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LABELS · 176eb255-05c0-4cfc-874f-1fb57136d34d

Alunbrig

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
2026-01-12
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 ALUNBRIG is indicated for the treatment of adult patients with anaplastic lymphoma kinase (ALK)-positive metastatic non-small cell lung cancer (NSCLC) as detected by an FDA-approved test [see Dosage and Administration (2.1) ] . ALUNBRIG is a kinase inhibitor indicated for the treatment of adult patients with anaplastic lymphoma kinase (ALK)-positive metastatic non-small cell lung cancer (NSCLC) as detected by an FDA-approved test. ( 1 , 2.1 )
Full extracted label fields
application numbers
  1. NDA208772
boxed warning exact
    brand names
    1. Alunbrig
    current indication status
    not_reconciled
    dailymed set url
    https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=0fe9ff20-d402-41f3-bc1e-7002ea7007db
    generic names
    1. BRIGATINIB
    id
    176eb255-05c0-4cfc-874f-1fb57136d34d
    indications and usage exact
    1. 1 INDICATIONS AND USAGE ALUNBRIG is indicated for the treatment of adult patients with anaplastic lymphoma kinase (ALK)-positive metastatic non-small cell lung cancer (NSCLC) as detected by an FDA-approved test [see Dosage and Administration (2.1) ] . ALUNBRIG is a kinase inhibitor indicated for the treatment of adult patients with anaplastic lymphoma kinase (ALK)-positive metastatic non-small cell lung cancer (NSCLC) as detected by an FDA-approved test. ( 1 , 2.1 )
    indications and usage tables exact
      is original packager
      1. true
      manufacturer names
      1. Takeda Pharmaceuticals America, Inc.
      matched search terms
      1. cancer
      2. lymphoma
      package ndcs
      1. 63020-113-30
      2. 63020-090-30
      3. 63020-090-07
      4. 63020-180-30
      5. 63020-198-30
      6. 63020-180-23
      product ndcs
      1. 63020-090
      2. 63020-113
      3. 63020-180
      4. 63020-198
      product types
      1. HUMAN PRESCRIPTION DRUG
      recent major changes exact
        record type
        complete_spl_indications_section_candidate
        routes
        1. ORAL
        rxcuis
        1. 1921222
        2. 1921228
        3. 1925494
        4. 1988768
        5. 1988770
        6. 1988772
        7. 1988785
        8. 1988786
        source batch
        file
        /private/tmp/cancer-full-research/indications/raw/labels-00000.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
        0
        total
        830
        sha256
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        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=0&sort=id%3Aasc
        source url
        https://api.fda.gov/drug/label.json?search=id%3A%22176eb255-05c0-4cfc-874f-1fb57136d34d%22
        spl effective date
        2026-01-12
        spl effective time
        20260112
        spl set id
        0fe9ff20-d402-41f3-bc1e-7002ea7007db
        spl version
        17
        substance names
        1. BRIGATINIB
        uniis
        1. HYW8DB273J
        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
        Drugs@FDA application source records
        1. application number
          NDA208772
          payload
          all indexed label documents
          1. Appl No
            208772
            Application Docs Date
            2017-04-28 00:00:00
            Application Docs ID
            48164
            Application Docs Title
            0
            Application Docs Type ID
            2
            Submission No
            1
            Submission Type
            ORIG
          2. Appl No
            208772
            Application Docs Date
            2018-12-26 00:00:00
            Application Docs ID
            57008
            Application Docs Title
            0
            Application Docs Type ID
            2
            Submission No
            4
            Submission Type
            SUPPL
          3. Appl No
            208772
            Application Docs Date
            2020-05-22 00:00:00
            Application Docs ID
            63288
            Application Docs Title
            0
            Application Docs Type ID
            2
            Submission No
            8
            Submission Type
            SUPPL
          4. Appl No
            208772
            Application Docs Date
            2021-09-29 00:00:00
            Application Docs ID
            68808
            Application Docs Title
            0
            Application Docs Type ID
            2
            Submission No
            12
            Submission Type
            SUPPL
          5. Appl No
            208772
            Application Docs Date
            2022-03-03 00:00:00
            Application Docs ID
            70387
            Application Docs Title
            0
            Application Docs Type ID
            2
            Submission No
            13
            Submission Type
            SUPPL
          all submission records
          1. Appl No
            208772
            Review Priority
            PRIORITY
            Submission Class Code ID
            7
            Submission No
            1
            Submission Status
            AP
            Submission Status Date
            2017-04-28 00:00:00
            Submission Type
            ORIG
            Submissions Public Notes
          2. Appl No
            208772
            Review Priority
            N/A
            Submission Class Code ID
            4
            Submission No
            2
            Submission Status
            AP
            Submission Status Date
            2017-10-02 00:00:00
            Submission Type
            SUPPL
            Submissions Public Notes
          3. Appl No
            208772
            Review Priority
            STANDARD
            Submission Class Code ID
            2
            Submission No
            4
            Submission Status
            AP
            Submission Status Date
            2018-12-21 00:00:00
            Submission Type
            SUPPL
            Submissions Public Notes
          4. Appl No
            208772
            Review Priority
            PRIORITY
            Submission Class Code ID
            2
            Submission No
            8
            Submission Status
            AP
            Submission Status Date
            2020-05-22 00:00:00
            Submission Type
            SUPPL
            Submissions Public Notes
          5. Appl No
            208772
            Review Priority
            STANDARD
            Submission Class Code ID
            3
            Submission No
            12
            Submission Status
            AP
            Submission Status Date
            2021-09-24 00:00:00
            Submission Type
            SUPPL
            Submissions Public Notes
          6. Appl No
            208772
            Review Priority
            STANDARD
            Submission Class Code ID
            2
            Submission No
            13
            Submission Status
            AP
            Submission Status Date
            2022-02-28 00:00:00
            Submission Type
            SUPPL
            Submissions Public Notes
          application number
          NDA208772
          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
          2022-02-28
          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
            208772
            Application Docs Date
            2022-03-03 00:00:00
            Application Docs ID
            70387
            Application Docs Title
            0
            Application Docs Type ID
            2
            Submission No
            13
            Submission Type
            SUPPL
          official application record
          Appl No
          208772
          Appl Public Notes
          Appl Type
          NDA
          Sponsor Name
          TAKEDA PHARMS USA
          openfda application present
          true
          products
          1. Active Ingredient
            BRIGATINIB
            Appl No
            208772
            Drug Name
            ALUNBRIG
            Form
            TABLET;ORAL
            Product No
            001
            Reference Drug
            1
            Reference Standard
            0
            Strength
            30MG
            marketing status
            1. Prescription
          2. Active Ingredient
            BRIGATINIB
            Appl No
            208772
            Drug Name
            ALUNBRIG
            Form
            TABLET;ORAL
            Product No
            002
            Reference Drug
            1
            Reference Standard
            1
            Strength
            90MG
            marketing status
            1. Prescription
          3. Active Ingredient
            BRIGATINIB
            Appl No
            208772
            Drug Name
            ALUNBRIG
            Form
            TABLET;ORAL
            Product No
            003
            Reference Drug
            1
            Reference Standard
            0
            Strength
            180MG
            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. NDA208772
        brand names
        1. Alunbrig
        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
        451
        end exclusive
        true
        exact text
        1 INDICATIONS AND USAGE ALUNBRIG is indicated for the treatment of adult patients with anaplastic lymphoma kinase (ALK)-positive metastatic non-small cell lung cancer (NSCLC) as detected by an FDA-approved test [see Dosage and Administration (2.1) ] . ALUNBRIG is a kinase inhibitor indicated for the treatment of adult patients with anaplastic lymphoma kinase (ALK)-positive metastatic non-small cell lung cancer (NSCLC) as detected by an FDA-approve
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        generic names
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        id
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        is indicated
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        qualifier mentions
        1. context exact
          ATIONS AND USAGE ALUNBRIG is indicated for the treatment of adult patients with anaplastic lymphoma kinase (ALK)-positive metastatic n
          kind
          age
          polarity
          not_inferred
          span
          end
          81
          end exclusive
          true
          exact text
          adult patients
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        2. context exact
          reatment of adult patients with anaplastic lymphoma kinase (ALK)-positive metastatic non-small cell lung cancer (NSCLC) as detected by an FDA-approved test [see Do
          kind
          biomarker
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          not_inferred
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          158
          end exclusive
          true
          exact text
          ALK)-positive metastatic non-small cell lun
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        3. context exact
          ult patients with anaplastic lymphoma kinase (ALK)-positive metastatic non-small cell lung cancer (NSCLC) as detected by an FDA-approved test [see Dosage and Adminis
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          end exclusive
          true
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          metastatic non-small cell lung cancer (NSCLC)
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        regulatory links
          schema version
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          source batch sha256
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          source defined aliases
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            definition exact
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            exact text
            non-small cell lung cancer (NSCLC)
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          1 INDICATIONS AND USAGE ALUNBRIG is indicated for the treatment of adult patients with anaplastic lymphoma kinase (ALK)-positive metastatic non-small cell lung cancer (NSCLC) as detected by an FDA-approved test [see Dosage and Administration (2.1) ] .
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          source url
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          spl effective date
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          spl set id
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          spl version
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          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. NDA208772
          brand names
          1. Alunbrig
          classification reasons
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          clinical review status
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          exact text
          e treatment of adult patients with anaplastic lymphoma kinase (ALK)-positive metastatic non-small cell lung cancer (NSCLC) as detected by an FDA-approved test [see Dosage and Administration (2.1) ] . ALUNBRIG is a kinase inhibitor indicated for the treatment of adult patients with anaplastic lymphoma kinase (ALK)-positive metastatic non-small cell lung cancer (NSCLC) as detected by an FDA-approved test. ( 1 , 2.1 )
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          current approval status
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          generic names
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          id
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          label id
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          end exclusive
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          exact text
          is a kinase inhibitor indicated
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          qualifier mentions
          1. context exact
            UNBRIG is a kinase inhibitor indicated for the treatment of adult patients with anaplastic lymphoma kinase (ALK)-positive metastatic n
            kind
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            polarity
            not_inferred
            span
            end
            328
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          2. context exact
            reatment of adult patients with anaplastic lymphoma kinase (ALK)-positive metastatic non-small cell lung cancer (NSCLC) as detected by an FDA-approved test.
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            ALK)-positive metastatic non-small cell lun
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            ult patients with anaplastic lymphoma kinase (ALK)-positive metastatic non-small cell lung cancer (NSCLC) as detected by an FDA-approved test.
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            ALUNBRIG is a kinase inhibitor indicated for the treatment of adult patients with anaplastic lymphoma kinase (ALK)-positive metastatic non-small cell lung cancer (NSCLC) as detected by an FDA-approved test.
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            source url
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            spl effective date
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            Source null
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            line
            Source null
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            Source null
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            Source null
            tumor histology
            Source null
            use intent
            tumor_directed_candidate
            Passage 3 · unclassified context
            application numbers
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            brand names
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            classification reasons
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            exact text
            G is a kinase inhibitor indicated for the treatment of adult patients with anaplastic lymphoma kinase (ALK)-positive metastatic non-small cell lung cancer (NSCLC) as detected by an FDA-approved test. ( 1 , 2.1 )
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                  exact text
                  non-small cell lung cancer (NSCLC)
                  label id
                  176eb255-05c0-4cfc-874f-1fb57136d34d
                  offset unit
                  unicode_code_points
                  source array index
                  0
                  source field
                  indications_and_usage_exact
                  source text sha256
                  32abb80e02f9a0cd12e47186781eb5846445ca65bad6d31d4403159fcb9065d3
                  start
                  140
                source span
                end
                470
                end exclusive
                true
                exact text
                ( 1 , 2.1 )
                label id
                176eb255-05c0-4cfc-874f-1fb57136d34d
                offset unit
                unicode_code_points
                source array index
                0
                source field
                indications_and_usage_exact
                source text sha256
                32abb80e02f9a0cd12e47186781eb5846445ca65bad6d31d4403159fcb9065d3
                start
                459
                source url
                https://api.fda.gov/drug/label.json?search=id%3A%22176eb255-05c0-4cfc-874f-1fb57136d34d%22
                spl effective date
                2026-01-12
                spl set id
                0fe9ff20-d402-41f3-bc1e-7002ea7007db
                spl version
                17
                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