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LABELS · 72755838-4a55-4245-949e-16cea13f2584

YERVOY

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

Label effective date
2026-08-20
Captured
2026-09-09T23:37:51.659493+00:00
Current indication reconciliation
Not reconciled

Indications and usage: exact source text

  1. 1 INDICATIONS AND USAGE YERVOY is a human cytotoxic T-lymphocyte antigen 4 (CTLA-4)-blocking antibody indicated for: Melanoma • Treatment of unresectable or metastatic melanoma in adults and pediatric patients 12 years and older as a single agent or in combination with nivolumab. (1.1) • Adjuvant treatment of adult patients with cutaneous melanoma with pathologic involvement of regional lymph nodes of more than 1 mm who have undergone complete resection, including total lymphadenectomy. (1.2) Renal Cell Carcinoma (RCC) • Treatment of adult patients with intermediate or poor risk advanced renal cell carcinoma, as first-line treatment in combination with nivolumab. (1.3) Colorectal Cancer • Treatment of adults and pediatric patients 12 years and older with unresectable or metastatic microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) colorectal cancer (CRC) as determined by an FDA-authorized test in combination with nivolumab. (1.4) Hepatocellular Carcinoma • adult patients with unresectable or metastatic hepatocellular carcinoma (HCC) as first-line treatment in combination with nivolumab. ( 1.5 ) • in combination with nivolumab in adult patients with unresectable or metastatic HCC who have been previously treated with sorafenib. (1.5) Non-Small Cell Lung Cancer (NSCLC) • Treatment of adult patients with metastatic non-small cell lung cancer expressing PD-L1 (≥1%) as determined by an FDA-authorized test, with no EGFR or ALK genomic tumor aberrations, as first-line treatment in combination with nivolumab. (1.6) • Treatment of adult patients with metastatic or recurrent non-small cell lung cancer with no EGFR or ALK genomic tumor aberrations as first-line treatment, in combination with nivolumab and 2 cycles of platinum-doublet chemotherapy. (1.6) Malignant Pleural Mesothelioma • Treatment of adult patients with unresectable malignant pleural mesothelioma, as first-line treatment in combination with nivolumab. (1.7) Esophageal Cancer • Treatment of adult patients with unresectable advanced or metastatic esophageal squamous cell carcinoma, as first line treatment in combination with nivolumab whose tumors express PD-L1 (≥1). (1.8) 1.1 Unresectable or Metastatic Melanoma YERVOY, as a single agent or in combination with nivolumab, is indicated for the treatment of unresectable or metastatic melanoma in adult and pediatric patients 12 years and older. 1.2 Adjuvant Treatment of Melanoma YERVOY is indicated for the adjuvant treatment of adult patients with cutaneous melanoma with pathologic involvement of regional lymph nodes of more than 1 mm who have undergone complete resection, including total lymphadenectomy. 1.3 Advanced Renal Cell Carcinoma YERVOY, in combination with nivolumab, is indicated for the first-line treatment of adult patients with intermediate or poor risk advanced renal cell carcinoma (RCC). 1.4 Microsatellite Instability-High or Mismatch Repair Deficient Metastatic Colorectal Cancer • YERVOY, in combination with nivolumab, is indicated for the treatment of adult and pediatric patients 12 years and older with unresectable or metastatic microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) colorectal cancer (CRC) as determined by an FDA-authorized test . 1.5 Hepatocellular Carcinoma • YERVOY, in combination with nivolumab, is indicated for the first-line treatment of adult patients with unresectable or metastatic hepatocellular carcinoma (HCC). • YERVOY, in combination with nivolumab, is indicated for the treatment of adult patients with unresectable or metastatic HCC who have been previously treated with sorafenib. 1.6 Metastatic Non-Small Cell Lung Cancer YERVOY, in combination with nivolumab, is indicated for the first-line treatment of adult patients with metastatic non-small cell lung cancer (NSCLC) whose tumors express PD-L1 (≥1%) as determined by an FDA-authorized test [see Dosage and Administration (2.1) ] , with no EGFR or ALK genomic tumor aberrations. YERVOY, in combination with nivolumab and 2 cycles of platinum-doublet chemotherapy, is indicated for the first-line treatment of adult patients with metastatic or recurrent NSCLC, with no EGFR or ALK genomic tumor aberrations. 1.7 Malignant Pleural Mesothelioma YERVOY, in combination with nivolumab, is indicated for the first-line treatment of adult patients with unresectable malignant pleural mesothelioma. 1.8 Esophageal Cancer YERVOY, in combination with nivolumab, is indicated for the first-line treatment of adult patients with unresectable advanced or metastatic esophageal squamous cell carcinoma (ESCC) whose tumors express PD-L1 (≥1) [see Dosage and Administration (2.1) ] .
Full extracted label fields
application numbers
  1. BLA125377
boxed warning exact
    brand names
    1. YERVOY
    current indication status
    not_reconciled
    dailymed set url
    https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=2265ef30-253e-11df-8a39-0800200c9a66
    generic names
    1. IPILIMUMAB
    id
    72755838-4a55-4245-949e-16cea13f2584
    indications and usage exact
    1. 1 INDICATIONS AND USAGE YERVOY is a human cytotoxic T-lymphocyte antigen 4 (CTLA-4)-blocking antibody indicated for: Melanoma • Treatment of unresectable or metastatic melanoma in adults and pediatric patients 12 years and older as a single agent or in combination with nivolumab. (1.1) • Adjuvant treatment of adult patients with cutaneous melanoma with pathologic involvement of regional lymph nodes of more than 1 mm who have undergone complete resection, including total lymphadenectomy. (1.2) Renal Cell Carcinoma (RCC) • Treatment of adult patients with intermediate or poor risk advanced renal cell carcinoma, as first-line treatment in combination with nivolumab. (1.3) Colorectal Cancer • Treatment of adults and pediatric patients 12 years and older with unresectable or metastatic microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) colorectal cancer (CRC) as determined by an FDA-authorized test in combination with nivolumab. (1.4) Hepatocellular Carcinoma • adult patients with unresectable or metastatic hepatocellular carcinoma (HCC) as first-line treatment in combination with nivolumab. ( 1.5 ) • in combination with nivolumab in adult patients with unresectable or metastatic HCC who have been previously treated with sorafenib. (1.5) Non-Small Cell Lung Cancer (NSCLC) • Treatment of adult patients with metastatic non-small cell lung cancer expressing PD-L1 (≥1%) as determined by an FDA-authorized test, with no EGFR or ALK genomic tumor aberrations, as first-line treatment in combination with nivolumab. (1.6) • Treatment of adult patients with metastatic or recurrent non-small cell lung cancer with no EGFR or ALK genomic tumor aberrations as first-line treatment, in combination with nivolumab and 2 cycles of platinum-doublet chemotherapy. (1.6) Malignant Pleural Mesothelioma • Treatment of adult patients with unresectable malignant pleural mesothelioma, as first-line treatment in combination with nivolumab. (1.7) Esophageal Cancer • Treatment of adult patients with unresectable advanced or metastatic esophageal squamous cell carcinoma, as first line treatment in combination with nivolumab whose tumors express PD-L1 (≥1). (1.8) 1.1 Unresectable or Metastatic Melanoma YERVOY, as a single agent or in combination with nivolumab, is indicated for the treatment of unresectable or metastatic melanoma in adult and pediatric patients 12 years and older. 1.2 Adjuvant Treatment of Melanoma YERVOY is indicated for the adjuvant treatment of adult patients with cutaneous melanoma with pathologic involvement of regional lymph nodes of more than 1 mm who have undergone complete resection, including total lymphadenectomy. 1.3 Advanced Renal Cell Carcinoma YERVOY, in combination with nivolumab, is indicated for the first-line treatment of adult patients with intermediate or poor risk advanced renal cell carcinoma (RCC). 1.4 Microsatellite Instability-High or Mismatch Repair Deficient Metastatic Colorectal Cancer • YERVOY, in combination with nivolumab, is indicated for the treatment of adult and pediatric patients 12 years and older with unresectable or metastatic microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) colorectal cancer (CRC) as determined by an FDA-authorized test . 1.5 Hepatocellular Carcinoma • YERVOY, in combination with nivolumab, is indicated for the first-line treatment of adult patients with unresectable or metastatic hepatocellular carcinoma (HCC). • YERVOY, in combination with nivolumab, is indicated for the treatment of adult patients with unresectable or metastatic HCC who have been previously treated with sorafenib. 1.6 Metastatic Non-Small Cell Lung Cancer YERVOY, in combination with nivolumab, is indicated for the first-line treatment of adult patients with metastatic non-small cell lung cancer (NSCLC) whose tumors express PD-L1 (≥1%) as determined by an FDA-authorized test [see Dosage and Administration (2.1) ] , with no EGFR or ALK genomic tumor aberrations. YERVOY, in combination with nivolumab and 2 cycles of platinum-doublet chemotherapy, is indicated for the first-line treatment of adult patients with metastatic or recurrent NSCLC, with no EGFR or ALK genomic tumor aberrations. 1.7 Malignant Pleural Mesothelioma YERVOY, in combination with nivolumab, is indicated for the first-line treatment of adult patients with unresectable malignant pleural mesothelioma. 1.8 Esophageal Cancer YERVOY, in combination with nivolumab, is indicated for the first-line treatment of adult patients with unresectable advanced or metastatic esophageal squamous cell carcinoma (ESCC) whose tumors express PD-L1 (≥1) [see Dosage and Administration (2.1) ] .
    indications and usage tables exact
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      1. cancer
      2. carcinoma
      3. melanoma
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      5. tumors
      6. malignant
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      2. 0003-2328-22
      product ndcs
      1. 0003-2327
      2. 0003-2328
      product types
      1. HUMAN PRESCRIPTION DRUG
      recent major changes exact
      1. Indications and Usage ( 1 ) 6/2026 Dosage and Administration (2) 6/2026 Warnings and Precautions (5) 8/2026
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      1. INTRAVENOUS
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      spl effective date
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      spl effective time
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      substance names
      1. IPILIMUMAB
      uniis
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      Drugs@FDA application source records
      1. application number
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        payload
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        1. Appl No
          125377
          Application Docs Date
          2011-03-25 00:00:00
          Application Docs ID
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          0
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          1
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          Application Docs Date
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          Application Docs ID
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          Application Docs Type ID
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          33
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        3. Appl No
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          Application Docs Date
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          0
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          Submission No
          72
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          SUPPL
        4. Appl No
          125377
          Application Docs Date
          2016-04-19 00:00:00
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          Application Docs Title
          0
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          Submission No
          73
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        5. Appl No
          125377
          Application Docs Date
          2013-05-23 00:00:00
          Application Docs ID
          39940
          Application Docs Title
          0
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          Submission No
          44
          Submission Type
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        6. Appl No
          125377
          Application Docs Date
          2013-12-06 00:00:00
          Application Docs ID
          39941
          Application Docs Title
          0
          Application Docs Type ID
          2
          Submission No
          55
          Submission Type
          SUPPL
        7. Appl No
          125377
          Application Docs Date
          2015-08-18 00:00:00
          Application Docs ID
          39942
          Application Docs Title
          0
          Application Docs Type ID
          2
          Submission No
          74
          Submission Type
          SUPPL
        8. Appl No
          125377
          Application Docs Date
          2017-07-25 00:00:00
          Application Docs ID
          49051
          Application Docs Title
          0
          Application Docs Type ID
          2
          Submission No
          87
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          SUPPL
        9. Appl No
          125377
          Application Docs Date
          2017-10-24 00:00:00
          Application Docs ID
          50163
          Application Docs Title
          0
          Application Docs Type ID
          2
          Submission No
          86
          Submission Type
          SUPPL
        10. Appl No
          125377
          Application Docs Date
          2017-12-14 00:00:00
          Application Docs ID
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          Application Docs Title
          0
          Application Docs Type ID
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          Submission No
          91
          Submission Type
          SUPPL
        11. Appl No
          125377
          Application Docs Date
          2018-02-09 00:00:00
          Application Docs ID
          52525
          Application Docs Title
          0
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          2
          Submission No
          93
          Submission Type
          SUPPL
        12. Appl No
          125377
          Application Docs Date
          2018-04-16 00:00:00
          Application Docs ID
          53678
          Application Docs Title
          0
          Application Docs Type ID
          2
          Submission No
          94
          Submission Type
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          Review Priority
          STANDARD
          Submission Class Code ID
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          Submission Status Date
          2026-08-31 00:00:00
          Submission Type
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          Submissions Public Notes
        2. Appl No
          125377
          Review Priority
          STANDARD
          Submission Class Code ID
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          Submission No
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          Submission Status Date
          2026-06-12 00:00:00
          Submission Type
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          Submissions Public Notes
        3. Appl No
          125377
          Review Priority
          PRIORITY
          Submission Class Code ID
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          Submission No
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          Submission Status
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          Submission Status Date
          2025-05-23 00:00:00
          Submission Type
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          Submissions Public Notes
        4. Appl No
          125377
          Review Priority
          PRIORITY
          Submission Class Code ID
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          Submission No
          135
          Submission Status
          AP
          Submission Status Date
          2025-04-08 00:00:00
          Submission Type
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          Submissions Public Notes
        5. Appl No
          125377
          Review Priority
          STANDARD
          Submission Class Code ID
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          Submission No
          133
          Submission Status
          AP
          Submission Status Date
          2025-04-11 00:00:00
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          Submissions Public Notes
        6. Appl No
          125377
          Review Priority
          STANDARD
          Submission Class Code ID
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          Submission No
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          Submission Status
          AP
          Submission Status Date
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          Submission Type
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          Submissions Public Notes
        7. Appl No
          125377
          Review Priority
          STANDARD
          Submission Class Code ID
          3
          Submission No
          130
          Submission Status
          AP
          Submission Status Date
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          Submission Type
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          Submissions Public Notes
        8. Appl No
          125377
          Review Priority
          PRIORITY
          Submission Class Code ID
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          Submission No
          129
          Submission Status
          AP
          Submission Status Date
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          Submissions Public Notes
        9. Appl No
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          Review Priority
          STANDARD
          Submission Class Code ID
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          Submission No
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          Submission Status Date
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          Submissions Public Notes
        10. Appl No
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          Review Priority
          STANDARD
          Submission Class Code ID
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          Submission No
          126
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          Submission Status Date
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        11. Appl No
          125377
          Review Priority
          STANDARD
          Submission Class Code ID
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          Submission No
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          Submissions Public Notes
        12. Appl No
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          Review Priority
          STANDARD
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          Submission No
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          Submission Status Date
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        application number
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          Application Docs Date
          2026-09-01 00:00:00
          Application Docs ID
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        official application record
        Appl No
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        Appl Public Notes
        Appl Type
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        Sponsor Name
        BRISTOL MYERS SQUIBB
        openfda application present
        true
        products
        1. Active Ingredient
          IPILIMUMAB
          Appl No
          125377
          Drug Name
          YERVOY
          Form
          INJECTABLE; INJECTION
          Product No
          001
          Reference Drug
          0
          Reference Standard
          Strength
          3MG
          marketing status
          1. Prescription

      Source passages and status connections

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

      Passage 1 · indication intro context
      application numbers
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      brand names
      1. YERVOY
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      1 INDICATIONS AND USAGE YERVOY is a human cytotoxic T-lymphocyte antigen 4 (CTLA-4)-blocking antibody indicated for: Melanoma • Treatment of unresectable or metastatic melanoma in adults and pediatric patients 12 years and older as a single agent or in combination with nivolumab. (1.1) • Adjuvant treatment of adult patients
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      is a human cytotoxic T-lymphocyte antigen 4 (CTLA-4)-blocking antibody indicated
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            Non-Small Cell Lung Cancer (NSCLC)
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          1 INDICATIONS AND USAGE YERVOY is a human cytotoxic T-lymphocyte antigen 4 (CTLA-4)-blocking antibody indicated for: Melanoma
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          spl effective date
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          spl set id
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          Passage 2 · positive indication candidate
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                                                            Passage 19 · unclassified context
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                                                                      • Treatment of adult patients with unresectable advanced or metastatic esophageal squamous cell carcinoma, as first line treatment in combination with nivolumab whose tumors express PD-L1 (≥1). (1.8) 1.1 Unresectable or Metastatic Melanoma YERVOY, as a single agent or in combination with nivolumab, is indicated for the treatment of unresectable or metastatic melanoma in adult and pediatric patients 12 years and older. 1.2 Adjuvant Treatment of Melanoma YERVOY is indicated for the adjuvant treatment of adult patients with cutaneous melanoma with pathologic involvement of regional lymph nodes of more than 1 mm who h
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                                                                        application numbers
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                                                                        tastatic Melanoma YERVOY, as a single agent or in combination with nivolumab, is indicated for the treatment of unresectable or metastatic melanoma in adult and pediatric patients 12 years and older. 1.2 Adjuvant Treatment of Melanoma YERVOY is indicated for the adjuvant treatment of adult patients with cutaneous melanoma with pathologic involvement of regional lymph nodes of more than 1 mm who have undergone complete resection, including total lymphadenectomy. 1.3 Advanced Renal Cell Carcinoma YERVOY, in combination with nivolumab, is indicated for the first-line treatment of adult patients with intermediate or poor risk advanced renal cell carcinoma (RCC)
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                                                                                              1.7 Malignant Pleural Mesothelioma YERVOY, in combination with nivolumab, is indicated for the first-line treatment of adult patients with unresectable malignant pleural mesothelioma.
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                                                                                              or aberrations. 1.7 Malignant Pleural Mesothelioma YERVOY, in combination with nivolumab, is indicated for the first-line treatment of adult patients with unresectable malignant pleural mesothelioma. 1.8 Esophageal Cancer YERVOY, in combination with nivolumab, is indicated for the first-line treatment of adult patients with unresectable advanced or metastatic esophageal squamous cell carcinoma (ESCC) whose tumors express PD-L1 (≥1) [see Dosage and Administration (2.1) ] .
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                                                                                                e treatment of adult patients with unresectable advanced or metastatic esophageal squamous cell carcinoma (ESCC) whose tumors express PD-L1 (≥1) [see Dosage and Ad
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                                                                                              3. context exact
                                                                                                phageal squamous cell carcinoma (ESCC) whose tumors express PD-L1 (≥1) [see Dosage and Administration (2.1) ] .
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                                                                                              4. context exact
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                                                                                              5. context exact
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                                                                                              6. context exact
                                                                                                1.8 Esophageal Cancer YERVOY, in combination with nivolumab, 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
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                                                                                                Preserved source evidence · Not medical advice