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LABELS · 7c285448-d5b9-4eca-b117-0d791b1b4de3

OPDUALAG

Open original source → · Download preserved record

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

Label effective date
2026-06-08
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 OPDUALAG™ is indicated for the treatment of adult and pediatric patients 12 years of age or older with unresectable or metastatic melanoma. OPDUALAG is a combination of nivolumab, a programmed death receptor-1 (PD-1) blocking antibody, and relatlimab, a lymphocyte activation gene-3 (LAG-3) blocking antibody, indicated for the treatment of adult and pediatric patients 12 years of age or older with unresectable or metastatic melanoma. (1)
Full extracted label fields
application numbers
  1. BLA761234
boxed warning exact
    brand names
    1. OPDUALAG
    current indication status
    not_reconciled
    dailymed set url
    https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=b22c9d83-3256-4e17-85f7-f331a504adc6
    generic names
    1. NIVOLUMAB AND RELATLIMAB-RMBW
    id
    7c285448-d5b9-4eca-b117-0d791b1b4de3
    indications and usage exact
    1. 1 INDICATIONS AND USAGE OPDUALAG™ is indicated for the treatment of adult and pediatric patients 12 years of age or older with unresectable or metastatic melanoma. OPDUALAG is a combination of nivolumab, a programmed death receptor-1 (PD-1) blocking antibody, and relatlimab, a lymphocyte activation gene-3 (LAG-3) blocking antibody, indicated for the treatment of adult and pediatric patients 12 years of age or older with unresectable or metastatic melanoma. (1)
    indications and usage tables exact
      is original packager
      1. true
      manufacturer names
      1. E.R. Squibb & Sons, L.L.C.
      matched search terms
      1. melanoma
      package ndcs
      1. 0003-7125-11
      product ndcs
      1. 0003-7125
      product types
      1. HUMAN PRESCRIPTION DRUG
      recent major changes exact
      1. Warnings and Precautions ( 5.1 ) 6/2026
      record type
      complete_spl_indications_section_candidate
      routes
      1. INTRAVENOUS
      rxcuis
      1. 2596778
      2. 2596784
      source batch
      file
      /private/tmp/cancer-full-research/indications/raw/labels-00400.json
      meta
      disclaimer
      Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. We may limit or otherwise restrict your access to the API in line with our Terms of Service.
      last updated
      2026-09-09
      results
      limit
      100
      skip
      400
      total
      830
      sha256
      a4bef6778baed183e5bcf581938b0b23d3576dfd9eb6150f2904934a750c5fef
      url
      https://api.fda.gov/drug/label.json?search=%28indications_and_usage%3Acancer+OR+indications_and_usage%3Acarcinoma+OR+indications_and_usage%3Acarcinomas+OR+indications_and_usage%3Alymphoma+OR+indications_and_usage%3Alymphomas+OR+indications_and_usage%3Aleukemia+OR+indications_and_usage%3Aleukaemia+OR+indications_and_usage%3Asarcoma+OR+indications_and_usage%3Asarcomas+OR+indications_and_usage%3Amelanoma+OR+indications_and_usage%3Amyeloma+OR+indications_and_usage%3Atumor+OR+indications_and_usage%3Atumors+OR+indications_and_usage%3Atumour+OR+indications_and_usage%3Atumours+OR+indications_and_usage%3Aneoplasm+OR+indications_and_usage%3Aneoplasms+OR+indications_and_usage%3Amalignant+OR+indications_and_usage%3Amalignancy+OR+indications_and_usage%3Amyelodysplastic+OR+indications_and_usage%3Amyelofibrosis+OR+indications_and_usage%3Amastocytosis+OR+indications_and_usage%3Aglioma+OR+indications_and_usage%3Aglioblastoma+OR+indications_and_usage%3Aneuroblastoma+OR+indications_and_usage%3Aretinoblastoma+OR+indications_and_usage%3Apheochromocytoma+OR+indications_and_usage%3Aparaganglioma+OR+indications_and_usage%3Amyeloproliferative+OR+indications_and_usage%3Awaldenstrom+OR+indications_and_usage%3Apolycythemia+OR+indications_and_usage%3Athrombocythemia+OR+indications_and_usage%3Adesmoid+OR+indications_and_usage%3Aneurofibromatosis+OR+indications_and_usage%3Ahistiocytosis%29+AND+%28openfda.application_number%3ANDA%2A+OR+openfda.application_number%3ABLA%2A%29&limit=100&skip=400&sort=id%3Aasc
      source url
      https://api.fda.gov/drug/label.json?search=id%3A%227c285448-d5b9-4eca-b117-0d791b1b4de3%22
      spl effective date
      2026-06-08
      spl effective time
      20260608
      spl set id
      b22c9d83-3256-4e17-85f7-f331a504adc6
      spl version
      3
      substance names
      1. NIVOLUMAB
      2. RELATLIMAB
      uniis
      1. 31YO63LBSN
      2. AF75XOF6W3
      verification flags
      1. oncology_keyword_candidate_not_clinically_classified
      2. spl_text_not_verified_identical_to_latest_approved_label
      3. individual_indications_not_split_or_reconciled
      4. fda_label_posted_after_spl_effective_date_requires_version_review
      Drugs@FDA application source records
      1. application number
        BLA761234
        payload
        all indexed label documents
        1. Appl No
          761234
          Application Docs Date
          2022-03-18 00:00:00
          Application Docs ID
          70562
          Application Docs Title
          0
          Application Docs Type ID
          2
          Submission No
          1
          Submission Type
          ORIG
        2. Appl No
          761234
          Application Docs Date
          2024-03-07 00:00:00
          Application Docs ID
          77752
          Application Docs Title
          0
          Application Docs Type ID
          2
          Submission No
          6
          Submission Type
          SUPPL
        3. Appl No
          761234
          Application Docs Date
          2026-06-16 00:00:00
          Application Docs ID
          86255
          Application Docs Title
          0
          Application Docs Type ID
          2
          Submission No
          11
          Submission Type
          SUPPL
        all submission records
        1. Appl No
          761234
          Review Priority
          PRIORITY
          Submission Class Code ID
          7
          Submission No
          1
          Submission Status
          AP
          Submission Status Date
          2022-03-18 00:00:00
          Submission Type
          ORIG
          Submissions Public Notes
        2. Appl No
          761234
          Review Priority
          STANDARD
          Submission Class Code ID
          3
          Submission No
          6
          Submission Status
          AP
          Submission Status Date
          2024-03-06 00:00:00
          Submission Type
          SUPPL
          Submissions Public Notes
        3. Appl No
          761234
          Review Priority
          STANDARD
          Submission Class Code ID
          3
          Submission No
          11
          Submission Status
          AP
          Submission Status Date
          2026-06-08 00:00:00
          Submission Type
          SUPPL
          Submissions Public Notes
        application number
        BLA761234
        approval interpretation
        Application linkage and approved submission are not indication-level current approval verification
        current indication status
        not_reconciled
        has approved submission record
        true
        latest approved submission date
        2026-06-08
        latest label selection rule
        max FDA ApplicationDocsDate, including all ties; posting date is not approval date and latest indexed document may be incomplete
        latest posted label documents
        1. Appl No
          761234
          Application Docs Date
          2026-06-16 00:00:00
          Application Docs ID
          86255
          Application Docs Title
          0
          Application Docs Type ID
          2
          Submission No
          11
          Submission Type
          SUPPL
        official application record
        Appl No
        761234
        Appl Public Notes
        Appl Type
        BLA
        Sponsor Name
        BRISTOL MYERS SQUIBB
        openfda application present
        true
        products
        1. Active Ingredient
          NIVOLUMAB;RELATLIMAB-RMBW
          Appl No
          761234
          Drug Name
          OPDUALAG
          Form
          SOLUTION;INTRAVENOUS
          Product No
          001
          Reference Drug
          0
          Reference Standard
          0
          Strength
          240MG;80MG
          marketing status
          1. Prescription

      Source passages and status connections

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

      Passage 1 · positive indication candidate
      application numbers
      1. BLA761234
      brand names
      1. OPDUALAG
      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
      363
      end exclusive
      true
      exact text
      1 INDICATIONS AND USAGE OPDUALAG™ is indicated for the treatment of adult and pediatric patients 12 years of age or older with unresectable or metastatic melanoma. OPDUALAG is a combination of nivolumab, a programmed death receptor-1 (PD-1) blocking antibody, and relatlimab, a lymphocyte activation gene-3 (LAG-3) blocking antibody, indicated for the treatment o
      label id
      7c285448-d5b9-4eca-b117-0d791b1b4de3
      offset unit
      unicode_code_points
      source array index
      0
      source field
      indications_and_usage_exact
      source text sha256
      5e0a48e8f1fe195bbacaf4e76f637c32134d090109973322cb53d223c60aa33b
      start
      0
      current approval status
      not_reconciled
      duplicate text group
      dup-435dee9890961297be66
      extraction review status
      automated_candidate_pending_source_review
      generic names
      1. NIVOLUMAB AND RELATLIMAB-RMBW
      id
      ind-span-601fb9f99599fd7adeb2
      label id
      7c285448-d5b9-4eca-b117-0d791b1b4de3
      positive predicate support span
      end
      46
      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
      34
      qualifier mentions
      1. context exact
        TIONS AND USAGE OPDUALAG™ is indicated for the treatment of adult and pediatric patients 12 years of age or older with unrese
        kind
        age
        polarity
        not_inferred
        span
        end
        73
        end exclusive
        true
        exact text
        adult
        label id
        7c285448-d5b9-4eca-b117-0d791b1b4de3
        offset unit
        unicode_code_points
        source array index
        0
        source field
        indications_and_usage_exact
        source text sha256
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        start
        68
      2. context exact
        USAGE OPDUALAG™ is indicated for the treatment of adult and pediatric patients 12 years of age or older with unresectable or metastatic me
        kind
        age
        polarity
        not_inferred
        span
        end
        96
        end exclusive
        true
        exact text
        pediatric patients
        label id
        7c285448-d5b9-4eca-b117-0d791b1b4de3
        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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      3. context exact
        indicated for the treatment of adult and pediatric patients 12 years of age or older with unresectable or metastatic melanoma.
        kind
        age
        polarity
        not_inferred
        span
        end
        112
        end exclusive
        true
        exact text
        12 years of age
        label id
        7c285448-d5b9-4eca-b117-0d791b1b4de3
        offset unit
        unicode_code_points
        source array index
        0
        source field
        indications_and_usage_exact
        source text sha256
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        start
        97
      4. context exact
        tric patients 12 years of age or older with unresectable or metastatic melanoma.
        kind
        biomarker
        polarity
        not_inferred
        span
        end
        162
        end exclusive
        true
        exact text
        metastatic melanoma
        label id
        7c285448-d5b9-4eca-b117-0d791b1b4de3
        offset unit
        unicode_code_points
        source array index
        0
        source field
        indications_and_usage_exact
        source text sha256
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        start
        143
      5. context exact
        adult and pediatric patients 12 years of age or older with unresectable or metastatic melanoma.
        kind
        stage_or_setting
        polarity
        not_inferred
        span
        end
        162
        end exclusive
        true
        exact text
        unresectable or metastatic melanoma
        label id
        7c285448-d5b9-4eca-b117-0d791b1b4de3
        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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      regulatory links
        schema version
        0.1.0
        source batch sha256
        a4bef6778baed183e5bcf581938b0b23d3576dfd9eb6150f2904934a750c5fef
        source defined aliases
          source span
          end
          163
          end exclusive
          true
          exact text
          1 INDICATIONS AND USAGE OPDUALAG™ is indicated for the treatment of adult and pediatric patients 12 years of age or older with unresectable or metastatic melanoma.
          label id
          7c285448-d5b9-4eca-b117-0d791b1b4de3
          offset unit
          unicode_code_points
          source array index
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          source field
          indications_and_usage_exact
          source text sha256
          5e0a48e8f1fe195bbacaf4e76f637c32134d090109973322cb53d223c60aa33b
          start
          0
          source url
          https://api.fda.gov/drug/label.json?search=id%3A%227c285448-d5b9-4eca-b117-0d791b1b4de3%22
          spl effective date
          2026-06-08
          spl set id
          b22c9d83-3256-4e17-85f7-f331a504adc6
          spl version
          3
          structured fields status
          not_extracted_no_values_inferred_from_mentions
          structured indication
          age
          Source null
          approval pathway
          Source null
          biomarker and test
          Source null
          disease stage
          Source null
          limitations
          Source null
          line
          Source null
          prior therapy
          Source null
          regimen
          Source null
          tumor histology
          Source null
          use intent
          tumor_directed_candidate
          Passage 2 · positive indication candidate
          application numbers
          1. BLA761234
          brand names
          1. OPDUALAG
          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
          464
          end exclusive
          true
          exact text
          1 INDICATIONS AND USAGE OPDUALAG™ is indicated for the treatment of adult and pediatric patients 12 years of age or older with unresectable or metastatic melanoma. OPDUALAG is a combination of nivolumab, a programmed death receptor-1 (PD-1) blocking antibody, and relatlimab, a lymphocyte activation gene-3 (LAG-3) blocking antibody, indicated for the treatment of adult and pediatric patients 12 years of age or older with unresectable or metastatic melanoma. (1)
          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
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          current approval status
          not_reconciled
          duplicate text group
          dup-67588518855f0fde93a8
          extraction review status
          automated_candidate_pending_source_review
          generic names
          1. NIVOLUMAB AND RELATLIMAB-RMBW
          id
          ind-span-f7f4bde393b378cae9c6
          label id
          7c285448-d5b9-4eca-b117-0d791b1b4de3
          positive predicate support span
          end
          347
          end exclusive
          true
          exact text
          indicated for
          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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          start
          334
          qualifier mentions
          1. context exact
            3 (LAG-3) blocking antibody, indicated for the treatment of adult and pediatric patients 12 years of age or older with unrese
            kind
            age
            polarity
            not_inferred
            span
            end
            370
            end exclusive
            true
            exact text
            adult
            label id
            7c285448-d5b9-4eca-b117-0d791b1b4de3
            offset unit
            unicode_code_points
            source array index
            0
            source field
            indications_and_usage_exact
            source text sha256
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            start
            365
          2. context exact
            blocking antibody, indicated for the treatment of adult and pediatric patients 12 years of age or older with unresectable or metastatic me
            kind
            age
            polarity
            not_inferred
            span
            end
            393
            end exclusive
            true
            exact text
            pediatric patients
            label id
            7c285448-d5b9-4eca-b117-0d791b1b4de3
            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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          3. context exact
            indicated for the treatment of adult and pediatric patients 12 years of age or older with unresectable or metastatic melanoma.
            kind
            age
            polarity
            not_inferred
            span
            end
            409
            end exclusive
            true
            exact text
            12 years of age
            label id
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            offset unit
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            source field
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            source text sha256
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            start
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          4. context exact
            tric patients 12 years of age or older with unresectable or metastatic melanoma.
            kind
            biomarker
            polarity
            not_inferred
            span
            end
            459
            end exclusive
            true
            exact text
            metastatic melanoma
            label id
            7c285448-d5b9-4eca-b117-0d791b1b4de3
            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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            start
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          5. context exact
            adult and pediatric patients 12 years of age or older with unresectable or metastatic melanoma.
            kind
            stage_or_setting
            polarity
            not_inferred
            span
            end
            459
            end exclusive
            true
            exact text
            unresectable or metastatic melanoma
            label id
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            offset unit
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            source array index
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            source text sha256
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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
              source span
              end
              460
              end exclusive
              true
              exact text
              OPDUALAG is a combination of nivolumab, a programmed death receptor-1 (PD-1) blocking antibody, and relatlimab, a lymphocyte activation gene-3 (LAG-3) blocking antibody, indicated for the treatment of adult and pediatric patients 12 years of age or older with unresectable or metastatic melanoma.
              label id
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              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
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              source url
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              spl effective date
              2026-06-08
              spl set id
              b22c9d83-3256-4e17-85f7-f331a504adc6
              spl version
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              structured fields status
              not_extracted_no_values_inferred_from_mentions
              structured indication
              age
              Source null
              approval pathway
              Source null
              biomarker and test
              Source null
              disease stage
              Source null
              limitations
              Source null
              line
              Source null
              prior therapy
              Source null
              regimen
              Source null
              tumor histology
              Source null
              use intent
              tumor_directed_candidate
              Passage 3 · unclassified context
              application numbers
              1. BLA761234
              brand names
              1. OPDUALAG
              classification reasons
              1. no_unambiguous_positive_indication_predicate
              clinical review status
              pending
              content role
              unclassified_context
              context span
              end
              464
              end exclusive
              true
              exact text
              nd relatlimab, a lymphocyte activation gene-3 (LAG-3) blocking antibody, indicated for the treatment of adult and pediatric patients 12 years of age or older with unresectable or metastatic melanoma. (1)
              label id
              7c285448-d5b9-4eca-b117-0d791b1b4de3
              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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              current approval status
              not_reconciled
              duplicate text group
              dup-72eb004574fa5a9ce044
              extraction review status
              automated_candidate_pending_source_review
              generic names
              1. NIVOLUMAB AND RELATLIMAB-RMBW
              id
              ind-span-33757158426208a86a49
              label id
              7c285448-d5b9-4eca-b117-0d791b1b4de3
              positive predicate support span
              Source null
              qualifier mentions
                regulatory links
                  schema version
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                  source batch sha256
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                  source defined aliases
                    source span
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                    464
                    end exclusive
                    true
                    exact text
                    (1)
                    label id
                    7c285448-d5b9-4eca-b117-0d791b1b4de3
                    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
                    461
                    source url
                    https://api.fda.gov/drug/label.json?search=id%3A%227c285448-d5b9-4eca-b117-0d791b1b4de3%22
                    spl effective date
                    2026-06-08
                    spl set id
                    b22c9d83-3256-4e17-85f7-f331a504adc6
                    spl version
                    3
                    structured fields status
                    not_extracted_no_values_inferred_from_mentions
                    structured indication
                    age
                    Source null
                    approval pathway
                    Source null
                    biomarker and test
                    Source null
                    disease stage
                    Source null
                    limitations
                    Source null
                    line
                    Source null
                    prior therapy
                    Source null
                    regimen
                    Source null
                    tumor histology
                    Source null
                    use intent
                    unclear

                    Preserved source evidence · Not medical advice