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LABELS · fa75c9ca-ecdf-4906-9cd3-0552e59b91ca

ZELBORAF

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
2026-08-28
Captured
2026-09-09T23:38:04.335995+00:00
Current indication reconciliation
Not reconciled

Indications and usage: exact source text

  1. 1 INDICATIONS AND USAGE ZELBORAF ® is a kinase inhibitor indicated for the treatment of patients with unresectable or metastatic melanoma with BRAF V600E mutation as detected by an FDA-approved test. ( 1.1 , 2.1 ) ZELBORAF ® is indicated for the treatment of patients with Erdheim- Chester Disease with BRAF V600 mutation. ( 1.2 , 2.1 ) Limitation of Use: ZELBORAF is not indicated for treatment of patients with wild-type BRAF melanoma ( 2.1 , 5.2 ) 1.1 Unresectable or Metastatic Melanoma ZELBORAF ® is indicated for the treatment of patients with unresectable or metastatic melanoma with BRAF V600E mutation as detected by an FDA-approved test. Limitation of Use: ZELBORAF is not indicated for treatment of patients with wild-type BRAF melanoma [see Warnings and Precautions (5.2) ] . 1.2 Erdheim-Chester Disease ZELBORAF ® is indicated for the treatment of patients with Erdheim-Chester Disease (ECD) with BRAF V600 mutation.
Full extracted label fields
application numbers
  1. NDA202429
boxed warning exact
    brand names
    1. ZELBORAF
    current indication status
    not_reconciled
    dailymed set url
    https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=38eea320-7e0c-485a-bc30-98c3c45e2763
    generic names
    1. VEMURAFENIB
    id
    fa75c9ca-ecdf-4906-9cd3-0552e59b91ca
    indications and usage exact
    1. 1 INDICATIONS AND USAGE ZELBORAF ® is a kinase inhibitor indicated for the treatment of patients with unresectable or metastatic melanoma with BRAF V600E mutation as detected by an FDA-approved test. ( 1.1 , 2.1 ) ZELBORAF ® is indicated for the treatment of patients with Erdheim- Chester Disease with BRAF V600 mutation. ( 1.2 , 2.1 ) Limitation of Use: ZELBORAF is not indicated for treatment of patients with wild-type BRAF melanoma ( 2.1 , 5.2 ) 1.1 Unresectable or Metastatic Melanoma ZELBORAF ® is indicated for the treatment of patients with unresectable or metastatic melanoma with BRAF V600E mutation as detected by an FDA-approved test. Limitation of Use: ZELBORAF is not indicated for treatment of patients with wild-type BRAF melanoma [see Warnings and Precautions (5.2) ] . 1.2 Erdheim-Chester Disease ZELBORAF ® is indicated for the treatment of patients with Erdheim-Chester Disease (ECD) with BRAF V600 mutation.
    indications and usage tables exact
      is original packager
      1. true
      manufacturer names
      1. Genentech, Inc.
      matched search terms
      1. melanoma
      package ndcs
      1. 50242-090-02
      product ndcs
      1. 50242-090
      product types
      1. HUMAN PRESCRIPTION DRUG
      recent major changes exact
        record type
        complete_spl_indications_section_candidate
        routes
        1. ORAL
        rxcuis
          source batch
          file
          /private/tmp/cancer-full-research/indications/raw/labels-00800.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
          800
          total
          830
          sha256
          8c4843bd18fc22d01ea4a91909737f3bbfdde09c17c5b243ce13d05c406cc6c7
          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=800&sort=id%3Aasc
          source url
          https://api.fda.gov/drug/label.json?search=id%3A%22fa75c9ca-ecdf-4906-9cd3-0552e59b91ca%22
          spl effective date
          2026-08-28
          spl effective time
          20260828
          spl set id
          38eea320-7e0c-485a-bc30-98c3c45e2763
          spl version
          29
          substance names
          1. VEMURAFENIB
          uniis
          1. 207SMY3FQT
          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
            NDA202429
            payload
            all indexed label documents
            1. Appl No
              202429
              Application Docs Date
              2013-07-05 00:00:00
              Application Docs ID
              19344
              Application Docs Title
              0
              Application Docs Type ID
              2
              Submission No
              3
              Submission Type
              SUPPL
            2. Appl No
              202429
              Application Docs Date
              2014-03-20 00:00:00
              Application Docs ID
              19345
              Application Docs Title
              0
              Application Docs Type ID
              2
              Submission No
              4
              Submission Type
              SUPPL
            3. Appl No
              202429
              Application Docs Date
              2014-02-07 00:00:00
              Application Docs ID
              19346
              Application Docs Title
              0
              Application Docs Type ID
              2
              Submission No
              5
              Submission Type
              SUPPL
            4. Appl No
              202429
              Application Docs Date
              2016-05-11 00:00:00
              Application Docs ID
              19347
              Application Docs Title
              0
              Application Docs Type ID
              2
              Submission No
              10
              Submission Type
              SUPPL
            5. Appl No
              202429
              Application Docs Date
              2011-08-17 00:00:00
              Application Docs ID
              40180
              Application Docs Title
              0
              Application Docs Type ID
              2
              Submission No
              1
              Submission Type
              ORIG
            6. Appl No
              202429
              Application Docs Date
              2013-07-05 00:00:00
              Application Docs ID
              40181
              Application Docs Title
              0
              Application Docs Type ID
              2
              Submission No
              2
              Submission Type
              SUPPL
            7. Appl No
              202429
              Application Docs Date
              2014-12-03 00:00:00
              Application Docs ID
              40182
              Application Docs Title
              0
              Application Docs Type ID
              2
              Submission No
              6
              Submission Type
              SUPPL
            8. Appl No
              202429
              Application Docs Date
              2015-08-12 00:00:00
              Application Docs ID
              40183
              Application Docs Title
              0
              Application Docs Type ID
              2
              Submission No
              8
              Submission Type
              SUPPL
            9. Appl No
              202429
              Application Docs Date
              2016-08-31 00:00:00
              Application Docs ID
              45161
              Application Docs Title
              0
              Application Docs Type ID
              2
              Submission No
              9
              Submission Type
              SUPPL
            10. Appl No
              202429
              Application Docs Date
              2017-04-18 00:00:00
              Application Docs ID
              48062
              Application Docs Title
              0
              Application Docs Type ID
              2
              Submission No
              12
              Submission Type
              SUPPL
            11. Appl No
              202429
              Application Docs Date
              2017-11-06 00:00:00
              Application Docs ID
              50292
              Application Docs Title
              0
              Application Docs Type ID
              2
              Submission No
              16
              Submission Type
              SUPPL
            12. Appl No
              202429
              Application Docs Date
              2020-05-29 00:00:00
              Application Docs ID
              63336
              Application Docs Title
              0
              Application Docs Type ID
              2
              Submission No
              19
              Submission Type
              SUPPL
            all submission records
            1. Appl No
              202429
              Review Priority
              PRIORITY
              Submission Class Code ID
              7
              Submission No
              1
              Submission Status
              AP
              Submission Status Date
              2011-08-17 00:00:00
              Submission Type
              ORIG
              Submissions Public Notes
            2. Appl No
              202429
              Review Priority
              STANDARD
              Submission Class Code ID
              3
              Submission No
              2
              Submission Status
              AP
              Submission Status Date
              2013-07-03 00:00:00
              Submission Type
              SUPPL
              Submissions Public Notes
            3. Appl No
              202429
              Review Priority
              STANDARD
              Submission Class Code ID
              3
              Submission No
              3
              Submission Status
              AP
              Submission Status Date
              2013-07-03 00:00:00
              Submission Type
              SUPPL
              Submissions Public Notes
            4. Appl No
              202429
              Review Priority
              STANDARD
              Submission Class Code ID
              2
              Submission No
              4
              Submission Status
              AP
              Submission Status Date
              2014-03-19 00:00:00
              Submission Type
              SUPPL
              Submissions Public Notes
            5. Appl No
              202429
              Review Priority
              STANDARD
              Submission Class Code ID
              3
              Submission No
              5
              Submission Status
              AP
              Submission Status Date
              2014-02-06 00:00:00
              Submission Type
              SUPPL
              Submissions Public Notes
            6. Appl No
              202429
              Review Priority
              STANDARD
              Submission Class Code ID
              3
              Submission No
              6
              Submission Status
              AP
              Submission Status Date
              2014-11-25 00:00:00
              Submission Type
              SUPPL
              Submissions Public Notes
            7. Appl No
              202429
              Review Priority
              PRIORITY
              Submission Class Code ID
              4
              Submission No
              7
              Submission Status
              AP
              Submission Status Date
              2014-09-23 00:00:00
              Submission Type
              SUPPL
              Submissions Public Notes
            8. Appl No
              202429
              Review Priority
              STANDARD
              Submission Class Code ID
              3
              Submission No
              8
              Submission Status
              AP
              Submission Status Date
              2015-08-11 00:00:00
              Submission Type
              SUPPL
              Submissions Public Notes
            9. Appl No
              202429
              Review Priority
              STANDARD
              Submission Class Code ID
              2
              Submission No
              9
              Submission Status
              AP
              Submission Status Date
              2016-08-31 00:00:00
              Submission Type
              SUPPL
              Submissions Public Notes
            10. Appl No
              202429
              Review Priority
              STANDARD
              Submission Class Code ID
              3
              Submission No
              10
              Submission Status
              AP
              Submission Status Date
              2016-05-09 00:00:00
              Submission Type
              SUPPL
              Submissions Public Notes
            11. Appl No
              202429
              Review Priority
              STANDARD
              Submission Class Code ID
              3
              Submission No
              12
              Submission Status
              AP
              Submission Status Date
              2017-04-17 00:00:00
              Submission Type
              SUPPL
              Submissions Public Notes
            12. Appl No
              202429
              Review Priority
              STANDARD
              Submission Class Code ID
              2
              Submission No
              14
              Submission Status
              AP
              Submission Status Date
              2017-09-13 00:00:00
              Submission Type
              SUPPL
              Submissions Public Notes
            application number
            NDA202429
            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
            2026-08-20
            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
              202429
              Application Docs Date
              2026-08-25 00:00:00
              Application Docs ID
              87023
              Application Docs Title
              0
              Application Docs Type ID
              2
              Submission No
              23
              Submission Type
              SUPPL
            official application record
            Appl No
            202429
            Appl Public Notes
            Appl Type
            NDA
            Sponsor Name
            HOFFMANN LA ROCHE
            openfda application present
            true
            products
            1. Active Ingredient
              VEMURAFENIB
              Appl No
              202429
              Drug Name
              ZELBORAF
              Form
              TABLET;ORAL
              Product No
              001
              Reference Drug
              1
              Reference Standard
              1
              Strength
              240MG
              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. NDA202429
          brand names
          1. ZELBORAF
          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
          399
          end exclusive
          true
          exact text
          1 INDICATIONS AND USAGE ZELBORAF ® is a kinase inhibitor indicated for the treatment of patients with unresectable or metastatic melanoma with BRAF V600E mutation as detected by an FDA-approved test. ( 1.1 , 2.1 ) ZELBORAF ® is indicated for the treatment of patients with Erdheim- Chester Disease with BRAF V600 mutation. ( 1.2 , 2.1 ) Limitation of Use: ZELBORAF is not indicated for treatment of
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          duplicate text group
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          generic names
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          id
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          label id
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          true
          exact text
          is a kinase inhibitor indicated
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          qualifier mentions
          1. context exact
            ndicated for the treatment of patients with unresectable or metastatic melanoma with BRAF V600E mutation as detected by an FDA-approved test.
            kind
            biomarker
            polarity
            not_inferred
            span
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            end exclusive
            true
            exact text
            metastatic melanoma with BRAF V600E mutatio
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          2. context exact
            nase inhibitor indicated for the treatment of patients with unresectable or metastatic melanoma with BRAF V600E mutation as detected by an FDA-approved test.
            kind
            stage_or_setting
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            not_inferred
            span
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            end exclusive
            true
            exact text
            unresectable or metastatic melanoma with BRAF V
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              1 INDICATIONS AND USAGE ZELBORAF ® is a kinase inhibitor indicated for the treatment of patients with unresectable or metastatic melanoma with BRAF V600E mutation as detected by an FDA-approved test.
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              source url
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              spl effective date
              2026-08-28
              spl set id
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              spl version
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              structured fields status
              not_extracted_no_values_inferred_from_mentions
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              Source null
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              Source null
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              Source null
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              Source null
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              Source null
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              Source null
              prior therapy
              Source null
              regimen
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              Source null
              use intent
              tumor_directed_candidate
              Passage 2 · positive indication candidate
              application numbers
              1. NDA202429
              brand names
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              classification reasons
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              clinical review status
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              1 INDICATIONS AND USAGE ZELBORAF ® is a kinase inhibitor indicated for the treatment of patients with unresectable or metastatic melanoma with BRAF V600E mutation as detected by an FDA-approved test. ( 1.1 , 2.1 ) ZELBORAF ® is indicated for the treatment of patients with Erdheim- Chester Disease with BRAF V600 mutation. ( 1.2 , 2.1 ) Limitation of Use: ZELBORAF is not indicated for treatment of patients with wild-type BRAF melanoma ( 2.1 , 5.2 ) 1.1 Unresectable or Metastatic Melanoma ZELBORAF ® is indicated for the
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                BRAF V600 mutation
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                  ( 1.1 , 2.1 ) ZELBORAF ® is indicated for the treatment of patients with Erdheim- Chester Disease with BRAF V600 mutation.
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                  source url
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                  spl effective date
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                  structured fields status
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                  biomarker and test
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                  use intent
                  non_oncology_or_unclear_candidate
                  Passage 3 · limitation of use
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                  650
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                  exact text
                  tatic melanoma with BRAF V600E mutation as detected by an FDA-approved test. ( 1.1 , 2.1 ) ZELBORAF ® is indicated for the treatment of patients with Erdheim- Chester Disease with BRAF V600 mutation. ( 1.2 , 2.1 ) Limitation of Use: ZELBORAF is not indicated for treatment of patients with wild-type BRAF melanoma ( 2.1 , 5.2 ) 1.1 Unresectable or Metastatic Melanoma ZELBORAF ® is indicated for the treatment of patients with unresectable or metastatic melanoma with BRAF V600E mutation as detected by an FDA-approved test. Li
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                                  Preserved source evidence · Not medical advice