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LABELS · 6c546993-1f7f-409b-b108-60f22e9b948a

Tafinlar

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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
2026-05-20
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 TAFINLAR is a kinase inhibitor indicated as a single agent 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 ) TAFINLAR is indicated, in combination with trametinib , for: the treatment of patients with unresectable or metastatic melanoma with BRAF V600E or V600K mutations as detected by an FDA-approved test. ( 1.2 , 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. ( 1.3 , 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. ( 1.4 , 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. ( 1.5 , 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 (ORR) and duration of response (DoR). Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s). ( 1.6 , 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. ( 1.7 , 2.1 ) Limitations of Use : TAFINLAR is not indicated for treatment of patients with colorectal cancer because of known intrinsic resistance to BRAF inhibition. ( 1.8 , 12.1 ) TAFINLAR is not indicated for treatment of patients with wild-type BRAF solid tumors. ( 5.2 ) 1.1 BRAF V600E Mutation-Positive Unresectable or Metastatic Melanoma TAFINLAR ® is indicated as a single agent for the treatment of patients with unresectable or metastatic melanoma with BRAF V600E mutation as detected by an FDA-approved test. 1.2 BRAF V600E or V600K Mutation-Positive Unresectable or Metastatic Melanoma TAFINLAR is indicated, in combination with trametinib, 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)] . 1.3 Adjuvant Treatment of BRAF V600E or V600K Mutation-Positive Melanoma TAFINLAR is indicated, in combination with trametinib, 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)] . 1.4 BRAF V600E Mutation-Positive Metastatic NSCLC TAFINLAR is indicated, in combination with trametinib, 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)] . 1.5 BRAF V600E Mutation-Positive Locally Advanced or Metastatic Anaplastic Thyroid Cancer TAFINLAR is indicated, in combination with trametinib, 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)] . 1.6 BRAF V600E Mutation-Positive Unresectable or Metastatic Solid Tumors TAFINLAR is indicated, in combination with trametinib, 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 (ORR) and duration of response (DoR) [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). 1.7 BRAF V600E Mutation-Positive Low-Grade Glioma TAFINLAR is indicated, in combination with trametinib, 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)] . 1.8 Limitations of Use TAFINLAR is not indicated for treatment of patients with colorectal cancer because of known intrinsic resistance to BRAF inhibition [see Indications and Usage (1.6), Clinical Pharmacology (12.1)] . TAFINLAR is not indicated for treatment of patients with wild-type BRAF solid tumors [see Warnings and Precautions (5.2)] .
Full extracted label fields
application numbers
  1. NDA202806
  2. NDA217514
boxed warning exact
    brand names
    1. Tafinlar
    current indication status
    not_reconciled
    dailymed set url
    https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=fee1e6b1-e1a5-4254-9f2e-a70e0f8dbdea
    generic names
    1. DABRAFENIB
    id
    6c546993-1f7f-409b-b108-60f22e9b948a
    indications and usage exact
    1. 1 INDICATIONS AND USAGE TAFINLAR is a kinase inhibitor indicated as a single agent 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 ) TAFINLAR is indicated, in combination with trametinib , for: the treatment of patients with unresectable or metastatic melanoma with BRAF V600E or V600K mutations as detected by an FDA-approved test. ( 1.2 , 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. ( 1.3 , 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. ( 1.4 , 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. ( 1.5 , 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 (ORR) and duration of response (DoR). Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s). ( 1.6 , 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. ( 1.7 , 2.1 ) Limitations of Use : TAFINLAR is not indicated for treatment of patients with colorectal cancer because of known intrinsic resistance to BRAF inhibition. ( 1.8 , 12.1 ) TAFINLAR is not indicated for treatment of patients with wild-type BRAF solid tumors. ( 5.2 ) 1.1 BRAF V600E Mutation-Positive Unresectable or Metastatic Melanoma TAFINLAR ® is indicated as a single agent for the treatment of patients with unresectable or metastatic melanoma with BRAF V600E mutation as detected by an FDA-approved test. 1.2 BRAF V600E or V600K Mutation-Positive Unresectable or Metastatic Melanoma TAFINLAR is indicated, in combination with trametinib, 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)] . 1.3 Adjuvant Treatment of BRAF V600E or V600K Mutation-Positive Melanoma TAFINLAR is indicated, in combination with trametinib, 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)] . 1.4 BRAF V600E Mutation-Positive Metastatic NSCLC TAFINLAR is indicated, in combination with trametinib, 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)] . 1.5 BRAF V600E Mutation-Positive Locally Advanced or Metastatic Anaplastic Thyroid Cancer TAFINLAR is indicated, in combination with trametinib, 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)] . 1.6 BRAF V600E Mutation-Positive Unresectable or Metastatic Solid Tumors TAFINLAR is indicated, in combination with trametinib, 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 (ORR) and duration of response (DoR) [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). 1.7 BRAF V600E Mutation-Positive Low-Grade Glioma TAFINLAR is indicated, in combination with trametinib, 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)] . 1.8 Limitations of Use TAFINLAR is not indicated for treatment of patients with colorectal cancer because of known intrinsic resistance to BRAF inhibition [see Indications and Usage (1.6), Clinical Pharmacology (12.1)] . TAFINLAR is not indicated for treatment of patients with wild-type BRAF solid tumors [see Warnings and Precautions (5.2)] .
    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. 0078-0682-66
      2. 0078-0681-66
      3. 0078-1154-21
      product ndcs
      1. 0078-0681
      2. 0078-0682
      3. 0078-1154
      product types
      1. HUMAN PRESCRIPTION DRUG
      recent major changes exact
      1. Warnings and Precautions, Uveitis ( 5.5 ) 4/2025
      record type
      complete_spl_indications_section_candidate
      routes
      1. ORAL
      rxcuis
      1. 1424916
      2. 1424918
      3. 1425228
      4. 1425230
      5. 2632552
      6. 2632556
      source batch
      file
      /private/tmp/cancer-full-research/indications/raw/labels-00400.json
      meta
      disclaimer
      Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. We may limit or otherwise restrict your access to the API in line with our Terms of Service.
      last updated
      2026-09-09
      results
      limit
      100
      skip
      400
      total
      830
      sha256
      a4bef6778baed183e5bcf581938b0b23d3576dfd9eb6150f2904934a750c5fef
      url
      https://api.fda.gov/drug/label.json?search=%28indications_and_usage%3Acancer+OR+indications_and_usage%3Acarcinoma+OR+indications_and_usage%3Acarcinomas+OR+indications_and_usage%3Alymphoma+OR+indications_and_usage%3Alymphomas+OR+indications_and_usage%3Aleukemia+OR+indications_and_usage%3Aleukaemia+OR+indications_and_usage%3Asarcoma+OR+indications_and_usage%3Asarcomas+OR+indications_and_usage%3Amelanoma+OR+indications_and_usage%3Amyeloma+OR+indications_and_usage%3Atumor+OR+indications_and_usage%3Atumors+OR+indications_and_usage%3Atumour+OR+indications_and_usage%3Atumours+OR+indications_and_usage%3Aneoplasm+OR+indications_and_usage%3Aneoplasms+OR+indications_and_usage%3Amalignant+OR+indications_and_usage%3Amalignancy+OR+indications_and_usage%3Amyelodysplastic+OR+indications_and_usage%3Amyelofibrosis+OR+indications_and_usage%3Amastocytosis+OR+indications_and_usage%3Aglioma+OR+indications_and_usage%3Aglioblastoma+OR+indications_and_usage%3Aneuroblastoma+OR+indications_and_usage%3Aretinoblastoma+OR+indications_and_usage%3Apheochromocytoma+OR+indications_and_usage%3Aparaganglioma+OR+indications_and_usage%3Amyeloproliferative+OR+indications_and_usage%3Awaldenstrom+OR+indications_and_usage%3Apolycythemia+OR+indications_and_usage%3Athrombocythemia+OR+indications_and_usage%3Adesmoid+OR+indications_and_usage%3Aneurofibromatosis+OR+indications_and_usage%3Ahistiocytosis%29+AND+%28openfda.application_number%3ANDA%2A+OR+openfda.application_number%3ABLA%2A%29&limit=100&skip=400&sort=id%3Aasc
      source url
      https://api.fda.gov/drug/label.json?search=id%3A%226c546993-1f7f-409b-b108-60f22e9b948a%22
      spl effective date
      2026-05-20
      spl effective time
      20260520
      spl set id
      fee1e6b1-e1a5-4254-9f2e-a70e0f8dbdea
      spl version
      37
      substance names
      1. DABRAFENIB MESYLATE
      uniis
      1. B6DC89I63E
      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
        NDA202806
        payload
        all indexed label documents
        1. Appl No
          202806
          Application Docs Date
          2014-01-10 00:00:00
          Application Docs ID
          19378
          Application Docs Title
          0
          Application Docs Type ID
          2
          Submission No
          2
          Submission Type
          SUPPL
        2. Appl No
          202806
          Application Docs Date
          2015-11-20 00:00:00
          Application Docs ID
          19379
          Application Docs Title
          0
          Application Docs Type ID
          2
          Submission No
          4
          Submission Type
          SUPPL
        3. Appl No
          202806
          Application Docs Date
          2016-06-21 00:00:00
          Application Docs ID
          19380
          Application Docs Title
          0
          Application Docs Type ID
          2
          Submission No
          5
          Submission Type
          SUPPL
        4. Appl No
          202806
          Application Docs Date
          2013-05-29 00:00:00
          Application Docs ID
          40221
          Application Docs Title
          0
          Application Docs Type ID
          2
          Submission No
          1
          Submission Type
          ORIG
        5. Appl No
          202806
          Application Docs Date
          2013-12-30 00:00:00
          Application Docs ID
          40222
          Application Docs Title
          0
          Application Docs Type ID
          2
          Submission No
          1
          Submission Type
          SUPPL
        6. Appl No
          202806
          Application Docs Date
          2017-06-19 00:00:00
          Application Docs ID
          48758
          Application Docs Title
          0
          Application Docs Type ID
          2
          Submission No
          7
          Submission Type
          SUPPL
        7. Appl No
          202806
          Application Docs Date
          2017-06-22 00:00:00
          Application Docs ID
          48808
          Application Docs Title
          0
          Application Docs Type ID
          2
          Submission No
          6
          Submission Type
          SUPPL
        8. Appl No
          202806
          Application Docs Date
          2018-04-20 00:00:00
          Application Docs ID
          53744
          Application Docs Title
          0
          Application Docs Type ID
          2
          Submission No
          9
          Submission Type
          SUPPL
        9. Appl No
          202806
          Application Docs Date
          2018-04-30 00:00:00
          Application Docs ID
          53873
          Application Docs Title
          0
          Application Docs Type ID
          2
          Submission No
          8
          Submission Type
          SUPPL
        10. Appl No
          202806
          Application Docs Date
          2018-05-04 00:00:00
          Application Docs ID
          54017
          Application Docs Title
          0
          Application Docs Type ID
          2
          Submission No
          10
          Submission Type
          SUPPL
        11. Appl No
          202806
          Application Docs Date
          2019-07-17 00:00:00
          Application Docs ID
          59362
          Application Docs Title
          0
          Application Docs Type ID
          2
          Submission No
          13
          Submission Type
          SUPPL
        12. Appl No
          202806
          Application Docs Date
          2019-10-07 00:00:00
          Application Docs ID
          60266
          Application Docs Title
          0
          Application Docs Type ID
          2
          Submission No
          12
          Submission Type
          SUPPL
        all submission records
        1. Appl No
          202806
          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
        2. Appl No
          202806
          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
        3. Appl No
          202806
          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
        4. Appl No
          202806
          Review Priority
          STANDARD
          Submission Class Code ID
          3
          Submission No
          36
          Submission Status
          AP
          Submission Status Date
          2025-01-30 00:00:00
          Submission Type
          SUPPL
          Submissions Public Notes
        5. Appl No
          202806
          Review Priority
          STANDARD
          Submission Class Code ID
          2
          Submission No
          33
          Submission Status
          AP
          Submission Status Date
          2025-03-07 00:00:00
          Submission Type
          SUPPL
          Submissions Public Notes
        6. Appl No
          202806
          Review Priority
          STANDARD
          Submission Class Code ID
          3
          Submission No
          31
          Submission Status
          AP
          Submission Status Date
          2024-07-11 00:00:00
          Submission Type
          SUPPL
          Submissions Public Notes
        7. Appl No
          202806
          Review Priority
          STANDARD
          Submission Class Code ID
          3
          Submission No
          30
          Submission Status
          AP
          Submission Status Date
          2024-03-29 00:00:00
          Submission Type
          SUPPL
          Submissions Public Notes
        8. Appl No
          202806
          Review Priority
          STANDARD
          Submission Class Code ID
          3
          Submission No
          29
          Submission Status
          AP
          Submission Status Date
          2024-02-27 00:00:00
          Submission Type
          SUPPL
          Submissions Public Notes
        9. Appl No
          202806
          Review Priority
          PRIORITY
          Submission Class Code ID
          2
          Submission No
          27
          Submission Status
          AP
          Submission Status Date
          2023-08-31 00:00:00
          Submission Type
          SUPPL
          Submissions Public Notes
        10. Appl No
          202806
          Review Priority
          STANDARD
          Submission Class Code ID
          3
          Submission No
          26
          Submission Status
          AP
          Submission Status Date
          2023-05-26 00:00:00
          Submission Type
          SUPPL
          Submissions Public Notes
        11. Appl No
          202806
          Review Priority
          PRIORITY
          Submission Class Code ID
          2
          Submission No
          25
          Submission Status
          AP
          Submission Status Date
          2023-03-16 00:00:00
          Submission Type
          SUPPL
          Submissions Public Notes
        12. Appl No
          202806
          Review Priority
          STANDARD
          Submission Class Code ID
          2
          Submission No
          23
          Submission Status
          AP
          Submission Status Date
          2022-05-27 00:00:00
          Submission Type
          SUPPL
          Submissions Public Notes
        application number
        NDA202806
        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
        2026-03-26
        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
          202806
          Application Docs Date
          2026-03-30 00:00:00
          Application Docs ID
          85568
          Application Docs Title
          0
          Application Docs Type ID
          2
          Submission No
          40
          Submission Type
          SUPPL
        official application record
        Appl No
        202806
        Appl Public Notes
        Appl Type
        NDA
        Sponsor Name
        NOVARTIS
        openfda application present
        true
        products
        1. Active Ingredient
          DABRAFENIB MESYLATE
          Appl No
          202806
          Drug Name
          TAFINLAR
          Form
          CAPSULE;ORAL
          Product No
          001
          Reference Drug
          1
          Reference Standard
          0
          Strength
          EQ 50MG BASE
          marketing status
          1. Prescription
        2. Active Ingredient
          DABRAFENIB MESYLATE
          Appl No
          202806
          Drug Name
          TAFINLAR
          Form
          CAPSULE;ORAL
          Product No
          002
          Reference Drug
          1
          Reference Standard
          1
          Strength
          EQ 75MG BASE
          marketing status
          1. Prescription
      2. application number
        NDA217514
        payload
        all indexed label documents
        1. Appl No
          217514
          Application Docs Date
          2023-03-17 00:00:00
          Application Docs ID
          73790
          Application Docs Title
          0
          Application Docs Type ID
          2
          Submission No
          1
          Submission Type
          ORIG
        2. Appl No
          217514
          Application Docs Date
          2024-02-28 00:00:00
          Application Docs ID
          77639
          Application Docs Title
          0
          Application Docs Type ID
          2
          Submission No
          2
          Submission Type
          SUPPL
        3. Appl No
          217514
          Application Docs Date
          2024-04-03 00:00:00
          Application Docs ID
          78037
          Application Docs Title
          0
          Application Docs Type ID
          2
          Submission No
          3
          Submission Type
          SUPPL
        4. Appl No
          217514
          Application Docs Date
          2024-07-18 00:00:00
          Application Docs ID
          79121
          Application Docs Title
          0
          Application Docs Type ID
          2
          Submission No
          4
          Submission Type
          SUPPL
        5. Appl No
          217514
          Application Docs Date
          2025-02-05 00:00:00
          Application Docs ID
          80971
          Application Docs Title
          0
          Application Docs Type ID
          2
          Submission No
          10
          Submission Type
          SUPPL
        6. Appl No
          217514
          Application Docs Date
          2025-03-11 00:00:00
          Application Docs ID
          81522
          Application Docs Title
          0
          Application Docs Type ID
          2
          Submission No
          6
          Submission Type
          SUPPL
        7. Appl No
          217514
          Application Docs Date
          2025-03-21 00:00:00
          Application Docs ID
          81670
          Application Docs Title
          0
          Application Docs Type ID
          2
          Submission No
          8
          Submission Type
          SUPPL
        8. Appl No
          217514
          Application Docs Date
          2025-04-08 00:00:00
          Application Docs ID
          81839
          Application Docs Title
          0
          Application Docs Type ID
          2
          Submission No
          9
          Submission Type
          SUPPL
        9. Appl No
          217514
          Application Docs Date
          2026-04-21 00:00:00
          Application Docs ID
          85732
          Application Docs Title
          0
          Application Docs Type ID
          2
          Submission No
          11
          Submission Type
          SUPPL
        all submission records
        1. Appl No
          217514
          Review Priority
          PRIORITY
          Submission Class Code ID
          26
          Submission No
          1
          Submission Status
          AP
          Submission Status Date
          2023-03-16 00:00:00
          Submission Type
          ORIG
          Submissions Public Notes
        2. Appl No
          217514
          Review Priority
          STANDARD
          Submission Class Code ID
          3
          Submission No
          2
          Submission Status
          AP
          Submission Status Date
          2024-02-27 00:00:00
          Submission Type
          SUPPL
          Submissions Public Notes
        3. Appl No
          217514
          Review Priority
          STANDARD
          Submission Class Code ID
          3
          Submission No
          3
          Submission Status
          AP
          Submission Status Date
          2024-03-29 00:00:00
          Submission Type
          SUPPL
          Submissions Public Notes
        4. Appl No
          217514
          Review Priority
          STANDARD
          Submission Class Code ID
          3
          Submission No
          4
          Submission Status
          AP
          Submission Status Date
          2024-07-11 00:00:00
          Submission Type
          SUPPL
          Submissions Public Notes
        5. Appl No
          217514
          Review Priority
          STANDARD
          Submission Class Code ID
          2
          Submission No
          6
          Submission Status
          AP
          Submission Status Date
          2025-03-07 00:00:00
          Submission Type
          SUPPL
          Submissions Public Notes
        6. Appl No
          217514
          Review Priority
          STANDARD
          Submission Class Code ID
          3
          Submission No
          8
          Submission Status
          AP
          Submission Status Date
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                                          4. context exact
                                            1.4 BRAF V600E Mutation-Positive Metastatic NSCLC TAFINLAR is indicated, in combination with trametinib, for the treatment of patie
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                                          6. context exact
                                            E Mutation-Positive Metastatic NSCLC TAFINLAR is indicated, in combination with trametinib, 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)] .
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                                            1.4 BRAF V600E Mutation-Positive Metastatic NSCLC TAFINLAR is indicated, in combination with trametinib, 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)] .
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                                              3. context exact
                                                1.6 BRAF V600E Mutation-Positive Unresectable or Metastatic Solid Tumors TAFINLAR is indicated, in combinati
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                                                BRAF V600E Mutation-Positive Unresectable or
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                                              4. context exact
                                                1.6 BRAF V600E Mutation-Positive Unresectable or Metastatic Solid Tumors TAFINLAR is indicated, in combination with trametinib, for the treatment of adu
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                                                Metastatic Solid Tumors TAFINLAR is indicat
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                                              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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                                              6. context exact
                                                1.6 BRAF V600E Mutation-Positive Unresectable or Metastatic Solid Tumors TAFINLAR is indicated, in combination with trametinib, for the trea
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                                                Unresectable or Metastatic Solid Tumors TAFINLA
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                                              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
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                                                unresectable or metastatic solid tumors with BR
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                                              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)] .
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                                                prior treatment and have no satisfactory alternative treatment options [see Dosage and Administration (2
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                                              9. context exact
                                                esectable or Metastatic Solid Tumors TAFINLAR is indicated, in combination with trametinib, 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
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                                                in combination with trametinib, 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
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                                                source defined aliases
                                                1. abbreviation
                                                  NSCLC
                                                  definition exact
                                                  non-small cell lung cancer
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                                                  end exclusive
                                                  true
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                                                  non-small cell lung cancer (NSCLC)
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                                                1.6 BRAF V600E Mutation-Positive Unresectable or Metastatic Solid Tumors TAFINLAR is indicated, in combination with trametinib, 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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                                                spl effective date
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                                                Source null
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                                                Source null
                                                line
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                                                Source null
                                                use intent
                                                tumor_directed_candidate
                                                Passage 19 · approval contingency
                                                application numbers
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                                                brand names
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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 (ORR) and duration of response (DoR) [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). 1.7 BRAF V600E Mutation-Positive Low-Grade Glioma TAFINLAR i
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                                                    source defined aliases
                                                    1. abbreviation
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                                                      definition exact
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                                                      non-small cell lung cancer (NSCLC)
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                                                    This indication is approved under accelerated approval based on overall response rate (ORR) and duration of response (DoR) [see Clinical Studies (14.6)] .
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                                                    ions [see Dosage and Administration (2.1)] . This indication is approved under accelerated approval based on overall response rate (ORR) and duration of response (DoR) [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). 1.7 BRAF V600E Mutation-Positive Low-Grade Glioma TAFINLAR is indicated, in combination with trametinib, for the treatment of pediatric patients 1 year of age and older with low-grade glioma (LGG) wi
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                                                        source defined aliases
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                                                          non-small cell lung cancer (NSCLC)
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                                                        Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s).
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                                                        Source null
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                                                        application numbers
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                                                        d duration of response (DoR) [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). 1.7 BRAF V600E Mutation-Positive Low-Grade Glioma TAFINLAR is indicated, in combination with trametinib, 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)] . 1.8 Limitations of Use TAFINLAR is not indicated for treatment of patients with colorectal cancer because of known intrinsic resistance to BRAF inhibition [see Indications and Usage (1.6), Clinical P
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                                                        qualifier mentions
                                                        1. context exact
                                                          cated, in combination with trametinib, for the treatment of pediatric patients 1 year of age and older with low-grade glioma (LGG) with a
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                                                          not_inferred
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                                                          pediatric patients
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                                                        2. context exact
                                                          1.7 BRAF V600E Mutation-Positive Low-Grade Glioma TAFINLAR is indicated, in combination with trametinib, for
                                                          kind
                                                          biomarker
                                                          polarity
                                                          not_inferred
                                                          span
                                                          end
                                                          4327
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                                                          true
                                                          exact text
                                                          BRAF V600E Mutation-Positive Low-Grade Gliom
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                                                          source array index
                                                          0
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                                                        3. context exact
                                                          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)] .
                                                          kind
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                                                          exact text
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                                                          1.7 BRAF V600E Mutation-Positive Low-Grade Glioma TAFINLAR is indicated, in combination with trametinib, 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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                                                          trametinib, 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)] . 1.8 Limitations of Use TAFINLAR is not indicated for treatment of patients with colorectal cancer because of known intrinsic resistance to BRAF inhibition [see Indications and Usage (1.6), Clinical Pharmacology (12.1)] . TAFINLAR is not indicated for treatment of patients with wild-type BRAF solid tumors [see Warnings and Precautions (5.2)] .
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                                                            e TAFINLAR is not indicated for treatment of patients with colorectal cancer because of known intrinsic resistance to BRAF inhibition [see Indications and Usage (1.6), Clinical Pharmacology (12.1)] . TAFINLAR is not indicated for treatment of patients with wild-type BRAF solid tumors [see Warnings and Precautions (5.2)] .
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                                                              Preserved source evidence · Not medical advice