based chemotherapy. 1.14 Gastric Cancer, Gastroesophageal Junction Cancer, and Esophageal Adenocarcinoma OPDIVO, in combination with fluoropyrimidine- and platinum-containing chemotherapy, is indicated for the treatment
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                                                                                                                                                                                                                                                                        generic names
                                                                                                                                                                                                                                                                        1. NIVOLUMAB
                                                                                                                                                                                                                                                                        id
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                                                                                                                                                                                                                                                                        positive predicate support span
                                                                                                                                                                                                                                                                        end
                                                                                                                                                                                                                                                                        11587
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                                                                                                                                                                                                                                                                        true
                                                                                                                                                                                                                                                                        exact text
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                                                                                                                                                                                                                                                                          2. abbreviation
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                                                                                                                                                                                                                                                                          true
                                                                                                                                                                                                                                                                          exact text
                                                                                                                                                                                                                                                                          • OPDIVO is indicated for the treatment of adult patients with unresectable advanced, recurrent or metastatic esophageal squamous cell carcinoma (ESCC) after prior fluoropyrimidine- and platinum-based chemotherapy.
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                                                                                                                                                                                                                                                                          application numbers
                                                                                                                                                                                                                                                                          1. BLA125554
                                                                                                                                                                                                                                                                          brand names
                                                                                                                                                                                                                                                                          1. OPDIVO
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                                                                                                                                                                                                                                                                          2. tumor_or_malignant_hematology_words_in_positive_statement
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                                                                                                                                                                                                                                                                          icated for the treatment of adult patients with unresectable advanced, recurrent or metastatic esophageal squamous cell carcinoma (ESCC) after prior fluoropyrimidine- and platinum-based chemotherapy. 1.14 Gastric Cancer, Gastroesophageal Junction Cancer, and Esophageal Adenocarcinoma OPDIVO, in combination with fluoropyrimidine- and platinum-containing chemotherapy, is indicated for the treatment of adult patients with advanced or metastatic gastric cancer, gastroesophageal junction cancer, and esophageal adenocarcinoma whose tumors express PD-L1 (≥1) [see Dosage and Administration (2.1) ] .
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                                                                                                                                                                                                                                                                          true
                                                                                                                                                                                                                                                                          exact text
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                                                                                                                                                                                                                                                                          qualifier mentions
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                                                                                                                                                                                                                                                                            -containing chemotherapy, is indicated for the treatment of adult patients with advanced or metastatic gastric cancer, gastroesophagea
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                                                                                                                                                                                                                                                                            true
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                                                                                                                                                                                                                                                                          2. context exact
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                                                                                                                                                                                                                                                                            true
                                                                                                                                                                                                                                                                            exact text
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                                                                                                                                                                                                                                                                          3. context exact
                                                                                                                                                                                                                                                                            cancer, and esophageal adenocarcinoma whose tumors express PD-L1 (≥1) [see Dosage and Administration (2.1) ] .
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                                                                                                                                                                                                                                                                            true
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                                                                                                                                                                                                                                                                            PD-L1 (≥1) [see Dosage and Administration (2
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                                                                                                                                                                                                                                                                          4. context exact
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                                                                                                                                                                                                                                                                            stage_or_setting
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                                                                                                                                                                                                                                                                            exact text
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                                                                                                                                                                                                                                                                          5. context exact
                                                                                                                                                                                                                                                                            geal Junction Cancer, and Esophageal Adenocarcinoma OPDIVO, in combination with fluoropyrimidine- and platinum-containing chemotherapy, is indicated for the treatment of adult patients with advanced or metastatic gastric cancer, gastroesophageal junction cancer, and esophageal adenocarcinoma whose
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                                                                                                                                                                                                                                                                            true
                                                                                                                                                                                                                                                                            exact text
                                                                                                                                                                                                                                                                            in combination with fluoropyrimidine- and platinum-containing chemotherapy, is indicated for the treatment of adult patients with advanced or metastatic gastric cancer, gastroesop
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                                                                                                                                                                                                                                                                              NSCLC
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                                                                                                                                                                                                                                                                              Non-Small Cell Lung Cancer
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                                                                                                                                                                                                                                                                              Non-Small Cell Lung Cancer (NSCLC)
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                                                                                                                                                                                                                                                                            2. abbreviation
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                                                                                                                                                                                                                                                                            1.14 Gastric Cancer, Gastroesophageal Junction Cancer, and Esophageal Adenocarcinoma OPDIVO, in combination with fluoropyrimidine- and platinum-containing chemotherapy, is indicated for the treatment of adult patients with advanced or metastatic gastric cancer, gastroesophageal junction cancer, and esophageal adenocarcinoma whose tumors express PD-L1 (≥1) [see Dosage and Administration (2.1) ] .
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                                                                                                                                                                                                                                                                            spl effective date
                                                                                                                                                                                                                                                                            2026-08-12
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                                                                                                                                                                                                                                                                            use intent
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                                                                                                                                                                                                                                                                            Preserved source evidence · Not medical advice