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LABELS · 1ce25608-1b8f-4d49-9ffd-6c8c61bf4f1a

OPDIVO QVANTIG

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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
2026-05-12
Captured
2026-09-09T23:37:39.774134+00:00
Current indication reconciliation
Not reconciled

Indications and usage: exact source text

  1. 1 INDICATIONS AND USAGE OPDIVO QVANTIG is a combination of nivolumab, a programmed death receptor-1 (PD-1)-blocking antibody, and hyaluronidase, an endoglycosidase, indicated for the treatment of: Renal Cell Carcinoma (RCC) • adult patients with intermediate or poor risk advanced RCC, as a first-line treatment following combination treatment with intravenous nivolumab and ipilimumab. (1.1) • Limitations of Use: OPDIVO QVANTIG is not indicated in combination with ipilimumab for the treatment of renal cell carcinoma. • adult patients with advanced RCC, as a first-line treatment in combination with cabozantinib. (1.1) • adult patients with advanced RCC who have received prior anti-angiogenic therapy. ( 1.1 ) Melanoma • adult and pediatric (12 years and older who weigh 30 kg or greater) patients with unresectable or metastatic melanoma. (1.2) • adult and pediatric (12 years and older who weigh 30 kg or greater) patients with unresectable or metastatic melanoma following combination treatment with intravenous nivolumab and ipilimumab. (1.2) • Limitations of Use: OPDIVO QVANTIG is not indicated in combination with ipilimumab for the treatment of unresectable or metastatic melanoma. • for the adjuvant treatment of adult and pediatric (12 years and older who weigh 30 kg or greater) patients with completely resected Stage IIB, Stage IIC, Stage III, or Stage IV melanoma. (1.3) Non-Small Cell Lung Cancer (NSCLC) • adult patients with resectable (tumors ≥4 cm or node positive) NSCLC in the neoadjuvant setting, in combination with platinum-doublet chemotherapy. (1.4) • adult patients with resectable (tumors ≥4 cm or node positive) NSCLC and no known EGFR mutations or ALK rearrangements, for neoadjuvant treatment, in combination with platinum-doublet chemotherapy, followed by OPDIVO QVANTIG monotherapy as adjuvant treatment after surgery. (1.5) • adult patients with metastatic NSCLC 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 QVANTIG. (1.6) • Limitations of Use: OPDIVO QVANTIG is not indicated in combination with ipilimumab for the treatment of metastatic NSCLC. Squamous Cell Carcinoma of the Head and Neck (SCCHN) • adult patients with recurrent or metastatic SCCHN with disease progression on or after a platinum-based therapy. (1.7) Urothelial Carcinoma (UC) • adjuvant treatment of adult patients with UC who are at high risk of recurrence after undergoing radical resection of UC. (1.8) • adult patients with unresectable or metastatic urothelial carcinoma, as first-line treatment in combination with cisplatin and gemcitabine. (1.8) • adult patients with locally advanced or metastatic UC 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. (1.8) Colorectal Cancer (CRC) • adult and pediatric (12 years and older who weigh 30 kg or greater) patients with unresectable or metastatic microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) colorectal cancer (CRC), following combination treatment with intravenous nivolumab and ipilimumab. (1.9) • Limitations of Use: OPDIVO QVANTIG is not indicated in combination with ipilimumab for the treatment of unresectable or metastatic MSI-H or dMMR CRC. • adult and pediatric (12 years and older who weigh 30 kg or greater) patients with MSI-H or dMMR metastatic CRC that has progressed following treatment with a fluoropyrimidine, oxaliplatin, and irinotecan. (1.9) • Limitations of Use: OPDIVO QVANTIG is not indicated in combination with ipilimumab for the treatment of unresectable or metastatic MSI-H or dMMR CRC. Hepatocellular Carcinoma (HCC) • adult patients with unresectable or metastatic HCC, as a first-line treatment following combination treatment with intravenous nivolumab and ipilimumab. (1.10) • adult patients with unresectable or metastatic HCC, who have been previously treated with sorafenib, following combination treatment with intravenous nivolumab and ipilimumab. (1.10) • Limitations of Use: OPDIVO QVANTIG is not indicated in combination with ipilimumab for the treatment of unresectable or metastatic HCC. Esophageal Cancer • adult patients with completely resected esophageal or gastroesophageal junction cancer with residual pathologic disease, who have received neoadjuvant chemoradiotherapy (CRT). (1.11) • adult patients with unresectable advanced or metastatic esophageal squamous cell carcinoma (ESCC) as first-line treatment in combination with fluoropyrimidine- and platinum-containing chemotherapy whose tumors express PD-L1 (≥1). (1.11) • Limitations of Use: OPDIVO QVANTIG is not indicated in combination with ipilimumab for the treatment of patients with unresectable advanced or metastatic ESCC. • adult patients with unresectable advanced, recurrent or metastatic ESCC after prior fluoropyrimidine- and platinum-based chemotherapy. (1.11) 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. (1.12) 1.1 Advanced Renal Cell Carcinoma OPDIVO QVANTIG™, as monotherapy, is indicated for the first-line treatment of adult patients with intermediate or poor risk advanced renal cell carcinoma (RCC) following treatment with intravenous nivolumab and ipilimumab combination therapy. Limitations of Use: OPDIVO QVANTIG is not indicated in combination with ipilimumab for the treatment of renal cell carcinoma. OPDIVO QVANTIG, in combination with cabozantinib, is indicated for the first-line treatment of adult patients with advanced RCC. OPDIVO QVANTIG, as monotherapy, is indicated for the treatment of adult patients with advanced RCC who have received prior anti-angiogenic therapy. 1.2 Unresectable or Metastatic Melanoma OPDIVO QVANTIG, as monotherapy, is indicated for the treatment of adult and pediatric patients 12 years and older who weigh 30 kg or greater with unresectable or metastatic melanoma. OPDIVO QVANTIG, as monotherapy, is indicated for the treatment of adult and pediatric patients 12 years and older who weigh 30 kg or greater with unresectable or metastatic melanoma following treatment with intravenous nivolumab and ipilimumab combination therapy. Limitations of Use: OPDIVO QVANTIG is not indicated in combination with ipilimumab for the treatment of unresectable or metastatic melanoma. 1.3 Adjuvant Treatment of Melanoma OPDIVO QVANTIG, as monotherapy, is indicated for the adjuvant treatment of adult and pediatric patients 12 years and older who weigh 30 kg or greater with completely resected Stage IIB, Stage IIC, Stage III, or Stage IV melanoma. 1.4 Neoadjuvant Treatment of Resectable Non-Small Cell Lung Cancer OPDIVO QVANTIG, 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). 1.5 Neoadjuvant and Adjuvant Treatment of Resectable Non-Small Cell Lung Cancer OPDIVO QVANTIG, 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 OPDIVO QVANTIG as monotherapy in the adjuvant setting after surgical resection. 1.6 Metastatic Non-Small Cell Lung Cancer OPDIVO QVANTIG, as monotherapy, is indicated for the treatment of adult patients with metastatic non-small cell lung cancer (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 QVANTIG. Limitations of Use: OPDIVO QVANTIG is not indicated in combination with ipilimumab for the treatment of metastatic NSCLC. 1.7 Squamous Cell Carcinoma of the Head and Neck OPDIVO QVANTIG, as monotherapy, 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. 1.8 Urothelial Carcinoma OPDIVO QVANTIG, as monotherapy, 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. OPDIVO QVANTIG, in combination with cisplatin and gemcitabine, is indicated for the first-line treatment of adult patients with unresectable or metastatic UC. OPDIVO QVANTIG, as monotherapy, is indicated for the treatment of adult patients with locally advanced or metastatic UC 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. 1.9 Microsatellite Instability-High or Mismatch Repair Deficient Metastatic Colorectal Cancer OPDIVO QVANTIG, as monotherapy, is indicated for the treatment of adult and pediatric patients 12 years and older who weigh 30 kg or greater with unresectable or metastatic microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) colorectal cancer (CRC) following treatment with intravenous nivolumab and ipilimumab combination therapy. OPDIVO QVANTIG, as monotherapy, is indicated for the treatment of adult and pediatric patients 12 years and older who weigh 30 kg or greater, with MSI-H or dMMR metastatic CRC that has progressed following treatment with a fluoropyrimidine, oxaliplatin, and irinotecan. Limitations of Use: OPDIVO QVANTIG is not indicated in combination with ipilimumab for the treatment of unresectable or metastatic MSI-H or dMMR CRC. 1.10 Hepatocellular Carcinoma • OPDIVO QVANTIG, as monotherapy, is indicated for the first-line treatment of adult patients with unresectable or metastatic hepatocellular carcinoma (HCC) following treatment with intravenous nivolumab and ipilimumab combination therapy. • OPDIVO QVANTIG, as monotherapy, is indicated for the treatment of adult patients with unresectable or metastatic hepatocellular carcinoma (HCC) who have been previously treated with sorafenib following treatment with intravenous nivolumab and ipilimumab combination therapy . Limitations of Use: OPDIVO QVANTIG is not indicated in combination with ipilimumab for the treatment of patients with unresectable or metastatic HCC. 1.11 Esophageal Cancer OPDIVO QVANTIG as monotherapy, 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 QVANTIG, 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 (2.2) ] . Limitations of Use: OPDIVO QVANTIG is not indicated in combination with ipilimumab for the treatment of patients with unresectable advanced or metastatic ESCC. OPDIVO QVANTIG as monotherapy, is indicated for the treatment of adult patients with unresectable advanced, recurrent, or metastatic ESCC after prior fluoropyrimidine- and platinum-based chemotherapy. 1.12 Gastric Cancer, Gastroesophageal Junction Cancer, and Esophageal Adenocarcinoma OPDIVO QVANTIG, 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 (2.2) ] .
Full extracted label fields
application numbers
  1. BLA761381
boxed warning exact
    brand names
    1. OPDIVO QVANTIG
    current indication status
    not_reconciled
    dailymed set url
    https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=7f8c38fa-42f4-4387-9e8c-7a1c66855d8b
    generic names
    1. NIVOLUMAB AND HYALURONIDASE-NVHY
    id
    1ce25608-1b8f-4d49-9ffd-6c8c61bf4f1a
    indications and usage exact
    1. 1 INDICATIONS AND USAGE OPDIVO QVANTIG is a combination of nivolumab, a programmed death receptor-1 (PD-1)-blocking antibody, and hyaluronidase, an endoglycosidase, indicated for the treatment of: Renal Cell Carcinoma (RCC) • adult patients with intermediate or poor risk advanced RCC, as a first-line treatment following combination treatment with intravenous nivolumab and ipilimumab. (1.1) • Limitations of Use: OPDIVO QVANTIG is not indicated in combination with ipilimumab for the treatment of renal cell carcinoma. • adult patients with advanced RCC, as a first-line treatment in combination with cabozantinib. (1.1) • adult patients with advanced RCC who have received prior anti-angiogenic therapy. ( 1.1 ) Melanoma • adult and pediatric (12 years and older who weigh 30 kg or greater) patients with unresectable or metastatic melanoma. (1.2) • adult and pediatric (12 years and older who weigh 30 kg or greater) patients with unresectable or metastatic melanoma following combination treatment with intravenous nivolumab and ipilimumab. (1.2) • Limitations of Use: OPDIVO QVANTIG is not indicated in combination with ipilimumab for the treatment of unresectable or metastatic melanoma. • for the adjuvant treatment of adult and pediatric (12 years and older who weigh 30 kg or greater) patients with completely resected Stage IIB, Stage IIC, Stage III, or Stage IV melanoma. (1.3) Non-Small Cell Lung Cancer (NSCLC) • adult patients with resectable (tumors ≥4 cm or node positive) NSCLC in the neoadjuvant setting, in combination with platinum-doublet chemotherapy. (1.4) • adult patients with resectable (tumors ≥4 cm or node positive) NSCLC and no known EGFR mutations or ALK rearrangements, for neoadjuvant treatment, in combination with platinum-doublet chemotherapy, followed by OPDIVO QVANTIG monotherapy as adjuvant treatment after surgery. (1.5) • adult patients with metastatic NSCLC 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 QVANTIG. (1.6) • Limitations of Use: OPDIVO QVANTIG is not indicated in combination with ipilimumab for the treatment of metastatic NSCLC. Squamous Cell Carcinoma of the Head and Neck (SCCHN) • adult patients with recurrent or metastatic SCCHN with disease progression on or after a platinum-based therapy. (1.7) Urothelial Carcinoma (UC) • adjuvant treatment of adult patients with UC who are at high risk of recurrence after undergoing radical resection of UC. (1.8) • adult patients with unresectable or metastatic urothelial carcinoma, as first-line treatment in combination with cisplatin and gemcitabine. (1.8) • adult patients with locally advanced or metastatic UC 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. (1.8) Colorectal Cancer (CRC) • adult and pediatric (12 years and older who weigh 30 kg or greater) patients with unresectable or metastatic microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) colorectal cancer (CRC), following combination treatment with intravenous nivolumab and ipilimumab. (1.9) • Limitations of Use: OPDIVO QVANTIG is not indicated in combination with ipilimumab for the treatment of unresectable or metastatic MSI-H or dMMR CRC. • adult and pediatric (12 years and older who weigh 30 kg or greater) patients with MSI-H or dMMR metastatic CRC that has progressed following treatment with a fluoropyrimidine, oxaliplatin, and irinotecan. (1.9) • Limitations of Use: OPDIVO QVANTIG is not indicated in combination with ipilimumab for the treatment of unresectable or metastatic MSI-H or dMMR CRC. Hepatocellular Carcinoma (HCC) • adult patients with unresectable or metastatic HCC, as a first-line treatment following combination treatment with intravenous nivolumab and ipilimumab. (1.10) • adult patients with unresectable or metastatic HCC, who have been previously treated with sorafenib, following combination treatment with intravenous nivolumab and ipilimumab. (1.10) • Limitations of Use: OPDIVO QVANTIG is not indicated in combination with ipilimumab for the treatment of unresectable or metastatic HCC. Esophageal Cancer • adult patients with completely resected esophageal or gastroesophageal junction cancer with residual pathologic disease, who have received neoadjuvant chemoradiotherapy (CRT). (1.11) • adult patients with unresectable advanced or metastatic esophageal squamous cell carcinoma (ESCC) as first-line treatment in combination with fluoropyrimidine- and platinum-containing chemotherapy whose tumors express PD-L1 (≥1). (1.11) • Limitations of Use: OPDIVO QVANTIG is not indicated in combination with ipilimumab for the treatment of patients with unresectable advanced or metastatic ESCC. • adult patients with unresectable advanced, recurrent or metastatic ESCC after prior fluoropyrimidine- and platinum-based chemotherapy. (1.11) 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. (1.12) 1.1 Advanced Renal Cell Carcinoma OPDIVO QVANTIG™, as monotherapy, is indicated for the first-line treatment of adult patients with intermediate or poor risk advanced renal cell carcinoma (RCC) following treatment with intravenous nivolumab and ipilimumab combination therapy. Limitations of Use: OPDIVO QVANTIG is not indicated in combination with ipilimumab for the treatment of renal cell carcinoma. OPDIVO QVANTIG, in combination with cabozantinib, is indicated for the first-line treatment of adult patients with advanced RCC. OPDIVO QVANTIG, as monotherapy, is indicated for the treatment of adult patients with advanced RCC who have received prior anti-angiogenic therapy. 1.2 Unresectable or Metastatic Melanoma OPDIVO QVANTIG, as monotherapy, is indicated for the treatment of adult and pediatric patients 12 years and older who weigh 30 kg or greater with unresectable or metastatic melanoma. OPDIVO QVANTIG, as monotherapy, is indicated for the treatment of adult and pediatric patients 12 years and older who weigh 30 kg or greater with unresectable or metastatic melanoma following treatment with intravenous nivolumab and ipilimumab combination therapy. Limitations of Use: OPDIVO QVANTIG is not indicated in combination with ipilimumab for the treatment of unresectable or metastatic melanoma. 1.3 Adjuvant Treatment of Melanoma OPDIVO QVANTIG, as monotherapy, is indicated for the adjuvant treatment of adult and pediatric patients 12 years and older who weigh 30 kg or greater with completely resected Stage IIB, Stage IIC, Stage III, or Stage IV melanoma. 1.4 Neoadjuvant Treatment of Resectable Non-Small Cell Lung Cancer OPDIVO QVANTIG, 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). 1.5 Neoadjuvant and Adjuvant Treatment of Resectable Non-Small Cell Lung Cancer OPDIVO QVANTIG, 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 OPDIVO QVANTIG as monotherapy in the adjuvant setting after surgical resection. 1.6 Metastatic Non-Small Cell Lung Cancer OPDIVO QVANTIG, as monotherapy, is indicated for the treatment of adult patients with metastatic non-small cell lung cancer (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 QVANTIG. Limitations of Use: OPDIVO QVANTIG is not indicated in combination with ipilimumab for the treatment of metastatic NSCLC. 1.7 Squamous Cell Carcinoma of the Head and Neck OPDIVO QVANTIG, as monotherapy, 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. 1.8 Urothelial Carcinoma OPDIVO QVANTIG, as monotherapy, 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. OPDIVO QVANTIG, in combination with cisplatin and gemcitabine, is indicated for the first-line treatment of adult patients with unresectable or metastatic UC. OPDIVO QVANTIG, as monotherapy, is indicated for the treatment of adult patients with locally advanced or metastatic UC 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. 1.9 Microsatellite Instability-High or Mismatch Repair Deficient Metastatic Colorectal Cancer OPDIVO QVANTIG, as monotherapy, is indicated for the treatment of adult and pediatric patients 12 years and older who weigh 30 kg or greater with unresectable or metastatic microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) colorectal cancer (CRC) following treatment with intravenous nivolumab and ipilimumab combination therapy. OPDIVO QVANTIG, as monotherapy, is indicated for the treatment of adult and pediatric patients 12 years and older who weigh 30 kg or greater, with MSI-H or dMMR metastatic CRC that has progressed following treatment with a fluoropyrimidine, oxaliplatin, and irinotecan. Limitations of Use: OPDIVO QVANTIG is not indicated in combination with ipilimumab for the treatment of unresectable or metastatic MSI-H or dMMR CRC. 1.10 Hepatocellular Carcinoma • OPDIVO QVANTIG, as monotherapy, is indicated for the first-line treatment of adult patients with unresectable or metastatic hepatocellular carcinoma (HCC) following treatment with intravenous nivolumab and ipilimumab combination therapy. • OPDIVO QVANTIG, as monotherapy, is indicated for the treatment of adult patients with unresectable or metastatic hepatocellular carcinoma (HCC) who have been previously treated with sorafenib following treatment with intravenous nivolumab and ipilimumab combination therapy . Limitations of Use: OPDIVO QVANTIG is not indicated in combination with ipilimumab for the treatment of patients with unresectable or metastatic HCC. 1.11 Esophageal Cancer OPDIVO QVANTIG as monotherapy, 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 QVANTIG, 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 (2.2) ] . Limitations of Use: OPDIVO QVANTIG is not indicated in combination with ipilimumab for the treatment of patients with unresectable advanced or metastatic ESCC. OPDIVO QVANTIG as monotherapy, is indicated for the treatment of adult patients with unresectable advanced, recurrent, or metastatic ESCC after prior fluoropyrimidine- and platinum-based chemotherapy. 1.12 Gastric Cancer, Gastroesophageal Junction Cancer, and Esophageal Adenocarcinoma OPDIVO QVANTIG, 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 (2.2) ] .
    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
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      1. 0003-6120-01
      2. 0003-3120-01
      product ndcs
      1. 0003-3120
      2. 0003-6120
      product types
      1. HUMAN PRESCRIPTION DRUG
      recent major changes exact
      1. Indications and Usage (1) 11/2025 Dosage and Administration (2) 11/2025 Warnings and Precautions (5) 5/2026
      record type
      complete_spl_indications_section_candidate
      routes
      1. SUBCUTANEOUS
      rxcuis
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      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
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      url
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      source url
      https://api.fda.gov/drug/label.json?search=id%3A%221ce25608-1b8f-4d49-9ffd-6c8c61bf4f1a%22
      spl effective date
      2026-05-12
      spl effective time
      20260512
      spl set id
      7f8c38fa-42f4-4387-9e8c-7a1c66855d8b
      spl version
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      substance names
      1. NIVOLUMAB
      2. HYALURONIDASE (HUMAN RECOMBINANT)
      uniis
      1. 743QUY4VD8
      2. 31YO63LBSN
      verification flags
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      Drugs@FDA application source records
      1. application number
        BLA761381
        payload
        all indexed label documents
        1. Appl No
          761381
          Application Docs Date
          2025-06-13 00:00:00
          Application Docs ID
          80780
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          Application Docs Type ID
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          Submission Type
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        2. Appl No
          761381
          Application Docs Date
          2025-06-02 00:00:00
          Application Docs ID
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          Application Docs Title
          0
          Application Docs Type ID
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          Submission No
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          SUPPL
        3. Appl No
          761381
          Application Docs Date
          2025-10-28 00:00:00
          Application Docs ID
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          Application Docs Title
          0
          Application Docs Type ID
          2
          Submission No
          1
          Submission Type
          SUPPL
        4. Appl No
          761381
          Application Docs Date
          2025-10-28 00:00:00
          Application Docs ID
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          Application Docs Title
          0
          Application Docs Type ID
          2
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          2
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          SUPPL
        5. Appl No
          761381
          Application Docs Date
          2025-11-25 00:00:00
          Application Docs ID
          84312
          Application Docs Title
          0
          Application Docs Type ID
          2
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          5
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          SUPPL
        6. Appl No
          761381
          Application Docs Date
          2026-05-18 00:00:00
          Application Docs ID
          85949
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          0
          Application Docs Type ID
          2
          Submission No
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          SUPPL
        7. Appl No
          761381
          Application Docs Date
          2026-05-18 00:00:00
          Application Docs ID
          85950
          Application Docs Title
          0
          Application Docs Type ID
          2
          Submission No
          12
          Submission Type
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        all submission records
        1. Appl No
          761381
          Review Priority
          STANDARD
          Submission Class Code ID
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        2. Appl No
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          Submission No
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        3. Appl No
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        4. Appl No
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        5. Appl No
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        6. Appl No
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        1. Active Ingredient
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          Reference Standard
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          1. Prescription

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          1 INDICATIONS AND USAGE OPDIVO QVANTIG is a combination of nivolumab, a programmed death receptor-1 (PD-1)-blocking antibody, and hyaluronidase, an endoglycosidase, indicated for the treatment of: Renal Cell Carcinoma (RCC)
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          OPDIVO QVANTIG is a combination of nivolumab, a programmed death receptor-1 (PD-1)-blocking antibody, and hyaluronidase, an endoglycosidase, indicated for the treatment of: Renal Cell Carcinoma (RCC) • adult patients with intermediate or poor risk advanced RCC, as a first-line treatment following combination treatment with intravenous nivolumab and ipilimumab. (1.1) • Limitations of Use: OPDIVO QVANTIG is not indicated in combination with ipilimumab for the treatment of renal cell carcinoma. • adult patients with advanced RCC, as a first-line treatment in
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                                Passage 10 · unclassified context
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                                    source url
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                                    Passage 11 · unclassified context
                                    application numbers
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                                    4. context exact
                                      r who weigh 30 kg or greater) patients with unresectable or metastatic melanoma following combination treatment with intravenous nivolumab and ipilimumab.
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                                    5. context exact
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                                        1424
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                                        true
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                                        1390
                                      2. abbreviation
                                        CRC
                                        definition exact
                                        Colorectal Cancer
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                                        3023
                                        end exclusive
                                        true
                                        exact text
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                                      source url
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                                      limitations
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                                      line
                                      Source null
                                      prior therapy
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                                      regimen
                                      Source null
                                      tumor histology
                                      Source null
                                      use intent
                                      unclear
                                      Passage 12 · unclassified context
                                      application numbers
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                                      brand names
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                                      classification reasons
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                                      content role
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                                      true
                                      exact text
                                      1.2) • adult and pediatric (12 years and older who weigh 30 kg or greater) patients with unresectable or metastatic melanoma following combination treatment with intravenous nivolumab and ipilimumab. (1.2) • Limitations of Use: OPDIVO QVANTIG is not indicated in combination with ipilimumab for the treatment of unresectable or metastatic melanoma. • for the adjuvant treatment of adult and pediatric (12
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                                          source defined aliases
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                                            1424
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                                            true
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                                          2. abbreviation
                                            CRC
                                            definition exact
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                                            end exclusive
                                            true
                                            exact text
                                            Colorectal Cancer (CRC)
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                                          biomarker and test
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                                          disease stage
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                                          line
                                          Source null
                                          prior therapy
                                          Source null
                                          regimen
                                          Source null
                                          tumor histology
                                          Source null
                                          use intent
                                          unclear
                                          Passage 13 · limitation of use
                                          application numbers
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                                          brand names
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                                                          • adult patients with resectable (tumors ≥4 cm or node positive) NSCLC and n
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                                                          sectable (tumors ≥4 cm or node positive) NSCLC and no known EGFR mutations or ALK rearrangements, for neoadjuvant treatment, in combination with platinum-do
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                                                          resectable (tumors ≥4 cm or node positive) NS
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                                                          SCLC and no known EGFR mutations or ALK rearrangements, for neoadjuvant treatment, in combination with platinum-doublet chemotherapy, followe
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                                                          neoadjuvant treatment
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                                                          Passage 19 · unclassified context
                                                          application numbers
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                                                                use intent
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                                                                Passage 21 · unclassified context
                                                                application numbers
                                                                1. BLA761381
                                                                brand names
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                                                                classification reasons
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                                                                    CRC
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                                                                  source url
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                                                                  Passage 22 · unclassified context
                                                                  application numbers
                                                                  1. BLA761381
                                                                  brand names
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                                                                  classification reasons
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                                                                        CRC
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                                                                      unclear
                                                                      Passage 23 · limitation of use
                                                                      application numbers
                                                                      1. BLA761381
                                                                      brand names
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                                                                      classification reasons
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                                                                        2. abbreviation
                                                                          CRC
                                                                          definition exact
                                                                          Colorectal Cancer
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                                                                          true
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                                                                                  application numbers
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                                                                                              Passage 31 · unclassified context
                                                                                              application numbers
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                                                                                                  CRC
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                                                                                                tumor histology
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                                                                                                unclear
                                                                                                Passage 32 · unclassified context
                                                                                                application numbers
                                                                                                1. BLA761381
                                                                                                brand names
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                                                                                                classification reasons
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                                                                                                      Non-Small Cell Lung Cancer
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                                                                                                      CRC
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                                                                                                    Source null
                                                                                                    use intent
                                                                                                    unclear
                                                                                                    Passage 33 · unclassified context
                                                                                                    application numbers
                                                                                                    1. BLA761381
                                                                                                    brand names
                                                                                                    1. OPDIVO QVANTIG
                                                                                                    classification reasons
                                                                                                    1. no_unambiguous_positive_indication_predicate
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                                                                                                      • have disease progression within 12 months of neoadjuvant or adjuvant treatment with platinum-containing chemotherapy.
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                                                                                                        CRC
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                                                                                                      Source null
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                                                                                                      unclear
                                                                                                      Passage 34 · unclassified context
                                                                                                      application numbers
                                                                                                      1. BLA761381
                                                                                                      brand names
                                                                                                      1. OPDIVO QVANTIG
                                                                                                      classification reasons
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                                                                                                      pending
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                                                                                                      generic names
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                                                                                                      id
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                                                                                                      label id
                                                                                                      1ce25608-1b8f-4d49-9ffd-6c8c61bf4f1a
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                                                                                                          source defined aliases
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                                                                                                          Passage 35 · unclassified context
                                                                                                          application numbers
                                                                                                          1. BLA761381
                                                                                                          brand names
                                                                                                          1. OPDIVO QVANTIG
                                                                                                          classification reasons
                                                                                                          1. no_unambiguous_positive_indication_predicate
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                                                                                                          2. context exact
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                                                                                                            age
                                                                                                            polarity
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                                                                                                            age
                                                                                                            polarity
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                                                                                                            3065
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                                                                                                            3047
                                                                                                          4. context exact
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                                                                                                            kind
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                                                                                                            3124
                                                                                                          5. context exact
                                                                                                            unresectable or metastatic microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) colorectal cancer (CRC), following combination treatment with
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                                                                                                            polarity
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                                                                                                          6. context exact
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                                                                                                            source defined aliases
                                                                                                            1. abbreviation
                                                                                                              NSCLC
                                                                                                              definition exact
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                                                                                                              1424
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                                                                                                            2. abbreviation
                                                                                                              CRC
                                                                                                              definition exact
                                                                                                              Colorectal Cancer
                                                                                                              definition span
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                                                                                                              3023
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                                                                                                            Passage 36 · unclassified context
                                                                                                            application numbers
                                                                                                            1. BLA761381
                                                                                                            brand names
                                                                                                            1. OPDIVO QVANTIG
                                                                                                            classification reasons
                                                                                                            1. no_unambiguous_positive_indication_predicate
                                                                                                            clinical review status
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                                                                                                                  definition exact
                                                                                                                  Non-Small Cell Lung Cancer
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                                                                                                                  CRC
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                                                                                                                  Colorectal Cancer
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                                                                                                                tumor histology
                                                                                                                Source null
                                                                                                                use intent
                                                                                                                unclear
                                                                                                                Passage 37 · limitation of use
                                                                                                                application numbers
                                                                                                                1. BLA761381
                                                                                                                brand names
                                                                                                                1. OPDIVO QVANTIG
                                                                                                                classification reasons
                                                                                                                1. negative_or_not_established_clause
                                                                                                                clinical review status
                                                                                                                pending
                                                                                                                content role
                                                                                                                limitation_of_use
                                                                                                                context span
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                                                                                                                end exclusive
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                                                                                                                exact text
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                                                                                                                extraction review status
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                                                                                                                1. NIVOLUMAB AND HYALURONIDASE-NVHY
                                                                                                                id
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                                                                                                                qualifier mentions
                                                                                                                1. context exact
                                                                                                                  nation with ipilimumab for the treatment of unresectable or metastatic MSI-H or dMMR CRC.
                                                                                                                  kind
                                                                                                                  biomarker
                                                                                                                  polarity
                                                                                                                  not_inferred
                                                                                                                  span
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                                                                                                                  true
                                                                                                                  exact text
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                                                                                                                2. context exact
                                                                                                                  dicated in combination with ipilimumab for the treatment of unresectable or metastatic MSI-H or dMMR CRC.
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                                                                                                                  stage_or_setting
                                                                                                                  polarity
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                                                                                                                  • Limitations of Use: OPDIVO QVANTIG is not indicated in combination with ipilimumab for the treatment of unresectable or metastatic MSI-H or dMMR CRC.
                                                                                                                  kind
                                                                                                                  regimen
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                                                                                                                    NSCLC
                                                                                                                    definition exact
                                                                                                                    Non-Small Cell Lung Cancer
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                                                                                                                    CRC
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                                                                                                                    Colorectal Cancer
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                                                                                                                  Passage 38 · unclassified context
                                                                                                                  application numbers
                                                                                                                  1. BLA761381
                                                                                                                  brand names
                                                                                                                  1. OPDIVO QVANTIG
                                                                                                                  classification reasons
                                                                                                                  1. no_unambiguous_positive_indication_predicate
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                                                                                                                  1. context exact
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                                                                                                                    polarity
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                                                                                                                    kind
                                                                                                                    age
                                                                                                                    polarity
                                                                                                                    not_inferred
                                                                                                                    span
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                                                                                                                  3. context exact
                                                                                                                    • adult and pediatric (12 years and older who weigh 30 kg or greater) patients with MSI-H or dMMR met
                                                                                                                    kind
                                                                                                                    age
                                                                                                                    polarity
                                                                                                                    not_inferred
                                                                                                                    span
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                                                                                                                    start
                                                                                                                    3492
                                                                                                                  4. context exact
                                                                                                                    2 years and older who weigh 30 kg or greater) patients with MSI-H or dMMR metastatic CRC that has progressed following treatment with a fluoropyrimidine, oxaliplatin
                                                                                                                    kind
                                                                                                                    biomarker
                                                                                                                    polarity
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                                                                                                                    span
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                                                                                                                    3598
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                                                                                                                    exact text
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                                                                                                                    start
                                                                                                                    3553
                                                                                                                  5. context exact
                                                                                                                    der who weigh 30 kg or greater) patients with MSI-H or dMMR metastatic CRC that has progressed following treatment with a fluoropyrimidine, oxaliplatin, and irinotec
                                                                                                                    kind
                                                                                                                    stage_or_setting
                                                                                                                    polarity
                                                                                                                    not_inferred
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                                                                                                                    3612
                                                                                                                    end exclusive
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                                                                                                                    exact text
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                                                                                                                    source defined aliases
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                                                                                                                      NSCLC
                                                                                                                      definition exact
                                                                                                                      Non-Small Cell Lung Cancer
                                                                                                                      definition span
                                                                                                                      end
                                                                                                                      1424
                                                                                                                      end exclusive
                                                                                                                      true
                                                                                                                      exact text
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                                                                                                                    2. abbreviation
                                                                                                                      CRC
                                                                                                                      definition exact
                                                                                                                      Colorectal Cancer
                                                                                                                      definition span
                                                                                                                      end
                                                                                                                      3023
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                                                                                                                      true
                                                                                                                      exact text
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                                                                                                                    true
                                                                                                                    exact text
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                                                                                                                    spl effective date
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                                                                                                                    prior therapy
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                                                                                                                    regimen
                                                                                                                    Source null
                                                                                                                    tumor histology
                                                                                                                    Source null
                                                                                                                    use intent
                                                                                                                    unclear
                                                                                                                    Passage 39 · unclassified context
                                                                                                                    application numbers
                                                                                                                    1. BLA761381
                                                                                                                    brand names
                                                                                                                    1. OPDIVO QVANTIG
                                                                                                                    classification reasons
                                                                                                                    1. no_unambiguous_positive_indication_predicate
                                                                                                                    clinical review status
                                                                                                                    pending
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                                                                                                                    exact text
                                                                                                                    and pediatric (12 years and older who weigh 30 kg or greater) patients with MSI-H or dMMR metastatic CRC that has progressed following treatment with a fluoropyrimidine, oxaliplatin, and irinotecan. (1.9) • Limitations of Use: OPDIVO QVANTIG is not indicated in combination with ipilimumab for the treatment of unresectable or metastatic MSI-H or dMMR CRC. Hepatocellular Carcinoma (HCC) • adult patients
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                                                                                                                    generic names
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                                                                                                                    id
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                                                                                                                    label id
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                                                                                                                    positive predicate support span
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                                                                                                                    qualifier mentions
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                                                                                                                        source defined aliases
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                                                                                                                          definition exact
                                                                                                                          Non-Small Cell Lung Cancer
                                                                                                                          definition span
                                                                                                                          end
                                                                                                                          1424
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                                                                                                                          true
                                                                                                                          exact text
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                                                                                                                          source field
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                                                                                                                        2. abbreviation
                                                                                                                          CRC
                                                                                                                          definition exact
                                                                                                                          Colorectal Cancer
                                                                                                                          definition span
                                                                                                                          end
                                                                                                                          3023
                                                                                                                          end exclusive
                                                                                                                          true
                                                                                                                          exact text
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                                                                                                                        exact text
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                                                                                                                        source url
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                                                                                                                        spl effective date
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                                                                                                                        age
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                                                                                                                        Source null
                                                                                                                        biomarker and test
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                                                                                                                        disease stage
                                                                                                                        Source null
                                                                                                                        limitations
                                                                                                                        Source null
                                                                                                                        line
                                                                                                                        Source null
                                                                                                                        prior therapy
                                                                                                                        Source null
                                                                                                                        regimen
                                                                                                                        Source null
                                                                                                                        tumor histology
                                                                                                                        Source null
                                                                                                                        use intent
                                                                                                                        unclear
                                                                                                                        Passage 40 · limitation of use
                                                                                                                        application numbers
                                                                                                                        1. BLA761381
                                                                                                                        brand names
                                                                                                                        1. OPDIVO QVANTIG
                                                                                                                        classification reasons
                                                                                                                        1. negative_or_not_established_clause
                                                                                                                        clinical review status
                                                                                                                        pending
                                                                                                                        content role
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                                                                                                                          brand names
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                                                                                                                              2. abbreviation
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                                                                                                                                Colorectal Cancer
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                                                                                                                              Passage 42 · unclassified context
                                                                                                                              application numbers
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                                                                                                                              brand names
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                                                                                                                              classification reasons
                                                                                                                              1. no_unambiguous_positive_indication_predicate
                                                                                                                              clinical review status
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                                                                                                                              generic names
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                                                                                                                                2. abbreviation
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                                                                                                                                  Colorectal Cancer
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                                                                                                                                Passage 43 · unclassified context
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                                                                                                                                brand names
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                                                                                                                                    Passage 44 · unclassified context
                                                                                                                                    application numbers
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                                                                                                                                    brand names
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                                                                                                                                    classification reasons
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                                                                                                                                    4. context exact
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                                                                                                                                        exact text
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                                                                                                                                      2. abbreviation
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                                                                                                                                        Colorectal Cancer
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                                                                                                                                      exact text
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                                                                                                                                      tumor histology
                                                                                                                                      Source null
                                                                                                                                      use intent
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                                                                                                                                      Passage 45 · unclassified context
                                                                                                                                      application numbers
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                                                                                                                                      brand names
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                                                                                                                                      classification reasons
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                                                                                                                                      generic names
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                                                                                                                                            definition exact
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                                                                                                                                            end
                                                                                                                                            1424
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                                                                                                                                            exact text
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                                                                                                                                          2. abbreviation
                                                                                                                                            CRC
                                                                                                                                            definition exact
                                                                                                                                            Colorectal Cancer
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                                                                                                                                            end
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                                                                                                                                            exact text
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                                                                                                                                          application numbers
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                                                                                                                                          brand names
                                                                                                                                          1. OPDIVO QVANTIG
                                                                                                                                          classification reasons
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                                                                                                                                            source defined aliases
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                                                                                                                                              NSCLC
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                                                                                                                                            2. abbreviation
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                                                                                                                                              Colorectal Cancer
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                                                                                                                                            exact text
                                                                                                                                            • Limitations of Use: OPDIVO QVANTIG is not indicated in combination with ipilimumab for the treatment of unresectable or metastatic HCC.
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                                                                                                                                            tumor histology
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                                                                                                                                            use intent
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                                                                                                                                            Passage 47 · unclassified context
                                                                                                                                            application numbers
                                                                                                                                            1. BLA761381
                                                                                                                                            brand names
                                                                                                                                            1. OPDIVO QVANTIG
                                                                                                                                            classification reasons
                                                                                                                                            1. no_unambiguous_positive_indication_predicate
                                                                                                                                            clinical review status
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                                                                                                                                            n treatment with intravenous nivolumab and ipilimumab. (1.10) • Limitations of Use: OPDIVO QVANTIG is not indicated in combination with ipilimumab for the treatment of unresectable or metastatic HCC. Esophageal Cancer • adult patients with completely resected esophageal or gastroesophageal junction cancer with residual pathologic disease, who have received neoadjuvant chemoradiotherapy (CRT). (1.11) • adult patien
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                                                                                                                                            generic names
                                                                                                                                            1. NIVOLUMAB AND HYALURONIDASE-NVHY
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                                                                                                                                                  definition exact
                                                                                                                                                  Non-Small Cell Lung Cancer
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                                                                                                                                                2. abbreviation
                                                                                                                                                  CRC
                                                                                                                                                  definition exact
                                                                                                                                                  Colorectal Cancer
                                                                                                                                                  definition span
                                                                                                                                                  end
                                                                                                                                                  3023
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                                                                                                                                                  true
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                                                                                                                                                Passage 48 · unclassified context
                                                                                                                                                application numbers
                                                                                                                                                1. BLA761381
                                                                                                                                                brand names
                                                                                                                                                1. OPDIVO QVANTIG
                                                                                                                                                classification reasons
                                                                                                                                                1. no_unambiguous_positive_indication_predicate
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                                                                                                                                                ntravenous nivolumab and ipilimumab. (1.10) • Limitations of Use: OPDIVO QVANTIG is not indicated in combination with ipilimumab for the treatment of unresectable or metastatic HCC. Esophageal Cancer • adult patients with completely resected esophageal or gastroesophageal junction cancer with residual pathologic disease, who have received neoadjuvant chemoradiotherapy (CRT). (1.11) • adult patients with unresectable advanced or metastatic esophageal squamous cell carcinoma (ESCC) as first-line treatment in combination with fluoropyrimidine- and platinum-containing chemot
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                                                                                                                                                extraction review status
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                                                                                                                                                generic names
                                                                                                                                                1. NIVOLUMAB AND HYALURONIDASE-NVHY
                                                                                                                                                id
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                                                                                                                                                2. context exact
                                                                                                                                                  cancer with residual pathologic disease, who have received neoadjuvant chemoradiotherapy (CRT).
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                                                                                                                                                  exact text
                                                                                                                                                  neoadjuvant chemoradiotherapy (CRT)
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                                                                                                                                                3. context exact
                                                                                                                                                  sophageal junction cancer with residual pathologic disease, who have received neoadjuvant chemoradiotherapy (CRT).
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                                                                                                                                                  exact text
                                                                                                                                                  who have received neoadjuvant chemoradiotherapy (CRT)
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                                                                                                                                                  source defined aliases
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                                                                                                                                                    definition exact
                                                                                                                                                    Non-Small Cell Lung Cancer
                                                                                                                                                    definition span
                                                                                                                                                    end
                                                                                                                                                    1424
                                                                                                                                                    end exclusive
                                                                                                                                                    true
                                                                                                                                                    exact text
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                                                                                                                                                  exact text
                                                                                                                                                  • adult patients with completely resected esophageal or gastroesophageal junction cancer with residual pathologic disease, who have received neoadjuvant chemoradiotherapy (CRT).
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                                                                                                                                                  Passage 49 · unclassified context
                                                                                                                                                  application numbers
                                                                                                                                                  1. BLA761381
                                                                                                                                                  brand names
                                                                                                                                                  1. OPDIVO QVANTIG
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                                                                                                                                                  1. no_unambiguous_positive_indication_predicate
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                                                                                                                                                  CC. Esophageal Cancer • adult patients with completely resected esophageal or gastroesophageal junction cancer with residual pathologic disease, who have received neoadjuvant chemoradiotherapy (CRT). (1.11) • adult patients with unresectable advanced or metastatic esophageal squamous cell carcinoma (ESCC) as first-line treatment in combination with fluoropyrimidine- and platinum-containing chemotherapy
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                                                                                                                                                  generic names
                                                                                                                                                  1. NIVOLUMAB AND HYALURONIDASE-NVHY
                                                                                                                                                  id
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                                                                                                                                                        NSCLC
                                                                                                                                                        definition exact
                                                                                                                                                        Non-Small Cell Lung Cancer
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                                                                                                                                                        1424
                                                                                                                                                        end exclusive
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                                                                                                                                                        exact text
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                                                                                                                                                      2. abbreviation
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                                                                                                                                                        definition exact
                                                                                                                                                        Colorectal Cancer
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                                                                                                                                                      (1.11)
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                                                                                                                                                      source url
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                                                                                                                                                      spl set id
                                                                                                                                                      7f8c38fa-42f4-4387-9e8c-7a1c66855d8b
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                                                                                                                                                      Source null
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                                                                                                                                                      tumor histology
                                                                                                                                                      Source null
                                                                                                                                                      use intent
                                                                                                                                                      unclear
                                                                                                                                                      Passage 50 · unclassified context
                                                                                                                                                      application numbers
                                                                                                                                                      1. BLA761381
                                                                                                                                                      brand names
                                                                                                                                                      1. OPDIVO QVANTIG
                                                                                                                                                      classification reasons
                                                                                                                                                      1. no_unambiguous_positive_indication_predicate
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                                                                                                                                                      phageal Cancer • adult patients with completely resected esophageal or gastroesophageal junction cancer with residual pathologic disease, who have received neoadjuvant chemoradiotherapy (CRT). (1.11) • adult patients with unresectable advanced or metastatic esophageal squamous cell carcinoma (ESCC) as first-line treatment in combination with fluoropyrimidine- and platinum-containing chemotherapy whose tumors express PD-L1 (≥1). (1.11) • Limitations of Use: OPDIVO QVANTIG is not indicated in combination with ipilimumab for the treatment of patients with unresectable advanced or metastatic ESCC. • adult patients with unresect
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                                                                                                                                                      extraction review status
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                                                                                                                                                      generic names
                                                                                                                                                      1. NIVOLUMAB AND HYALURONIDASE-NVHY
                                                                                                                                                      id
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                                                                                                                                                      qualifier mentions
                                                                                                                                                      1. context exact
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                                                                                                                                                        adult patients
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                                                                                                                                                        metastatic esophageal squamous cell carcino
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                                                                                                                                                      3. context exact
                                                                                                                                                        - and platinum-containing chemotherapy whose tumors express PD-L1 (≥1).
                                                                                                                                                        kind
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                                                                                                                                                        PD-L1 (≥1)
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                                                                                                                                                      4. context exact
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                                                                                                                                                        stage_or_setting
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                                                                                                                                                        true
                                                                                                                                                        exact text
                                                                                                                                                        unresectable advanced or metastatic esophageal
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                                                                                                                                                      5. context exact
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                                                                                                                                                      6. context exact
                                                                                                                                                        geal squamous cell carcinoma (ESCC) as first-line treatment in combination with fluoropyrimidine- and platinum-containing chemotherapy whose tumors express PD-L1 (≥1).
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                                                                                                                                                        exact text
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                                                                                                                                                        source defined aliases
                                                                                                                                                        1. abbreviation
                                                                                                                                                          NSCLC
                                                                                                                                                          definition exact
                                                                                                                                                          Non-Small Cell Lung Cancer
                                                                                                                                                          definition span
                                                                                                                                                          end
                                                                                                                                                          1424
                                                                                                                                                          end exclusive
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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
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                                                                                                                                                          3023
                                                                                                                                                          end exclusive
                                                                                                                                                          true
                                                                                                                                                          exact text
                                                                                                                                                          Colorectal Cancer (CRC)
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                                                                                                                                                        exact text
                                                                                                                                                        • adult patients with unresectable advanced or metastatic esophageal squamous cell carcinoma (ESCC) as first-line treatment in combination with fluoropyrimidine- and platinum-containing chemotherapy whose tumors express PD-L1 (≥1).
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                                                                                                                                                        source url
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                                                                                                                                                        spl effective date
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                                                                                                                                                        approval pathway
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                                                                                                                                                        biomarker and test
                                                                                                                                                        Source null
                                                                                                                                                        disease stage
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                                                                                                                                                        limitations
                                                                                                                                                        Source null
                                                                                                                                                        line
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                                                                                                                                                        prior therapy
                                                                                                                                                        Source null
                                                                                                                                                        regimen
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                                                                                                                                                        tumor histology
                                                                                                                                                        Source null
                                                                                                                                                        use intent
                                                                                                                                                        unclear
                                                                                                                                                        Passage 51 · unclassified context
                                                                                                                                                        application numbers
                                                                                                                                                        1. BLA761381
                                                                                                                                                        brand names
                                                                                                                                                        1. OPDIVO QVANTIG
                                                                                                                                                        classification reasons
                                                                                                                                                        1. no_unambiguous_positive_indication_predicate
                                                                                                                                                        clinical review status
                                                                                                                                                        pending
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                                                                                                                                                        le advanced or metastatic esophageal squamous cell carcinoma (ESCC) as first-line treatment in combination with fluoropyrimidine- and platinum-containing chemotherapy whose tumors express PD-L1 (≥1). (1.11) • Limitations of Use: OPDIVO QVANTIG is not indicated in combination with ipilimumab for the treatment of patients with unresectable advanced or metastatic ESCC. • adult patients with unresectable ad
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                                                                                                                                                        current approval status
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                                                                                                                                                        extraction review status
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                                                                                                                                                        generic names
                                                                                                                                                        1. NIVOLUMAB AND HYALURONIDASE-NVHY
                                                                                                                                                        id
                                                                                                                                                        ind-span-0cecc5f7adefd705e4f2
                                                                                                                                                        label id
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                                                                                                                                                        positive predicate support span
                                                                                                                                                        Source null
                                                                                                                                                        qualifier mentions
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                                                                                                                                                            source defined aliases
                                                                                                                                                            1. abbreviation
                                                                                                                                                              NSCLC
                                                                                                                                                              definition exact
                                                                                                                                                              Non-Small Cell Lung Cancer
                                                                                                                                                              definition span
                                                                                                                                                              end
                                                                                                                                                              1424
                                                                                                                                                              end exclusive
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                                                                                                                                                              exact text
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                                                                                                                                                            2. abbreviation
                                                                                                                                                              CRC
                                                                                                                                                              definition exact
                                                                                                                                                              Colorectal Cancer
                                                                                                                                                              definition span
                                                                                                                                                              end
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                                                                                                                                                              Colorectal Cancer (CRC)
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                                                                                                                                                              source field
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                                                                                                                                                            exact text
                                                                                                                                                            (1.11)
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                                                                                                                                                            source url
                                                                                                                                                            https://api.fda.gov/drug/label.json?search=id%3A%221ce25608-1b8f-4d49-9ffd-6c8c61bf4f1a%22
                                                                                                                                                            spl effective date
                                                                                                                                                            2026-05-12
                                                                                                                                                            spl set id
                                                                                                                                                            7f8c38fa-42f4-4387-9e8c-7a1c66855d8b
                                                                                                                                                            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 52 · limitation of use
                                                                                                                                                            application numbers
                                                                                                                                                            1. BLA761381
                                                                                                                                                            brand names
                                                                                                                                                            1. OPDIVO QVANTIG
                                                                                                                                                            classification reasons
                                                                                                                                                            1. negative_or_not_established_clause
                                                                                                                                                            clinical review status
                                                                                                                                                            pending
                                                                                                                                                            content role
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                                                                                                                                                            context span
                                                                                                                                                            end
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                                                                                                                                                            end exclusive
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                                                                                                                                                            exact text
                                                                                                                                                            nced or metastatic esophageal squamous cell carcinoma (ESCC) as first-line treatment in combination with fluoropyrimidine- and platinum-containing chemotherapy whose tumors express PD-L1 (≥1). (1.11) • Limitations of Use: OPDIVO QVANTIG is not indicated in combination with ipilimumab for the treatment of patients with unresectable advanced or metastatic ESCC. • adult patients with unresectable advanced, recurrent or metastatic ESCC after prior fluoropyrimidine- and platinum-based chemotherapy. (1.11) Gastric Cancer, Gastroesophageal Junction Cancer, and E
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                                                                                                                                                            current approval status
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                                                                                                                                                            duplicate text group
                                                                                                                                                            dup-9766147085df91ab073f
                                                                                                                                                            extraction review status
                                                                                                                                                            automated_candidate_pending_source_review
                                                                                                                                                            generic names
                                                                                                                                                            1. NIVOLUMAB AND HYALURONIDASE-NVHY
                                                                                                                                                            id
                                                                                                                                                            ind-span-452963e952e66c8cdd6d
                                                                                                                                                            label id
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                                                                                                                                                            positive predicate support span
                                                                                                                                                            Source null
                                                                                                                                                            qualifier mentions
                                                                                                                                                            1. context exact
                                                                                                                                                              for the treatment of patients with unresectable advanced or metastatic ESCC.
                                                                                                                                                              kind
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                                                                                                                                                              polarity
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                                                                                                                                                              exact text
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                                                                                                                                                            2. context exact
                                                                                                                                                              bination with ipilimumab for the treatment of patients with unresectable advanced or metastatic ESCC.
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                                                                                                                                                              polarity
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                                                                                                                                                              span
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                                                                                                                                                              exact text
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                                                                                                                                                              4912
                                                                                                                                                            3. context exact
                                                                                                                                                              • Limitations of Use: OPDIVO QVANTIG is not indicated in combination with ipilimumab for the treatment of patients with unresectable advanced or metastatic ESCC.
                                                                                                                                                              kind
                                                                                                                                                              regimen
                                                                                                                                                              polarity
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                                                                                                                                                              span
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                                                                                                                                                              4952
                                                                                                                                                              end exclusive
                                                                                                                                                              true
                                                                                                                                                              exact text
                                                                                                                                                              in combination with ipilimumab for the treatment of patients with unresectable advanced or metastatic ESCC
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                                                                                                                                                            regulatory links
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                                                                                                                                                              source defined aliases
                                                                                                                                                              1. abbreviation
                                                                                                                                                                NSCLC
                                                                                                                                                                definition exact
                                                                                                                                                                Non-Small Cell Lung Cancer
                                                                                                                                                                definition span
                                                                                                                                                                end
                                                                                                                                                                1424
                                                                                                                                                                end exclusive
                                                                                                                                                                true
                                                                                                                                                                exact text
                                                                                                                                                                Non-Small Cell Lung Cancer (NSCLC)
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                                                                                                                                                                1ce25608-1b8f-4d49-9ffd-6c8c61bf4f1a
                                                                                                                                                                offset unit
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                                                                                                                                                                source array index
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                                                                                                                                                                source field
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                                                                                                                                                                1390
                                                                                                                                                              2. abbreviation
                                                                                                                                                                CRC
                                                                                                                                                                definition exact
                                                                                                                                                                Colorectal Cancer
                                                                                                                                                                definition span
                                                                                                                                                                end
                                                                                                                                                                3023
                                                                                                                                                                end exclusive
                                                                                                                                                                true
                                                                                                                                                                exact text
                                                                                                                                                                Colorectal Cancer (CRC)
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                                                                                                                                                                source array index
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                                                                                                                                                              source span
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                                                                                                                                                              4953
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                                                                                                                                                              exact text
                                                                                                                                                              • Limitations of Use: OPDIVO QVANTIG is not indicated in combination with ipilimumab for the treatment of patients with unresectable advanced or metastatic ESCC.
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                                                                                                                                                              source url
                                                                                                                                                              https://api.fda.gov/drug/label.json?search=id%3A%221ce25608-1b8f-4d49-9ffd-6c8c61bf4f1a%22
                                                                                                                                                              spl effective date
                                                                                                                                                              2026-05-12
                                                                                                                                                              spl set id
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                                                                                                                                                              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
                                                                                                                                                              not_applicable
                                                                                                                                                              Passage 53 · unclassified context
                                                                                                                                                              application numbers
                                                                                                                                                              1. BLA761381
                                                                                                                                                              brand names
                                                                                                                                                              1. OPDIVO QVANTIG
                                                                                                                                                              classification reasons
                                                                                                                                                              1. no_unambiguous_positive_indication_predicate
                                                                                                                                                              clinical review status
                                                                                                                                                              pending
                                                                                                                                                              content role
                                                                                                                                                              unclassified_context
                                                                                                                                                              context span
                                                                                                                                                              end
                                                                                                                                                              5290
                                                                                                                                                              end exclusive
                                                                                                                                                              true
                                                                                                                                                              exact text
                                                                                                                                                              ose tumors express PD-L1 (≥1). (1.11) • Limitations of Use: OPDIVO QVANTIG is not indicated in combination with ipilimumab for the treatment of patients with unresectable advanced or metastatic ESCC. • adult patients with unresectable advanced, recurrent or metastatic ESCC after prior fluoropyrimidine- and platinum-based chemotherapy. (1.11) Gastric Cancer, Gastroesophageal Junction Cancer, and Esophageal Adenocarcinoma • adult patients with advanced or metastatic gastric cancer, gastroesophageal junction cancer, and esophageal ad
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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 AND HYALURONIDASE-NVHY
                                                                                                                                                              id
                                                                                                                                                              ind-span-4a4d97bc9da58c083672
                                                                                                                                                              label id
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                                                                                                                                                              positive predicate support span
                                                                                                                                                              Source null
                                                                                                                                                              qualifier mentions
                                                                                                                                                              1. context exact
                                                                                                                                                                • adult patients with unresectable advanced, recurrent or metastatic ESCC af
                                                                                                                                                                kind
                                                                                                                                                                age
                                                                                                                                                                polarity
                                                                                                                                                                not_inferred
                                                                                                                                                                span
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                                                                                                                                                                4970
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                                                                                                                                                                true
                                                                                                                                                                exact text
                                                                                                                                                                adult patients
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                                                                                                                                                                source field
                                                                                                                                                                indications_and_usage_exact
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                                                                                                                                                              2. context exact
                                                                                                                                                                • adult patients with unresectable advanced, recurrent or metastatic ESCC after prior fluoropyrimidine- and platinum-based chemotherapy.
                                                                                                                                                                kind
                                                                                                                                                                biomarker
                                                                                                                                                                polarity
                                                                                                                                                                not_inferred
                                                                                                                                                                span
                                                                                                                                                                end
                                                                                                                                                                5055
                                                                                                                                                                end exclusive
                                                                                                                                                                true
                                                                                                                                                                exact text
                                                                                                                                                                metastatic ESCC after prior fluoropyrimidin
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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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                                                                                                                                                                5012
                                                                                                                                                              3. context exact
                                                                                                                                                                • adult patients with unresectable advanced, recurrent or metastatic ESCC after prior fluoropyrimidine-
                                                                                                                                                                kind
                                                                                                                                                                stage_or_setting
                                                                                                                                                                polarity
                                                                                                                                                                not_inferred
                                                                                                                                                                span
                                                                                                                                                                end
                                                                                                                                                                4997
                                                                                                                                                                end exclusive
                                                                                                                                                                true
                                                                                                                                                                exact text
                                                                                                                                                                unresectable advanced
                                                                                                                                                                label id
                                                                                                                                                                1ce25608-1b8f-4d49-9ffd-6c8c61bf4f1a
                                                                                                                                                                offset unit
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                                                                                                                                                              4. context exact
                                                                                                                                                                • adult patients with unresectable advanced, recurrent or metastatic ESCC after prior fluoropyrimidine- and platinum-based chemotherapy.
                                                                                                                                                                kind
                                                                                                                                                                stage_or_setting
                                                                                                                                                                polarity
                                                                                                                                                                not_inferred
                                                                                                                                                                span
                                                                                                                                                                end
                                                                                                                                                                5043
                                                                                                                                                                end exclusive
                                                                                                                                                                true
                                                                                                                                                                exact text
                                                                                                                                                                recurrent or metastatic ESCC after prior flu
                                                                                                                                                                label id
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                                                                                                                                                                source field
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                                                                                                                                                              regulatory links
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                                                                                                                                                                source defined aliases
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                                                                                                                                                                  definition exact
                                                                                                                                                                  Non-Small Cell Lung Cancer
                                                                                                                                                                  definition span
                                                                                                                                                                  end
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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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                                                                                                                                                                  true
                                                                                                                                                                  exact text
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                                                                                                                                                                • adult patients with unresectable advanced, recurrent or metastatic ESCC after prior fluoropyrimidine- and platinum-based chemotherapy.
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                                                                                                                                                                Source null
                                                                                                                                                                biomarker and test
                                                                                                                                                                Source null
                                                                                                                                                                disease stage
                                                                                                                                                                Source null
                                                                                                                                                                limitations
                                                                                                                                                                Source null
                                                                                                                                                                line
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                                                                                                                                                                prior therapy
                                                                                                                                                                Source null
                                                                                                                                                                regimen
                                                                                                                                                                Source null
                                                                                                                                                                tumor histology
                                                                                                                                                                Source null
                                                                                                                                                                use intent
                                                                                                                                                                unclear
                                                                                                                                                                Passage 54 · unclassified context
                                                                                                                                                                application numbers
                                                                                                                                                                1. BLA761381
                                                                                                                                                                brand names
                                                                                                                                                                1. OPDIVO QVANTIG
                                                                                                                                                                classification reasons
                                                                                                                                                                1. no_unambiguous_positive_indication_predicate
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                                                                                                                                                                ent of patients with unresectable advanced or metastatic ESCC. • adult patients with unresectable advanced, recurrent or metastatic ESCC after prior fluoropyrimidine- and platinum-based chemotherapy. (1.11) 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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                                                                                                                                                                extraction review status
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                                                                                                                                                                generic names
                                                                                                                                                                1. NIVOLUMAB AND HYALURONIDASE-NVHY
                                                                                                                                                                id
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                                                                                                                                                                    source defined aliases
                                                                                                                                                                    1. abbreviation
                                                                                                                                                                      NSCLC
                                                                                                                                                                      definition exact
                                                                                                                                                                      Non-Small Cell Lung Cancer
                                                                                                                                                                      definition span
                                                                                                                                                                      end
                                                                                                                                                                      1424
                                                                                                                                                                      end exclusive
                                                                                                                                                                      true
                                                                                                                                                                      exact text
                                                                                                                                                                      Non-Small Cell Lung Cancer (NSCLC)
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                                                                                                                                                                      unicode_code_points
                                                                                                                                                                      source array index
                                                                                                                                                                      0
                                                                                                                                                                      source field
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                                                                                                                                                                      source text sha256
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                                                                                                                                                                      1390
                                                                                                                                                                    2. abbreviation
                                                                                                                                                                      CRC
                                                                                                                                                                      definition exact
                                                                                                                                                                      Colorectal Cancer
                                                                                                                                                                      definition span
                                                                                                                                                                      end
                                                                                                                                                                      3023
                                                                                                                                                                      end exclusive
                                                                                                                                                                      true
                                                                                                                                                                      exact text
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                                                                                                                                                                    (1.11) Gastric Cancer, Gastroesophageal Junction Cancer, and Esophageal Adenocarcinoma
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                                                                                                                                                                    spl version
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                                                                                                                                                                    approval pathway
                                                                                                                                                                    Source null
                                                                                                                                                                    biomarker and test
                                                                                                                                                                    Source null
                                                                                                                                                                    disease stage
                                                                                                                                                                    Source null
                                                                                                                                                                    limitations
                                                                                                                                                                    Source null
                                                                                                                                                                    line
                                                                                                                                                                    Source null
                                                                                                                                                                    prior therapy
                                                                                                                                                                    Source null
                                                                                                                                                                    regimen
                                                                                                                                                                    Source null
                                                                                                                                                                    tumor histology
                                                                                                                                                                    Source null
                                                                                                                                                                    use intent
                                                                                                                                                                    unclear
                                                                                                                                                                    Passage 55 · unclassified context
                                                                                                                                                                    application numbers
                                                                                                                                                                    1. BLA761381
                                                                                                                                                                    brand names
                                                                                                                                                                    1. OPDIVO QVANTIG
                                                                                                                                                                    classification reasons
                                                                                                                                                                    1. no_unambiguous_positive_indication_predicate
                                                                                                                                                                    clinical review status
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                                                                                                                                                                    unclassified_context
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                                                                                                                                                                    resectable advanced, recurrent or metastatic ESCC after prior fluoropyrimidine- and platinum-based chemotherapy. (1.11) 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. (1.12) 1.1 Advanced Renal Cell Carcinoma OPDIVO QVANTIG™, as monotherapy, is indicated for the first-line treatment of adult patients with intermediate or poor risk advanced renal cell carcinoma (RCC
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                                                                                                                                                                    generic names
                                                                                                                                                                    1. NIVOLUMAB AND HYALURONIDASE-NVHY
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                                                                                                                                                                    qualifier mentions
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                                                                                                                                                                      kind
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                                                                                                                                                                    2. context exact
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                                                                                                                                                                      kind
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                                                                                                                                                                    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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                                                                                                                                                                      exact text
                                                                                                                                                                      PD-L1 (≥1) in combination with fluoropyrimidi
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                                                                                                                                                                      unicode_code_points
                                                                                                                                                                      source array index
                                                                                                                                                                      0
                                                                                                                                                                      source field
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                                                                                                                                                                      source text sha256
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                                                                                                                                                                    4. context exact
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                                                                                                                                                                      kind
                                                                                                                                                                      stage_or_setting
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                                                                                                                                                                      true
                                                                                                                                                                      exact text
                                                                                                                                                                      advanced or metastatic gastric cancer
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                                                                                                                                                                      0
                                                                                                                                                                      source field
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                                                                                                                                                                    5. context exact
                                                                                                                                                                      d esophageal adenocarcinoma whose tumors express PD-L1 (≥1) in combination with fluoropyrimidine- and platinum-containing chemotherapy.
                                                                                                                                                                      kind
                                                                                                                                                                      regimen
                                                                                                                                                                      polarity
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                                                                                                                                                                      exact text
                                                                                                                                                                      in combination with fluoropyrimidine- and platinum-containing chemotherapy
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                                                                                                                                                                      unicode_code_points
                                                                                                                                                                      source array index
                                                                                                                                                                      0
                                                                                                                                                                      source field
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                                                                                                                                                                      source text sha256
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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
                                                                                                                                                                        1424
                                                                                                                                                                        end exclusive
                                                                                                                                                                        true
                                                                                                                                                                        exact text
                                                                                                                                                                        Non-Small Cell Lung Cancer (NSCLC)
                                                                                                                                                                        label id
                                                                                                                                                                        1ce25608-1b8f-4d49-9ffd-6c8c61bf4f1a
                                                                                                                                                                        offset unit
                                                                                                                                                                        unicode_code_points
                                                                                                                                                                        source array index
                                                                                                                                                                        0
                                                                                                                                                                        source field
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                                                                                                                                                                        source text sha256
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                                                                                                                                                                      2. abbreviation
                                                                                                                                                                        CRC
                                                                                                                                                                        definition exact
                                                                                                                                                                        Colorectal Cancer
                                                                                                                                                                        definition span
                                                                                                                                                                        end
                                                                                                                                                                        3023
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                                                                                                                                                                        true
                                                                                                                                                                        exact text
                                                                                                                                                                        Colorectal Cancer (CRC)
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                                                                                                                                                                        unicode_code_points
                                                                                                                                                                        source array index
                                                                                                                                                                        0
                                                                                                                                                                        source field
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                                                                                                                                                                        source text sha256
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                                                                                                                                                                      source span
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                                                                                                                                                                      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.
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                                                                                                                                                                      0
                                                                                                                                                                      source field
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                                                                                                                                                                      source text sha256
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                                                                                                                                                                      source url
                                                                                                                                                                      https://api.fda.gov/drug/label.json?search=id%3A%221ce25608-1b8f-4d49-9ffd-6c8c61bf4f1a%22
                                                                                                                                                                      spl effective date
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                                                                                                                                                                      approval pathway
                                                                                                                                                                      Source null
                                                                                                                                                                      biomarker and test
                                                                                                                                                                      Source null
                                                                                                                                                                      disease stage
                                                                                                                                                                      Source null
                                                                                                                                                                      limitations
                                                                                                                                                                      Source null
                                                                                                                                                                      line
                                                                                                                                                                      Source null
                                                                                                                                                                      prior therapy
                                                                                                                                                                      Source null
                                                                                                                                                                      regimen
                                                                                                                                                                      Source null
                                                                                                                                                                      tumor histology
                                                                                                                                                                      Source null
                                                                                                                                                                      use intent
                                                                                                                                                                      unclear
                                                                                                                                                                      Passage 56 · unclassified context
                                                                                                                                                                      application numbers
                                                                                                                                                                      1. BLA761381
                                                                                                                                                                      brand names
                                                                                                                                                                      1. OPDIVO QVANTIG
                                                                                                                                                                      classification reasons
                                                                                                                                                                      1. no_unambiguous_positive_indication_predicate
                                                                                                                                                                      clinical review status
                                                                                                                                                                      pending
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                                                                                                                                                                      1. NIVOLUMAB AND HYALURONIDASE-NVHY
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                                                                                                                                                                          Passage 57 · positive indication candidate
                                                                                                                                                                          application numbers
                                                                                                                                                                          1. BLA761381
                                                                                                                                                                          brand names
                                                                                                                                                                          1. OPDIVO QVANTIG
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                                                                                                                                                                          atic gastric cancer, gastroesophageal junction cancer, and esophageal adenocarcinoma whose tumors express PD-L1 (≥1) in combination with fluoropyrimidine- and platinum-containing chemotherapy. (1.12) 1.1 Advanced Renal Cell Carcinoma OPDIVO QVANTIG™, as monotherapy, is indicated for the first-line treatment of adult patients with intermediate or poor risk advanced renal cell carcinoma (RCC) following treatment with intravenous nivolumab and ipilimumab combination therapy. Limitations of Use: OPDIVO QVANTIG is not indicated in combination with ipilimumab for the treatment of renal cell carcinoma. OPDIVO QVANTIG, in combination with cabozantinib, is indicated for the fi
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                                                                                                                                                                          generic names
                                                                                                                                                                          1. NIVOLUMAB AND HYALURONIDASE-NVHY
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                                                                                                                                                                          2. context exact
                                                                                                                                                                            1.1 Advanced Renal Cell Carcinoma OPDIVO QVANTIG™, as monotherapy, is indicated for the first-line treatmen
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                                                                                                                                                                          4. context exact
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                                                                                                                                                                            kind
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                                                                                                                                                                          5. context exact
                                                                                                                                                                            1.1 Advanced Renal Cell Carcinoma OPDIVO QVANTIG™, as monotherapy, is indicated for the first-line treatment of adult patients with intermediate or poor risk advanced renal cell carcinoma (RCC) following treatment with intravenous nivolumab and ipilimumab combination therapy.
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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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                                                                                                                                                                              3023
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                                                                                                                                                                            prior therapy
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                                                                                                                                                                            use intent
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                                                                                                                                                                            Passage 58 · limitation of use
                                                                                                                                                                            application numbers
                                                                                                                                                                            1. BLA761381
                                                                                                                                                                            brand names
                                                                                                                                                                            1. OPDIVO QVANTIG
                                                                                                                                                                            classification reasons
                                                                                                                                                                            1. negative_or_not_established_clause
                                                                                                                                                                            clinical review status
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                                                                                                                                                                            exact text
                                                                                                                                                                            ed for the first-line treatment of adult patients with intermediate or poor risk advanced renal cell carcinoma (RCC) following treatment with intravenous nivolumab and ipilimumab combination therapy. Limitations of Use: OPDIVO QVANTIG is not indicated in combination with ipilimumab for the treatment of renal cell carcinoma. OPDIVO QVANTIG, in combination with cabozantinib, is indicated for the first-line treatment of adult patients with advanced RCC. OPDIVO QVANTIG, as monotherapy, is indicated for the treatment of adul
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                                                                                                                                                                            generic names
                                                                                                                                                                            1. NIVOLUMAB AND HYALURONIDASE-NVHY
                                                                                                                                                                            id
                                                                                                                                                                            ind-span-bd64e1db48b4db4419fd
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                                                                                                                                                                            qualifier mentions
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                                                                                                                                                                              Limitations of Use: OPDIVO QVANTIG is not indicated in combination with ipilimumab for the treatment of renal cell carcinoma.
                                                                                                                                                                              kind
                                                                                                                                                                              regimen
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                                                                                                                                                                              exact text
                                                                                                                                                                              in combination with ipilimumab for the treatment of renal cell carcinoma
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                                                                                                                                                                              source defined aliases
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                                                                                                                                                                                definition exact
                                                                                                                                                                                Non-Small Cell Lung Cancer
                                                                                                                                                                                definition span
                                                                                                                                                                                end
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                                                                                                                                                                                exact text
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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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                                                                                                                                                                                exact text
                                                                                                                                                                                Colorectal Cancer (CRC)
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                                                                                                                                                                              exact text
                                                                                                                                                                              Limitations of Use: OPDIVO QVANTIG is not indicated in combination with ipilimumab for the treatment of renal cell carcinoma.
                                                                                                                                                                              label id
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                                                                                                                                                                              source url
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                                                                                                                                                                              spl effective date
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                                                                                                                                                                              structured fields status
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                                                                                                                                                                              approval pathway
                                                                                                                                                                              Source null
                                                                                                                                                                              biomarker and test
                                                                                                                                                                              Source null
                                                                                                                                                                              disease stage
                                                                                                                                                                              Source null
                                                                                                                                                                              limitations
                                                                                                                                                                              Source null
                                                                                                                                                                              line
                                                                                                                                                                              Source null
                                                                                                                                                                              prior therapy
                                                                                                                                                                              Source null
                                                                                                                                                                              regimen
                                                                                                                                                                              Source null
                                                                                                                                                                              tumor histology
                                                                                                                                                                              Source null
                                                                                                                                                                              use intent
                                                                                                                                                                              not_applicable
                                                                                                                                                                              Passage 59 · positive indication candidate
                                                                                                                                                                              application numbers
                                                                                                                                                                              1. BLA761381
                                                                                                                                                                              brand names
                                                                                                                                                                              1. OPDIVO QVANTIG
                                                                                                                                                                              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
                                                                                                                                                                              6149
                                                                                                                                                                              end exclusive
                                                                                                                                                                              true
                                                                                                                                                                              exact text
                                                                                                                                                                              treatment with intravenous nivolumab and ipilimumab combination therapy. Limitations of Use: OPDIVO QVANTIG is not indicated in combination with ipilimumab for the treatment of renal cell carcinoma. OPDIVO QVANTIG, in combination with cabozantinib, is indicated for the first-line treatment of adult patients with advanced RCC. OPDIVO QVANTIG, as monotherapy, is indicated for the treatment of adult patients with advanced RCC who have received prior anti-angiogenic therapy. 1.2 Unresectable or Metastatic Melanoma OPDIVO QVAN
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                                                                                                                                                                              current approval status
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                                                                                                                                                                              duplicate text group
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                                                                                                                                                                              extraction review status
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                                                                                                                                                                              generic names
                                                                                                                                                                              1. NIVOLUMAB AND HYALURONIDASE-NVHY
                                                                                                                                                                              id
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                                                                                                                                                                              label id
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                                                                                                                                                                              true
                                                                                                                                                                              exact text
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                                                                                                                                                                              qualifier mentions
                                                                                                                                                                              1. context exact
                                                                                                                                                                                cabozantinib, is indicated for the first-line treatment of adult patients with advanced RCC.
                                                                                                                                                                                kind
                                                                                                                                                                                age
                                                                                                                                                                                polarity
                                                                                                                                                                                not_inferred
                                                                                                                                                                                span
                                                                                                                                                                                end
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                                                                                                                                                                                exact text
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                                                                                                                                                                                5916
                                                                                                                                                                              2. context exact
                                                                                                                                                                                dicated for the first-line treatment of adult patients with advanced RCC.
                                                                                                                                                                                kind
                                                                                                                                                                                stage_or_setting
                                                                                                                                                                                polarity
                                                                                                                                                                                not_inferred
                                                                                                                                                                                span
                                                                                                                                                                                end
                                                                                                                                                                                5948
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                                                                                                                                                                                true
                                                                                                                                                                                exact text
                                                                                                                                                                                advanced RCC
                                                                                                                                                                                label id
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                                                                                                                                                                              3. context exact
                                                                                                                                                                                TIG, in combination with cabozantinib, is indicated for the first-line treatment of adult patients with advanced RCC.
                                                                                                                                                                                kind
                                                                                                                                                                                prior_therapy_or_line
                                                                                                                                                                                polarity
                                                                                                                                                                                not_inferred
                                                                                                                                                                                span
                                                                                                                                                                                end
                                                                                                                                                                                5948
                                                                                                                                                                                end exclusive
                                                                                                                                                                                true
                                                                                                                                                                                exact text
                                                                                                                                                                                first-line treatment of adult patients with advanced RCC
                                                                                                                                                                                label id
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                                                                                                                                                                                5892
                                                                                                                                                                              4. context exact
                                                                                                                                                                                OPDIVO QVANTIG, in combination with cabozantinib, is indicated for the first-line treatment of adult patients with advanced RCC.
                                                                                                                                                                                kind
                                                                                                                                                                                regimen
                                                                                                                                                                                polarity
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                                                                                                                                                                                span
                                                                                                                                                                                end
                                                                                                                                                                                5948
                                                                                                                                                                                end exclusive
                                                                                                                                                                                true
                                                                                                                                                                                exact text
                                                                                                                                                                                in combination with cabozantinib, is indicated for the first-line treatment of adult patients with advanced RCC
                                                                                                                                                                                label id
                                                                                                                                                                                1ce25608-1b8f-4d49-9ffd-6c8c61bf4f1a
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                                                                                                                                                                                source batch sha256
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                                                                                                                                                                                source defined aliases
                                                                                                                                                                                1. abbreviation
                                                                                                                                                                                  NSCLC
                                                                                                                                                                                  definition exact
                                                                                                                                                                                  Non-Small Cell Lung Cancer
                                                                                                                                                                                  definition span
                                                                                                                                                                                  end
                                                                                                                                                                                  1424
                                                                                                                                                                                  end exclusive
                                                                                                                                                                                  true
                                                                                                                                                                                  exact text
                                                                                                                                                                                  Non-Small Cell Lung Cancer (NSCLC)
                                                                                                                                                                                  label id
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                                                                                                                                                                                  source field
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                                                                                                                                                                                  source text sha256
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                                                                                                                                                                                  1390
                                                                                                                                                                                2. abbreviation
                                                                                                                                                                                  CRC
                                                                                                                                                                                  definition exact
                                                                                                                                                                                  Colorectal Cancer
                                                                                                                                                                                  definition span
                                                                                                                                                                                  end
                                                                                                                                                                                  3023
                                                                                                                                                                                  end exclusive
                                                                                                                                                                                  true
                                                                                                                                                                                  exact text
                                                                                                                                                                                  Colorectal Cancer (CRC)
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                                                                                                                                                                                exact text
                                                                                                                                                                                OPDIVO QVANTIG, in combination with cabozantinib, is indicated for the first-line treatment of adult patients with advanced RCC.
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                                                                                                                                                                                source url
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                                                                                                                                                                                spl effective date
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                                                                                                                                                                                structured indication
                                                                                                                                                                                age
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                                                                                                                                                                                approval pathway
                                                                                                                                                                                Source null
                                                                                                                                                                                biomarker and test
                                                                                                                                                                                Source null
                                                                                                                                                                                disease stage
                                                                                                                                                                                Source null
                                                                                                                                                                                limitations
                                                                                                                                                                                Source null
                                                                                                                                                                                line
                                                                                                                                                                                Source null
                                                                                                                                                                                prior therapy
                                                                                                                                                                                Source null
                                                                                                                                                                                regimen
                                                                                                                                                                                Source null
                                                                                                                                                                                tumor histology
                                                                                                                                                                                Source null
                                                                                                                                                                                use intent
                                                                                                                                                                                non_oncology_or_unclear_candidate
                                                                                                                                                                                Passage 60 · positive indication candidate
                                                                                                                                                                                application numbers
                                                                                                                                                                                1. BLA761381
                                                                                                                                                                                brand names
                                                                                                                                                                                1. OPDIVO QVANTIG
                                                                                                                                                                                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
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                                                                                                                                                                                true
                                                                                                                                                                                exact text
                                                                                                                                                                                combination with ipilimumab for the treatment of renal cell carcinoma. OPDIVO QVANTIG, in combination with cabozantinib, is indicated for the first-line treatment of adult patients with advanced RCC. OPDIVO QVANTIG, as monotherapy, is indicated for the treatment of adult patients with advanced RCC who have received prior anti-angiogenic therapy. 1.2 Unresectable or Metastatic Melanoma OPDIVO QVANTIG, as monotherapy, is indicated for the treatment of adult and pediatric patients 12 years and older who weigh 30 kg or greater with unresectable
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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 AND HYALURONIDASE-NVHY
                                                                                                                                                                                id
                                                                                                                                                                                ind-span-b20671b2d36e7f525685
                                                                                                                                                                                label id
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                                                                                                                                                                                positive predicate support span
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                                                                                                                                                                                true
                                                                                                                                                                                exact text
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                                                                                                                                                                                qualifier mentions
                                                                                                                                                                                1. context exact
                                                                                                                                                                                  QVANTIG, as monotherapy, is indicated for the treatment of adult patients with advanced RCC who have received prior anti-angiogenic t
                                                                                                                                                                                  kind
                                                                                                                                                                                  age
                                                                                                                                                                                  polarity
                                                                                                                                                                                  not_inferred
                                                                                                                                                                                  span
                                                                                                                                                                                  end
                                                                                                                                                                                  6030
                                                                                                                                                                                  end exclusive
                                                                                                                                                                                  true
                                                                                                                                                                                  exact text
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                                                                                                                                                                                  6016
                                                                                                                                                                                2. context exact
                                                                                                                                                                                  rapy, is indicated for the treatment of adult patients with advanced RCC who have received prior anti-angiogenic therapy.
                                                                                                                                                                                  kind
                                                                                                                                                                                  stage_or_setting
                                                                                                                                                                                  polarity
                                                                                                                                                                                  not_inferred
                                                                                                                                                                                  span
                                                                                                                                                                                  end
                                                                                                                                                                                  6079
                                                                                                                                                                                  end exclusive
                                                                                                                                                                                  true
                                                                                                                                                                                  exact text
                                                                                                                                                                                  advanced RCC who have received prior anti-a
                                                                                                                                                                                  label id
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                                                                                                                                                                                3. context exact
                                                                                                                                                                                  cated for the treatment of adult patients with advanced RCC who have received prior anti-angiogenic therapy.
                                                                                                                                                                                  kind
                                                                                                                                                                                  prior_therapy_or_line
                                                                                                                                                                                  polarity
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                                                                                                                                                                                  span
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                                                                                                                                                                                  true
                                                                                                                                                                                  exact text
                                                                                                                                                                                  who have received prior anti-angiogenic therapy
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                                                                                                                                                                                4. context exact
                                                                                                                                                                                  OPDIVO QVANTIG, as monotherapy, is indicated for the treatment of adult patients with advanced RCC who have received prior anti-angiogenic therapy.
                                                                                                                                                                                  kind
                                                                                                                                                                                  regimen
                                                                                                                                                                                  polarity
                                                                                                                                                                                  not_inferred
                                                                                                                                                                                  span
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                                                                                                                                                                                  exact text
                                                                                                                                                                                  as monotherapy, is indicated for the treatment of adult patients with advanced RCC who have received prior anti-angiogenic therapy
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                                                                                                                                                                                  1ce25608-1b8f-4d49-9ffd-6c8c61bf4f1a
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                                                                                                                                                                                  1. abbreviation
                                                                                                                                                                                    NSCLC
                                                                                                                                                                                    definition exact
                                                                                                                                                                                    Non-Small Cell Lung Cancer
                                                                                                                                                                                    definition span
                                                                                                                                                                                    end
                                                                                                                                                                                    1424
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                                                                                                                                                                                    exact text
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                                                                                                                                                                                  2. abbreviation
                                                                                                                                                                                    CRC
                                                                                                                                                                                    definition exact
                                                                                                                                                                                    Colorectal Cancer
                                                                                                                                                                                    definition span
                                                                                                                                                                                    end
                                                                                                                                                                                    3023
                                                                                                                                                                                    end exclusive
                                                                                                                                                                                    true
                                                                                                                                                                                    exact text
                                                                                                                                                                                    Colorectal Cancer (CRC)
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                                                                                                                                                                                  end exclusive
                                                                                                                                                                                  true
                                                                                                                                                                                  exact text
                                                                                                                                                                                  OPDIVO QVANTIG, as monotherapy, is indicated for the treatment of adult patients with advanced RCC who have received prior anti-angiogenic therapy.
                                                                                                                                                                                  label id
                                                                                                                                                                                  1ce25608-1b8f-4d49-9ffd-6c8c61bf4f1a
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                                                                                                                                                                                  source url
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                                                                                                                                                                                  spl effective date
                                                                                                                                                                                  2026-05-12
                                                                                                                                                                                  spl set id
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                                                                                                                                                                                  spl version
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                                                                                                                                                                                  structured fields status
                                                                                                                                                                                  not_extracted_no_values_inferred_from_mentions
                                                                                                                                                                                  structured indication
                                                                                                                                                                                  age
                                                                                                                                                                                  Source null
                                                                                                                                                                                  approval pathway
                                                                                                                                                                                  Source null
                                                                                                                                                                                  biomarker and test
                                                                                                                                                                                  Source null
                                                                                                                                                                                  disease stage
                                                                                                                                                                                  Source null
                                                                                                                                                                                  limitations
                                                                                                                                                                                  Source null
                                                                                                                                                                                  line
                                                                                                                                                                                  Source null
                                                                                                                                                                                  prior therapy
                                                                                                                                                                                  Source null
                                                                                                                                                                                  regimen
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                                                                                                                                                                                  tumor histology
                                                                                                                                                                                  Source null
                                                                                                                                                                                  use intent
                                                                                                                                                                                  non_oncology_or_unclear_candidate
                                                                                                                                                                                  Passage 61 · positive indication candidate
                                                                                                                                                                                  application numbers
                                                                                                                                                                                  1. BLA761381
                                                                                                                                                                                  brand names
                                                                                                                                                                                  1. OPDIVO QVANTIG
                                                                                                                                                                                  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
                                                                                                                                                                                  6520
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                                                                                                                                                                                  true
                                                                                                                                                                                  exact text
                                                                                                                                                                                  line treatment of adult patients with advanced RCC. OPDIVO QVANTIG, as monotherapy, is indicated for the treatment of adult patients with advanced RCC who have received prior anti-angiogenic therapy. 1.2 Unresectable or Metastatic Melanoma OPDIVO QVANTIG, as monotherapy, is indicated for the treatment of adult and pediatric patients 12 years and older who weigh 30 kg or greater with unresectable or metastatic melanoma. OPDIVO QVANTIG, as monotherapy, is indicated for the treatment of adult and pediatric patients 12 years and older who weigh 30 kg or greater with unresectable or metastatic melanoma following treatme
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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 AND HYALURONIDASE-NVHY
                                                                                                                                                                                  id
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                                                                                                                                                                                  true
                                                                                                                                                                                  exact text
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                                                                                                                                                                                  qualifier mentions
                                                                                                                                                                                  1. context exact
                                                                                                                                                                                    QVANTIG, as monotherapy, is indicated for the treatment of adult and pediatric patients 12 years and older who weigh 30 kg o
                                                                                                                                                                                    kind
                                                                                                                                                                                    age
                                                                                                                                                                                    polarity
                                                                                                                                                                                    not_inferred
                                                                                                                                                                                    span
                                                                                                                                                                                    end
                                                                                                                                                                                    6209
                                                                                                                                                                                    end exclusive
                                                                                                                                                                                    true
                                                                                                                                                                                    exact text
                                                                                                                                                                                    adult
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                                                                                                                                                                                    6204
                                                                                                                                                                                  2. context exact
                                                                                                                                                                                    as monotherapy, is indicated for the treatment of adult and pediatric patients 12 years and older who weigh 30 kg or greater with unresect
                                                                                                                                                                                    kind
                                                                                                                                                                                    age
                                                                                                                                                                                    polarity
                                                                                                                                                                                    not_inferred
                                                                                                                                                                                    span
                                                                                                                                                                                    end
                                                                                                                                                                                    6232
                                                                                                                                                                                    end exclusive
                                                                                                                                                                                    true
                                                                                                                                                                                    exact text
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                                                                                                                                                                                    6214
                                                                                                                                                                                  3. context exact
                                                                                                                                                                                    indicated for the treatment of adult and pediatric patients 12 years and older who weigh 30 kg or greater with unresectable or metastatic
                                                                                                                                                                                    kind
                                                                                                                                                                                    age
                                                                                                                                                                                    polarity
                                                                                                                                                                                    not_inferred
                                                                                                                                                                                    span
                                                                                                                                                                                    end
                                                                                                                                                                                    6251
                                                                                                                                                                                    end exclusive
                                                                                                                                                                                    true
                                                                                                                                                                                    exact text
                                                                                                                                                                                    12 years and older
                                                                                                                                                                                    label id
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                                                                                                                                                                                    6233
                                                                                                                                                                                  4. context exact
                                                                                                                                                                                    1.2 Unresectable or Metastatic Melanoma OPDIVO QVANTIG, as monotherapy, is indicated for the treatment of adult an
                                                                                                                                                                                    kind
                                                                                                                                                                                    biomarker
                                                                                                                                                                                    polarity
                                                                                                                                                                                    not_inferred
                                                                                                                                                                                    span
                                                                                                                                                                                    end
                                                                                                                                                                                    6152
                                                                                                                                                                                    end exclusive
                                                                                                                                                                                    true
                                                                                                                                                                                    exact text
                                                                                                                                                                                    Metastatic Melanoma OPDIVO QVANTIG
                                                                                                                                                                                    label id
                                                                                                                                                                                    1ce25608-1b8f-4d49-9ffd-6c8c61bf4f1a
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                                                                                                                                                                                    6118
                                                                                                                                                                                  5. context exact
                                                                                                                                                                                    s and older who weigh 30 kg or greater with unresectable or metastatic melanoma.
                                                                                                                                                                                    kind
                                                                                                                                                                                    biomarker
                                                                                                                                                                                    polarity
                                                                                                                                                                                    not_inferred
                                                                                                                                                                                    span
                                                                                                                                                                                    end
                                                                                                                                                                                    6319
                                                                                                                                                                                    end exclusive
                                                                                                                                                                                    true
                                                                                                                                                                                    exact text
                                                                                                                                                                                    metastatic melanoma
                                                                                                                                                                                    label id
                                                                                                                                                                                    1ce25608-1b8f-4d49-9ffd-6c8c61bf4f1a
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                                                                                                                                                                                    6300
                                                                                                                                                                                  6. context exact
                                                                                                                                                                                    1.2 Unresectable or Metastatic Melanoma OPDIVO QVANTIG, as monotherapy, is indicated for the treatment of adult
                                                                                                                                                                                    kind
                                                                                                                                                                                    stage_or_setting
                                                                                                                                                                                    polarity
                                                                                                                                                                                    not_inferred
                                                                                                                                                                                    span
                                                                                                                                                                                    end
                                                                                                                                                                                    6149
                                                                                                                                                                                    end exclusive
                                                                                                                                                                                    true
                                                                                                                                                                                    exact text
                                                                                                                                                                                    Unresectable or Metastatic Melanoma OPDIVO QVAN
                                                                                                                                                                                    label id
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                                                                                                                                                                                    6102
                                                                                                                                                                                  7. context exact
                                                                                                                                                                                    patients 12 years and older who weigh 30 kg or greater with unresectable or metastatic melanoma.
                                                                                                                                                                                    kind
                                                                                                                                                                                    stage_or_setting
                                                                                                                                                                                    polarity
                                                                                                                                                                                    not_inferred
                                                                                                                                                                                    span
                                                                                                                                                                                    end
                                                                                                                                                                                    6319
                                                                                                                                                                                    end exclusive
                                                                                                                                                                                    true
                                                                                                                                                                                    exact text
                                                                                                                                                                                    unresectable or metastatic melanoma
                                                                                                                                                                                    label id
                                                                                                                                                                                    1ce25608-1b8f-4d49-9ffd-6c8c61bf4f1a
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                                                                                                                                                                                    0
                                                                                                                                                                                    source field
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                                                                                                                                                                                    start
                                                                                                                                                                                    6284
                                                                                                                                                                                  8. context exact
                                                                                                                                                                                    1.2 Unresectable or Metastatic Melanoma OPDIVO QVANTIG, as monotherapy, is indicated for the treatment of adult and pediatric patients 12 years and older who weigh 30 kg or greater with unresectable or metastatic melanoma.
                                                                                                                                                                                    kind
                                                                                                                                                                                    regimen
                                                                                                                                                                                    polarity
                                                                                                                                                                                    not_inferred
                                                                                                                                                                                    span
                                                                                                                                                                                    end
                                                                                                                                                                                    6319
                                                                                                                                                                                    end exclusive
                                                                                                                                                                                    true
                                                                                                                                                                                    exact text
                                                                                                                                                                                    as monotherapy, is indicated for the treatment of adult and pediatric patients 12 years and older who weigh 30 kg or greater with unresectable or metastatic melanoma
                                                                                                                                                                                    label id
                                                                                                                                                                                    1ce25608-1b8f-4d49-9ffd-6c8c61bf4f1a
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                                                                                                                                                                                  regulatory links
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                                                                                                                                                                                    source defined aliases
                                                                                                                                                                                    1. abbreviation
                                                                                                                                                                                      NSCLC
                                                                                                                                                                                      definition exact
                                                                                                                                                                                      Non-Small Cell Lung Cancer
                                                                                                                                                                                      definition span
                                                                                                                                                                                      end
                                                                                                                                                                                      1424
                                                                                                                                                                                      end exclusive
                                                                                                                                                                                      true
                                                                                                                                                                                      exact text
                                                                                                                                                                                      Non-Small Cell Lung Cancer (NSCLC)
                                                                                                                                                                                      label id
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                                                                                                                                                                                      offset unit
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                                                                                                                                                                                      source array index
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                                                                                                                                                                                      source field
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                                                                                                                                                                                      source text sha256
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                                                                                                                                                                                      1390
                                                                                                                                                                                    2. abbreviation
                                                                                                                                                                                      CRC
                                                                                                                                                                                      definition exact
                                                                                                                                                                                      Colorectal Cancer
                                                                                                                                                                                      definition span
                                                                                                                                                                                      end
                                                                                                                                                                                      3023
                                                                                                                                                                                      end exclusive
                                                                                                                                                                                      true
                                                                                                                                                                                      exact text
                                                                                                                                                                                      Colorectal Cancer (CRC)
                                                                                                                                                                                      label id
                                                                                                                                                                                      1ce25608-1b8f-4d49-9ffd-6c8c61bf4f1a
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                                                                                                                                                                                      3000
                                                                                                                                                                                    source span
                                                                                                                                                                                    end
                                                                                                                                                                                    6320
                                                                                                                                                                                    end exclusive
                                                                                                                                                                                    true
                                                                                                                                                                                    exact text
                                                                                                                                                                                    1.2 Unresectable or Metastatic Melanoma OPDIVO QVANTIG, as monotherapy, is indicated for the treatment of adult and pediatric patients 12 years and older who weigh 30 kg or greater with unresectable or metastatic melanoma.
                                                                                                                                                                                    label id
                                                                                                                                                                                    1ce25608-1b8f-4d49-9ffd-6c8c61bf4f1a
                                                                                                                                                                                    offset unit
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                                                                                                                                                                                    source url
                                                                                                                                                                                    https://api.fda.gov/drug/label.json?search=id%3A%221ce25608-1b8f-4d49-9ffd-6c8c61bf4f1a%22
                                                                                                                                                                                    spl effective date
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                                                                                                                                                                                    spl set id
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                                                                                                                                                                                    spl version
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                                                                                                                                                                                    structured fields status
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                                                                                                                                                                                    structured indication
                                                                                                                                                                                    age
                                                                                                                                                                                    Source null
                                                                                                                                                                                    approval pathway
                                                                                                                                                                                    Source null
                                                                                                                                                                                    biomarker and test
                                                                                                                                                                                    Source null
                                                                                                                                                                                    disease stage
                                                                                                                                                                                    Source null
                                                                                                                                                                                    limitations
                                                                                                                                                                                    Source null
                                                                                                                                                                                    line
                                                                                                                                                                                    Source null
                                                                                                                                                                                    prior therapy
                                                                                                                                                                                    Source null
                                                                                                                                                                                    regimen
                                                                                                                                                                                    Source null
                                                                                                                                                                                    tumor histology
                                                                                                                                                                                    Source null
                                                                                                                                                                                    use intent
                                                                                                                                                                                    tumor_directed_candidate
                                                                                                                                                                                    Passage 62 · positive indication candidate
                                                                                                                                                                                    application numbers
                                                                                                                                                                                    1. BLA761381
                                                                                                                                                                                    brand names
                                                                                                                                                                                    1. OPDIVO QVANTIG
                                                                                                                                                                                    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
                                                                                                                                                                                    6785
                                                                                                                                                                                    end exclusive
                                                                                                                                                                                    true
                                                                                                                                                                                    exact text
                                                                                                                                                                                    astatic Melanoma OPDIVO QVANTIG, as monotherapy, is indicated for the treatment of adult and pediatric patients 12 years and older who weigh 30 kg or greater with unresectable or metastatic melanoma. OPDIVO QVANTIG, as monotherapy, is indicated for the treatment of adult and pediatric patients 12 years and older who weigh 30 kg or greater with unresectable or metastatic melanoma following treatment with intravenous nivolumab and ipilimumab combination therapy. Limitations of Use: OPDIVO QVANTIG is not indicated in combination with ipilimumab for the treatment of unresectable or metastatic melanoma. 1.3 Adjuvant Treatment of Melanoma OPDIVO QVANTIG, as mono
                                                                                                                                                                                    label id
                                                                                                                                                                                    1ce25608-1b8f-4d49-9ffd-6c8c61bf4f1a
                                                                                                                                                                                    offset unit
                                                                                                                                                                                    unicode_code_points
                                                                                                                                                                                    source array index
                                                                                                                                                                                    0
                                                                                                                                                                                    source field
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                                                                                                                                                                                    source text sha256
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                                                                                                                                                                                    current approval status
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                                                                                                                                                                                    duplicate text group
                                                                                                                                                                                    dup-4aa2d54d6003c8aca468
                                                                                                                                                                                    extraction review status
                                                                                                                                                                                    automated_candidate_pending_source_review
                                                                                                                                                                                    generic names
                                                                                                                                                                                    1. NIVOLUMAB AND HYALURONIDASE-NVHY
                                                                                                                                                                                    id
                                                                                                                                                                                    ind-span-7678d6b6c7460f8e5b48
                                                                                                                                                                                    label id
                                                                                                                                                                                    1ce25608-1b8f-4d49-9ffd-6c8c61bf4f1a
                                                                                                                                                                                    positive predicate support span
                                                                                                                                                                                    end
                                                                                                                                                                                    6365
                                                                                                                                                                                    end exclusive
                                                                                                                                                                                    true
                                                                                                                                                                                    exact text
                                                                                                                                                                                    is indicated
                                                                                                                                                                                    label id
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                                                                                                                                                                                    source text sha256
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                                                                                                                                                                                    qualifier mentions
                                                                                                                                                                                    1. context exact
                                                                                                                                                                                      QVANTIG, as monotherapy, is indicated for the treatment of adult and pediatric patients 12 years and older who weigh 30 kg o
                                                                                                                                                                                      kind
                                                                                                                                                                                      age
                                                                                                                                                                                      polarity
                                                                                                                                                                                      not_inferred
                                                                                                                                                                                      span
                                                                                                                                                                                      end
                                                                                                                                                                                      6392
                                                                                                                                                                                      end exclusive
                                                                                                                                                                                      true
                                                                                                                                                                                      exact text
                                                                                                                                                                                      adult
                                                                                                                                                                                      label id
                                                                                                                                                                                      1ce25608-1b8f-4d49-9ffd-6c8c61bf4f1a
                                                                                                                                                                                      offset unit
                                                                                                                                                                                      unicode_code_points
                                                                                                                                                                                      source array index
                                                                                                                                                                                      0
                                                                                                                                                                                      source field
                                                                                                                                                                                      indications_and_usage_exact
                                                                                                                                                                                      source text sha256
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                                                                                                                                                                                      start
                                                                                                                                                                                      6387
                                                                                                                                                                                    2. context exact
                                                                                                                                                                                      as monotherapy, is indicated for the treatment of adult and pediatric patients 12 years and older who weigh 30 kg or greater with unresect
                                                                                                                                                                                      kind
                                                                                                                                                                                      age
                                                                                                                                                                                      polarity
                                                                                                                                                                                      not_inferred
                                                                                                                                                                                      span
                                                                                                                                                                                      end
                                                                                                                                                                                      6415
                                                                                                                                                                                      end exclusive
                                                                                                                                                                                      true
                                                                                                                                                                                      exact text
                                                                                                                                                                                      pediatric patients
                                                                                                                                                                                      label id
                                                                                                                                                                                      1ce25608-1b8f-4d49-9ffd-6c8c61bf4f1a
                                                                                                                                                                                      offset unit
                                                                                                                                                                                      unicode_code_points
                                                                                                                                                                                      source array index
                                                                                                                                                                                      0
                                                                                                                                                                                      source field
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                                                                                                                                                                                      6397
                                                                                                                                                                                    3. context exact
                                                                                                                                                                                      indicated for the treatment of adult and pediatric patients 12 years and older who weigh 30 kg or greater with unresectable or metastatic
                                                                                                                                                                                      kind
                                                                                                                                                                                      age
                                                                                                                                                                                      polarity
                                                                                                                                                                                      not_inferred
                                                                                                                                                                                      span
                                                                                                                                                                                      end
                                                                                                                                                                                      6434
                                                                                                                                                                                      end exclusive
                                                                                                                                                                                      true
                                                                                                                                                                                      exact text
                                                                                                                                                                                      12 years and older
                                                                                                                                                                                      label id
                                                                                                                                                                                      1ce25608-1b8f-4d49-9ffd-6c8c61bf4f1a
                                                                                                                                                                                      offset unit
                                                                                                                                                                                      unicode_code_points
                                                                                                                                                                                      source array index
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                                                                                                                                                                                      source field
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                                                                                                                                                                                      source text sha256
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                                                                                                                                                                                      start
                                                                                                                                                                                      6416
                                                                                                                                                                                    4. context exact
                                                                                                                                                                                      s and older who weigh 30 kg or greater with unresectable or metastatic melanoma following treatment with intravenous nivolumab and ipilimumab combination therapy.
                                                                                                                                                                                      kind
                                                                                                                                                                                      biomarker
                                                                                                                                                                                      polarity
                                                                                                                                                                                      not_inferred
                                                                                                                                                                                      span
                                                                                                                                                                                      end
                                                                                                                                                                                      6526
                                                                                                                                                                                      end exclusive
                                                                                                                                                                                      true
                                                                                                                                                                                      exact text
                                                                                                                                                                                      metastatic melanoma following treatment wit
                                                                                                                                                                                      label id
                                                                                                                                                                                      1ce25608-1b8f-4d49-9ffd-6c8c61bf4f1a
                                                                                                                                                                                      offset unit
                                                                                                                                                                                      unicode_code_points
                                                                                                                                                                                      source array index
                                                                                                                                                                                      0
                                                                                                                                                                                      source field
                                                                                                                                                                                      indications_and_usage_exact
                                                                                                                                                                                      source text sha256
                                                                                                                                                                                      2752de64f809563e0adb6a2f4f307e1f930b4fe55c5721c928890afcb9aff780
                                                                                                                                                                                      start
                                                                                                                                                                                      6483
                                                                                                                                                                                    5. context exact
                                                                                                                                                                                      patients 12 years and older who weigh 30 kg or greater with unresectable or metastatic melanoma following treatment with intravenous nivolumab and ipilimumab combinati
                                                                                                                                                                                      kind
                                                                                                                                                                                      stage_or_setting
                                                                                                                                                                                      polarity
                                                                                                                                                                                      not_inferred
                                                                                                                                                                                      span
                                                                                                                                                                                      end
                                                                                                                                                                                      6514
                                                                                                                                                                                      end exclusive
                                                                                                                                                                                      true
                                                                                                                                                                                      exact text
                                                                                                                                                                                      unresectable or metastatic melanoma following t
                                                                                                                                                                                      label id
                                                                                                                                                                                      1ce25608-1b8f-4d49-9ffd-6c8c61bf4f1a
                                                                                                                                                                                      offset unit
                                                                                                                                                                                      unicode_code_points
                                                                                                                                                                                      source array index
                                                                                                                                                                                      0
                                                                                                                                                                                      source field
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                                                                                                                                                                                      source text sha256
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                                                                                                                                                                                      start
                                                                                                                                                                                      6467
                                                                                                                                                                                    6. context exact
                                                                                                                                                                                      OPDIVO QVANTIG, as monotherapy, is indicated for the treatment of adult and pediatric patients 12 years and older who weigh 30 kg or greater with unresectable or metastatic melanoma following treatment with intravenous nivolumab and ipilimumab combin
                                                                                                                                                                                      kind
                                                                                                                                                                                      regimen
                                                                                                                                                                                      polarity
                                                                                                                                                                                      not_inferred
                                                                                                                                                                                      span
                                                                                                                                                                                      end
                                                                                                                                                                                      6511
                                                                                                                                                                                      end exclusive
                                                                                                                                                                                      true
                                                                                                                                                                                      exact text
                                                                                                                                                                                      as monotherapy, is indicated for the treatment of adult and pediatric patients 12 years and older who weigh 30 kg or greater with unresectable or metastatic melanoma followin
                                                                                                                                                                                      label id
                                                                                                                                                                                      1ce25608-1b8f-4d49-9ffd-6c8c61bf4f1a
                                                                                                                                                                                      offset unit
                                                                                                                                                                                      unicode_code_points
                                                                                                                                                                                      source array index
                                                                                                                                                                                      0
                                                                                                                                                                                      source field
                                                                                                                                                                                      indications_and_usage_exact
                                                                                                                                                                                      source text sha256
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                                                                                                                                                                                      6337
                                                                                                                                                                                    regulatory links
                                                                                                                                                                                      schema version
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                                                                                                                                                                                      source batch sha256
                                                                                                                                                                                      0dba7a040bbbf460aa9f482c5b67c9f28f75fc9df775ee1e7b345b758f780e07
                                                                                                                                                                                      source defined aliases
                                                                                                                                                                                      1. abbreviation
                                                                                                                                                                                        NSCLC
                                                                                                                                                                                        definition exact
                                                                                                                                                                                        Non-Small Cell Lung Cancer
                                                                                                                                                                                        definition span
                                                                                                                                                                                        end
                                                                                                                                                                                        1424
                                                                                                                                                                                        end exclusive
                                                                                                                                                                                        true
                                                                                                                                                                                        exact text
                                                                                                                                                                                        Non-Small Cell Lung Cancer (NSCLC)
                                                                                                                                                                                        label id
                                                                                                                                                                                        1ce25608-1b8f-4d49-9ffd-6c8c61bf4f1a
                                                                                                                                                                                        offset unit
                                                                                                                                                                                        unicode_code_points
                                                                                                                                                                                        source array index
                                                                                                                                                                                        0
                                                                                                                                                                                        source field
                                                                                                                                                                                        indications_and_usage_exact
                                                                                                                                                                                        source text sha256
                                                                                                                                                                                        2752de64f809563e0adb6a2f4f307e1f930b4fe55c5721c928890afcb9aff780
                                                                                                                                                                                        start
                                                                                                                                                                                        1390
                                                                                                                                                                                      2. abbreviation
                                                                                                                                                                                        CRC
                                                                                                                                                                                        definition exact
                                                                                                                                                                                        Colorectal Cancer
                                                                                                                                                                                        definition span
                                                                                                                                                                                        end
                                                                                                                                                                                        3023
                                                                                                                                                                                        end exclusive
                                                                                                                                                                                        true
                                                                                                                                                                                        exact text
                                                                                                                                                                                        Colorectal Cancer (CRC)
                                                                                                                                                                                        label id
                                                                                                                                                                                        1ce25608-1b8f-4d49-9ffd-6c8c61bf4f1a
                                                                                                                                                                                        offset unit
                                                                                                                                                                                        unicode_code_points
                                                                                                                                                                                        source array index
                                                                                                                                                                                        0
                                                                                                                                                                                        source field
                                                                                                                                                                                        indications_and_usage_exact
                                                                                                                                                                                        source text sha256
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                                                                                                                                                                                        start
                                                                                                                                                                                        3000
                                                                                                                                                                                      source span
                                                                                                                                                                                      end
                                                                                                                                                                                      6585
                                                                                                                                                                                      end exclusive
                                                                                                                                                                                      true
                                                                                                                                                                                      exact text
                                                                                                                                                                                      OPDIVO QVANTIG, as monotherapy, is indicated for the treatment of adult and pediatric patients 12 years and older who weigh 30 kg or greater with unresectable or metastatic melanoma following treatment with intravenous nivolumab and ipilimumab combination therapy.
                                                                                                                                                                                      label id
                                                                                                                                                                                      1ce25608-1b8f-4d49-9ffd-6c8c61bf4f1a
                                                                                                                                                                                      offset unit
                                                                                                                                                                                      unicode_code_points
                                                                                                                                                                                      source array index
                                                                                                                                                                                      0
                                                                                                                                                                                      source field
                                                                                                                                                                                      indications_and_usage_exact
                                                                                                                                                                                      source text sha256
                                                                                                                                                                                      2752de64f809563e0adb6a2f4f307e1f930b4fe55c5721c928890afcb9aff780
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                                                                                                                                                                                      6321
                                                                                                                                                                                      source url
                                                                                                                                                                                      https://api.fda.gov/drug/label.json?search=id%3A%221ce25608-1b8f-4d49-9ffd-6c8c61bf4f1a%22
                                                                                                                                                                                      spl effective date
                                                                                                                                                                                      2026-05-12
                                                                                                                                                                                      spl set id
                                                                                                                                                                                      7f8c38fa-42f4-4387-9e8c-7a1c66855d8b
                                                                                                                                                                                      spl version
                                                                                                                                                                                      9
                                                                                                                                                                                      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 63 · limitation of use
                                                                                                                                                                                      application numbers
                                                                                                                                                                                      1. BLA761381
                                                                                                                                                                                      brand names
                                                                                                                                                                                      1. OPDIVO QVANTIG
                                                                                                                                                                                      classification reasons
                                                                                                                                                                                      1. negative_or_not_established_clause
                                                                                                                                                                                      clinical review status
                                                                                                                                                                                      pending
                                                                                                                                                                                      content role
                                                                                                                                                                                      limitation_of_use
                                                                                                                                                                                      context span
                                                                                                                                                                                      end
                                                                                                                                                                                      6926
                                                                                                                                                                                      end exclusive
                                                                                                                                                                                      true
                                                                                                                                                                                      exact text
                                                                                                                                                                                      adult and pediatric patients 12 years and older who weigh 30 kg or greater with unresectable or metastatic melanoma following treatment with intravenous nivolumab and ipilimumab combination therapy. Limitations of Use: OPDIVO QVANTIG is not indicated in combination with ipilimumab for the treatment of unresectable or metastatic melanoma. 1.3 Adjuvant Treatment of Melanoma OPDIVO QVANTIG, as monotherapy, is indicated for the adjuvant treatment of adult and pediatric patients 12 years and older who weigh 30 kg or greater with completel
                                                                                                                                                                                      label id
                                                                                                                                                                                      1ce25608-1b8f-4d49-9ffd-6c8c61bf4f1a
                                                                                                                                                                                      offset unit
                                                                                                                                                                                      unicode_code_points
                                                                                                                                                                                      source array index
                                                                                                                                                                                      0
                                                                                                                                                                                      source field
                                                                                                                                                                                      indications_and_usage_exact
                                                                                                                                                                                      source text sha256
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                                                                                                                                                                                      start
                                                                                                                                                                                      6386
                                                                                                                                                                                      current approval status
                                                                                                                                                                                      not_reconciled
                                                                                                                                                                                      duplicate text group
                                                                                                                                                                                      dup-5c506ca5c80f49026c53
                                                                                                                                                                                      extraction review status
                                                                                                                                                                                      automated_candidate_pending_source_review
                                                                                                                                                                                      generic names
                                                                                                                                                                                      1. NIVOLUMAB AND HYALURONIDASE-NVHY
                                                                                                                                                                                      id
                                                                                                                                                                                      ind-span-d5619431e155b34c8167
                                                                                                                                                                                      label id
                                                                                                                                                                                      1ce25608-1b8f-4d49-9ffd-6c8c61bf4f1a
                                                                                                                                                                                      positive predicate support span
                                                                                                                                                                                      Source null
                                                                                                                                                                                      qualifier mentions
                                                                                                                                                                                      1. context exact
                                                                                                                                                                                        nation with ipilimumab for the treatment of unresectable or metastatic melanoma.
                                                                                                                                                                                        kind
                                                                                                                                                                                        biomarker
                                                                                                                                                                                        polarity
                                                                                                                                                                                        not_inferred
                                                                                                                                                                                        span
                                                                                                                                                                                        end
                                                                                                                                                                                        6725
                                                                                                                                                                                        end exclusive
                                                                                                                                                                                        true
                                                                                                                                                                                        exact text
                                                                                                                                                                                        metastatic melanoma
                                                                                                                                                                                        label id
                                                                                                                                                                                        1ce25608-1b8f-4d49-9ffd-6c8c61bf4f1a
                                                                                                                                                                                        offset unit
                                                                                                                                                                                        unicode_code_points
                                                                                                                                                                                        source array index
                                                                                                                                                                                        0
                                                                                                                                                                                        source field
                                                                                                                                                                                        indications_and_usage_exact
                                                                                                                                                                                        source text sha256
                                                                                                                                                                                        2752de64f809563e0adb6a2f4f307e1f930b4fe55c5721c928890afcb9aff780
                                                                                                                                                                                        start
                                                                                                                                                                                        6706
                                                                                                                                                                                      2. context exact
                                                                                                                                                                                        dicated in combination with ipilimumab for the treatment of unresectable or metastatic melanoma.
                                                                                                                                                                                        kind
                                                                                                                                                                                        stage_or_setting
                                                                                                                                                                                        polarity
                                                                                                                                                                                        not_inferred
                                                                                                                                                                                        span
                                                                                                                                                                                        end
                                                                                                                                                                                        6725
                                                                                                                                                                                        end exclusive
                                                                                                                                                                                        true
                                                                                                                                                                                        exact text
                                                                                                                                                                                        unresectable or metastatic melanoma
                                                                                                                                                                                        label id
                                                                                                                                                                                        1ce25608-1b8f-4d49-9ffd-6c8c61bf4f1a
                                                                                                                                                                                        offset unit
                                                                                                                                                                                        unicode_code_points
                                                                                                                                                                                        source array index
                                                                                                                                                                                        0
                                                                                                                                                                                        source field
                                                                                                                                                                                        indications_and_usage_exact
                                                                                                                                                                                        source text sha256
                                                                                                                                                                                        2752de64f809563e0adb6a2f4f307e1f930b4fe55c5721c928890afcb9aff780
                                                                                                                                                                                        start
                                                                                                                                                                                        6690
                                                                                                                                                                                      3. context exact
                                                                                                                                                                                        Limitations of Use: OPDIVO QVANTIG is not indicated in combination with ipilimumab for the treatment of unresectable or metastatic melanoma.
                                                                                                                                                                                        kind
                                                                                                                                                                                        regimen
                                                                                                                                                                                        polarity
                                                                                                                                                                                        not_inferred
                                                                                                                                                                                        span
                                                                                                                                                                                        end
                                                                                                                                                                                        6725
                                                                                                                                                                                        end exclusive
                                                                                                                                                                                        true
                                                                                                                                                                                        exact text
                                                                                                                                                                                        in combination with ipilimumab for the treatment of unresectable or metastatic melanoma
                                                                                                                                                                                        label id
                                                                                                                                                                                        1ce25608-1b8f-4d49-9ffd-6c8c61bf4f1a
                                                                                                                                                                                        offset unit
                                                                                                                                                                                        unicode_code_points
                                                                                                                                                                                        source array index
                                                                                                                                                                                        0
                                                                                                                                                                                        source field
                                                                                                                                                                                        indications_and_usage_exact
                                                                                                                                                                                        source text sha256
                                                                                                                                                                                        2752de64f809563e0adb6a2f4f307e1f930b4fe55c5721c928890afcb9aff780
                                                                                                                                                                                        start
                                                                                                                                                                                        6638
                                                                                                                                                                                      regulatory links
                                                                                                                                                                                        schema version
                                                                                                                                                                                        0.1.0
                                                                                                                                                                                        source batch sha256
                                                                                                                                                                                        0dba7a040bbbf460aa9f482c5b67c9f28f75fc9df775ee1e7b345b758f780e07
                                                                                                                                                                                        source defined aliases
                                                                                                                                                                                        1. abbreviation
                                                                                                                                                                                          NSCLC
                                                                                                                                                                                          definition exact
                                                                                                                                                                                          Non-Small Cell Lung Cancer
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                                                                                                                                                                                        Limitations of Use: OPDIVO QVANTIG is not indicated in combination with ipilimumab for the treatment of unresectable or metastatic melanoma.
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                                                                                                                                                                                        Source null
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                                                                                                                                                                                        Source null
                                                                                                                                                                                        limitations
                                                                                                                                                                                        Source null
                                                                                                                                                                                        line
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                                                                                                                                                                                        prior therapy
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                                                                                                                                                                                        Source null
                                                                                                                                                                                        use intent
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                                                                                                                                                                                        Passage 64 · positive indication candidate
                                                                                                                                                                                        application numbers
                                                                                                                                                                                        1. BLA761381
                                                                                                                                                                                        brand names
                                                                                                                                                                                        1. OPDIVO QVANTIG
                                                                                                                                                                                        classification reasons
                                                                                                                                                                                        1. explicit_positive_indication_predicate
                                                                                                                                                                                        2. tumor_or_malignant_hematology_words_in_positive_statement
                                                                                                                                                                                        clinical review status
                                                                                                                                                                                        pending
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                                                                                                                                                                                        exact text
                                                                                                                                                                                        intravenous nivolumab and ipilimumab combination therapy. Limitations of Use: OPDIVO QVANTIG is not indicated in combination with ipilimumab for the treatment of unresectable or metastatic melanoma. 1.3 Adjuvant Treatment of Melanoma OPDIVO QVANTIG, as monotherapy, is indicated for the adjuvant treatment of adult and pediatric patients 12 years and older who weigh 30 kg or greater with completely resected Stage IIB, Stage IIC, Stage III, or Stage IV melanoma. 1.4 Neoadjuvant Treatment of Resectable Non-Small Cell Lung Cancer OPDIVO QVANTIG, in combination with platinum-doublet chemotherapy, is indicated as neoadjuvant treatment of adult patients with rese
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                                                                                                                                                                                        generic names
                                                                                                                                                                                        1. NIVOLUMAB AND HYALURONIDASE-NVHY
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                                                                                                                                                                                        qualifier mentions
                                                                                                                                                                                        1. context exact
                                                                                                                                                                                          as monotherapy, is indicated for the adjuvant treatment of adult and pediatric patients 12 years and older who weigh 30 kg o
                                                                                                                                                                                          kind
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                                                                                                                                                                                        2. context exact
                                                                                                                                                                                          erapy, is indicated for the adjuvant treatment of adult and pediatric patients 12 years and older who weigh 30 kg or greater with complete
                                                                                                                                                                                          kind
                                                                                                                                                                                          age
                                                                                                                                                                                          polarity
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                                                                                                                                                                                        3. context exact
                                                                                                                                                                                          for the adjuvant treatment of adult and pediatric patients 12 years and older who weigh 30 kg or greater with completely resected Stage I
                                                                                                                                                                                          kind
                                                                                                                                                                                          age
                                                                                                                                                                                          polarity
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                                                                                                                                                                                        4. context exact
                                                                                                                                                                                          1.3 Adjuvant Treatment of Melanoma OPDIVO QVANTIG, as monotherapy, is indicated for the adjuvant treatment
                                                                                                                                                                                          kind
                                                                                                                                                                                          stage_or_setting
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                                                                                                                                                                                          6774
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                                                                                                                                                                                          exact text
                                                                                                                                                                                          Adjuvant Treatment of Melanoma OPDIVO QVANT
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                                                                                                                                                                                        5. context exact
                                                                                                                                                                                          lanoma OPDIVO QVANTIG, as monotherapy, is indicated for the adjuvant treatment of adult and pediatric patients 12 years and older who weigh 30 kg or greater with c
                                                                                                                                                                                          kind
                                                                                                                                                                                          stage_or_setting
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                                                                                                                                                                                          exact text
                                                                                                                                                                                          adjuvant treatment of adult and pediatric p
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                                                                                                                                                                                        6. context exact
                                                                                                                                                                                          1.3 Adjuvant Treatment of Melanoma OPDIVO QVANTIG, as monotherapy, is indicated for the adjuvant treatment of adult and pediatric patients 12 years and older who weigh 30 kg or greater with completely resected Stage IIB, Stage IIC, Stage III, or Stage IV melanoma.
                                                                                                                                                                                          kind
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                                                                                                                                                                                          as monotherapy, is indicated for the adjuvant treatment of adult and pediatric patients 12 years and older who weigh 30 kg or greater with completely resected Stage IIB, Stag
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                                                                                                                                                                                          1. abbreviation
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                                                                                                                                                                                            Non-Small Cell Lung Cancer
                                                                                                                                                                                            definition span
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                                                                                                                                                                                            1424
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                                                                                                                                                                                          2. abbreviation
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                                                                                                                                                                                            Colorectal Cancer
                                                                                                                                                                                            definition span
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                                                                                                                                                                                          1.3 Adjuvant Treatment of Melanoma OPDIVO QVANTIG, as monotherapy, is indicated for the adjuvant treatment of adult and pediatric patients 12 years and older who weigh 30 kg or greater with completely resected Stage IIB, Stage IIC, Stage III, or Stage IV melanoma.
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                                                                                                                                                                                          prior therapy
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                                                                                                                                                                                          use intent
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                                                                                                                                                                                          Passage 65 · positive indication candidate
                                                                                                                                                                                          application numbers
                                                                                                                                                                                          1. BLA761381
                                                                                                                                                                                          brand names
                                                                                                                                                                                          1. OPDIVO QVANTIG
                                                                                                                                                                                          classification reasons
                                                                                                                                                                                          1. explicit_positive_indication_predicate
                                                                                                                                                                                          2. tumor_or_malignant_hematology_words_in_positive_statement
                                                                                                                                                                                          clinical review status
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                                                                                                                                                                                          , is indicated for the adjuvant treatment of adult and pediatric patients 12 years and older who weigh 30 kg or greater with completely resected Stage IIB, Stage IIC, Stage III, or Stage IV melanoma. 1.4 Neoadjuvant Treatment of Resectable Non-Small Cell Lung Cancer OPDIVO QVANTIG, 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). 1.5 Neoadjuvant and Adjuvant Treatment of Resectable Non-Small Cell Lung Cancer OPDIVO QVANTIG, in combination with platinum-doublet chemotherapy, is indicated for the neoadjuvant treatment of adult
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                                                                                                                                                                                          extraction review status
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                                                                                                                                                                                          generic names
                                                                                                                                                                                          1. NIVOLUMAB AND HYALURONIDASE-NVHY
                                                                                                                                                                                          id
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                                                                                                                                                                                          qualifier mentions
                                                                                                                                                                                          1. context exact
                                                                                                                                                                                            blet chemotherapy, is indicated as neoadjuvant treatment of adult patients with resectable (tumors ≥4 cm or node positive) non-small c
                                                                                                                                                                                            kind
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                                                                                                                                                                                            brand names
                                                                                                                                                                                            1. OPDIVO QVANTIG
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                                                                                                                                                                                            1. NIVOLUMAB AND HYALURONIDASE-NVHY
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                                                                                                                                                                                            7. context exact
                                                                                                                                                                                              nt of Resectable Non-Small Cell Lung Cancer OPDIVO QVANTIG, 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 anaplas
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                                                                                                                                                                                            8. context exact
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                                                                                                                                                                                                Non-Small Cell Lung Cancer
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                                                                                                                                                                                                exact text
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                                                                                                                                                                                              1.5 Neoadjuvant and Adjuvant Treatment of Resectable Non-Small Cell Lung Cancer OPDIVO QVANTIG, 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 OPDIVO QVANTIG as monotherapy in the adjuvant setting after surgical resection.
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                                                                                                                                                                                              use intent
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                                                                                                                                                                                              Passage 67 · positive indication candidate
                                                                                                                                                                                              application numbers
                                                                                                                                                                                              1. BLA761381
                                                                                                                                                                                              brand names
                                                                                                                                                                                              1. OPDIVO QVANTIG
                                                                                                                                                                                              classification reasons
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                                                                                                                                                                                              exact text
                                                                                                                                                                                              known epidermal growth factor receptor (EGFR) mutations or anaplastic lymphoma kinase (ALK) rearrangements, followed by OPDIVO QVANTIG as monotherapy in the adjuvant setting after surgical resection. 1.6 Metastatic Non-Small Cell Lung Cancer OPDIVO QVANTIG, as monotherapy, is indicated for the treatment of adult patients with metastatic non-small cell lung cancer (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 QVANTIG. Limitations of Use: OPDIVO QVANTIG
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                                                                                                                                                                                              1. NIVOLUMAB AND HYALURONIDASE-NVHY
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                                                                                                                                                                                              3. context exact
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                                                                                                                                                                                                metastatic non-small cell lung cancer (NSCL
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                                                                                                                                                                                              5. context exact
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                                                                                                                                                                                              6. context exact
                                                                                                                                                                                                1.6 Metastatic Non-Small Cell Lung Cancer OPDIVO QVANTIG, as monotherapy, is indicated for the treatment of adult patients with metastatic non-small cell lung cancer (NSCLC) with progression on or after platinum-based chemotherapy.
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                                                                                                                                                                                                as monotherapy, is indicated for the treatment of adult patients with metastatic non-small cell lung cancer (NSCLC) with progression on or after platinum-based chemotherapy
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                                                                                                                                                                                                source defined aliases
                                                                                                                                                                                                1. abbreviation
                                                                                                                                                                                                  NSCLC
                                                                                                                                                                                                  definition exact
                                                                                                                                                                                                  Non-Small Cell Lung Cancer
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                                                                                                                                                                                                  Non-Small Cell Lung Cancer (NSCLC)
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                                                                                                                                                                                                use intent
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                                                                                                                                                                                                Passage 68 · unclassified context
                                                                                                                                                                                                application numbers
                                                                                                                                                                                                1. BLA761381
                                                                                                                                                                                                brand names
                                                                                                                                                                                                1. OPDIVO QVANTIG
                                                                                                                                                                                                classification reasons
                                                                                                                                                                                                1. no_unambiguous_positive_indication_predicate
                                                                                                                                                                                                clinical review status
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                                                                                                                                                                                                ng Cancer OPDIVO QVANTIG, as monotherapy, is indicated for the treatment of adult patients with metastatic non-small cell lung cancer (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 QVANTIG. Limitations of Use: OPDIVO QVANTIG is not indicated in combination with ipilimumab for the treatment of metastatic NSCLC. 1.7 Squamous Cell Carcinoma of the Head and Neck OPDIVO QVANTIG, as monothera
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                                                                                                                                                                                                generic names
                                                                                                                                                                                                1. NIVOLUMAB AND HYALURONIDASE-NVHY
                                                                                                                                                                                                id
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                                                                                                                                                                                                positive predicate support span
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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
                                                                                                                                                                                                  kind
                                                                                                                                                                                                  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
                                                                                                                                                                                                    1424
                                                                                                                                                                                                    end exclusive
                                                                                                                                                                                                    true
                                                                                                                                                                                                    exact text
                                                                                                                                                                                                    Non-Small Cell Lung Cancer (NSCLC)
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                                                                                                                                                                                                    unicode_code_points
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                                                                                                                                                                                                  2. abbreviation
                                                                                                                                                                                                    CRC
                                                                                                                                                                                                    definition exact
                                                                                                                                                                                                    Colorectal Cancer
                                                                                                                                                                                                    definition span
                                                                                                                                                                                                    end
                                                                                                                                                                                                    3023
                                                                                                                                                                                                    end exclusive
                                                                                                                                                                                                    true
                                                                                                                                                                                                    exact text
                                                                                                                                                                                                    Colorectal Cancer (CRC)
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                                                                                                                                                                                                  exact text
                                                                                                                                                                                                  Patients with EGFR or ALK genomic tumor aberrations should have disease progression on FDA-approved therapy for these aberrations prior to receiving OPDIVO QVANTIG.
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                                                                                                                                                                                                  source url
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                                                                                                                                                                                                  spl effective date
                                                                                                                                                                                                  2026-05-12
                                                                                                                                                                                                  spl set id
                                                                                                                                                                                                  7f8c38fa-42f4-4387-9e8c-7a1c66855d8b
                                                                                                                                                                                                  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 69 · limitation of use
                                                                                                                                                                                                  application numbers
                                                                                                                                                                                                  1. BLA761381
                                                                                                                                                                                                  brand names
                                                                                                                                                                                                  1. OPDIVO QVANTIG
                                                                                                                                                                                                  classification reasons
                                                                                                                                                                                                  1. negative_or_not_established_clause
                                                                                                                                                                                                  clinical review status
                                                                                                                                                                                                  pending
                                                                                                                                                                                                  content role
                                                                                                                                                                                                  limitation_of_use
                                                                                                                                                                                                  context span
                                                                                                                                                                                                  end
                                                                                                                                                                                                  8453
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                                                                                                                                                                                                  true
                                                                                                                                                                                                  exact text
                                                                                                                                                                                                  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 QVANTIG. Limitations of Use: OPDIVO QVANTIG is not indicated in combination with ipilimumab for the treatment of metastatic NSCLC. 1.7 Squamous Cell Carcinoma of the Head and Neck OPDIVO QVANTIG, as monotherapy, is indicated for the treatment of adult patients with recurrent or metastatic squamous cell carcinoma of the head and
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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 AND HYALURONIDASE-NVHY
                                                                                                                                                                                                  id
                                                                                                                                                                                                  ind-span-d1c7e7105d840dcd93a9
                                                                                                                                                                                                  label id
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                                                                                                                                                                                                  positive predicate support span
                                                                                                                                                                                                  Source null
                                                                                                                                                                                                  qualifier mentions
                                                                                                                                                                                                  1. context exact
                                                                                                                                                                                                    dicated in combination with ipilimumab for the treatment of metastatic NSCLC.
                                                                                                                                                                                                    kind
                                                                                                                                                                                                    biomarker
                                                                                                                                                                                                    polarity
                                                                                                                                                                                                    not_inferred
                                                                                                                                                                                                    span
                                                                                                                                                                                                    end
                                                                                                                                                                                                    8252
                                                                                                                                                                                                    end exclusive
                                                                                                                                                                                                    true
                                                                                                                                                                                                    exact text
                                                                                                                                                                                                    metastatic NSCLC
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                                                                                                                                                                                                  2. context exact
                                                                                                                                                                                                    dicated in combination with ipilimumab for the treatment of metastatic NSCLC.
                                                                                                                                                                                                    kind
                                                                                                                                                                                                    stage_or_setting
                                                                                                                                                                                                    polarity
                                                                                                                                                                                                    not_inferred
                                                                                                                                                                                                    span
                                                                                                                                                                                                    end
                                                                                                                                                                                                    8252
                                                                                                                                                                                                    end exclusive
                                                                                                                                                                                                    true
                                                                                                                                                                                                    exact text
                                                                                                                                                                                                    metastatic NSCLC
                                                                                                                                                                                                    label id
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                                                                                                                                                                                                  3. context exact
                                                                                                                                                                                                    Limitations of Use: OPDIVO QVANTIG is not indicated in combination with ipilimumab for the treatment of metastatic NSCLC.
                                                                                                                                                                                                    kind
                                                                                                                                                                                                    regimen
                                                                                                                                                                                                    polarity
                                                                                                                                                                                                    not_inferred
                                                                                                                                                                                                    span
                                                                                                                                                                                                    end
                                                                                                                                                                                                    8252
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                                                                                                                                                                                                    true
                                                                                                                                                                                                    exact text
                                                                                                                                                                                                    in combination with ipilimumab for the treatment of metastatic NSCLC
                                                                                                                                                                                                    label id
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                                                                                                                                                                                                    source defined aliases
                                                                                                                                                                                                    1. abbreviation
                                                                                                                                                                                                      NSCLC
                                                                                                                                                                                                      definition exact
                                                                                                                                                                                                      Non-Small Cell Lung Cancer
                                                                                                                                                                                                      definition span
                                                                                                                                                                                                      end
                                                                                                                                                                                                      1424
                                                                                                                                                                                                      end exclusive
                                                                                                                                                                                                      true
                                                                                                                                                                                                      exact text
                                                                                                                                                                                                      Non-Small Cell Lung Cancer (NSCLC)
                                                                                                                                                                                                      label id
                                                                                                                                                                                                      1ce25608-1b8f-4d49-9ffd-6c8c61bf4f1a
                                                                                                                                                                                                      offset unit
                                                                                                                                                                                                      unicode_code_points
                                                                                                                                                                                                      source array index
                                                                                                                                                                                                      0
                                                                                                                                                                                                      source field
                                                                                                                                                                                                      indications_and_usage_exact
                                                                                                                                                                                                      source text sha256
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                                                                                                                                                                                                      1390
                                                                                                                                                                                                    2. abbreviation
                                                                                                                                                                                                      CRC
                                                                                                                                                                                                      definition exact
                                                                                                                                                                                                      Colorectal Cancer
                                                                                                                                                                                                      definition span
                                                                                                                                                                                                      end
                                                                                                                                                                                                      3023
                                                                                                                                                                                                      end exclusive
                                                                                                                                                                                                      true
                                                                                                                                                                                                      exact text
                                                                                                                                                                                                      Colorectal Cancer (CRC)
                                                                                                                                                                                                      label id
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                                                                                                                                                                                                      source array index
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                                                                                                                                                                                                      source field
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                                                                                                                                                                                                    8253
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                                                                                                                                                                                                    true
                                                                                                                                                                                                    exact text
                                                                                                                                                                                                    Limitations of Use: OPDIVO QVANTIG is not indicated in combination with ipilimumab for the treatment of metastatic NSCLC.
                                                                                                                                                                                                    label id
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                                                                                                                                                                                                    source url
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                                                                                                                                                                                                    spl effective date
                                                                                                                                                                                                    2026-05-12
                                                                                                                                                                                                    spl set id
                                                                                                                                                                                                    7f8c38fa-42f4-4387-9e8c-7a1c66855d8b
                                                                                                                                                                                                    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
                                                                                                                                                                                                    not_applicable
                                                                                                                                                                                                    Passage 70 · positive indication candidate
                                                                                                                                                                                                    application numbers
                                                                                                                                                                                                    1. BLA761381
                                                                                                                                                                                                    brand names
                                                                                                                                                                                                    1. OPDIVO QVANTIG
                                                                                                                                                                                                    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
                                                                                                                                                                                                    8726
                                                                                                                                                                                                    end exclusive
                                                                                                                                                                                                    true
                                                                                                                                                                                                    exact text
                                                                                                                                                                                                    FDA-approved therapy for these aberrations prior to receiving OPDIVO QVANTIG. Limitations of Use: OPDIVO QVANTIG is not indicated in combination with ipilimumab for the treatment of metastatic NSCLC. 1.7 Squamous Cell Carcinoma of the Head and Neck OPDIVO QVANTIG, as monotherapy, 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. 1.8 Urothelial Carcinoma OPDIVO QVANTIG, as monotherapy, is indicated for the adjuvant treatment of adult patients with urothelial carcinoma (UC) who are at high risk of recurrence after undergoing r
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                                                                                                                                                                                                    current approval status
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                                                                                                                                                                                                    duplicate text group
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                                                                                                                                                                                                    extraction review status
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                                                                                                                                                                                                    generic names
                                                                                                                                                                                                    1. NIVOLUMAB AND HYALURONIDASE-NVHY
                                                                                                                                                                                                    id
                                                                                                                                                                                                    ind-span-2fb6aba24c4ec56f3530
                                                                                                                                                                                                    label id
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                                                                                                                                                                                                    positive predicate support span
                                                                                                                                                                                                    end
                                                                                                                                                                                                    8347
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                                                                                                                                                                                                    true
                                                                                                                                                                                                    exact text
                                                                                                                                                                                                    is indicated
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                                                                                                                                                                                                    qualifier mentions
                                                                                                                                                                                                    1. context exact
                                                                                                                                                                                                      QVANTIG, as monotherapy, is indicated for the treatment of adult patients with recurrent or metastatic squamous cell carcinoma of the
                                                                                                                                                                                                      kind
                                                                                                                                                                                                      age
                                                                                                                                                                                                      polarity
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                                                                                                                                                                                                      span
                                                                                                                                                                                                      end
                                                                                                                                                                                                      8383
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                                                                                                                                                                                                      exact text
                                                                                                                                                                                                      adult patients
                                                                                                                                                                                                      label id
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                                                                                                                                                                                                      8369
                                                                                                                                                                                                    2. context exact
                                                                                                                                                                                                      cated 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 pl
                                                                                                                                                                                                      kind
                                                                                                                                                                                                      biomarker
                                                                                                                                                                                                      polarity
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                                                                                                                                                                                                      span
                                                                                                                                                                                                      end
                                                                                                                                                                                                      8445
                                                                                                                                                                                                      end exclusive
                                                                                                                                                                                                      true
                                                                                                                                                                                                      exact text
                                                                                                                                                                                                      metastatic squamous cell carcinoma of the h
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                                                                                                                                                                                                      8402
                                                                                                                                                                                                    3. context exact
                                                                                                                                                                                                      rapy, 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
                                                                                                                                                                                                      kind
                                                                                                                                                                                                      stage_or_setting
                                                                                                                                                                                                      polarity
                                                                                                                                                                                                      not_inferred
                                                                                                                                                                                                      span
                                                                                                                                                                                                      end
                                                                                                                                                                                                      8433
                                                                                                                                                                                                      end exclusive
                                                                                                                                                                                                      true
                                                                                                                                                                                                      exact text
                                                                                                                                                                                                      recurrent or metastatic squamous cell carcin
                                                                                                                                                                                                      label id
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                                                                                                                                                                                                    4. context exact
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                                                                                                                                                                                                      1.7 Squamous Cell Carcinoma of the Head and Neck OPDIVO QVANTIG, as monotherapy, 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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                                                                                                                                                                                                      application numbers
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                                                                                                                                                                                                      brand names
                                                                                                                                                                                                      1. OPDIVO QVANTIG
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                                                                                                                                                                                                      herapy, 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. 1.8 Urothelial Carcinoma OPDIVO QVANTIG, as monotherapy, 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. OPDIVO QVANTIG, in combination with cisplatin and gemcitabine, is indicated for the first-line treatment of adult patients with unresectable or metastatic UC. OPDIVO QVANTIG, as monotherapy, is indic
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                                                                                                                                                                                                      2. context exact
                                                                                                                                                                                                        cinoma OPDIVO QVANTIG, as monotherapy, is indicated for the adjuvant treatment of adult patients with urothelial carcinoma (UC) who are at high risk of recurrence
                                                                                                                                                                                                        kind
                                                                                                                                                                                                        stage_or_setting
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                                                                                                                                                                                                      3. context exact
                                                                                                                                                                                                        1.8 Urothelial Carcinoma OPDIVO QVANTIG, as monotherapy, 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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                                                                                                                                                                                                        as monotherapy, is indicated for the adjuvant treatment of adult patients with urothelial carcinoma (UC) who are at high risk of recurrence after undergoing radical resection
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                                                                                                                                                                                                        source defined aliases
                                                                                                                                                                                                        1. abbreviation
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                                                                                                                                                                                                          definition exact
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                                                                                                                                                                                                          definition span
                                                                                                                                                                                                          end
                                                                                                                                                                                                          1424
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                                                                                                                                                                                                          exact text
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                                                                                                                                                                                                        2. abbreviation
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                                                                                                                                                                                                          Colorectal Cancer
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                                                                                                                                                                                                          3023
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                                                                                                                                                                                                        1.8 Urothelial Carcinoma OPDIVO QVANTIG, as monotherapy, 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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                                                                                                                                                                                                        prior therapy
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                                                                                                                                                                                                        tumor histology
                                                                                                                                                                                                        Source null
                                                                                                                                                                                                        use intent
                                                                                                                                                                                                        tumor_directed_candidate
                                                                                                                                                                                                        Passage 72 · positive indication candidate
                                                                                                                                                                                                        application numbers
                                                                                                                                                                                                        1. BLA761381
                                                                                                                                                                                                        brand names
                                                                                                                                                                                                        1. OPDIVO QVANTIG
                                                                                                                                                                                                        classification reasons
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                                                                                                                                                                                                        clinical review status
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                                                                                                                                                                                                        a OPDIVO QVANTIG, as monotherapy, 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. OPDIVO QVANTIG, in combination with cisplatin and gemcitabine, is indicated for the first-line treatment of adult patients with unresectable or metastatic UC. OPDIVO QVANTIG, as monotherapy, is indicated for the treatment of adult patients with locally advanced or metastatic UC who: • have disease progression during or following platinum-containing chemoth
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                                                                                                                                                                                                        1. NIVOLUMAB AND HYALURONIDASE-NVHY
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                                                                                                                                                                                                        qualifier mentions
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                                                                                                                                                                                                          d gemcitabine, is indicated for the first-line treatment of adult patients with unresectable or metastatic UC.
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                                                                                                                                                                                                          8858
                                                                                                                                                                                                        2. context exact
                                                                                                                                                                                                          first-line treatment of adult patients with unresectable or metastatic UC.
                                                                                                                                                                                                          kind
                                                                                                                                                                                                          biomarker
                                                                                                                                                                                                          polarity
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                                                                                                                                                                                                          span
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                                                                                                                                                                                                          8907
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                                                                                                                                                                                                          true
                                                                                                                                                                                                          exact text
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                                                                                                                                                                                                          8894
                                                                                                                                                                                                        3. context exact
                                                                                                                                                                                                          dicated for the first-line treatment of adult patients with unresectable or metastatic UC.
                                                                                                                                                                                                          kind
                                                                                                                                                                                                          stage_or_setting
                                                                                                                                                                                                          polarity
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                                                                                                                                                                                                          span
                                                                                                                                                                                                          end
                                                                                                                                                                                                          8907
                                                                                                                                                                                                          end exclusive
                                                                                                                                                                                                          true
                                                                                                                                                                                                          exact text
                                                                                                                                                                                                          unresectable or metastatic UC
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                                                                                                                                                                                                          8878
                                                                                                                                                                                                        4. context exact
                                                                                                                                                                                                          nation with cisplatin and gemcitabine, is indicated for the first-line treatment of adult patients with unresectable or metastatic UC.
                                                                                                                                                                                                          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 or metastatic UC
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                                                                                                                                                                                                          8834
                                                                                                                                                                                                        5. context exact
                                                                                                                                                                                                          OPDIVO QVANTIG, in combination with cisplatin and gemcitabine, is indicated for the first-line treatment of adult patients with unresectable or metastatic UC.
                                                                                                                                                                                                          kind
                                                                                                                                                                                                          regimen
                                                                                                                                                                                                          polarity
                                                                                                                                                                                                          not_inferred
                                                                                                                                                                                                          span
                                                                                                                                                                                                          end
                                                                                                                                                                                                          8907
                                                                                                                                                                                                          end exclusive
                                                                                                                                                                                                          true
                                                                                                                                                                                                          exact text
                                                                                                                                                                                                          in combination with cisplatin and gemcitabine, is indicated for the first-line treatment of adult patients with unresectable or metastatic UC
                                                                                                                                                                                                          label id
                                                                                                                                                                                                          1ce25608-1b8f-4d49-9ffd-6c8c61bf4f1a
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                                                                                                                                                                                                          source batch sha256
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                                                                                                                                                                                                          source defined aliases
                                                                                                                                                                                                          1. abbreviation
                                                                                                                                                                                                            NSCLC
                                                                                                                                                                                                            definition exact
                                                                                                                                                                                                            Non-Small Cell Lung Cancer
                                                                                                                                                                                                            definition span
                                                                                                                                                                                                            end
                                                                                                                                                                                                            1424
                                                                                                                                                                                                            end exclusive
                                                                                                                                                                                                            true
                                                                                                                                                                                                            exact text
                                                                                                                                                                                                            Non-Small Cell Lung Cancer (NSCLC)
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                                                                                                                                                                                                            offset unit
                                                                                                                                                                                                            unicode_code_points
                                                                                                                                                                                                            source array index
                                                                                                                                                                                                            0
                                                                                                                                                                                                            source field
                                                                                                                                                                                                            indications_and_usage_exact
                                                                                                                                                                                                            source text sha256
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                                                                                                                                                                                                            start
                                                                                                                                                                                                            1390
                                                                                                                                                                                                          2. abbreviation
                                                                                                                                                                                                            CRC
                                                                                                                                                                                                            definition exact
                                                                                                                                                                                                            Colorectal Cancer
                                                                                                                                                                                                            definition span
                                                                                                                                                                                                            end
                                                                                                                                                                                                            3023
                                                                                                                                                                                                            end exclusive
                                                                                                                                                                                                            true
                                                                                                                                                                                                            exact text
                                                                                                                                                                                                            Colorectal Cancer (CRC)
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                                                                                                                                                                                                            unicode_code_points
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                                                                                                                                                                                                            source field
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                                                                                                                                                                                                            source text sha256
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                                                                                                                                                                                                            3000
                                                                                                                                                                                                          source span
                                                                                                                                                                                                          end
                                                                                                                                                                                                          8908
                                                                                                                                                                                                          end exclusive
                                                                                                                                                                                                          true
                                                                                                                                                                                                          exact text
                                                                                                                                                                                                          OPDIVO QVANTIG, in combination with cisplatin and gemcitabine, is indicated for the first-line treatment of adult patients with unresectable or metastatic UC.
                                                                                                                                                                                                          label id
                                                                                                                                                                                                          1ce25608-1b8f-4d49-9ffd-6c8c61bf4f1a
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                                                                                                                                                                                                          unicode_code_points
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                                                                                                                                                                                                          source url
                                                                                                                                                                                                          https://api.fda.gov/drug/label.json?search=id%3A%221ce25608-1b8f-4d49-9ffd-6c8c61bf4f1a%22
                                                                                                                                                                                                          spl effective date
                                                                                                                                                                                                          2026-05-12
                                                                                                                                                                                                          spl set id
                                                                                                                                                                                                          7f8c38fa-42f4-4387-9e8c-7a1c66855d8b
                                                                                                                                                                                                          spl version
                                                                                                                                                                                                          9
                                                                                                                                                                                                          structured fields status
                                                                                                                                                                                                          not_extracted_no_values_inferred_from_mentions
                                                                                                                                                                                                          structured indication
                                                                                                                                                                                                          age
                                                                                                                                                                                                          Source null
                                                                                                                                                                                                          approval pathway
                                                                                                                                                                                                          Source null
                                                                                                                                                                                                          biomarker and test
                                                                                                                                                                                                          Source null
                                                                                                                                                                                                          disease stage
                                                                                                                                                                                                          Source null
                                                                                                                                                                                                          limitations
                                                                                                                                                                                                          Source null
                                                                                                                                                                                                          line
                                                                                                                                                                                                          Source null
                                                                                                                                                                                                          prior therapy
                                                                                                                                                                                                          Source null
                                                                                                                                                                                                          regimen
                                                                                                                                                                                                          Source null
                                                                                                                                                                                                          tumor histology
                                                                                                                                                                                                          Source null
                                                                                                                                                                                                          use intent
                                                                                                                                                                                                          non_oncology_or_unclear_candidate
                                                                                                                                                                                                          Passage 73 · positive indication candidate
                                                                                                                                                                                                          application numbers
                                                                                                                                                                                                          1. BLA761381
                                                                                                                                                                                                          brand names
                                                                                                                                                                                                          1. OPDIVO QVANTIG
                                                                                                                                                                                                          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
                                                                                                                                                                                                          9233
                                                                                                                                                                                                          end exclusive
                                                                                                                                                                                                          true
                                                                                                                                                                                                          exact text
                                                                                                                                                                                                          fter undergoing radical resection of UC. OPDIVO QVANTIG, in combination with cisplatin and gemcitabine, is indicated for the first-line treatment of adult patients with unresectable or metastatic UC. OPDIVO QVANTIG, as monotherapy, is indicated for the treatment of adult patients with locally advanced or metastatic UC 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
                                                                                                                                                                                                          label id
                                                                                                                                                                                                          1ce25608-1b8f-4d49-9ffd-6c8c61bf4f1a
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                                                                                                                                                                                                          unicode_code_points
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                                                                                                                                                                                                          source field
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                                                                                                                                                                                                          8709
                                                                                                                                                                                                          current approval status
                                                                                                                                                                                                          not_reconciled
                                                                                                                                                                                                          duplicate text group
                                                                                                                                                                                                          dup-981b89d250a3b97890e9
                                                                                                                                                                                                          extraction review status
                                                                                                                                                                                                          automated_candidate_pending_source_review
                                                                                                                                                                                                          generic names
                                                                                                                                                                                                          1. NIVOLUMAB AND HYALURONIDASE-NVHY
                                                                                                                                                                                                          id
                                                                                                                                                                                                          ind-span-dda615189ec764d45288
                                                                                                                                                                                                          label id
                                                                                                                                                                                                          1ce25608-1b8f-4d49-9ffd-6c8c61bf4f1a
                                                                                                                                                                                                          positive predicate support span
                                                                                                                                                                                                          end
                                                                                                                                                                                                          8953
                                                                                                                                                                                                          end exclusive
                                                                                                                                                                                                          true
                                                                                                                                                                                                          exact text
                                                                                                                                                                                                          is indicated
                                                                                                                                                                                                          label id
                                                                                                                                                                                                          1ce25608-1b8f-4d49-9ffd-6c8c61bf4f1a
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                                                                                                                                                                                                          unicode_code_points
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                                                                                                                                                                                                          source field
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                                                                                                                                                                                                          8941
                                                                                                                                                                                                          qualifier mentions
                                                                                                                                                                                                          1. context exact
                                                                                                                                                                                                            QVANTIG, as monotherapy, is indicated for the treatment of adult patients with locally advanced or metastatic UC who:
                                                                                                                                                                                                            kind
                                                                                                                                                                                                            age
                                                                                                                                                                                                            polarity
                                                                                                                                                                                                            not_inferred
                                                                                                                                                                                                            span
                                                                                                                                                                                                            end
                                                                                                                                                                                                            8989
                                                                                                                                                                                                            end exclusive
                                                                                                                                                                                                            true
                                                                                                                                                                                                            exact text
                                                                                                                                                                                                            adult patients
                                                                                                                                                                                                            label id
                                                                                                                                                                                                            1ce25608-1b8f-4d49-9ffd-6c8c61bf4f1a
                                                                                                                                                                                                            offset unit
                                                                                                                                                                                                            unicode_code_points
                                                                                                                                                                                                            source array index
                                                                                                                                                                                                            0
                                                                                                                                                                                                            source field
                                                                                                                                                                                                            indications_and_usage_exact
                                                                                                                                                                                                            source text sha256
                                                                                                                                                                                                            2752de64f809563e0adb6a2f4f307e1f930b4fe55c5721c928890afcb9aff780
                                                                                                                                                                                                            start
                                                                                                                                                                                                            8975
                                                                                                                                                                                                          2. context exact
                                                                                                                                                                                                            or the treatment of adult patients with locally advanced or metastatic UC who:
                                                                                                                                                                                                            kind
                                                                                                                                                                                                            biomarker
                                                                                                                                                                                                            polarity
                                                                                                                                                                                                            not_inferred
                                                                                                                                                                                                            span
                                                                                                                                                                                                            end
                                                                                                                                                                                                            9033
                                                                                                                                                                                                            end exclusive
                                                                                                                                                                                                            true
                                                                                                                                                                                                            exact text
                                                                                                                                                                                                            metastatic UC who:
                                                                                                                                                                                                            label id
                                                                                                                                                                                                            1ce25608-1b8f-4d49-9ffd-6c8c61bf4f1a
                                                                                                                                                                                                            offset unit
                                                                                                                                                                                                            unicode_code_points
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                                                                                                                                                                                                            0
                                                                                                                                                                                                            source field
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                                                                                                                                                                                                            2752de64f809563e0adb6a2f4f307e1f930b4fe55c5721c928890afcb9aff780
                                                                                                                                                                                                            start
                                                                                                                                                                                                            9015
                                                                                                                                                                                                          3. context exact
                                                                                                                                                                                                            rapy, is indicated for the treatment of adult patients with locally advanced or metastatic UC who:
                                                                                                                                                                                                            kind
                                                                                                                                                                                                            stage_or_setting
                                                                                                                                                                                                            polarity
                                                                                                                                                                                                            not_inferred
                                                                                                                                                                                                            span
                                                                                                                                                                                                            end
                                                                                                                                                                                                            9033
                                                                                                                                                                                                            end exclusive
                                                                                                                                                                                                            true
                                                                                                                                                                                                            exact text
                                                                                                                                                                                                            locally advanced or metastatic UC who:
                                                                                                                                                                                                            label id
                                                                                                                                                                                                            1ce25608-1b8f-4d49-9ffd-6c8c61bf4f1a
                                                                                                                                                                                                            offset unit
                                                                                                                                                                                                            unicode_code_points
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                                                                                                                                                                                                            0
                                                                                                                                                                                                            source field
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                                                                                                                                                                                                            2752de64f809563e0adb6a2f4f307e1f930b4fe55c5721c928890afcb9aff780
                                                                                                                                                                                                            start
                                                                                                                                                                                                            8995
                                                                                                                                                                                                          4. context exact
                                                                                                                                                                                                            OPDIVO QVANTIG, as monotherapy, is indicated for the treatment of adult patients with locally advanced or metastatic UC who:
                                                                                                                                                                                                            kind
                                                                                                                                                                                                            regimen
                                                                                                                                                                                                            polarity
                                                                                                                                                                                                            not_inferred
                                                                                                                                                                                                            span
                                                                                                                                                                                                            end
                                                                                                                                                                                                            9033
                                                                                                                                                                                                            end exclusive
                                                                                                                                                                                                            true
                                                                                                                                                                                                            exact text
                                                                                                                                                                                                            as monotherapy, is indicated for the treatment of adult patients with locally advanced or metastatic UC who:
                                                                                                                                                                                                            label id
                                                                                                                                                                                                            1ce25608-1b8f-4d49-9ffd-6c8c61bf4f1a
                                                                                                                                                                                                            offset unit
                                                                                                                                                                                                            unicode_code_points
                                                                                                                                                                                                            source array index
                                                                                                                                                                                                            0
                                                                                                                                                                                                            source field
                                                                                                                                                                                                            indications_and_usage_exact
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                                                                                                                                                                                                            2752de64f809563e0adb6a2f4f307e1f930b4fe55c5721c928890afcb9aff780
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                                                                                                                                                                                                            8925
                                                                                                                                                                                                          regulatory links
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                                                                                                                                                                                                            0.1.0
                                                                                                                                                                                                            source batch sha256
                                                                                                                                                                                                            0dba7a040bbbf460aa9f482c5b67c9f28f75fc9df775ee1e7b345b758f780e07
                                                                                                                                                                                                            source defined aliases
                                                                                                                                                                                                            1. abbreviation
                                                                                                                                                                                                              NSCLC
                                                                                                                                                                                                              definition exact
                                                                                                                                                                                                              Non-Small Cell Lung Cancer
                                                                                                                                                                                                              definition span
                                                                                                                                                                                                              end
                                                                                                                                                                                                              1424
                                                                                                                                                                                                              end exclusive
                                                                                                                                                                                                              true
                                                                                                                                                                                                              exact text
                                                                                                                                                                                                              Non-Small Cell Lung Cancer (NSCLC)
                                                                                                                                                                                                              label id
                                                                                                                                                                                                              1ce25608-1b8f-4d49-9ffd-6c8c61bf4f1a
                                                                                                                                                                                                              offset unit
                                                                                                                                                                                                              unicode_code_points
                                                                                                                                                                                                              source array index
                                                                                                                                                                                                              0
                                                                                                                                                                                                              source field
                                                                                                                                                                                                              indications_and_usage_exact
                                                                                                                                                                                                              source text sha256
                                                                                                                                                                                                              2752de64f809563e0adb6a2f4f307e1f930b4fe55c5721c928890afcb9aff780
                                                                                                                                                                                                              start
                                                                                                                                                                                                              1390
                                                                                                                                                                                                            2. abbreviation
                                                                                                                                                                                                              CRC
                                                                                                                                                                                                              definition exact
                                                                                                                                                                                                              Colorectal Cancer
                                                                                                                                                                                                              definition span
                                                                                                                                                                                                              end
                                                                                                                                                                                                              3023
                                                                                                                                                                                                              end exclusive
                                                                                                                                                                                                              true
                                                                                                                                                                                                              exact text
                                                                                                                                                                                                              Colorectal Cancer (CRC)
                                                                                                                                                                                                              label id
                                                                                                                                                                                                              1ce25608-1b8f-4d49-9ffd-6c8c61bf4f1a
                                                                                                                                                                                                              offset unit
                                                                                                                                                                                                              unicode_code_points
                                                                                                                                                                                                              source array index
                                                                                                                                                                                                              0
                                                                                                                                                                                                              source field
                                                                                                                                                                                                              indications_and_usage_exact
                                                                                                                                                                                                              source text sha256
                                                                                                                                                                                                              2752de64f809563e0adb6a2f4f307e1f930b4fe55c5721c928890afcb9aff780
                                                                                                                                                                                                              start
                                                                                                                                                                                                              3000
                                                                                                                                                                                                            source span
                                                                                                                                                                                                            end
                                                                                                                                                                                                            9033
                                                                                                                                                                                                            end exclusive
                                                                                                                                                                                                            true
                                                                                                                                                                                                            exact text
                                                                                                                                                                                                            OPDIVO QVANTIG, as monotherapy, is indicated for the treatment of adult patients with locally advanced or metastatic UC who:
                                                                                                                                                                                                            label id
                                                                                                                                                                                                            1ce25608-1b8f-4d49-9ffd-6c8c61bf4f1a
                                                                                                                                                                                                            offset unit
                                                                                                                                                                                                            unicode_code_points
                                                                                                                                                                                                            source array index
                                                                                                                                                                                                            0
                                                                                                                                                                                                            source field
                                                                                                                                                                                                            indications_and_usage_exact
                                                                                                                                                                                                            source text sha256
                                                                                                                                                                                                            2752de64f809563e0adb6a2f4f307e1f930b4fe55c5721c928890afcb9aff780
                                                                                                                                                                                                            start
                                                                                                                                                                                                            8909
                                                                                                                                                                                                            source url
                                                                                                                                                                                                            https://api.fda.gov/drug/label.json?search=id%3A%221ce25608-1b8f-4d49-9ffd-6c8c61bf4f1a%22
                                                                                                                                                                                                            spl effective date
                                                                                                                                                                                                            2026-05-12
                                                                                                                                                                                                            spl set id
                                                                                                                                                                                                            7f8c38fa-42f4-4387-9e8c-7a1c66855d8b
                                                                                                                                                                                                            spl version
                                                                                                                                                                                                            9
                                                                                                                                                                                                            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
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                                                                                                                                                                                                            Source null
                                                                                                                                                                                                            use intent
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                                                                                                                                                                                                            Passage 74 · unclassified context
                                                                                                                                                                                                            application numbers
                                                                                                                                                                                                            1. BLA761381
                                                                                                                                                                                                            brand names
                                                                                                                                                                                                            1. OPDIVO QVANTIG
                                                                                                                                                                                                            classification reasons
                                                                                                                                                                                                            1. no_unambiguous_positive_indication_predicate
                                                                                                                                                                                                            clinical review status
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                                                                                                                                                                                                            first-line treatment of adult patients with unresectable or metastatic UC. OPDIVO QVANTIG, as monotherapy, is indicated for the treatment of adult patients with locally advanced or metastatic UC 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. 1.9 Microsatellite Instability-High or Mismatch Repair Deficient Metastatic Col
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                                                                                                                                                                                                            generic names
                                                                                                                                                                                                            1. NIVOLUMAB AND HYALURONIDASE-NVHY
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                                                                                                                                                                                                            ind-span-8b79c7560f89ffb1a865
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                                                                                                                                                                                                            qualifier mentions
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                                                                                                                                                                                                                source defined aliases
                                                                                                                                                                                                                1. abbreviation
                                                                                                                                                                                                                  NSCLC
                                                                                                                                                                                                                  definition exact
                                                                                                                                                                                                                  Non-Small Cell Lung Cancer
                                                                                                                                                                                                                  definition span
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                                                                                                                                                                                                                2. abbreviation
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                                                                                                                                                                                                                  Colorectal Cancer
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                                                                                                                                                                                                                  3023
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                                                                                                                                                                                                                • have disease progression during or following platinum-containing chemotherapy.
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                                                                                                                                                                                                                Source null
                                                                                                                                                                                                                approval pathway
                                                                                                                                                                                                                Source null
                                                                                                                                                                                                                biomarker and test
                                                                                                                                                                                                                Source null
                                                                                                                                                                                                                disease stage
                                                                                                                                                                                                                Source null
                                                                                                                                                                                                                limitations
                                                                                                                                                                                                                Source null
                                                                                                                                                                                                                line
                                                                                                                                                                                                                Source null
                                                                                                                                                                                                                prior therapy
                                                                                                                                                                                                                Source null
                                                                                                                                                                                                                regimen
                                                                                                                                                                                                                Source null
                                                                                                                                                                                                                tumor histology
                                                                                                                                                                                                                Source null
                                                                                                                                                                                                                use intent
                                                                                                                                                                                                                unclear
                                                                                                                                                                                                                Passage 75 · unclassified context
                                                                                                                                                                                                                application numbers
                                                                                                                                                                                                                1. BLA761381
                                                                                                                                                                                                                brand names
                                                                                                                                                                                                                1. OPDIVO QVANTIG
                                                                                                                                                                                                                classification reasons
                                                                                                                                                                                                                1. no_unambiguous_positive_indication_predicate
                                                                                                                                                                                                                clinical review status
                                                                                                                                                                                                                pending
                                                                                                                                                                                                                content role
                                                                                                                                                                                                                unclassified_context
                                                                                                                                                                                                                context span
                                                                                                                                                                                                                end
                                                                                                                                                                                                                9434
                                                                                                                                                                                                                end exclusive
                                                                                                                                                                                                                true
                                                                                                                                                                                                                exact text
                                                                                                                                                                                                                QVANTIG, as monotherapy, is indicated for the treatment of adult patients with locally advanced or metastatic UC 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. 1.9 Microsatellite Instability-High or Mismatch Repair Deficient Metastatic Colorectal Cancer OPDIVO QVANTIG, as monotherapy, is indicated for the treatment of adult and pediatric patients 12 years a
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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 AND HYALURONIDASE-NVHY
                                                                                                                                                                                                                id
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                                                                                                                                                                                                                qualifier mentions
                                                                                                                                                                                                                1. context exact
                                                                                                                                                                                                                  • have disease progression within 12 months of neoadjuvant or adjuvant treatment with platinum-containing chemotherapy.
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                                                                                                                                                                                                                  exact text
                                                                                                                                                                                                                  neoadjuvant or adjuvant treatment with platinu
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                                                                                                                                                                                                                regulatory links
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                                                                                                                                                                                                                  source defined aliases
                                                                                                                                                                                                                  1. abbreviation
                                                                                                                                                                                                                    NSCLC
                                                                                                                                                                                                                    definition exact
                                                                                                                                                                                                                    Non-Small Cell Lung Cancer
                                                                                                                                                                                                                    definition span
                                                                                                                                                                                                                    end
                                                                                                                                                                                                                    1424
                                                                                                                                                                                                                    end exclusive
                                                                                                                                                                                                                    true
                                                                                                                                                                                                                    exact text
                                                                                                                                                                                                                    Non-Small Cell Lung Cancer (NSCLC)
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                                                                                                                                                                                                                    1390
                                                                                                                                                                                                                  2. abbreviation
                                                                                                                                                                                                                    CRC
                                                                                                                                                                                                                    definition exact
                                                                                                                                                                                                                    Colorectal Cancer
                                                                                                                                                                                                                    definition span
                                                                                                                                                                                                                    end
                                                                                                                                                                                                                    3023
                                                                                                                                                                                                                    end exclusive
                                                                                                                                                                                                                    true
                                                                                                                                                                                                                    exact text
                                                                                                                                                                                                                    Colorectal Cancer (CRC)
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                                                                                                                                                                                                                  source span
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                                                                                                                                                                                                                  9234
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                                                                                                                                                                                                                  • have disease progression within 12 months of neoadjuvant or adjuvant treatment with platinum-containing chemotherapy.
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                                                                                                                                                                                                                  source url
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                                                                                                                                                                                                                  spl effective date
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                                                                                                                                                                                                                  limitations
                                                                                                                                                                                                                  Source null
                                                                                                                                                                                                                  line
                                                                                                                                                                                                                  Source null
                                                                                                                                                                                                                  prior therapy
                                                                                                                                                                                                                  Source null
                                                                                                                                                                                                                  regimen
                                                                                                                                                                                                                  Source null
                                                                                                                                                                                                                  tumor histology
                                                                                                                                                                                                                  Source null
                                                                                                                                                                                                                  use intent
                                                                                                                                                                                                                  unclear
                                                                                                                                                                                                                  Passage 76 · positive indication candidate
                                                                                                                                                                                                                  application numbers
                                                                                                                                                                                                                  1. BLA761381
                                                                                                                                                                                                                  brand names
                                                                                                                                                                                                                  1. OPDIVO QVANTIG
                                                                                                                                                                                                                  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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                                                                                                                                                                                                                  9884
                                                                                                                                                                                                                  end exclusive
                                                                                                                                                                                                                  true
                                                                                                                                                                                                                  exact text
                                                                                                                                                                                                                  have disease progression during or following platinum-containing chemotherapy. • have disease progression within 12 months of neoadjuvant or adjuvant treatment with platinum-containing chemotherapy. 1.9 Microsatellite Instability-High or Mismatch Repair Deficient Metastatic Colorectal Cancer OPDIVO QVANTIG, as monotherapy, is indicated for the treatment of adult and pediatric patients 12 years and older who weigh 30 kg or greater with unresectable or metastatic microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) colorectal cancer (CRC) following treatment with intravenous nivolumab and ipilimumab combination therapy. OPDIVO QVANTIG, as monotherapy, is indicated for the treatment of adult and pediatric patients 12 years and older who weigh 30 kg or greater, with MSI-H or dMMR metastatic CRC that has progressed fol
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                                                                                                                                                                                                                  current approval status
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                                                                                                                                                                                                                  extraction review status
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                                                                                                                                                                                                                  generic names
                                                                                                                                                                                                                  1. NIVOLUMAB AND HYALURONIDASE-NVHY
                                                                                                                                                                                                                  id
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                                                                                                                                                                                                                  positive predicate support span
                                                                                                                                                                                                                  end
                                                                                                                                                                                                                  9373
                                                                                                                                                                                                                  end exclusive
                                                                                                                                                                                                                  true
                                                                                                                                                                                                                  exact text
                                                                                                                                                                                                                  is indicated
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                                                                                                                                                                                                                  source field
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                                                                                                                                                                                                                  9361
                                                                                                                                                                                                                  qualifier mentions
                                                                                                                                                                                                                  1. context exact
                                                                                                                                                                                                                    QVANTIG, as monotherapy, is indicated for the treatment of adult and pediatric patients 12 years and older who weigh 30 kg o
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                                                                                                                                                                                                                    age
                                                                                                                                                                                                                    polarity
                                                                                                                                                                                                                    not_inferred
                                                                                                                                                                                                                    span
                                                                                                                                                                                                                    end
                                                                                                                                                                                                                    9400
                                                                                                                                                                                                                    end exclusive
                                                                                                                                                                                                                    true
                                                                                                                                                                                                                    exact text
                                                                                                                                                                                                                    adult
                                                                                                                                                                                                                    label id
                                                                                                                                                                                                                    1ce25608-1b8f-4d49-9ffd-6c8c61bf4f1a
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                                                                                                                                                                                                                    source field
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                                                                                                                                                                                                                    start
                                                                                                                                                                                                                    9395
                                                                                                                                                                                                                  2. context exact
                                                                                                                                                                                                                    as monotherapy, is indicated for the treatment of adult and pediatric patients 12 years and older who weigh 30 kg or greater with unresect
                                                                                                                                                                                                                    kind
                                                                                                                                                                                                                    age
                                                                                                                                                                                                                    polarity
                                                                                                                                                                                                                    not_inferred
                                                                                                                                                                                                                    span
                                                                                                                                                                                                                    end
                                                                                                                                                                                                                    9423
                                                                                                                                                                                                                    end exclusive
                                                                                                                                                                                                                    true
                                                                                                                                                                                                                    exact text
                                                                                                                                                                                                                    pediatric patients
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                                                                                                                                                                                                                    0
                                                                                                                                                                                                                    source field
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                                                                                                                                                                                                                    9405
                                                                                                                                                                                                                  3. context exact
                                                                                                                                                                                                                    indicated for the treatment of adult and pediatric patients 12 years and older who weigh 30 kg or greater with unresectable or metastatic
                                                                                                                                                                                                                    kind
                                                                                                                                                                                                                    age
                                                                                                                                                                                                                    polarity
                                                                                                                                                                                                                    not_inferred
                                                                                                                                                                                                                    span
                                                                                                                                                                                                                    end
                                                                                                                                                                                                                    9442
                                                                                                                                                                                                                    end exclusive
                                                                                                                                                                                                                    true
                                                                                                                                                                                                                    exact text
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                                                                                                                                                                                                                    9424
                                                                                                                                                                                                                  4. context exact
                                                                                                                                                                                                                    icrosatellite Instability-High or Mismatch Repair Deficient Metastatic Colorectal Cancer OPDIVO QVANTIG, as monotherapy, is indicated for the treatment of adult an
                                                                                                                                                                                                                    kind
                                                                                                                                                                                                                    biomarker
                                                                                                                                                                                                                    polarity
                                                                                                                                                                                                                    not_inferred
                                                                                                                                                                                                                    span
                                                                                                                                                                                                                    end
                                                                                                                                                                                                                    9343
                                                                                                                                                                                                                    end exclusive
                                                                                                                                                                                                                    true
                                                                                                                                                                                                                    exact text
                                                                                                                                                                                                                    Metastatic Colorectal Cancer OPDIVO QVANTIG
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                                                                                                                                                                                                                    start
                                                                                                                                                                                                                    9300
                                                                                                                                                                                                                  5. context exact
                                                                                                                                                                                                                    s and older who weigh 30 kg or greater with unresectable or metastatic microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) colorectal cance
                                                                                                                                                                                                                    kind
                                                                                                                                                                                                                    biomarker
                                                                                                                                                                                                                    polarity
                                                                                                                                                                                                                    not_inferred
                                                                                                                                                                                                                    span
                                                                                                                                                                                                                    end
                                                                                                                                                                                                                    9534
                                                                                                                                                                                                                    end exclusive
                                                                                                                                                                                                                    true
                                                                                                                                                                                                                    exact text
                                                                                                                                                                                                                    metastatic microsatellite instability-high
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                                                                                                                                                                                                                    source field
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                                                                                                                                                                                                                    start
                                                                                                                                                                                                                    9491
                                                                                                                                                                                                                  6. context exact
                                                                                                                                                                                                                    unresectable or metastatic microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) colorectal cancer (CRC) following treatment with intravenous n
                                                                                                                                                                                                                    kind
                                                                                                                                                                                                                    biomarker
                                                                                                                                                                                                                    polarity
                                                                                                                                                                                                                    not_inferred
                                                                                                                                                                                                                    span
                                                                                                                                                                                                                    end
                                                                                                                                                                                                                    9580
                                                                                                                                                                                                                    end exclusive
                                                                                                                                                                                                                    true
                                                                                                                                                                                                                    exact text
                                                                                                                                                                                                                    MSI-H) or mismatch repair deficient (dMMR) co
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                                                                                                                                                                                                                    source field
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                                                                                                                                                                                                                    start
                                                                                                                                                                                                                    9535
                                                                                                                                                                                                                  7. context exact
                                                                                                                                                                                                                    icrosatellite Instability-High or Mismatch Repair Deficient Metastatic Colorectal Cancer OPDIVO QVANTIG, as monotherapy, is indicated for the treatment of adult an
                                                                                                                                                                                                                    kind
                                                                                                                                                                                                                    stage_or_setting
                                                                                                                                                                                                                    polarity
                                                                                                                                                                                                                    not_inferred
                                                                                                                                                                                                                    span
                                                                                                                                                                                                                    end
                                                                                                                                                                                                                    9343
                                                                                                                                                                                                                    end exclusive
                                                                                                                                                                                                                    true
                                                                                                                                                                                                                    exact text
                                                                                                                                                                                                                    Metastatic Colorectal Cancer OPDIVO QVANTIG
                                                                                                                                                                                                                    label id
                                                                                                                                                                                                                    1ce25608-1b8f-4d49-9ffd-6c8c61bf4f1a
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                                                                                                                                                                                                                    source field
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                                                                                                                                                                                                                    source text sha256
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                                                                                                                                                                                                                    start
                                                                                                                                                                                                                    9300
                                                                                                                                                                                                                  8. context exact
                                                                                                                                                                                                                    patients 12 years and older who weigh 30 kg or greater with unresectable or metastatic microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) colo
                                                                                                                                                                                                                    kind
                                                                                                                                                                                                                    stage_or_setting
                                                                                                                                                                                                                    polarity
                                                                                                                                                                                                                    not_inferred
                                                                                                                                                                                                                    span
                                                                                                                                                                                                                    end
                                                                                                                                                                                                                    9522
                                                                                                                                                                                                                    end exclusive
                                                                                                                                                                                                                    true
                                                                                                                                                                                                                    exact text
                                                                                                                                                                                                                    unresectable or metastatic microsatellite insta
                                                                                                                                                                                                                    label id
                                                                                                                                                                                                                    1ce25608-1b8f-4d49-9ffd-6c8c61bf4f1a
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                                                                                                                                                                                                                    source field
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                                                                                                                                                                                                                    start
                                                                                                                                                                                                                    9475
                                                                                                                                                                                                                  9. context exact
                                                                                                                                                                                                                    pair Deficient Metastatic Colorectal Cancer OPDIVO QVANTIG, as monotherapy, is indicated for the treatment of adult and pediatric patients 12 years and older who weigh 30 kg or greater with unresectable or metastatic microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) c
                                                                                                                                                                                                                    kind
                                                                                                                                                                                                                    regimen
                                                                                                                                                                                                                    polarity
                                                                                                                                                                                                                    not_inferred
                                                                                                                                                                                                                    span
                                                                                                                                                                                                                    end
                                                                                                                                                                                                                    9519
                                                                                                                                                                                                                    end exclusive
                                                                                                                                                                                                                    true
                                                                                                                                                                                                                    exact text
                                                                                                                                                                                                                    as monotherapy, is indicated for the treatment of adult and pediatric patients 12 years and older who weigh 30 kg or greater with unresectable or metastatic microsatellite in
                                                                                                                                                                                                                    label id
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                                                                                                                                                                                                                    source array index
                                                                                                                                                                                                                    0
                                                                                                                                                                                                                    source field
                                                                                                                                                                                                                    indications_and_usage_exact
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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
                                                                                                                                                                                                                      1424
                                                                                                                                                                                                                      end exclusive
                                                                                                                                                                                                                      true
                                                                                                                                                                                                                      exact text
                                                                                                                                                                                                                      Non-Small Cell Lung Cancer (NSCLC)
                                                                                                                                                                                                                      label id
                                                                                                                                                                                                                      1ce25608-1b8f-4d49-9ffd-6c8c61bf4f1a
                                                                                                                                                                                                                      offset unit
                                                                                                                                                                                                                      unicode_code_points
                                                                                                                                                                                                                      source array index
                                                                                                                                                                                                                      0
                                                                                                                                                                                                                      source field
                                                                                                                                                                                                                      indications_and_usage_exact
                                                                                                                                                                                                                      source text sha256
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                                                                                                                                                                                                                      1390
                                                                                                                                                                                                                    2. abbreviation
                                                                                                                                                                                                                      CRC
                                                                                                                                                                                                                      definition exact
                                                                                                                                                                                                                      Colorectal Cancer
                                                                                                                                                                                                                      definition span
                                                                                                                                                                                                                      end
                                                                                                                                                                                                                      3023
                                                                                                                                                                                                                      end exclusive
                                                                                                                                                                                                                      true
                                                                                                                                                                                                                      exact text
                                                                                                                                                                                                                      Colorectal Cancer (CRC)
                                                                                                                                                                                                                      label id
                                                                                                                                                                                                                      1ce25608-1b8f-4d49-9ffd-6c8c61bf4f1a
                                                                                                                                                                                                                      offset unit
                                                                                                                                                                                                                      unicode_code_points
                                                                                                                                                                                                                      source array index
                                                                                                                                                                                                                      0
                                                                                                                                                                                                                      source field
                                                                                                                                                                                                                      indications_and_usage_exact
                                                                                                                                                                                                                      source text sha256
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                                                                                                                                                                                                                      start
                                                                                                                                                                                                                      3000
                                                                                                                                                                                                                    source span
                                                                                                                                                                                                                    end
                                                                                                                                                                                                                    9684
                                                                                                                                                                                                                    end exclusive
                                                                                                                                                                                                                    true
                                                                                                                                                                                                                    exact text
                                                                                                                                                                                                                    1.9 Microsatellite Instability-High or Mismatch Repair Deficient Metastatic Colorectal Cancer OPDIVO QVANTIG, as monotherapy, is indicated for the treatment of adult and pediatric patients 12 years and older who weigh 30 kg or greater with unresectable or metastatic microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) colorectal cancer (CRC) following treatment with intravenous nivolumab and ipilimumab combination therapy.
                                                                                                                                                                                                                    label id
                                                                                                                                                                                                                    1ce25608-1b8f-4d49-9ffd-6c8c61bf4f1a
                                                                                                                                                                                                                    offset unit
                                                                                                                                                                                                                    unicode_code_points
                                                                                                                                                                                                                    source array index
                                                                                                                                                                                                                    0
                                                                                                                                                                                                                    source field
                                                                                                                                                                                                                    indications_and_usage_exact
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                                                                                                                                                                                                                    start
                                                                                                                                                                                                                    9235
                                                                                                                                                                                                                    source url
                                                                                                                                                                                                                    https://api.fda.gov/drug/label.json?search=id%3A%221ce25608-1b8f-4d49-9ffd-6c8c61bf4f1a%22
                                                                                                                                                                                                                    spl effective date
                                                                                                                                                                                                                    2026-05-12
                                                                                                                                                                                                                    spl set id
                                                                                                                                                                                                                    7f8c38fa-42f4-4387-9e8c-7a1c66855d8b
                                                                                                                                                                                                                    spl version
                                                                                                                                                                                                                    9
                                                                                                                                                                                                                    structured fields status
                                                                                                                                                                                                                    not_extracted_no_values_inferred_from_mentions
                                                                                                                                                                                                                    structured indication
                                                                                                                                                                                                                    age
                                                                                                                                                                                                                    Source null
                                                                                                                                                                                                                    approval pathway
                                                                                                                                                                                                                    Source null
                                                                                                                                                                                                                    biomarker and test
                                                                                                                                                                                                                    Source null
                                                                                                                                                                                                                    disease stage
                                                                                                                                                                                                                    Source null
                                                                                                                                                                                                                    limitations
                                                                                                                                                                                                                    Source null
                                                                                                                                                                                                                    line
                                                                                                                                                                                                                    Source null
                                                                                                                                                                                                                    prior therapy
                                                                                                                                                                                                                    Source null
                                                                                                                                                                                                                    regimen
                                                                                                                                                                                                                    Source null
                                                                                                                                                                                                                    tumor histology
                                                                                                                                                                                                                    Source null
                                                                                                                                                                                                                    use intent
                                                                                                                                                                                                                    tumor_directed_candidate
                                                                                                                                                                                                                    Passage 77 · positive indication candidate
                                                                                                                                                                                                                    application numbers
                                                                                                                                                                                                                    1. BLA761381
                                                                                                                                                                                                                    brand names
                                                                                                                                                                                                                    1. OPDIVO QVANTIG
                                                                                                                                                                                                                    classification reasons
                                                                                                                                                                                                                    1. explicit_positive_indication_predicate
                                                                                                                                                                                                                    2. no_tumor_directed_keyword_in_positive_statement
                                                                                                                                                                                                                    3. source_defined_disease_abbreviation
                                                                                                                                                                                                                    clinical review status
                                                                                                                                                                                                                    pending
                                                                                                                                                                                                                    content role
                                                                                                                                                                                                                    positive_indication_candidate
                                                                                                                                                                                                                    context span
                                                                                                                                                                                                                    end
                                                                                                                                                                                                                    10154
                                                                                                                                                                                                                    end exclusive
                                                                                                                                                                                                                    true
                                                                                                                                                                                                                    exact text
                                                                                                                                                                                                                    le or metastatic microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) colorectal cancer (CRC) following treatment with intravenous nivolumab and ipilimumab combination therapy. OPDIVO QVANTIG, as monotherapy, is indicated for the treatment of adult and pediatric patients 12 years and older who weigh 30 kg or greater, with MSI-H or dMMR metastatic CRC that has progressed following treatment with a fluoropyrimidine, oxaliplatin, and irinotecan. Limitations of Use: OPDIVO QVANTIG is not indicated in combination with ipilimumab for the treatment of unresectable or metastatic MSI-H or dMMR CRC. 1.10 Hepatocellular Carcinoma • OPDIVO QVANTIG, a
                                                                                                                                                                                                                    label id
                                                                                                                                                                                                                    1ce25608-1b8f-4d49-9ffd-6c8c61bf4f1a
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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
                                                                                                                                                                                                                    9485
                                                                                                                                                                                                                    current approval status
                                                                                                                                                                                                                    not_reconciled
                                                                                                                                                                                                                    duplicate text group
                                                                                                                                                                                                                    dup-ae7ffdd999bb18d8139e
                                                                                                                                                                                                                    extraction review status
                                                                                                                                                                                                                    automated_candidate_pending_source_review
                                                                                                                                                                                                                    generic names
                                                                                                                                                                                                                    1. NIVOLUMAB AND HYALURONIDASE-NVHY
                                                                                                                                                                                                                    id
                                                                                                                                                                                                                    ind-span-e4d180467623823129c2
                                                                                                                                                                                                                    label id
                                                                                                                                                                                                                    1ce25608-1b8f-4d49-9ffd-6c8c61bf4f1a
                                                                                                                                                                                                                    positive predicate support span
                                                                                                                                                                                                                    end
                                                                                                                                                                                                                    9729
                                                                                                                                                                                                                    end exclusive
                                                                                                                                                                                                                    true
                                                                                                                                                                                                                    exact text
                                                                                                                                                                                                                    is indicated
                                                                                                                                                                                                                    label id
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                                                                                                                                                                                                                    offset unit
                                                                                                                                                                                                                    unicode_code_points
                                                                                                                                                                                                                    source array index
                                                                                                                                                                                                                    0
                                                                                                                                                                                                                    source field
                                                                                                                                                                                                                    indications_and_usage_exact
                                                                                                                                                                                                                    source text sha256
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                                                                                                                                                                                                                    start
                                                                                                                                                                                                                    9717
                                                                                                                                                                                                                    qualifier mentions
                                                                                                                                                                                                                    1. context exact
                                                                                                                                                                                                                      QVANTIG, as monotherapy, is indicated for the treatment of adult and pediatric patients 12 years and older who weigh 30 kg o
                                                                                                                                                                                                                      kind
                                                                                                                                                                                                                      age
                                                                                                                                                                                                                      polarity
                                                                                                                                                                                                                      not_inferred
                                                                                                                                                                                                                      span
                                                                                                                                                                                                                      end
                                                                                                                                                                                                                      9756
                                                                                                                                                                                                                      end exclusive
                                                                                                                                                                                                                      true
                                                                                                                                                                                                                      exact text
                                                                                                                                                                                                                      adult
                                                                                                                                                                                                                      label id
                                                                                                                                                                                                                      1ce25608-1b8f-4d49-9ffd-6c8c61bf4f1a
                                                                                                                                                                                                                      offset unit
                                                                                                                                                                                                                      unicode_code_points
                                                                                                                                                                                                                      source array index
                                                                                                                                                                                                                      0
                                                                                                                                                                                                                      source field
                                                                                                                                                                                                                      indications_and_usage_exact
                                                                                                                                                                                                                      source text sha256
                                                                                                                                                                                                                      2752de64f809563e0adb6a2f4f307e1f930b4fe55c5721c928890afcb9aff780
                                                                                                                                                                                                                      start
                                                                                                                                                                                                                      9751
                                                                                                                                                                                                                    2. context exact
                                                                                                                                                                                                                      as monotherapy, is indicated for the treatment of adult and pediatric patients 12 years and older who weigh 30 kg or greater, with MSI-H o
                                                                                                                                                                                                                      kind
                                                                                                                                                                                                                      age
                                                                                                                                                                                                                      polarity
                                                                                                                                                                                                                      not_inferred
                                                                                                                                                                                                                      span
                                                                                                                                                                                                                      end
                                                                                                                                                                                                                      9779
                                                                                                                                                                                                                      end exclusive
                                                                                                                                                                                                                      true
                                                                                                                                                                                                                      exact text
                                                                                                                                                                                                                      pediatric patients
                                                                                                                                                                                                                      label id
                                                                                                                                                                                                                      1ce25608-1b8f-4d49-9ffd-6c8c61bf4f1a
                                                                                                                                                                                                                      offset unit
                                                                                                                                                                                                                      unicode_code_points
                                                                                                                                                                                                                      source array index
                                                                                                                                                                                                                      0
                                                                                                                                                                                                                      source field
                                                                                                                                                                                                                      indications_and_usage_exact
                                                                                                                                                                                                                      source text sha256
                                                                                                                                                                                                                      2752de64f809563e0adb6a2f4f307e1f930b4fe55c5721c928890afcb9aff780
                                                                                                                                                                                                                      start
                                                                                                                                                                                                                      9761
                                                                                                                                                                                                                    3. context exact
                                                                                                                                                                                                                      indicated for the treatment of adult and pediatric patients 12 years and older who weigh 30 kg or greater, with MSI-H or dMMR metastatic C
                                                                                                                                                                                                                      kind
                                                                                                                                                                                                                      age
                                                                                                                                                                                                                      polarity
                                                                                                                                                                                                                      not_inferred
                                                                                                                                                                                                                      span
                                                                                                                                                                                                                      end
                                                                                                                                                                                                                      9798
                                                                                                                                                                                                                      end exclusive
                                                                                                                                                                                                                      true
                                                                                                                                                                                                                      exact text
                                                                                                                                                                                                                      12 years and older
                                                                                                                                                                                                                      label id
                                                                                                                                                                                                                      1ce25608-1b8f-4d49-9ffd-6c8c61bf4f1a
                                                                                                                                                                                                                      offset unit
                                                                                                                                                                                                                      unicode_code_points
                                                                                                                                                                                                                      source array index
                                                                                                                                                                                                                      0
                                                                                                                                                                                                                      source field
                                                                                                                                                                                                                      indications_and_usage_exact
                                                                                                                                                                                                                      source text sha256
                                                                                                                                                                                                                      2752de64f809563e0adb6a2f4f307e1f930b4fe55c5721c928890afcb9aff780
                                                                                                                                                                                                                      start
                                                                                                                                                                                                                      9780
                                                                                                                                                                                                                    4. context exact
                                                                                                                                                                                                                      atients 12 years and older who weigh 30 kg or greater, with MSI-H or dMMR metastatic CRC that has progressed following treatment with a fluoropyrimidine, oxaliplatin
                                                                                                                                                                                                                      kind
                                                                                                                                                                                                                      biomarker
                                                                                                                                                                                                                      polarity
                                                                                                                                                                                                                      not_inferred
                                                                                                                                                                                                                      span
                                                                                                                                                                                                                      end
                                                                                                                                                                                                                      9877
                                                                                                                                                                                                                      end exclusive
                                                                                                                                                                                                                      true
                                                                                                                                                                                                                      exact text
                                                                                                                                                                                                                      MSI-H or dMMR metastatic CRC that has progres
                                                                                                                                                                                                                      label id
                                                                                                                                                                                                                      1ce25608-1b8f-4d49-9ffd-6c8c61bf4f1a
                                                                                                                                                                                                                      offset unit
                                                                                                                                                                                                                      unicode_code_points
                                                                                                                                                                                                                      source array index
                                                                                                                                                                                                                      0
                                                                                                                                                                                                                      source field
                                                                                                                                                                                                                      indications_and_usage_exact
                                                                                                                                                                                                                      source text sha256
                                                                                                                                                                                                                      2752de64f809563e0adb6a2f4f307e1f930b4fe55c5721c928890afcb9aff780
                                                                                                                                                                                                                      start
                                                                                                                                                                                                                      9832
                                                                                                                                                                                                                    5. context exact
                                                                                                                                                                                                                      rs and older who weigh 30 kg or greater, with MSI-H or dMMR metastatic CRC that has progressed following treatment with a fluoropyrimidine, oxaliplatin, and irinotec
                                                                                                                                                                                                                      kind
                                                                                                                                                                                                                      stage_or_setting
                                                                                                                                                                                                                      polarity
                                                                                                                                                                                                                      not_inferred
                                                                                                                                                                                                                      span
                                                                                                                                                                                                                      end
                                                                                                                                                                                                                      9891
                                                                                                                                                                                                                      end exclusive
                                                                                                                                                                                                                      true
                                                                                                                                                                                                                      exact text
                                                                                                                                                                                                                      metastatic CRC that has progressed following
                                                                                                                                                                                                                      label id
                                                                                                                                                                                                                      1ce25608-1b8f-4d49-9ffd-6c8c61bf4f1a
                                                                                                                                                                                                                      offset unit
                                                                                                                                                                                                                      unicode_code_points
                                                                                                                                                                                                                      source array index
                                                                                                                                                                                                                      0
                                                                                                                                                                                                                      source field
                                                                                                                                                                                                                      indications_and_usage_exact
                                                                                                                                                                                                                      source text sha256
                                                                                                                                                                                                                      2752de64f809563e0adb6a2f4f307e1f930b4fe55c5721c928890afcb9aff780
                                                                                                                                                                                                                      start
                                                                                                                                                                                                                      9846
                                                                                                                                                                                                                    6. context exact
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                                                                                                                                                                                                                      application numbers
                                                                                                                                                                                                                      1. BLA761381
                                                                                                                                                                                                                      brand names
                                                                                                                                                                                                                      1. OPDIVO QVANTIG
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                                                                                                                                                                                                                      clinical review status
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                                                                                                                                                                                                                      qualifier mentions
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                                                                                                                                                                                                                      2. context exact
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                                                                                                                                                                                                                      3. context exact
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                                                                                                                                                                                                                          definition span
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                                                                                                                                                                                                                          definition span
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                                                                                                                                                                                                                          true
                                                                                                                                                                                                                          exact text
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                                                                                                                                                                                                                        Limitations of Use: OPDIVO QVANTIG is not indicated in combination with ipilimumab for the treatment of unresectable or metastatic MSI-H or dMMR CRC.
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                                                                                                                                                                                                                        application numbers
                                                                                                                                                                                                                        1. BLA761381
                                                                                                                                                                                                                        brand names
                                                                                                                                                                                                                        1. OPDIVO QVANTIG
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                                                                                                                                                                                                                        clinical review status
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                                                                                                                                                                                                                              definition exact
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                                                                                                                                                                                                                              definition span
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                                                                                                                                                                                                                              exact text
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                                                                                                                                                                                                                            2. abbreviation
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                                                                                                                                                                                                                              definition exact
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                                                                                                                                                                                                                              definition span
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                                                                                                                                                                                                                              exact text
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                                                                                                                                                                                                                            application numbers
                                                                                                                                                                                                                            1. BLA761381
                                                                                                                                                                                                                            brand names
                                                                                                                                                                                                                            1. OPDIVO QVANTIG
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                                                                                                                                                                                                                            2. tumor_or_malignant_hematology_words_in_positive_statement
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                                                                                                                                                                                                                              application numbers
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                                                                                                                                                                                                                              brand names
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                                                                                                                                                                                                                              generic names
                                                                                                                                                                                                                              1. NIVOLUMAB AND HYALURONIDASE-NVHY
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                                                                                                                                                                                                                              2. context exact
                                                                                                                                                                                                                                ed for the treatment of adult patients with unresectable or metastatic hepatocellular carcinoma (HCC) who have been previously treated with sorafenib following tre
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                                                                                                                                                                                                                                polarity
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                                                                                                                                                                                                                                span
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                                                                                                                                                                                                                                10522
                                                                                                                                                                                                                                end exclusive
                                                                                                                                                                                                                                true
                                                                                                                                                                                                                                exact text
                                                                                                                                                                                                                                metastatic hepatocellular carcinoma (HCC) w
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                                                                                                                                                                                                                                start
                                                                                                                                                                                                                                10479
                                                                                                                                                                                                                              3. context exact
                                                                                                                                                                                                                                rapy, is indicated for the treatment of adult patients with unresectable or metastatic hepatocellular carcinoma (HCC) who have been previously treated with sorafenib f
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                                                                                                                                                                                                                                true
                                                                                                                                                                                                                                exact text
                                                                                                                                                                                                                                unresectable or metastatic hepatocellular carci
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                                                                                                                                                                                                                                10463
                                                                                                                                                                                                                              4. context exact
                                                                                                                                                                                                                                or metastatic hepatocellular carcinoma (HCC) who have been previously treated with sorafenib following treatment with intravenous nivolumab and ipilimumab combination therapy .
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                                                                                                                                                                                                                                span
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                                                                                                                                                                                                                                10651
                                                                                                                                                                                                                                end exclusive
                                                                                                                                                                                                                                true
                                                                                                                                                                                                                                exact text
                                                                                                                                                                                                                                previously treated with sorafenib following treatment with intravenous nivolumab and ipilimumab combination therapy
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                                                                                                                                                                                                                                start
                                                                                                                                                                                                                                10535
                                                                                                                                                                                                                              5. context exact
                                                                                                                                                                                                                                • OPDIVO QVANTIG, as monotherapy, is indicated for the treatment of adult patients with unresectable or metastatic hepatocellular carcinoma (HCC) who have been previously treated with sorafenib following treatment with intravenous nivolumab and ipilimu
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                                                                                                                                                                                                                                span
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                                                                                                                                                                                                                                10567
                                                                                                                                                                                                                                end exclusive
                                                                                                                                                                                                                                true
                                                                                                                                                                                                                                exact text
                                                                                                                                                                                                                                as monotherapy, is indicated for the treatment of adult patients with unresectable or metastatic hepatocellular carcinoma (HCC) who have been previously treated with sorafeni
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                                                                                                                                                                                                                                10393
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                                                                                                                                                                                                                                source defined aliases
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                                                                                                                                                                                                                                  NSCLC
                                                                                                                                                                                                                                  definition exact
                                                                                                                                                                                                                                  Non-Small Cell Lung Cancer
                                                                                                                                                                                                                                  definition span
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                                                                                                                                                                                                                                  1424
                                                                                                                                                                                                                                  end exclusive
                                                                                                                                                                                                                                  true
                                                                                                                                                                                                                                  exact text
                                                                                                                                                                                                                                  Non-Small Cell Lung Cancer (NSCLC)
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                                                                                                                                                                                                                                  source field
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                                                                                                                                                                                                                                2. abbreviation
                                                                                                                                                                                                                                  CRC
                                                                                                                                                                                                                                  definition exact
                                                                                                                                                                                                                                  Colorectal Cancer
                                                                                                                                                                                                                                  definition span
                                                                                                                                                                                                                                  end
                                                                                                                                                                                                                                  3023
                                                                                                                                                                                                                                  end exclusive
                                                                                                                                                                                                                                  true
                                                                                                                                                                                                                                  exact text
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                                                                                                                                                                                                                                true
                                                                                                                                                                                                                                exact text
                                                                                                                                                                                                                                • OPDIVO QVANTIG, as monotherapy, is indicated for the treatment of adult patients with unresectable or metastatic hepatocellular carcinoma (HCC) who have been previously treated with sorafenib following treatment with intravenous nivolumab and ipilimumab combination therapy .
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                                                                                                                                                                                                                                disease stage
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                                                                                                                                                                                                                                limitations
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                                                                                                                                                                                                                                line
                                                                                                                                                                                                                                Source null
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                                                                                                                                                                                                                                Source null
                                                                                                                                                                                                                                regimen
                                                                                                                                                                                                                                Source null
                                                                                                                                                                                                                                tumor histology
                                                                                                                                                                                                                                Source null
                                                                                                                                                                                                                                use intent
                                                                                                                                                                                                                                tumor_directed_candidate
                                                                                                                                                                                                                                Passage 82 · limitation of use
                                                                                                                                                                                                                                application numbers
                                                                                                                                                                                                                                1. BLA761381
                                                                                                                                                                                                                                brand names
                                                                                                                                                                                                                                1. OPDIVO QVANTIG
                                                                                                                                                                                                                                classification reasons
                                                                                                                                                                                                                                1. negative_or_not_established_clause
                                                                                                                                                                                                                                clinical review status
                                                                                                                                                                                                                                pending
                                                                                                                                                                                                                                content role
                                                                                                                                                                                                                                limitation_of_use
                                                                                                                                                                                                                                context span
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                                                                                                                                                                                                                                11002
                                                                                                                                                                                                                                end exclusive
                                                                                                                                                                                                                                true
                                                                                                                                                                                                                                exact text
                                                                                                                                                                                                                                ents with unresectable or metastatic hepatocellular carcinoma (HCC) who have been previously treated with sorafenib following treatment with intravenous nivolumab and ipilimumab combination therapy . Limitations of Use: OPDIVO QVANTIG is not indicated in combination with ipilimumab for the treatment of patients with unresectable or metastatic HCC. 1.11 Esophageal Cancer OPDIVO QVANTIG as monotherapy, is indicated for the adjuvant treatment of completely resected esophageal or gastroesophageal junction cancer with residual pathologic disease in
                                                                                                                                                                                                                                label id
                                                                                                                                                                                                                                1ce25608-1b8f-4d49-9ffd-6c8c61bf4f1a
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                                                                                                                                                                                                                                unicode_code_points
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                                                                                                                                                                                                                                source field
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                                                                                                                                                                                                                                current approval status
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                                                                                                                                                                                                                                generic names
                                                                                                                                                                                                                                1. NIVOLUMAB AND HYALURONIDASE-NVHY
                                                                                                                                                                                                                                id
                                                                                                                                                                                                                                ind-span-78209fbe77ae016ee74b
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                                                                                                                                                                                                                                1ce25608-1b8f-4d49-9ffd-6c8c61bf4f1a
                                                                                                                                                                                                                                positive predicate support span
                                                                                                                                                                                                                                Source null
                                                                                                                                                                                                                                qualifier mentions
                                                                                                                                                                                                                                1. context exact
                                                                                                                                                                                                                                  ilimumab for the treatment of patients with unresectable or metastatic HCC.
                                                                                                                                                                                                                                  kind
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                                                                                                                                                                                                                                  span
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                                                                                                                                                                                                                                  10801
                                                                                                                                                                                                                                  end exclusive
                                                                                                                                                                                                                                  true
                                                                                                                                                                                                                                  exact text
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                                                                                                                                                                                                                                  start
                                                                                                                                                                                                                                  10787
                                                                                                                                                                                                                                2. context exact
                                                                                                                                                                                                                                  bination with ipilimumab for the treatment of patients with unresectable or metastatic HCC.
                                                                                                                                                                                                                                  kind
                                                                                                                                                                                                                                  stage_or_setting
                                                                                                                                                                                                                                  polarity
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                                                                                                                                                                                                                                  span
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                                                                                                                                                                                                                                  10801
                                                                                                                                                                                                                                  end exclusive
                                                                                                                                                                                                                                  true
                                                                                                                                                                                                                                  exact text
                                                                                                                                                                                                                                  unresectable or metastatic HCC
                                                                                                                                                                                                                                  label id
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                                                                                                                                                                                                                                  source field
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                                                                                                                                                                                                                                  10771
                                                                                                                                                                                                                                3. context exact
                                                                                                                                                                                                                                  Limitations of Use: OPDIVO QVANTIG is not indicated in combination with ipilimumab for the treatment of patients with unresectable or metastatic HCC.
                                                                                                                                                                                                                                  kind
                                                                                                                                                                                                                                  regimen
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                                                                                                                                                                                                                                  span
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                                                                                                                                                                                                                                  10801
                                                                                                                                                                                                                                  end exclusive
                                                                                                                                                                                                                                  true
                                                                                                                                                                                                                                  exact text
                                                                                                                                                                                                                                  in combination with ipilimumab for the treatment of patients with unresectable or metastatic HCC
                                                                                                                                                                                                                                  label id
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                                                                                                                                                                                                                                  offset unit
                                                                                                                                                                                                                                  unicode_code_points
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                                                                                                                                                                                                                                  source field
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                                                                                                                                                                                                                                  source batch sha256
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                                                                                                                                                                                                                                  source defined aliases
                                                                                                                                                                                                                                  1. abbreviation
                                                                                                                                                                                                                                    NSCLC
                                                                                                                                                                                                                                    definition exact
                                                                                                                                                                                                                                    Non-Small Cell Lung Cancer
                                                                                                                                                                                                                                    definition span
                                                                                                                                                                                                                                    end
                                                                                                                                                                                                                                    1424
                                                                                                                                                                                                                                    end exclusive
                                                                                                                                                                                                                                    true
                                                                                                                                                                                                                                    exact text
                                                                                                                                                                                                                                    Non-Small Cell Lung Cancer (NSCLC)
                                                                                                                                                                                                                                    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
                                                                                                                                                                                                                                    1390
                                                                                                                                                                                                                                  2. abbreviation
                                                                                                                                                                                                                                    CRC
                                                                                                                                                                                                                                    definition exact
                                                                                                                                                                                                                                    Colorectal Cancer
                                                                                                                                                                                                                                    definition span
                                                                                                                                                                                                                                    end
                                                                                                                                                                                                                                    3023
                                                                                                                                                                                                                                    end exclusive
                                                                                                                                                                                                                                    true
                                                                                                                                                                                                                                    exact text
                                                                                                                                                                                                                                    Colorectal Cancer (CRC)
                                                                                                                                                                                                                                    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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                                                                                                                                                                                                                                  source span
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                                                                                                                                                                                                                                  10802
                                                                                                                                                                                                                                  end exclusive
                                                                                                                                                                                                                                  true
                                                                                                                                                                                                                                  exact text
                                                                                                                                                                                                                                  Limitations of Use: OPDIVO QVANTIG is not indicated in combination with ipilimumab for the treatment of patients with unresectable or metastatic HCC.
                                                                                                                                                                                                                                  label id
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                                                                                                                                                                                                                                  spl effective date
                                                                                                                                                                                                                                  2026-05-12
                                                                                                                                                                                                                                  spl set id
                                                                                                                                                                                                                                  7f8c38fa-42f4-4387-9e8c-7a1c66855d8b
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                                                                                                                                                                                                                                  structured fields status
                                                                                                                                                                                                                                  not_extracted_no_values_inferred_from_mentions
                                                                                                                                                                                                                                  structured indication
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                                                                                                                                                                                                                                  approval pathway
                                                                                                                                                                                                                                  Source null
                                                                                                                                                                                                                                  biomarker and test
                                                                                                                                                                                                                                  Source null
                                                                                                                                                                                                                                  disease stage
                                                                                                                                                                                                                                  Source null
                                                                                                                                                                                                                                  limitations
                                                                                                                                                                                                                                  Source null
                                                                                                                                                                                                                                  line
                                                                                                                                                                                                                                  Source null
                                                                                                                                                                                                                                  prior therapy
                                                                                                                                                                                                                                  Source null
                                                                                                                                                                                                                                  regimen
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                                                                                                                                                                                                                                  tumor histology
                                                                                                                                                                                                                                  Source null
                                                                                                                                                                                                                                  use intent
                                                                                                                                                                                                                                  not_applicable
                                                                                                                                                                                                                                  Passage 83 · positive indication candidate
                                                                                                                                                                                                                                  application numbers
                                                                                                                                                                                                                                  1. BLA761381
                                                                                                                                                                                                                                  brand names
                                                                                                                                                                                                                                  1. OPDIVO QVANTIG
                                                                                                                                                                                                                                  classification reasons
                                                                                                                                                                                                                                  1. explicit_positive_indication_predicate
                                                                                                                                                                                                                                  2. tumor_or_malignant_hematology_words_in_positive_statement
                                                                                                                                                                                                                                  clinical review status
                                                                                                                                                                                                                                  pending
                                                                                                                                                                                                                                  content role
                                                                                                                                                                                                                                  positive_indication_candidate
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                                                                                                                                                                                                                                  1. NIVOLUMAB AND HYALURONIDASE-NVHY
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                                                                                                                                                                                                                                  2. context exact
                                                                                                                                                                                                                                    Cancer OPDIVO QVANTIG as monotherapy, is indicated for the adjuvant treatment of completely resected esophageal or gastroesophageal junction cancer with residual
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                                                                                                                                                                                                                                  3. context exact
                                                                                                                                                                                                                                    dual pathologic disease in adult patients who have received neoadjuvant chemoradiotherapy (CRT).
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                                                                                                                                                                                                                                    1.11 Esophageal Cancer OPDIVO QVANTIG as monotherapy, 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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                                                                                                                                                                                                                                      NSCLC
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                                                                                                                                                                                                                                      Non-Small Cell Lung Cancer
                                                                                                                                                                                                                                      definition span
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                                                                                                                                                                                                                                    1.11 Esophageal Cancer OPDIVO QVANTIG as monotherapy, 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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                                                                                                                                                                                                                                    use intent
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                                                                                                                                                                                                                                    Passage 84 · positive indication candidate
                                                                                                                                                                                                                                    application numbers
                                                                                                                                                                                                                                    1. BLA761381
                                                                                                                                                                                                                                    brand names
                                                                                                                                                                                                                                    1. OPDIVO QVANTIG
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                                                                                                                                                                                                                                    2. tumor_or_malignant_hematology_words_in_positive_statement
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                                                                                                                                                                                                                                    generic names
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                                                                                                                                                                                                                                    qualifier mentions
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                                                                                                                                                                                                                                      chemotherapy, is indicated for the first-line treatment of adult patients with unresectable advanced or metastatic esophageal squamou
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                                                                                                                                                                                                                                      OPDIVO QVANTIG, 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
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                                                                                                                                                                                                                                      OPDIVO QVANTIG, 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 (2.2) ] .
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                                                                                                                                                                                                                                      Passage 85 · limitation of use
                                                                                                                                                                                                                                      application numbers
                                                                                                                                                                                                                                      1. BLA761381
                                                                                                                                                                                                                                      brand names
                                                                                                                                                                                                                                      1. OPDIVO QVANTIG
                                                                                                                                                                                                                                      classification reasons
                                                                                                                                                                                                                                      1. negative_or_not_established_clause
                                                                                                                                                                                                                                      clinical review status
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                                                                                                                                                                                                                                      qualifier mentions
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                                                                                                                                                                                                                                        exact text
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                                                                                                                                                                                                                                        true
                                                                                                                                                                                                                                        exact text
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                                                                                                                                                                                                                                        true
                                                                                                                                                                                                                                        exact text
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                                                                                                                                                                                                                                        source defined aliases
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                                                                                                                                                                                                                                          definition exact
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                                                                                                                                                                                                                                          definition span
                                                                                                                                                                                                                                          end
                                                                                                                                                                                                                                          1424
                                                                                                                                                                                                                                          end exclusive
                                                                                                                                                                                                                                          true
                                                                                                                                                                                                                                          exact text
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                                                                                                                                                                                                                                        2. abbreviation
                                                                                                                                                                                                                                          CRC
                                                                                                                                                                                                                                          definition exact
                                                                                                                                                                                                                                          Colorectal Cancer
                                                                                                                                                                                                                                          definition span
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                                                                                                                                                                                                                                          3023
                                                                                                                                                                                                                                          end exclusive
                                                                                                                                                                                                                                          true
                                                                                                                                                                                                                                          exact text
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                                                                                                                                                                                                                                        end exclusive
                                                                                                                                                                                                                                        true
                                                                                                                                                                                                                                        exact text
                                                                                                                                                                                                                                        Limitations of Use: OPDIVO QVANTIG is not indicated in combination with ipilimumab for the treatment of patients with unresectable advanced or metastatic ESCC.
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                                                                                                                                                                                                                                        line
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                                                                                                                                                                                                                                        regimen
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                                                                                                                                                                                                                                        Source null
                                                                                                                                                                                                                                        use intent
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                                                                                                                                                                                                                                        Passage 86 · positive indication candidate
                                                                                                                                                                                                                                        application numbers
                                                                                                                                                                                                                                        1. BLA761381
                                                                                                                                                                                                                                        brand names
                                                                                                                                                                                                                                        1. OPDIVO QVANTIG
                                                                                                                                                                                                                                        classification reasons
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                                                                                                                                                                                                                                        2. no_tumor_directed_keyword_in_positive_statement
                                                                                                                                                                                                                                        clinical review status
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                                                                                                                                                                                                                                        11941
                                                                                                                                                                                                                                        end exclusive
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                                                                                                                                                                                                                                        exact text
                                                                                                                                                                                                                                        see Dosage and Administration (2.2) ] . Limitations of Use: OPDIVO QVANTIG is not indicated in combination with ipilimumab for the treatment of patients with unresectable advanced or metastatic ESCC. OPDIVO QVANTIG as monotherapy, is indicated for the treatment of adult patients with unresectable advanced, recurrent, or metastatic ESCC after prior fluoropyrimidine- and platinum-based chemotherapy. 1.12 Gastric Cancer, Gastroesophageal Junction Cancer, and Esophageal Adenocarcinoma OPDIVO QVANTIG, in combination with fluoropyrimidine- and platinum-containing chemotherapy, is indicated for the t
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                                                                                                                                                                                                                                        automated_candidate_pending_source_review
                                                                                                                                                                                                                                        generic names
                                                                                                                                                                                                                                        1. NIVOLUMAB AND HYALURONIDASE-NVHY
                                                                                                                                                                                                                                        id
                                                                                                                                                                                                                                        ind-span-b7d31a5442d821914bdc
                                                                                                                                                                                                                                        label id
                                                                                                                                                                                                                                        1ce25608-1b8f-4d49-9ffd-6c8c61bf4f1a
                                                                                                                                                                                                                                        positive predicate support span
                                                                                                                                                                                                                                        end
                                                                                                                                                                                                                                        11584
                                                                                                                                                                                                                                        end exclusive
                                                                                                                                                                                                                                        true
                                                                                                                                                                                                                                        exact text
                                                                                                                                                                                                                                        is indicated
                                                                                                                                                                                                                                        label id
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                                                                                                                                                                                                                                        source field
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                                                                                                                                                                                                                                        11572
                                                                                                                                                                                                                                        qualifier mentions
                                                                                                                                                                                                                                        1. context exact
                                                                                                                                                                                                                                          O QVANTIG as monotherapy, is indicated for the treatment of adult patients with unresectable advanced, recurrent, or metastatic ESCC a
                                                                                                                                                                                                                                          kind
                                                                                                                                                                                                                                          age
                                                                                                                                                                                                                                          polarity
                                                                                                                                                                                                                                          not_inferred
                                                                                                                                                                                                                                          span
                                                                                                                                                                                                                                          end
                                                                                                                                                                                                                                          11620
                                                                                                                                                                                                                                          end exclusive
                                                                                                                                                                                                                                          true
                                                                                                                                                                                                                                          exact text
                                                                                                                                                                                                                                          adult patients
                                                                                                                                                                                                                                          label id
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                                                                                                                                                                                                                                          source field
                                                                                                                                                                                                                                          indications_and_usage_exact
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                                                                                                                                                                                                                                          start
                                                                                                                                                                                                                                          11606
                                                                                                                                                                                                                                        2. context exact
                                                                                                                                                                                                                                          of adult patients with unresectable advanced, recurrent, or metastatic ESCC after prior fluoropyrimidine- and platinum-based chemotherapy.
                                                                                                                                                                                                                                          kind
                                                                                                                                                                                                                                          biomarker
                                                                                                                                                                                                                                          polarity
                                                                                                                                                                                                                                          not_inferred
                                                                                                                                                                                                                                          span
                                                                                                                                                                                                                                          end
                                                                                                                                                                                                                                          11706
                                                                                                                                                                                                                                          end exclusive
                                                                                                                                                                                                                                          true
                                                                                                                                                                                                                                          exact text
                                                                                                                                                                                                                                          metastatic ESCC after prior fluoropyrimidin
                                                                                                                                                                                                                                          label id
                                                                                                                                                                                                                                          1ce25608-1b8f-4d49-9ffd-6c8c61bf4f1a
                                                                                                                                                                                                                                          offset unit
                                                                                                                                                                                                                                          unicode_code_points
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                                                                                                                                                                                                                                          source field
                                                                                                                                                                                                                                          indications_and_usage_exact
                                                                                                                                                                                                                                          source text sha256
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                                                                                                                                                                                                                                          start
                                                                                                                                                                                                                                          11663
                                                                                                                                                                                                                                        3. context exact
                                                                                                                                                                                                                                          rapy, is indicated for the treatment of adult patients with unresectable advanced, recurrent, or metastatic ESCC after prior fluoropyrimidine
                                                                                                                                                                                                                                          kind
                                                                                                                                                                                                                                          stage_or_setting
                                                                                                                                                                                                                                          polarity
                                                                                                                                                                                                                                          not_inferred
                                                                                                                                                                                                                                          span
                                                                                                                                                                                                                                          end
                                                                                                                                                                                                                                          11647
                                                                                                                                                                                                                                          end exclusive
                                                                                                                                                                                                                                          true
                                                                                                                                                                                                                                          exact text
                                                                                                                                                                                                                                          unresectable advanced
                                                                                                                                                                                                                                          label id
                                                                                                                                                                                                                                          1ce25608-1b8f-4d49-9ffd-6c8c61bf4f1a
                                                                                                                                                                                                                                          offset unit
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                                                                                                                                                                                                                                          source array index
                                                                                                                                                                                                                                          0
                                                                                                                                                                                                                                          source field
                                                                                                                                                                                                                                          indications_and_usage_exact
                                                                                                                                                                                                                                          source text sha256
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                                                                                                                                                                                                                                          start
                                                                                                                                                                                                                                          11626
                                                                                                                                                                                                                                        4. context exact
                                                                                                                                                                                                                                          the treatment of adult patients with unresectable advanced, recurrent, or metastatic ESCC after prior fluoropyrimidine- and plati
                                                                                                                                                                                                                                          kind
                                                                                                                                                                                                                                          stage_or_setting
                                                                                                                                                                                                                                          polarity
                                                                                                                                                                                                                                          not_inferred
                                                                                                                                                                                                                                          span
                                                                                                                                                                                                                                          end
                                                                                                                                                                                                                                          11658
                                                                                                                                                                                                                                          end exclusive
                                                                                                                                                                                                                                          true
                                                                                                                                                                                                                                          exact text
                                                                                                                                                                                                                                          recurrent
                                                                                                                                                                                                                                          label id
                                                                                                                                                                                                                                          1ce25608-1b8f-4d49-9ffd-6c8c61bf4f1a
                                                                                                                                                                                                                                          offset unit
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                                                                                                                                                                                                                                          source array index
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                                                                                                                                                                                                                                          source field
                                                                                                                                                                                                                                          indications_and_usage_exact
                                                                                                                                                                                                                                          source text sha256
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                                                                                                                                                                                                                                          start
                                                                                                                                                                                                                                          11649
                                                                                                                                                                                                                                        5. context exact
                                                                                                                                                                                                                                          of adult patients with unresectable advanced, recurrent, or metastatic ESCC after prior fluoropyrimidine- and platinum-based chemotherapy.
                                                                                                                                                                                                                                          kind
                                                                                                                                                                                                                                          stage_or_setting
                                                                                                                                                                                                                                          polarity
                                                                                                                                                                                                                                          not_inferred
                                                                                                                                                                                                                                          span
                                                                                                                                                                                                                                          end
                                                                                                                                                                                                                                          11708
                                                                                                                                                                                                                                          end exclusive
                                                                                                                                                                                                                                          true
                                                                                                                                                                                                                                          exact text
                                                                                                                                                                                                                                          metastatic ESCC after prior fluoropyrimidine-
                                                                                                                                                                                                                                          label id
                                                                                                                                                                                                                                          1ce25608-1b8f-4d49-9ffd-6c8c61bf4f1a
                                                                                                                                                                                                                                          offset unit
                                                                                                                                                                                                                                          unicode_code_points
                                                                                                                                                                                                                                          source array index
                                                                                                                                                                                                                                          0
                                                                                                                                                                                                                                          source field
                                                                                                                                                                                                                                          indications_and_usage_exact
                                                                                                                                                                                                                                          source text sha256
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                                                                                                                                                                                                                                          start
                                                                                                                                                                                                                                          11663
                                                                                                                                                                                                                                        6. context exact
                                                                                                                                                                                                                                          OPDIVO QVANTIG as monotherapy, is indicated for the treatment of adult patients with unresectable advanced, recurrent, or metastatic ESCC after prior fluoropyrimidine- and platinum-based chemotherapy.
                                                                                                                                                                                                                                          kind
                                                                                                                                                                                                                                          regimen
                                                                                                                                                                                                                                          polarity
                                                                                                                                                                                                                                          not_inferred
                                                                                                                                                                                                                                          span
                                                                                                                                                                                                                                          end
                                                                                                                                                                                                                                          11730
                                                                                                                                                                                                                                          end exclusive
                                                                                                                                                                                                                                          true
                                                                                                                                                                                                                                          exact text
                                                                                                                                                                                                                                          as monotherapy, is indicated for the treatment of adult patients with unresectable advanced, recurrent, or metastatic ESCC after prior fluoropyrimidine- and platinum-based ch
                                                                                                                                                                                                                                          label id
                                                                                                                                                                                                                                          1ce25608-1b8f-4d49-9ffd-6c8c61bf4f1a
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                                                                                                                                                                                                                                          unicode_code_points
                                                                                                                                                                                                                                          source array index
                                                                                                                                                                                                                                          0
                                                                                                                                                                                                                                          source field
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                                                                                                                                                                                                                                          start
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                                                                                                                                                                                                                                        regulatory links
                                                                                                                                                                                                                                          schema version
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                                                                                                                                                                                                                                          source batch sha256
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                                                                                                                                                                                                                                          source defined aliases
                                                                                                                                                                                                                                          1. abbreviation
                                                                                                                                                                                                                                            NSCLC
                                                                                                                                                                                                                                            definition exact
                                                                                                                                                                                                                                            Non-Small Cell Lung Cancer
                                                                                                                                                                                                                                            definition span
                                                                                                                                                                                                                                            end
                                                                                                                                                                                                                                            1424
                                                                                                                                                                                                                                            end exclusive
                                                                                                                                                                                                                                            true
                                                                                                                                                                                                                                            exact text
                                                                                                                                                                                                                                            Non-Small Cell Lung Cancer (NSCLC)
                                                                                                                                                                                                                                            label id
                                                                                                                                                                                                                                            1ce25608-1b8f-4d49-9ffd-6c8c61bf4f1a
                                                                                                                                                                                                                                            offset unit
                                                                                                                                                                                                                                            unicode_code_points
                                                                                                                                                                                                                                            source array index
                                                                                                                                                                                                                                            0
                                                                                                                                                                                                                                            source field
                                                                                                                                                                                                                                            indications_and_usage_exact
                                                                                                                                                                                                                                            source text sha256
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                                                                                                                                                                                                                                            start
                                                                                                                                                                                                                                            1390
                                                                                                                                                                                                                                          2. abbreviation
                                                                                                                                                                                                                                            CRC
                                                                                                                                                                                                                                            definition exact
                                                                                                                                                                                                                                            Colorectal Cancer
                                                                                                                                                                                                                                            definition span
                                                                                                                                                                                                                                            end
                                                                                                                                                                                                                                            3023
                                                                                                                                                                                                                                            end exclusive
                                                                                                                                                                                                                                            true
                                                                                                                                                                                                                                            exact text
                                                                                                                                                                                                                                            Colorectal Cancer (CRC)
                                                                                                                                                                                                                                            label id
                                                                                                                                                                                                                                            1ce25608-1b8f-4d49-9ffd-6c8c61bf4f1a
                                                                                                                                                                                                                                            offset unit
                                                                                                                                                                                                                                            unicode_code_points
                                                                                                                                                                                                                                            source array index
                                                                                                                                                                                                                                            0
                                                                                                                                                                                                                                            source field
                                                                                                                                                                                                                                            indications_and_usage_exact
                                                                                                                                                                                                                                            source text sha256
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                                                                                                                                                                                                                                            start
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                                                                                                                                                                                                                                          source span
                                                                                                                                                                                                                                          end
                                                                                                                                                                                                                                          11741
                                                                                                                                                                                                                                          end exclusive
                                                                                                                                                                                                                                          true
                                                                                                                                                                                                                                          exact text
                                                                                                                                                                                                                                          OPDIVO QVANTIG as monotherapy, is indicated for the treatment of adult patients with unresectable advanced, recurrent, or metastatic ESCC after prior fluoropyrimidine- and platinum-based chemotherapy.
                                                                                                                                                                                                                                          label id
                                                                                                                                                                                                                                          1ce25608-1b8f-4d49-9ffd-6c8c61bf4f1a
                                                                                                                                                                                                                                          offset unit
                                                                                                                                                                                                                                          unicode_code_points
                                                                                                                                                                                                                                          source array index
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                                                                                                                                                                                                                                          source field
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                                                                                                                                                                                                                                          source text sha256
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                                                                                                                                                                                                                                          start
                                                                                                                                                                                                                                          11541
                                                                                                                                                                                                                                          source url
                                                                                                                                                                                                                                          https://api.fda.gov/drug/label.json?search=id%3A%221ce25608-1b8f-4d49-9ffd-6c8c61bf4f1a%22
                                                                                                                                                                                                                                          spl effective date
                                                                                                                                                                                                                                          2026-05-12
                                                                                                                                                                                                                                          spl set id
                                                                                                                                                                                                                                          7f8c38fa-42f4-4387-9e8c-7a1c66855d8b
                                                                                                                                                                                                                                          spl version
                                                                                                                                                                                                                                          9
                                                                                                                                                                                                                                          structured fields status
                                                                                                                                                                                                                                          not_extracted_no_values_inferred_from_mentions
                                                                                                                                                                                                                                          structured indication
                                                                                                                                                                                                                                          age
                                                                                                                                                                                                                                          Source null
                                                                                                                                                                                                                                          approval pathway
                                                                                                                                                                                                                                          Source null
                                                                                                                                                                                                                                          biomarker and test
                                                                                                                                                                                                                                          Source null
                                                                                                                                                                                                                                          disease stage
                                                                                                                                                                                                                                          Source null
                                                                                                                                                                                                                                          limitations
                                                                                                                                                                                                                                          Source null
                                                                                                                                                                                                                                          line
                                                                                                                                                                                                                                          Source null
                                                                                                                                                                                                                                          prior therapy
                                                                                                                                                                                                                                          Source null
                                                                                                                                                                                                                                          regimen
                                                                                                                                                                                                                                          Source null
                                                                                                                                                                                                                                          tumor histology
                                                                                                                                                                                                                                          Source null
                                                                                                                                                                                                                                          use intent
                                                                                                                                                                                                                                          non_oncology_or_unclear_candidate
                                                                                                                                                                                                                                          Passage 87 · positive indication candidate
                                                                                                                                                                                                                                          application numbers
                                                                                                                                                                                                                                          1. BLA761381
                                                                                                                                                                                                                                          brand names
                                                                                                                                                                                                                                          1. OPDIVO QVANTIG
                                                                                                                                                                                                                                          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
                                                                                                                                                                                                                                          12148
                                                                                                                                                                                                                                          end exclusive
                                                                                                                                                                                                                                          true
                                                                                                                                                                                                                                          exact text
                                                                                                                                                                                                                                          PDIVO QVANTIG as monotherapy, is indicated for the treatment of adult patients with unresectable advanced, recurrent, or metastatic ESCC after prior fluoropyrimidine- and platinum-based chemotherapy. 1.12 Gastric Cancer, Gastroesophageal Junction Cancer, and Esophageal Adenocarcinoma OPDIVO QVANTIG, 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 (2.2) ] .
                                                                                                                                                                                                                                          label id
                                                                                                                                                                                                                                          1ce25608-1b8f-4d49-9ffd-6c8c61bf4f1a
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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
                                                                                                                                                                                                                                          11542
                                                                                                                                                                                                                                          current approval status
                                                                                                                                                                                                                                          not_reconciled
                                                                                                                                                                                                                                          duplicate text group
                                                                                                                                                                                                                                          dup-0e219da5cac0ef98ba33
                                                                                                                                                                                                                                          extraction review status
                                                                                                                                                                                                                                          automated_candidate_pending_source_review
                                                                                                                                                                                                                                          generic names
                                                                                                                                                                                                                                          1. NIVOLUMAB AND HYALURONIDASE-NVHY
                                                                                                                                                                                                                                          id
                                                                                                                                                                                                                                          ind-span-2a2cec0cfa782de9d98a
                                                                                                                                                                                                                                          label id
                                                                                                                                                                                                                                          1ce25608-1b8f-4d49-9ffd-6c8c61bf4f1a
                                                                                                                                                                                                                                          positive predicate support span
                                                                                                                                                                                                                                          end
                                                                                                                                                                                                                                          11931
                                                                                                                                                                                                                                          end exclusive
                                                                                                                                                                                                                                          true
                                                                                                                                                                                                                                          exact text
                                                                                                                                                                                                                                          is indicated
                                                                                                                                                                                                                                          label id
                                                                                                                                                                                                                                          1ce25608-1b8f-4d49-9ffd-6c8c61bf4f1a
                                                                                                                                                                                                                                          offset unit
                                                                                                                                                                                                                                          unicode_code_points
                                                                                                                                                                                                                                          source array index
                                                                                                                                                                                                                                          0
                                                                                                                                                                                                                                          source field
                                                                                                                                                                                                                                          indications_and_usage_exact
                                                                                                                                                                                                                                          source text sha256
                                                                                                                                                                                                                                          2752de64f809563e0adb6a2f4f307e1f930b4fe55c5721c928890afcb9aff780
                                                                                                                                                                                                                                          start
                                                                                                                                                                                                                                          11919
                                                                                                                                                                                                                                          qualifier mentions
                                                                                                                                                                                                                                          1. context exact
                                                                                                                                                                                                                                            -containing chemotherapy, is indicated for the treatment of adult patients with advanced or metastatic gastric cancer, gastroesophagea
                                                                                                                                                                                                                                            kind
                                                                                                                                                                                                                                            age
                                                                                                                                                                                                                                            polarity
                                                                                                                                                                                                                                            not_inferred
                                                                                                                                                                                                                                            span
                                                                                                                                                                                                                                            end
                                                                                                                                                                                                                                            11967
                                                                                                                                                                                                                                            end exclusive
                                                                                                                                                                                                                                            true
                                                                                                                                                                                                                                            exact text
                                                                                                                                                                                                                                            adult patients
                                                                                                                                                                                                                                            label id
                                                                                                                                                                                                                                            1ce25608-1b8f-4d49-9ffd-6c8c61bf4f1a
                                                                                                                                                                                                                                            offset unit
                                                                                                                                                                                                                                            unicode_code_points
                                                                                                                                                                                                                                            source array index
                                                                                                                                                                                                                                            0
                                                                                                                                                                                                                                            source field
                                                                                                                                                                                                                                            indications_and_usage_exact
                                                                                                                                                                                                                                            source text sha256
                                                                                                                                                                                                                                            2752de64f809563e0adb6a2f4f307e1f930b4fe55c5721c928890afcb9aff780
                                                                                                                                                                                                                                            start
                                                                                                                                                                                                                                            11953
                                                                                                                                                                                                                                          2. context exact
                                                                                                                                                                                                                                            icated for the treatment of adult patients with advanced or metastatic gastric cancer, gastroesophageal junction cancer, and esophageal adenocarc
                                                                                                                                                                                                                                            kind
                                                                                                                                                                                                                                            biomarker
                                                                                                                                                                                                                                            polarity
                                                                                                                                                                                                                                            not_inferred
                                                                                                                                                                                                                                            span
                                                                                                                                                                                                                                            end
                                                                                                                                                                                                                                            12010
                                                                                                                                                                                                                                            end exclusive
                                                                                                                                                                                                                                            true
                                                                                                                                                                                                                                            exact text
                                                                                                                                                                                                                                            metastatic gastric cancer
                                                                                                                                                                                                                                            label id
                                                                                                                                                                                                                                            1ce25608-1b8f-4d49-9ffd-6c8c61bf4f1a
                                                                                                                                                                                                                                            offset unit
                                                                                                                                                                                                                                            unicode_code_points
                                                                                                                                                                                                                                            source array index
                                                                                                                                                                                                                                            0
                                                                                                                                                                                                                                            source field
                                                                                                                                                                                                                                            indications_and_usage_exact
                                                                                                                                                                                                                                            source text sha256
                                                                                                                                                                                                                                            2752de64f809563e0adb6a2f4f307e1f930b4fe55c5721c928890afcb9aff780
                                                                                                                                                                                                                                            start
                                                                                                                                                                                                                                            11985
                                                                                                                                                                                                                                          3. context exact
                                                                                                                                                                                                                                            cancer, and esophageal adenocarcinoma whose tumors express PD-L1 (≥1) [see Dosage and Administration (2.2) ] .
                                                                                                                                                                                                                                            kind
                                                                                                                                                                                                                                            biomarker
                                                                                                                                                                                                                                            polarity
                                                                                                                                                                                                                                            not_inferred
                                                                                                                                                                                                                                            span
                                                                                                                                                                                                                                            end
                                                                                                                                                                                                                                            12141
                                                                                                                                                                                                                                            end exclusive
                                                                                                                                                                                                                                            true
                                                                                                                                                                                                                                            exact text
                                                                                                                                                                                                                                            PD-L1 (≥1) [see Dosage and Administration (2
                                                                                                                                                                                                                                            label id
                                                                                                                                                                                                                                            1ce25608-1b8f-4d49-9ffd-6c8c61bf4f1a
                                                                                                                                                                                                                                            offset unit
                                                                                                                                                                                                                                            unicode_code_points
                                                                                                                                                                                                                                            source array index
                                                                                                                                                                                                                                            0
                                                                                                                                                                                                                                            source field
                                                                                                                                                                                                                                            indications_and_usage_exact
                                                                                                                                                                                                                                            source text sha256
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                                                                                                                                                                                                                                            start
                                                                                                                                                                                                                                            12097
                                                                                                                                                                                                                                          4. context exact
                                                                                                                                                                                                                                            rapy, is indicated for the treatment of adult patients with advanced or metastatic gastric cancer, gastroesophageal junction cancer, and esophageal adenocarc
                                                                                                                                                                                                                                            kind
                                                                                                                                                                                                                                            stage_or_setting
                                                                                                                                                                                                                                            polarity
                                                                                                                                                                                                                                            not_inferred
                                                                                                                                                                                                                                            span
                                                                                                                                                                                                                                            end
                                                                                                                                                                                                                                            12010
                                                                                                                                                                                                                                            end exclusive
                                                                                                                                                                                                                                            true
                                                                                                                                                                                                                                            exact text
                                                                                                                                                                                                                                            advanced or metastatic gastric cancer
                                                                                                                                                                                                                                            label id
                                                                                                                                                                                                                                            1ce25608-1b8f-4d49-9ffd-6c8c61bf4f1a
                                                                                                                                                                                                                                            offset unit
                                                                                                                                                                                                                                            unicode_code_points
                                                                                                                                                                                                                                            source array index
                                                                                                                                                                                                                                            0
                                                                                                                                                                                                                                            source field
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                                                                                                                                                                                                                                            ction Cancer, and Esophageal Adenocarcinoma OPDIVO QVANTIG, 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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                                                                                                                                                                                                                                            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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                                                                                                                                                                                                                                            1. abbreviation
                                                                                                                                                                                                                                              NSCLC
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                                                                                                                                                                                                                                              Non-Small Cell Lung Cancer
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                                                                                                                                                                                                                                            exact text
                                                                                                                                                                                                                                            1.12 Gastric Cancer, Gastroesophageal Junction Cancer, and Esophageal Adenocarcinoma OPDIVO QVANTIG, 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 (2.2) ] .
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                                                                                                                                                                                                                                            Preserved source evidence · Not medical advice