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LABELS · 7dd6ed01-4c55-49ef-b55d-6d82c5dfc02e

BRAFTOVI

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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
2026-02-26
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 BRAFTOVI is a kinase inhibitor indicated: Melanoma • in combination with binimetinib, for the treatment of patients with unresectable or metastatic melanoma with a BRAF V600E or V600K mutation, as detected by an FDA-authorized test. ( 1.1 , 2.1 ) Colorectal Cancer (CRC) • in combination with cetuximab and fluorouracil-based chemotherapy, for the treatment of adult patients with metastatic colorectal cancer (mCRC) with a BRAF V600E mutation, as detected by an FDA‑authorized test. ( 1.2 , 2.1 ) • in combination with cetuximab, for the treatment of adult patients with mCRC with a BRAF V600E mutation, as detected by an FDA-authorized test, after prior therapy. ( 1.2 , 2.1 ) Non-Small Cell Lung Cancer (NSCLC) • in combination with binimetinib, for the treatment of adult patients with metastatic non–small cell lung cancer (NSCLC) with a BRAF V600E mutation, as detected by an FDA-authorized test. ( 1.3 , 2.1 ) Limitations of Use BRAFTOVI is not indicated for treatment of patients with wild-type BRAF melanoma, wild-type BRAF CRC, or wild-type BRAF NSCLC. ( 1.4 , 5.2 ) 1.1 BRAF V600E or V600K Mutation–Positive Unresectable or Metastatic Melanoma BRAFTOVI is indicated, in combination with binimetinib, for the treatment of patients with unresectable or metastatic melanoma with a BRAF V600E or V600K mutation, as detected by an FDA-authorized test [see Dosage and Administration (2.1) ] . 1.2 BRAF V600E Mutation-Positive Metastatic Colorectal Cancer (mCRC) • BRAFTOVI is indicated, in combination with cetuximab and fluorouracil-based chemotherapy , for the treatment of adult patients with metastatic colorectal cancer (mCRC) with a BRAF V600E mutation, as detected by an FDA- authorized test [see Dosage and Administration (2.1) ]. • BRAFTOVI is indicated, in combination with cetuximab, for the treatment of adult patients with mCRC with a BRAF V600E mutation, as detected by an FDA- authorized test, after prior therapy [see Dosage and Administration (2.1) ]. 1.3 BRAF V600E Mutation-Positive Metastatic Non-Small Cell Lung Cancer (NSCLC) BRAFTOVI is indicated, in combination with binimetinib, for the treatment of adult patients with metastatic non-small cell lung cancer (NSCLC) with a BRAF V600E mutation, as detected by an FDA-authorized test [see Dosage and Administration (2.1) ] . 1.4 Limitations of Use BRAFTOVI is not indicated for treatment of patients with wild-type BRAF melanoma, wild-type BRAF CRC, or wild-type BRAF NSCLC [see Warnings and Precautions (5.2)] .
Full extracted label fields
application numbers
  1. NDA210496
boxed warning exact
    brand names
    1. BRAFTOVI
    current indication status
    not_reconciled
    dailymed set url
    https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=235dfc38-0f0b-4037-b501-7a9f4294740c
    generic names
    1. ENCORAFENIB
    id
    7dd6ed01-4c55-49ef-b55d-6d82c5dfc02e
    indications and usage exact
    1. 1 INDICATIONS AND USAGE BRAFTOVI is a kinase inhibitor indicated: Melanoma • in combination with binimetinib, for the treatment of patients with unresectable or metastatic melanoma with a BRAF V600E or V600K mutation, as detected by an FDA-authorized test. ( 1.1 , 2.1 ) Colorectal Cancer (CRC) • in combination with cetuximab and fluorouracil-based chemotherapy, for the treatment of adult patients with metastatic colorectal cancer (mCRC) with a BRAF V600E mutation, as detected by an FDA‑authorized test. ( 1.2 , 2.1 ) • in combination with cetuximab, for the treatment of adult patients with mCRC with a BRAF V600E mutation, as detected by an FDA-authorized test, after prior therapy. ( 1.2 , 2.1 ) Non-Small Cell Lung Cancer (NSCLC) • in combination with binimetinib, for the treatment of adult patients with metastatic non–small cell lung cancer (NSCLC) with a BRAF V600E mutation, as detected by an FDA-authorized test. ( 1.3 , 2.1 ) Limitations of Use BRAFTOVI is not indicated for treatment of patients with wild-type BRAF melanoma, wild-type BRAF CRC, or wild-type BRAF NSCLC. ( 1.4 , 5.2 ) 1.1 BRAF V600E or V600K Mutation–Positive Unresectable or Metastatic Melanoma BRAFTOVI is indicated, in combination with binimetinib, for the treatment of patients with unresectable or metastatic melanoma with a BRAF V600E or V600K mutation, as detected by an FDA-authorized test [see Dosage and Administration (2.1) ] . 1.2 BRAF V600E Mutation-Positive Metastatic Colorectal Cancer (mCRC) • BRAFTOVI is indicated, in combination with cetuximab and fluorouracil-based chemotherapy , for the treatment of adult patients with metastatic colorectal cancer (mCRC) with a BRAF V600E mutation, as detected by an FDA- authorized test [see Dosage and Administration (2.1) ]. • BRAFTOVI is indicated, in combination with cetuximab, for the treatment of adult patients with mCRC with a BRAF V600E mutation, as detected by an FDA- authorized test, after prior therapy [see Dosage and Administration (2.1) ]. 1.3 BRAF V600E Mutation-Positive Metastatic Non-Small Cell Lung Cancer (NSCLC) BRAFTOVI is indicated, in combination with binimetinib, for the treatment of adult patients with metastatic non-small cell lung cancer (NSCLC) with a BRAF V600E mutation, as detected by an FDA-authorized test [see Dosage and Administration (2.1) ] . 1.4 Limitations of Use BRAFTOVI is not indicated for treatment of patients with wild-type BRAF melanoma, wild-type BRAF CRC, or wild-type BRAF NSCLC [see Warnings and Precautions (5.2)] .
    indications and usage tables exact
      is original packager
      1. true
      manufacturer names
      1. Array BioPharma Inc.
      matched search terms
      1. cancer
      2. melanoma
      package ndcs
      1. 70255-025-02
      2. 70255-025-01
      3. 70255-025-04
      4. 70255-025-03
      5. 70255-025-06
      6. 70255-025-05
      product ndcs
      1. 70255-025
      product types
      1. HUMAN PRESCRIPTION DRUG
      recent major changes exact
      1. Indications and Usage ( 1.2 ) 2/2026 Dosage and Administration ( 2.1 , 2.3 , 2.5 ) 2/2026 Warnings and Precautions ( 5.1 , 5.4 , 5.5 , 5.6 , 5.7 , 5.10 ) 2/2026
      record type
      complete_spl_indications_section_candidate
      routes
      1. ORAL
      rxcuis
      1. 2049119
      2. 2049121
      source batch
      file
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      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
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      skip
      400
      total
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      sha256
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      url
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      source url
      https://api.fda.gov/drug/label.json?search=id%3A%227dd6ed01-4c55-49ef-b55d-6d82c5dfc02e%22
      spl effective date
      2026-02-26
      spl effective time
      20260226
      spl set id
      235dfc38-0f0b-4037-b501-7a9f4294740c
      spl version
      23
      substance names
      1. ENCORAFENIB
      uniis
      1. 8L7891MRB6
      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
        NDA210496
        payload
        all indexed label documents
        1. Appl No
          210496
          Application Docs Date
          2018-06-27 00:00:00
          Application Docs ID
          54695
          Application Docs Title
          0
          Application Docs Type ID
          2
          Submission No
          1
          Submission Type
          ORIG
        2. Appl No
          210496
          Application Docs Date
          2019-01-25 00:00:00
          Application Docs ID
          57340
          Application Docs Title
          0
          Application Docs Type ID
          2
          Submission No
          1
          Submission Type
          SUPPL
        3. Appl No
          210496
          Application Docs Date
          2019-05-29 00:00:00
          Application Docs ID
          58868
          Application Docs Title
          0
          Application Docs Type ID
          2
          Submission No
          3
          Submission Type
          SUPPL
        4. Appl No
          210496
          Application Docs Date
          2020-04-08 00:00:00
          Application Docs ID
          62509
          Application Docs Title
          0
          Application Docs Type ID
          2
          Submission No
          6
          Submission Type
          SUPPL
        5. Appl No
          210496
          Application Docs Date
          2022-02-14 00:00:00
          Application Docs ID
          70159
          Application Docs Title
          0
          Application Docs Type ID
          2
          Submission No
          13
          Submission Type
          SUPPL
        6. Appl No
          210496
          Application Docs Date
          2023-10-11 00:00:00
          Application Docs ID
          75706
          Application Docs Title
          0
          Application Docs Type ID
          2
          Submission No
          14
          Submission Type
          SUPPL
        7. Appl No
          210496
          Application Docs Date
          2023-10-17 00:00:00
          Application Docs ID
          75793
          Application Docs Title
          0
          Application Docs Type ID
          2
          Submission No
          15
          Submission Type
          SUPPL
        8. Appl No
          210496
          Application Docs Date
          2024-09-16 00:00:00
          Application Docs ID
          79592
          Application Docs Title
          0
          Application Docs Type ID
          2
          Submission No
          16
          Submission Type
          SUPPL
        9. Appl No
          210496
          Application Docs Date
          2024-12-20 00:00:00
          Application Docs ID
          80673
          Application Docs Title
          0
          Application Docs Type ID
          2
          Submission No
          17
          Submission Type
          SUPPL
        10. Appl No
          210496
          Application Docs Date
          2025-03-17 00:00:00
          Application Docs ID
          81580
          Application Docs Title
          0
          Application Docs Type ID
          2
          Submission No
          18
          Submission Type
          SUPPL
        11. Appl No
          210496
          Application Docs Date
          2026-02-25 00:00:00
          Application Docs ID
          85161
          Application Docs Title
          0
          Application Docs Type ID
          2
          Submission No
          19
          Submission Type
          SUPPL
        12. Appl No
          210496
          Application Docs Date
          2026-02-25 00:00:00
          Application Docs ID
          85164
          Application Docs Title
          0
          Application Docs Type ID
          2
          Submission No
          21
          Submission Type
          SUPPL
        all submission records
        1. Appl No
          210496
          Review Priority
          STANDARD
          Submission Class Code ID
          7
          Submission No
          1
          Submission Status
          AP
          Submission Status Date
          2018-06-27 00:00:00
          Submission Type
          ORIG
          Submissions Public Notes
        2. Appl No
          210496
          Review Priority
          STANDARD
          Submission Class Code ID
          2
          Submission No
          1
          Submission Status
          AP
          Submission Status Date
          2019-01-23 00:00:00
          Submission Type
          SUPPL
          Submissions Public Notes
        3. Appl No
          210496
          Review Priority
          STANDARD
          Submission Class Code ID
          2
          Submission No
          3
          Submission Status
          AP
          Submission Status Date
          2019-05-24 00:00:00
          Submission Type
          SUPPL
          Submissions Public Notes
        4. Appl No
          210496
          Review Priority
          PRIORITY
          Submission Class Code ID
          2
          Submission No
          6
          Submission Status
          AP
          Submission Status Date
          2020-04-08 00:00:00
          Submission Type
          SUPPL
          Submissions Public Notes
        5. Appl No
          210496
          Review Priority
          STANDARD
          Submission Class Code ID
          3
          Submission No
          13
          Submission Status
          AP
          Submission Status Date
          2022-02-11 00:00:00
          Submission Type
          SUPPL
          Submissions Public Notes
        6. Appl No
          210496
          Review Priority
          STANDARD
          Submission Class Code ID
          2
          Submission No
          14
          Submission Status
          AP
          Submission Status Date
          2023-10-11 00:00:00
          Submission Type
          SUPPL
          Submissions Public Notes
        7. Appl No
          210496
          Review Priority
          STANDARD
          Submission Class Code ID
          3
          Submission No
          15
          Submission Status
          AP
          Submission Status Date
          2023-10-13 00:00:00
          Submission Type
          SUPPL
          Submissions Public Notes
        8. Appl No
          210496
          Review Priority
          STANDARD
          Submission Class Code ID
          2
          Submission No
          16
          Submission Status
          AP
          Submission Status Date
          2024-09-12 00:00:00
          Submission Type
          SUPPL
          Submissions Public Notes
        9. Appl No
          210496
          Review Priority
          PRIORITY
          Submission Class Code ID
          2
          Submission No
          17
          Submission Status
          AP
          Submission Status Date
          2024-12-20 00:00:00
          Submission Type
          SUPPL
          Submissions Public Notes
        10. Appl No
          210496
          Review Priority
          STANDARD
          Submission Class Code ID
          2
          Submission No
          18
          Submission Status
          AP
          Submission Status Date
          2025-03-12 00:00:00
          Submission Type
          SUPPL
          Submissions Public Notes
        11. Appl No
          210496
          Review Priority
          STANDARD
          Submission Class Code ID
          2
          Submission No
          19
          Submission Status
          AP
          Submission Status Date
          2026-02-24 00:00:00
          Submission Type
          SUPPL
          Submissions Public Notes
        12. Appl No
          210496
          Review Priority
          STANDARD
          Submission Class Code ID
          2
          Submission No
          21
          Submission Status
          AP
          Submission Status Date
          2026-02-24 00:00:00
          Submission Type
          SUPPL
          Submissions Public Notes
        application number
        NDA210496
        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
        2026-02-24
        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
          210496
          Application Docs Date
          2026-02-25 00:00:00
          Application Docs ID
          85161
          Application Docs Title
          0
          Application Docs Type ID
          2
          Submission No
          19
          Submission Type
          SUPPL
        2. Appl No
          210496
          Application Docs Date
          2026-02-25 00:00:00
          Application Docs ID
          85164
          Application Docs Title
          0
          Application Docs Type ID
          2
          Submission No
          21
          Submission Type
          SUPPL
        official application record
        Appl No
        210496
        Appl Public Notes
        Appl Type
        NDA
        Sponsor Name
        ARRAY BIOPHARMA INC
        openfda application present
        true
        products
        1. Active Ingredient
          ENCORAFENIB
          Appl No
          210496
          Drug Name
          BRAFTOVI
          Form
          CAPSULE;ORAL
          Product No
          001
          Reference Drug
          1
          Reference Standard
          0
          Strength
          50MG
          marketing status
          1. Discontinued
        2. Active Ingredient
          ENCORAFENIB
          Appl No
          210496
          Drug Name
          BRAFTOVI
          Form
          CAPSULE;ORAL
          Product No
          002
          Reference Drug
          1
          Reference Standard
          1
          Strength
          75MG
          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
      1. NDA210496
      brand names
      1. BRAFTOVI
      classification reasons
      1. explicit_positive_indication_predicate
      2. tumor_or_malignant_hematology_words_in_positive_statement
      3. incomplete_colon_led_indication_intro
      clinical review status
      pending
      content role
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      context span
      end
      274
      end exclusive
      true
      exact text
      1 INDICATIONS AND USAGE BRAFTOVI is a kinase inhibitor indicated: Melanoma • in combination with binimetinib, for the treatment of patients with unresectable or metastatic melanoma with a BRAF V600E or V600K mutation, as detected by an FDA-authorized test. ( 1.1 , 2.1 ) Col
      label id
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      source text sha256
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      start
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      current approval status
      not_reconciled
      duplicate text group
      dup-19828c8b936572f3474a
      extraction review status
      automated_candidate_pending_source_review
      generic names
      1. ENCORAFENIB
      id
      ind-span-2499f7ca5d20789317b5
      label id
      7dd6ed01-4c55-49ef-b55d-6d82c5dfc02e
      positive predicate support span
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      end exclusive
      true
      exact text
      is a kinase inhibitor indicated
      label id
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      offset unit
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      qualifier mentions
      1. context exact
        1 INDICATIONS AND USAGE BRAFTOVI is a kinase inhibitor indicated: Melanoma
        kind
        biomarker
        polarity
        not_inferred
        span
        end
        68
        end exclusive
        true
        exact text
        BRAFTOVI is a kinase inhibitor indicated: Me
        label id
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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
        1. abbreviation
          NSCLC
          definition exact
          Non-Small Cell Lung Cancer
          definition span
          end
          737
          end exclusive
          true
          exact text
          Non-Small Cell Lung Cancer (NSCLC)
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        2. abbreviation
          CRC
          definition exact
          Colorectal Cancer
          definition span
          end
          294
          end exclusive
          true
          exact text
          Colorectal Cancer (CRC)
          label id
          7dd6ed01-4c55-49ef-b55d-6d82c5dfc02e
          offset unit
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        source span
        end
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        end exclusive
        true
        exact text
        1 INDICATIONS AND USAGE BRAFTOVI is a kinase inhibitor indicated: Melanoma
        label id
        7dd6ed01-4c55-49ef-b55d-6d82c5dfc02e
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        source text sha256
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        start
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        source url
        https://api.fda.gov/drug/label.json?search=id%3A%227dd6ed01-4c55-49ef-b55d-6d82c5dfc02e%22
        spl effective date
        2026-02-26
        spl set id
        235dfc38-0f0b-4037-b501-7a9f4294740c
        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
        not_applicable
        Passage 2 · positive indication candidate
        application numbers
        1. NDA210496
        brand names
        1. BRAFTOVI
        classification reasons
        1. inherited_predicate_from_same_label_section_requires_review
        2. tumor_or_malignant_hematology_words_in_positive_statement
        clinical review status
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        content role
        positive_indication_candidate
        context span
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        456
        end exclusive
        true
        exact text
        1 INDICATIONS AND USAGE BRAFTOVI is a kinase inhibitor indicated: Melanoma • in combination with binimetinib, for the treatment of patients with unresectable or metastatic melanoma with a BRAF V600E or V600K mutation, as detected by an FDA-authorized test. ( 1.1 , 2.1 ) Colorectal Cancer (CRC) • in combination with cetuximab and fluorouracil-based chemotherapy, for the treatment of adult patients with metastatic colorectal cancer (mCRC) with a BRAF V60
        label id
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        offset unit
        unicode_code_points
        source array index
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        positive predicate support span
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        true
        exact text
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                                              Preserved source evidence · Not medical advice