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LABELS · 235e3bc1-099b-4587-9d72-b02fcc3387d1

Mekinist

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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
2026-05-07
Captured
2026-09-09T23:37:42.544548+00:00
Current indication reconciliation
Not reconciled

Indications and usage: exact source text

  1. 1 INDICATIONS AND USAGE MEKINIST is a kinase inhibitor indicated as a single agent for the treatment of BRAF-inhibitor treatment-naïve patients with unresectable or metastatic melanoma with BRAF V600E or V600K mutations as detected by an FDA-approved test. ( 1.1 , 2.1 ) MEKINIST is indicated, in combination with dabrafenib, for: the treatment of patients with unresectable or metastatic melanoma with BRAF V600E or V600K mutations as detected by an FDA-approved test. ( 1.1 , 2.1 ) the adjuvant treatment of patients with melanoma with BRAF V600E or V600K mutations, as detected by an FDA-approved test, and involvement of lymph node(s), following complete resection. ( 1.2 , 2.1 ) the treatment of patients with metastatic non-small cell lung cancer (NSCLC) with BRAF V600E mutation as detected by an FDA-approved test. ( 1.3 , 2.1 ) the treatment of patients with locally advanced or metastatic anaplastic thyroid cancer (ATC) with BRAF V600E mutation, as detected by an FDA-approved test, and with no satisfactory locoregional treatment options. ( 1.4 , 2.1 ) the treatment of adult and pediatric patients 1 year of age and older with unresectable or metastatic solid tumors with BRAF V600E mutation who have progressed following prior treatment and have no satisfactory alternative treatment options. This indication is approved under accelerated approval based on overall response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s). ( 1.5 , 2.1 ) the treatment of pediatric patients 1 year of age and older with low-grade glioma (LGG) with a BRAF V600E mutation who require systemic therapy. ( 1.6 , 2.1 ) Limitations of Use : MEKINIST is not indicated for treatment of patients with colorectal cancer because of known intrinsic resistance to BRAF inhibition. ( 1.7 , 12.1 ) 1.1 BRAF V600E or V600K Mutation-Positive Unresectable or Metastatic Melanoma MEKINIST ® is indicated, as a single agent in BRAF-inhibitor treatment-naïve patients or in combination with dabrafenib, for the treatment of patients with unresectable or metastatic melanoma with BRAF V600E or V600K mutations, as detected by an FDA-approved test [see Dosage and Administration (2.1)] . 1.2 Adjuvant Treatment of BRAF V600E or V600K Mutation-Positive Melanoma MEKINIST is indicated, in combination with dabrafenib, for the adjuvant treatment of patients with melanoma with BRAF V600E or V600K mutations as detected by an FDA-approved test, and involvement of lymph node(s), following complete resection [see Dosage and Administration (2.1)]. 1.3 BRAF V600E Mutation-Positive Metastatic NSCLC MEKINIST is indicated, in combination with dabrafenib, for the treatment of patients with metastatic non-small cell lung cancer (NSCLC) with BRAF V600E mutation as detected by an FDA-approved test [see Dosage and Administration (2.1)] . 1.4 BRAF V600E Mutation-Positive Locally Advanced or Metastatic Anaplastic Thyroid Cancer MEKINIST is indicated, in combination with dabrafenib, for the treatment of patients with locally advanced or metastatic anaplastic thyroid cancer (ATC) with BRAF V600E mutation, as detected by an FDA-approved test, and with no satisfactory locoregional treatment options [see Dosage and Administration (2.1)] . 1.5 BRAF V600E Mutation-Positive Unresectable or Metastatic Solid Tumors MEKINIST is indicated, in combination with dabrafenib, for the treatment of adult and pediatric patients 1 year of age and older with unresectable or metastatic solid tumors with BRAF V600E mutation who have progressed following prior treatment and have no satisfactory alternative treatment options [see Dosage and Administration (2.1)] . This indication is approved under accelerated approval based on overall response rate and duration of response [see Clinical Studies (14.6)] . Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s). 1.6 BRAF V600E Mutation-Positive Low-Grade Glioma MEKINIST is indicated, in combination with dabrafenib, for the treatment of pediatric patients 1 year of age and older with low-grade glioma (LGG) with a BRAF V600E mutation who require systemic therapy [see Dosage and Administration (2.1)] . 1.7 Limitations of Use MEKINIST is not indicated for treatment of patients with colorectal cancer because of known intrinsic resistance to BRAF inhibition [see Indications and Usage (1.5), Clinical Pharmacology (12.1)] .
Full extracted label fields
application numbers
  1. NDA204114
  2. NDA217513
boxed warning exact
    brand names
    1. Mekinist
    current indication status
    not_reconciled
    dailymed set url
    https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=0002ad27-779d-42ab-83b5-bc65453412a1
    generic names
    1. TRAMETINIB
    id
    235e3bc1-099b-4587-9d72-b02fcc3387d1
    indications and usage exact
    1. 1 INDICATIONS AND USAGE MEKINIST is a kinase inhibitor indicated as a single agent for the treatment of BRAF-inhibitor treatment-naïve patients with unresectable or metastatic melanoma with BRAF V600E or V600K mutations as detected by an FDA-approved test. ( 1.1 , 2.1 ) MEKINIST is indicated, in combination with dabrafenib, for: the treatment of patients with unresectable or metastatic melanoma with BRAF V600E or V600K mutations as detected by an FDA-approved test. ( 1.1 , 2.1 ) the adjuvant treatment of patients with melanoma with BRAF V600E or V600K mutations, as detected by an FDA-approved test, and involvement of lymph node(s), following complete resection. ( 1.2 , 2.1 ) the treatment of patients with metastatic non-small cell lung cancer (NSCLC) with BRAF V600E mutation as detected by an FDA-approved test. ( 1.3 , 2.1 ) the treatment of patients with locally advanced or metastatic anaplastic thyroid cancer (ATC) with BRAF V600E mutation, as detected by an FDA-approved test, and with no satisfactory locoregional treatment options. ( 1.4 , 2.1 ) the treatment of adult and pediatric patients 1 year of age and older with unresectable or metastatic solid tumors with BRAF V600E mutation who have progressed following prior treatment and have no satisfactory alternative treatment options. This indication is approved under accelerated approval based on overall response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s). ( 1.5 , 2.1 ) the treatment of pediatric patients 1 year of age and older with low-grade glioma (LGG) with a BRAF V600E mutation who require systemic therapy. ( 1.6 , 2.1 ) Limitations of Use : MEKINIST is not indicated for treatment of patients with colorectal cancer because of known intrinsic resistance to BRAF inhibition. ( 1.7 , 12.1 ) 1.1 BRAF V600E or V600K Mutation-Positive Unresectable or Metastatic Melanoma MEKINIST ® is indicated, as a single agent in BRAF-inhibitor treatment-naïve patients or in combination with dabrafenib, for the treatment of patients with unresectable or metastatic melanoma with BRAF V600E or V600K mutations, as detected by an FDA-approved test [see Dosage and Administration (2.1)] . 1.2 Adjuvant Treatment of BRAF V600E or V600K Mutation-Positive Melanoma MEKINIST is indicated, in combination with dabrafenib, for the adjuvant treatment of patients with melanoma with BRAF V600E or V600K mutations as detected by an FDA-approved test, and involvement of lymph node(s), following complete resection [see Dosage and Administration (2.1)]. 1.3 BRAF V600E Mutation-Positive Metastatic NSCLC MEKINIST is indicated, in combination with dabrafenib, for the treatment of patients with metastatic non-small cell lung cancer (NSCLC) with BRAF V600E mutation as detected by an FDA-approved test [see Dosage and Administration (2.1)] . 1.4 BRAF V600E Mutation-Positive Locally Advanced or Metastatic Anaplastic Thyroid Cancer MEKINIST is indicated, in combination with dabrafenib, for the treatment of patients with locally advanced or metastatic anaplastic thyroid cancer (ATC) with BRAF V600E mutation, as detected by an FDA-approved test, and with no satisfactory locoregional treatment options [see Dosage and Administration (2.1)] . 1.5 BRAF V600E Mutation-Positive Unresectable or Metastatic Solid Tumors MEKINIST is indicated, in combination with dabrafenib, for the treatment of adult and pediatric patients 1 year of age and older with unresectable or metastatic solid tumors with BRAF V600E mutation who have progressed following prior treatment and have no satisfactory alternative treatment options [see Dosage and Administration (2.1)] . This indication is approved under accelerated approval based on overall response rate and duration of response [see Clinical Studies (14.6)] . Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s). 1.6 BRAF V600E Mutation-Positive Low-Grade Glioma MEKINIST is indicated, in combination with dabrafenib, for the treatment of pediatric patients 1 year of age and older with low-grade glioma (LGG) with a BRAF V600E mutation who require systemic therapy [see Dosage and Administration (2.1)] . 1.7 Limitations of Use MEKINIST is not indicated for treatment of patients with colorectal cancer because of known intrinsic resistance to BRAF inhibition [see Indications and Usage (1.5), Clinical Pharmacology (12.1)] .
    indications and usage tables exact
      is original packager
      1. true
      manufacturer names
      1. Novartis Pharmaceuticals Corporation
      matched search terms
      1. cancer
      2. melanoma
      3. tumors
      4. glioma
      package ndcs
      1. 0078-1105-15
      2. 0078-1112-15
      3. 0078-1112-94
      4. 0078-1161-47
      product ndcs
      1. 0078-1105
      2. 0078-1112
      3. 0078-1161
      product types
      1. HUMAN PRESCRIPTION DRUG
      recent major changes exact
      1. Warnings and Precautions ( 5.6 ) 5/2026
      record type
      complete_spl_indications_section_candidate
      routes
      1. ORAL
      rxcuis
      1. 1425110
      2. 1425116
      3. 1425118
      4. 2632560
      5. 2632564
      6. 1425104
      source batch
      file
      /private/tmp/cancer-full-research/indications/raw/labels-00100.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
      100
      total
      830
      sha256
      fc39a8c5cf96bf95ca20b85578140167b66b2741f7d9217f500d9ba0847ac058
      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=100&sort=id%3Aasc
      source url
      https://api.fda.gov/drug/label.json?search=id%3A%22235e3bc1-099b-4587-9d72-b02fcc3387d1%22
      spl effective date
      2026-05-07
      spl effective time
      20260507
      spl set id
      0002ad27-779d-42ab-83b5-bc65453412a1
      spl version
      35
      substance names
      1. TRAMETINIB DIMETHYL SULFOXIDE
      uniis
      1. BSB9VJ5TUT
      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
        NDA204114
        payload
        all indexed label documents
        1. Appl No
          204114
          Application Docs Date
          2013-05-29 00:00:00
          Application Docs ID
          19528
          Application Docs Title
          0
          Application Docs Type ID
          2
          Submission No
          1
          Submission Type
          ORIG
        2. Appl No
          204114
          Application Docs Date
          2014-01-09 00:00:00
          Application Docs ID
          40355
          Application Docs Title
          0
          Application Docs Type ID
          2
          Submission No
          1
          Submission Type
          SUPPL
        3. Appl No
          204114
          Application Docs Date
          2015-11-20 00:00:00
          Application Docs ID
          40356
          Application Docs Title
          0
          Application Docs Type ID
          2
          Submission No
          4
          Submission Type
          SUPPL
        4. Appl No
          204114
          Application Docs Date
          2017-02-27 00:00:00
          Application Docs ID
          47338
          Application Docs Title
          0
          Application Docs Type ID
          2
          Submission No
          6
          Submission Type
          SUPPL
        5. Appl No
          204114
          Application Docs Date
          2017-06-22 00:00:00
          Application Docs ID
          48810
          Application Docs Title
          0
          Application Docs Type ID
          2
          Submission No
          5
          Submission Type
          SUPPL
        6. Appl No
          204114
          Application Docs Date
          2018-03-13 00:00:00
          Application Docs ID
          52922
          Application Docs Title
          0
          Application Docs Type ID
          2
          Submission No
          8
          Submission Type
          SUPPL
        7. Appl No
          204114
          Application Docs Date
          2018-04-30 00:00:00
          Application Docs ID
          53872
          Application Docs Title
          0
          Application Docs Type ID
          2
          Submission No
          7
          Submission Type
          SUPPL
        8. Appl No
          204114
          Application Docs Date
          2018-05-04 00:00:00
          Application Docs ID
          54016
          Application Docs Title
          0
          Application Docs Type ID
          2
          Submission No
          9
          Submission Type
          SUPPL
        9. Appl No
          204114
          Application Docs Date
          2019-07-18 00:00:00
          Application Docs ID
          59368
          Application Docs Title
          0
          Application Docs Type ID
          2
          Submission No
          13
          Submission Type
          SUPPL
        10. Appl No
          204114
          Application Docs Date
          2019-10-07 00:00:00
          Application Docs ID
          60265
          Application Docs Title
          0
          Application Docs Type ID
          2
          Submission No
          12
          Submission Type
          SUPPL
        11. Appl No
          204114
          Application Docs Date
          2020-04-15 00:00:00
          Application Docs ID
          62575
          Application Docs Title
          0
          Application Docs Type ID
          2
          Submission No
          14
          Submission Type
          SUPPL
        12. Appl No
          204114
          Application Docs Date
          2020-06-24 00:00:00
          Application Docs ID
          63681
          Application Docs Title
          0
          Application Docs Type ID
          2
          Submission No
          16
          Submission Type
          SUPPL
        all submission records
        1. Appl No
          204114
          Review Priority
          STANDARD
          Submission Class Code ID
          3
          Submission No
          42
          Submission Status
          AP
          Submission Status Date
          2026-05-07 00:00:00
          Submission Type
          SUPPL
          Submissions Public Notes
        2. Appl No
          204114
          Review Priority
          STANDARD
          Submission Class Code ID
          3
          Submission No
          40
          Submission Status
          AP
          Submission Status Date
          2026-03-26 00:00:00
          Submission Type
          SUPPL
          Submissions Public Notes
        3. Appl No
          204114
          Review Priority
          STANDARD
          Submission Class Code ID
          3
          Submission No
          39
          Submission Status
          AP
          Submission Status Date
          2025-04-21 00:00:00
          Submission Type
          SUPPL
          Submissions Public Notes
        4. Appl No
          204114
          Review Priority
          STANDARD
          Submission Class Code ID
          3
          Submission No
          38
          Submission Status
          AP
          Submission Status Date
          2025-04-07 00:00:00
          Submission Type
          SUPPL
          Submissions Public Notes
        5. Appl No
          204114
          Review Priority
          STANDARD
          Submission Class Code ID
          3
          Submission No
          37
          Submission Status
          AP
          Submission Status Date
          2025-03-19 00:00:00
          Submission Type
          SUPPL
          Submissions Public Notes
        6. Appl No
          204114
          Review Priority
          STANDARD
          Submission Class Code ID
          3
          Submission No
          36
          Submission Status
          AP
          Submission Status Date
          2025-01-24 00:00:00
          Submission Type
          SUPPL
          Submissions Public Notes
        7. Appl No
          204114
          Review Priority
          STANDARD
          Submission Class Code ID
          2
          Submission No
          34
          Submission Status
          AP
          Submission Status Date
          2025-03-07 00:00:00
          Submission Type
          SUPPL
          Submissions Public Notes
        8. Appl No
          204114
          Review Priority
          STANDARD
          Submission Class Code ID
          3
          Submission No
          33
          Submission Status
          AP
          Submission Status Date
          2024-07-11 00:00:00
          Submission Type
          SUPPL
          Submissions Public Notes
        9. Appl No
          204114
          Review Priority
          STANDARD
          Submission Class Code ID
          3
          Submission No
          32
          Submission Status
          AP
          Submission Status Date
          2024-03-29 00:00:00
          Submission Type
          SUPPL
          Submissions Public Notes
        10. Appl No
          204114
          Review Priority
          STANDARD
          Submission Class Code ID
          3
          Submission No
          31
          Submission Status
          AP
          Submission Status Date
          2024-02-27 00:00:00
          Submission Type
          SUPPL
          Submissions Public Notes
        11. Appl No
          204114
          Review Priority
          PRIORITY
          Submission Class Code ID
          2
          Submission No
          29
          Submission Status
          AP
          Submission Status Date
          2023-08-31 00:00:00
          Submission Type
          SUPPL
          Submissions Public Notes
        12. Appl No
          204114
          Review Priority
          STANDARD
          Submission Class Code ID
          3
          Submission No
          28
          Submission Status
          AP
          Submission Status Date
          2023-05-26 00:00:00
          Submission Type
          SUPPL
          Submissions Public Notes
        application number
        NDA204114
        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
        2026-05-07
        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
          204114
          Application Docs Date
          2026-05-18 00:00:00
          Application Docs ID
          85933
          Application Docs Title
          0
          Application Docs Type ID
          2
          Submission No
          42
          Submission Type
          SUPPL
        official application record
        Appl No
        204114
        Appl Public Notes
        Appl Type
        NDA
        Sponsor Name
        NOVARTIS
        openfda application present
        true
        products
        1. Active Ingredient
          TRAMETINIB DIMETHYL SULFOXIDE
          Appl No
          204114
          Drug Name
          MEKINIST
          Form
          TABLET;ORAL
          Product No
          001
          Reference Drug
          1
          Reference Standard
          0
          Strength
          EQ 0.5MG
          marketing status
          1. Prescription
        2. Active Ingredient
          TRAMETINIB DIMETHYL SULFOXIDE
          Appl No
          204114
          Drug Name
          MEKINIST
          Form
          TABLET;ORAL
          Product No
          002
          Reference Drug
          1
          Reference Standard
          0
          Strength
          EQ 1MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
          marketing status
          1. Discontinued
        3. Active Ingredient
          TRAMETINIB DIMETHYL SULFOXIDE
          Appl No
          204114
          Drug Name
          MEKINIST
          Form
          TABLET;ORAL
          Product No
          003
          Reference Drug
          1
          Reference Standard
          1
          Strength
          EQ 2MG
          marketing status
          1. Prescription
      2. application number
        NDA217513
        payload
        all indexed label documents
        1. Appl No
          217513
          Application Docs Date
          2023-03-17 00:00:00
          Application Docs ID
          73795
          Application Docs Title
          0
          Application Docs Type ID
          2
          Submission No
          1
          Submission Type
          ORIG
        2. Appl No
          217513
          Application Docs Date
          2024-02-28 00:00:00
          Application Docs ID
          77637
          Application Docs Title
          0
          Application Docs Type ID
          2
          Submission No
          2
          Submission Type
          SUPPL
        3. Appl No
          217513
          Application Docs Date
          2024-04-03 00:00:00
          Application Docs ID
          78036
          Application Docs Title
          0
          Application Docs Type ID
          2
          Submission No
          3
          Submission Type
          SUPPL
        4. Appl No
          217513
          Application Docs Date
          2024-07-15 00:00:00
          Application Docs ID
          79100
          Application Docs Title
          0
          Application Docs Type ID
          2
          Submission No
          4
          Submission Type
          SUPPL
        5. Appl No
          217513
          Application Docs Date
          2024-10-24 00:00:00
          Application Docs ID
          79970
          Application Docs Title
          0
          Application Docs Type ID
          2
          Submission No
          7
          Submission Type
          SUPPL
        6. Appl No
          217513
          Application Docs Date
          2025-03-21 00:00:00
          Application Docs ID
          81525
          Application Docs Title
          0
          Application Docs Type ID
          2
          Application Docs URL
          https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/204114Orig1s034; 217513Orig1s005lbl.pdf
          Submission No
          5
          Submission Type
          SUPPL
        7. Appl No
          217513
          Application Docs Date
          2025-03-21 00:00:00
          Application Docs ID
          81667
          Application Docs Title
          0
          Application Docs Type ID
          2
          Submission No
          8
          Submission Type
          SUPPL
        8. Appl No
          217513
          Application Docs Date
          2025-04-08 00:00:00
          Application Docs ID
          81837
          Application Docs Title
          0
          Application Docs Type ID
          2
          Submission No
          9
          Submission Type
          SUPPL
        9. Appl No
          217513
          Application Docs Date
          2026-04-02 00:00:00
          Application Docs ID
          85625
          Application Docs Title
          0
          Application Docs Type ID
          2
          Submission No
          11
          Submission Type
          SUPPL
        all submission records
        1. Appl No
          217513
          Review Priority
          UNKNOWN
          Submission Class Code ID
          3
          Submission No
          11
          Submission Status
          AP
          Submission Status Date
          2026-03-26 00:00:00
          Submission Type
          SUPPL
          Submissions Public Notes
        2. Appl No
          217513
          Review Priority
          STANDARD
          Submission Class Code ID
          3
          Submission No
          10
          Submission Status
          AP
          Submission Status Date
          2025-01-24 00:00:00
          Submission Type
          SUPPL
          Submissions Public Notes
        3. Appl No
          217513
          Review Priority
          STANDARD
          Submission Class Code ID
          3
          Submission No
          9
          Submission Status
          AP
          Submission Status Date
          2025-04-07 00:00:00
          Submission Type
          SUPPL
          Submissions Public Notes
        4. Appl No
          217513
          Review Priority
          STANDARD
          Submission Class Code ID
          3
          Submission No
          8
          Submission Status
          AP
          Submission Status Date
          2025-03-19 00:00:00
          Submission Type
          SUPPL
          Submissions Public Notes
        5. Appl No
          217513
          Review Priority
          STANDARD
          Submission Class Code ID
          3
          Submission No
          7
          Submission Status
          AP
          Submission Status Date
          2024-10-01 00:00:00
          Submission Type
          SUPPL
          Submissions Public Notes
        6. Appl No
          217513
          Review Priority
          STANDARD
          Submission Class Code ID
          2
          Submission No
          5
          Submission Status
          AP
          Submission Status Date
          2025-03-07 00:00:00
          Submission Type
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      Source passages and status connections

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                                    1.1 BRAF V600E or V600K Mutation-Positive Unresectable or Metastatic Melanoma MEKINIST ® is indicated, as a single agent in BRAF-inhibitor treatment-naïve patients or in combination with dabrafenib, for the treatment of patients with unresectable or metastatic melanoma with BRAF V600E or V600K mutations, as detected by an FDA-approved test [see Dosage and Administration (2.1)] .
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                                          1.4 BRAF V600E Mutation-Positive Locally Advanced or Metastatic Anaplastic Thyroid Cancer MEKINIST is indica
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                                          2972
                                          end exclusive
                                          true
                                          exact text
                                          BRAF V600E Mutation-Positive Locally Advance
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                                          start
                                          2928
                                        2. context exact
                                          1.4 BRAF V600E Mutation-Positive Locally Advanced or Metastatic Anaplastic Thyroid Cancer MEKINIST is indicated, in combination with dabrafenib, for the tre
                                          kind
                                          biomarker
                                          polarity
                                          not_inferred
                                          span
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                                          3020
                                          end exclusive
                                          true
                                          exact text
                                          Metastatic Anaplastic Thyroid Cancer MEKINI
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                                          2977
                                        3. context exact
                                          nib, for the treatment of patients with locally advanced or metastatic anaplastic thyroid cancer (ATC) with BRAF V600E mutation, as detected by an FDA-approved tes
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                                          biomarker
                                          polarity
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                                          3167
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                                          true
                                          exact text
                                          metastatic anaplastic thyroid cancer (ATC)
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                                          3124
                                        4. context exact
                                          advanced or metastatic anaplastic thyroid cancer (ATC) with BRAF V600E mutation, as detected by an FDA-approved test, and with no satisfact
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                                          biomarker
                                          polarity
                                          not_inferred
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                                          3191
                                          end exclusive
                                          true
                                          exact text
                                          BRAF V600E mutation
                                          label id
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                                          start
                                          3172
                                        5. context exact
                                          1.4 BRAF V600E Mutation-Positive Locally Advanced or Metastatic Anaplastic Thyroid Cancer MEKINIST is indicated, in combination with dabrafenib,
                                          kind
                                          stage_or_setting
                                          polarity
                                          not_inferred
                                          span
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                                          3008
                                          end exclusive
                                          true
                                          exact text
                                          Locally Advanced or Metastatic Anaplastic Thyroid C
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                                          start
                                          2957
                                        6. context exact
                                          ination with dabrafenib, for the treatment of patients with locally advanced or metastatic anaplastic thyroid cancer (ATC) with BRAF V600E mutation, as detected by an FDA-
                                          kind
                                          stage_or_setting
                                          polarity
                                          not_inferred
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                                          3155
                                          end exclusive
                                          true
                                          exact text
                                          locally advanced or metastatic anaplastic thyroid c
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                                          start
                                          3104
                                        7. context exact
                                          Metastatic Anaplastic Thyroid Cancer MEKINIST is indicated, in combination with dabrafenib, for the treatment of patients with locally advanced or metastatic anaplastic thyroid cancer (ATC) with BRAF V600E mutation, as detected by an FDA-approved test, and with no satisfactory locoregional treatmen
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                                          regimen
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                                          3216
                                          end exclusive
                                          true
                                          exact text
                                          in combination with dabrafenib, for the treatment of patients with locally advanced or metastatic anaplastic thyroid cancer (ATC) with BRAF V600E mutation, as detected by an FDA-a
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                                          start
                                          3037
                                        regulatory links
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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
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                                            760
                                            end exclusive
                                            true
                                            exact text
                                            non-small cell lung cancer (NSCLC)
                                            label id
                                            235e3bc1-099b-4587-9d72-b02fcc3387d1
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                                            source text sha256
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                                            726
                                          source span
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                                          3325
                                          end exclusive
                                          true
                                          exact text
                                          1.4 BRAF V600E Mutation-Positive Locally Advanced or Metastatic Anaplastic Thyroid Cancer MEKINIST is indicated, in combination with dabrafenib, for the treatment of patients with locally advanced or metastatic anaplastic thyroid cancer (ATC) with BRAF V600E mutation, as detected by an FDA-approved test, and with no satisfactory locoregional treatment options [see Dosage and Administration (2.1)] .
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                                          start
                                          2924
                                          source url
                                          https://api.fda.gov/drug/label.json?search=id%3A%22235e3bc1-099b-4587-9d72-b02fcc3387d1%22
                                          spl effective date
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                                          spl set id
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                                          structured fields status
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                                          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
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                                          tumor histology
                                          Source null
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                                          tumor_directed_candidate
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                                          application numbers
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                                          3938
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                                          true
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                                          tastatic anaplastic thyroid cancer (ATC) with BRAF V600E mutation, as detected by an FDA-approved test, and with no satisfactory locoregional treatment options [see Dosage and Administration (2.1)] . 1.5 BRAF V600E Mutation-Positive Unresectable or Metastatic Solid Tumors MEKINIST is indicated, in combination with dabrafenib, for the treatment of adult and pediatric patients 1 year of age and older with unresectable or metastatic solid tumors with BRAF V600E mutation who have progressed following prior treatment and have no satisfactory alternative treatment options [see Dosage and Administration (2.1)] . This indication is approved under accelerated approval based on overall response rate and duration of response [see Clinical Studies (14.6)] . Continued approval for this indication may be contingent
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                                          end exclusive
                                          true
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                                          is indicated
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                                          3408
                                          qualifier mentions
                                          1. context exact
                                            cated, in combination with dabrafenib, for the treatment of adult and pediatric patients 1 year of age and older with unresec
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                                            age
                                            polarity
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                                            3480
                                            end exclusive
                                            true
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                                            adult
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                                            3475
                                          2. context exact
                                            combination with dabrafenib, for the treatment of adult and pediatric patients 1 year of age and older with unresectable or metastatic sol
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                                            3503
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                                            start
                                            3485
                                          3. context exact
                                            1.5 BRAF V600E Mutation-Positive Unresectable or Metastatic Solid Tumors MEKINIST is indicated, in combinati
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                                            biomarker
                                            polarity
                                            not_inferred
                                            span
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                                            3374
                                            end exclusive
                                            true
                                            exact text
                                            BRAF V600E Mutation-Positive Unresectable or
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                                            source text sha256
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                                            start
                                            3330
                                          4. context exact
                                            1.5 BRAF V600E Mutation-Positive Unresectable or Metastatic Solid Tumors MEKINIST is indicated, in combination with dabrafenib, for the treatment of adu
                                            kind
                                            biomarker
                                            polarity
                                            not_inferred
                                            span
                                            end
                                            3418
                                            end exclusive
                                            true
                                            exact text
                                            Metastatic Solid Tumors MEKINIST is indicat
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                                            start
                                            3375
                                          5. context exact
                                            atric patients 1 year of age and older with unresectable or metastatic solid tumors with BRAF V600E mutation who have progressed following prior treatment and have
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                                            biomarker
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                                            not_inferred
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                                            3592
                                            end exclusive
                                            true
                                            exact text
                                            metastatic solid tumors with BRAF V600E mut
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                                            235e3bc1-099b-4587-9d72-b02fcc3387d1
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                                            0
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                                            indications_and_usage_exact
                                            source text sha256
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                                            start
                                            3549
                                          6. context exact
                                            1.5 BRAF V600E Mutation-Positive Unresectable or Metastatic Solid Tumors MEKINIST is indicated, in combination with dabrafenib, for the trea
                                            kind
                                            stage_or_setting
                                            polarity
                                            not_inferred
                                            span
                                            end
                                            3406
                                            end exclusive
                                            true
                                            exact text
                                            Unresectable or Metastatic Solid Tumors MEKINIS
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                                            start
                                            3359
                                          7. context exact
                                            f adult and pediatric patients 1 year of age and older with unresectable or metastatic solid tumors with BRAF V600E mutation who have progressed following prior treatm
                                            kind
                                            stage_or_setting
                                            polarity
                                            not_inferred
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                                            3580
                                            end exclusive
                                            true
                                            exact text
                                            unresectable or metastatic solid tumors with BR
                                            label id
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                                            unicode_code_points
                                            source array index
                                            0
                                            source field
                                            indications_and_usage_exact
                                            source text sha256
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                                            start
                                            3533
                                          8. context exact
                                            mors with BRAF V600E mutation who have progressed following prior treatment and have no satisfactory alternative treatment options [see Dosage and Administration (2.1)] .
                                            kind
                                            prior_therapy_or_line
                                            polarity
                                            not_inferred
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                                            end
                                            3732
                                            end exclusive
                                            true
                                            exact text
                                            prior treatment and have no satisfactory alternative treatment options [see Dosage and Administration (2
                                            label id
                                            235e3bc1-099b-4587-9d72-b02fcc3387d1
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                                            unicode_code_points
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                                            start
                                            3628
                                          9. context exact
                                            esectable or Metastatic Solid Tumors MEKINIST is indicated, in combination with dabrafenib, for the treatment of adult and pediatric patients 1 year of age and older with unresectable or metastatic solid tumors with BRAF V600E mutation who have progressed following prior treatment and have no satis
                                            kind
                                            regimen
                                            polarity
                                            not_inferred
                                            span
                                            end
                                            3601
                                            end exclusive
                                            true
                                            exact text
                                            in combination with dabrafenib, for the treatment of adult and pediatric patients 1 year of age and older with unresectable or metastatic solid tumors with BRAF V600E mutation who
                                            label id
                                            235e3bc1-099b-4587-9d72-b02fcc3387d1
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                                            0
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                                            start
                                            3422
                                          regulatory links
                                            schema version
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                                            source batch sha256
                                            fc39a8c5cf96bf95ca20b85578140167b66b2741f7d9217f500d9ba0847ac058
                                            source defined aliases
                                            1. abbreviation
                                              NSCLC
                                              definition exact
                                              non-small cell lung cancer
                                              definition span
                                              end
                                              760
                                              end exclusive
                                              true
                                              exact text
                                              non-small cell lung cancer (NSCLC)
                                              label id
                                              235e3bc1-099b-4587-9d72-b02fcc3387d1
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                                              726
                                            source span
                                            end
                                            3738
                                            end exclusive
                                            true
                                            exact text
                                            1.5 BRAF V600E Mutation-Positive Unresectable or Metastatic Solid Tumors MEKINIST is indicated, in combination with dabrafenib, for the treatment of adult and pediatric patients 1 year of age and older with unresectable or metastatic solid tumors with BRAF V600E mutation who have progressed following prior treatment and have no satisfactory alternative treatment options [see Dosage and Administration (2.1)] .
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                                            start
                                            3326
                                            source url
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                                            spl effective date
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                                            spl set id
                                            0002ad27-779d-42ab-83b5-bc65453412a1
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                                            structured fields status
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                                            Source null
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                                            disease stage
                                            Source null
                                            limitations
                                            Source null
                                            line
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                                            prior therapy
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                                            Source null
                                            tumor histology
                                            Source null
                                            use intent
                                            tumor_directed_candidate
                                            Passage 17 · approval contingency
                                            application numbers
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                                            brand names
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                                            4081
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                                            true
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                                            ctable or metastatic solid tumors with BRAF V600E mutation who have progressed following prior treatment and have no satisfactory alternative treatment options [see Dosage and Administration (2.1)] . This indication is approved under accelerated approval based on overall response rate and duration of response [see Clinical Studies (14.6)] . Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s). 1.6 BRAF V600E Mutation-Positive Low-Grade Glioma MEKINIST i
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                                            positive predicate support span
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                                                source batch sha256
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                                                source defined aliases
                                                1. abbreviation
                                                  NSCLC
                                                  definition exact
                                                  non-small cell lung cancer
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                                                  760
                                                  end exclusive
                                                  true
                                                  exact text
                                                  non-small cell lung cancer (NSCLC)
                                                  label id
                                                  235e3bc1-099b-4587-9d72-b02fcc3387d1
                                                  offset unit
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                                                  source array index
                                                  0
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                                                  indications_and_usage_exact
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                                                  726
                                                source span
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                                                3881
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                                                true
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                                                This indication is approved under accelerated approval based on overall response rate and duration of response [see Clinical Studies (14.6)] .
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                                                source url
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                                                reatment options [see Dosage and Administration (2.1)] . This indication is approved under accelerated approval based on overall response rate and duration of response [see Clinical Studies (14.6)] . Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s). 1.6 BRAF V600E Mutation-Positive Low-Grade Glioma MEKINIST is indicated, in combination with dabrafenib, for the treatment of pediatric patients 1 year of age and older with low-grade glioma (LGG) wi
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                                                      E Mutation-Positive Low-Grade Glioma MEKINIST is indicated, in combination with dabrafenib, for the treatment of pediatric patients 1 year of age and older with low-grade glioma (LGG) with a BRAF V600E mutation who require systemic therapy [see Dosage and Administration (2.1)] .
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                                                      1.6 BRAF V600E Mutation-Positive Low-Grade Glioma MEKINIST is indicated, in combination with dabrafenib, for the treatment of pediatric patients 1 year of age and older with low-grade glioma (LGG) with a BRAF V600E mutation who require systemic therapy [see Dosage and Administration (2.1)] .
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                                                        Preserved source evidence · Not medical advice