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LABELS · 0e3ba6e7-af8d-4840-9409-a537a09e1263

VITRAKVI

Open original source → · Download preserved record

Preserved label snapshot, not confirmation of a current approved indication. Approval/withdrawal status must be checked for the exact disease, setting and regimen.

Label effective date
2026-05-22
Captured
2026-09-09T23:37:39.774134+00:00
Current indication reconciliation
Not reconciled

Indications and usage: exact source text

  1. 1 INDICATIONS AND USAGE VITRAKVI is indicated for the treatment of adult and pediatric patients with solid tumors that: have a neurotrophic receptor tyrosine kinase ( NTRK ) gene fusion without a known acquired resistance mutation, are metastatic or where surgical resection is likely to result in severe morbidity, and have no satisfactory alternative treatments or that have progressed following treatment. Select patients for therapy based on an FDA-approved test [see Dosage and Administration (2.1) ]. VITRAKVI is a kinase inhibitor indicated for the treatment of adult and pediatric patients with solid tumors that: have a neurotrophic receptor tyrosine kinase ( NTRK ) gene fusion without a known acquired resistance mutation, are metastatic or where surgical resection is likely to result in severe morbidity, and have no satisfactory alternative treatments or that have progressed following treatment. Select patients for therapy based on an FDA-approved test. ( 1 , 2.1 )
Full extracted label fields
application numbers
  1. NDA210861
  2. NDA211710
boxed warning exact
    brand names
    1. VITRAKVI
    current indication status
    not_reconciled
    dailymed set url
    https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=0c8ca614-58b2-4aa4-83d3-0387a8f782fd
    generic names
    1. LAROTRECTINIB
    id
    0e3ba6e7-af8d-4840-9409-a537a09e1263
    indications and usage exact
    1. 1 INDICATIONS AND USAGE VITRAKVI is indicated for the treatment of adult and pediatric patients with solid tumors that: have a neurotrophic receptor tyrosine kinase ( NTRK ) gene fusion without a known acquired resistance mutation, are metastatic or where surgical resection is likely to result in severe morbidity, and have no satisfactory alternative treatments or that have progressed following treatment. Select patients for therapy based on an FDA-approved test [see Dosage and Administration (2.1) ]. VITRAKVI is a kinase inhibitor indicated for the treatment of adult and pediatric patients with solid tumors that: have a neurotrophic receptor tyrosine kinase ( NTRK ) gene fusion without a known acquired resistance mutation, are metastatic or where surgical resection is likely to result in severe morbidity, and have no satisfactory alternative treatments or that have progressed following treatment. Select patients for therapy based on an FDA-approved test. ( 1 , 2.1 )
    indications and usage tables exact
      is original packager
      1. true
      manufacturer names
      1. Bayer HealthCare Pharmaceuticals Inc.
      matched search terms
      1. tumors
      package ndcs
      1. 50419-390-01
      2. 50419-391-01
      3. 50419-392-01
      4. 50419-393-02
      5. 50419-393-03
      product ndcs
      1. 50419-390
      2. 50419-391
      3. 50419-392
      4. 50419-393
      product types
      1. HUMAN PRESCRIPTION DRUG
      recent major changes exact
      1. Indications and Usage ( 1 ) 4/2025 Dosage and Administration ( 2.1 ) 4/2025 Warnings and Precautions ( 5.1 , 5.2 , 5.3 ) 4/2025
      record type
      complete_spl_indications_section_candidate
      routes
      1. ORAL
      2. OROPHARYNGEAL
      rxcuis
      1. 2105633
      2. 2105645
      3. 2105649
      4. 2105653
      5. 2105655
      6. 2105657
      source batch
      file
      /private/tmp/cancer-full-research/indications/raw/labels-00000.json
      meta
      disclaimer
      Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. We may limit or otherwise restrict your access to the API in line with our Terms of Service.
      last updated
      2026-09-09
      results
      limit
      100
      skip
      0
      total
      830
      sha256
      0dba7a040bbbf460aa9f482c5b67c9f28f75fc9df775ee1e7b345b758f780e07
      url
      https://api.fda.gov/drug/label.json?search=%28indications_and_usage%3Acancer+OR+indications_and_usage%3Acarcinoma+OR+indications_and_usage%3Acarcinomas+OR+indications_and_usage%3Alymphoma+OR+indications_and_usage%3Alymphomas+OR+indications_and_usage%3Aleukemia+OR+indications_and_usage%3Aleukaemia+OR+indications_and_usage%3Asarcoma+OR+indications_and_usage%3Asarcomas+OR+indications_and_usage%3Amelanoma+OR+indications_and_usage%3Amyeloma+OR+indications_and_usage%3Atumor+OR+indications_and_usage%3Atumors+OR+indications_and_usage%3Atumour+OR+indications_and_usage%3Atumours+OR+indications_and_usage%3Aneoplasm+OR+indications_and_usage%3Aneoplasms+OR+indications_and_usage%3Amalignant+OR+indications_and_usage%3Amalignancy+OR+indications_and_usage%3Amyelodysplastic+OR+indications_and_usage%3Amyelofibrosis+OR+indications_and_usage%3Amastocytosis+OR+indications_and_usage%3Aglioma+OR+indications_and_usage%3Aglioblastoma+OR+indications_and_usage%3Aneuroblastoma+OR+indications_and_usage%3Aretinoblastoma+OR+indications_and_usage%3Apheochromocytoma+OR+indications_and_usage%3Aparaganglioma+OR+indications_and_usage%3Amyeloproliferative+OR+indications_and_usage%3Awaldenstrom+OR+indications_and_usage%3Apolycythemia+OR+indications_and_usage%3Athrombocythemia+OR+indications_and_usage%3Adesmoid+OR+indications_and_usage%3Aneurofibromatosis+OR+indications_and_usage%3Ahistiocytosis%29+AND+%28openfda.application_number%3ANDA%2A+OR+openfda.application_number%3ABLA%2A%29&limit=100&skip=0&sort=id%3Aasc
      source url
      https://api.fda.gov/drug/label.json?search=id%3A%220e3ba6e7-af8d-4840-9409-a537a09e1263%22
      spl effective date
      2026-05-22
      spl effective time
      20260522
      spl set id
      0c8ca614-58b2-4aa4-83d3-0387a8f782fd
      spl version
      21
      substance names
      1. LAROTRECTINIB
      uniis
      1. PF9462I9HX
      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
        NDA210861
        payload
        all indexed label documents
        1. Appl No
          210861
          Application Docs Date
          2018-11-26 00:00:00
          Application Docs ID
          56563
          Application Docs Title
          0
          Application Docs Type ID
          2
          Submission No
          1
          Submission Type
          ORIG
        2. Appl No
          210861
          Application Docs Date
          2021-03-26 00:00:00
          Application Docs ID
          66886
          Application Docs Title
          0
          Application Docs Type ID
          2
          Submission No
          6
          Submission Type
          SUPPL
        3. Appl No
          210861
          Application Docs Date
          2022-11-28 00:00:00
          Application Docs ID
          72727
          Application Docs Title
          0
          Application Docs Type ID
          2
          Submission No
          8
          Submission Type
          SUPPL
        4. Appl No
          210861
          Application Docs Date
          2023-11-06 00:00:00
          Application Docs ID
          76385
          Application Docs Title
          0
          Application Docs Type ID
          2
          Submission No
          10
          Submission Type
          SUPPL
        5. Appl No
          210861
          Application Docs Date
          2025-04-25 00:00:00
          Application Docs ID
          82012
          Application Docs Title
          0
          Application Docs Type ID
          2
          Submission No
          12
          Submission Type
          SUPPL
        all submission records
        1. Appl No
          210861
          Review Priority
          STANDARD
          Submission Class Code ID
          2
          Submission No
          12
          Submission Status
          AP
          Submission Status Date
          2025-04-09 00:00:00
          Submission Type
          SUPPL
          Submissions Public Notes
        2. Appl No
          210861
          Review Priority
          STANDARD
          Submission Class Code ID
          3
          Submission No
          10
          Submission Status
          AP
          Submission Status Date
          2023-11-03 00:00:00
          Submission Type
          SUPPL
          Submissions Public Notes
        3. Appl No
          210861
          Review Priority
          STANDARD
          Submission Class Code ID
          3
          Submission No
          8
          Submission Status
          AP
          Submission Status Date
          2022-11-23 00:00:00
          Submission Type
          SUPPL
          Submissions Public Notes
        4. Appl No
          210861
          Review Priority
          STANDARD
          Submission Class Code ID
          3
          Submission No
          6
          Submission Status
          AP
          Submission Status Date
          2021-03-25 00:00:00
          Submission Type
          SUPPL
          Submissions Public Notes
        5. Appl No
          210861
          Review Priority
          STANDARD
          Submission Class Code ID
          2
          Submission No
          4
          Submission Status
          AP
          Submission Status Date
          2021-03-25 00:00:00
          Submission Type
          SUPPL
          Submissions Public Notes
        6. Appl No
          210861
          Review Priority
          PRIORITY
          Submission Class Code ID
          7
          Submission No
          1
          Submission Status
          AP
          Submission Status Date
          2018-11-26 00:00:00
          Submission Type
          ORIG
          Submissions Public Notes
        application number
        NDA210861
        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
        2025-04-09
        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
          210861
          Application Docs Date
          2025-04-25 00:00:00
          Application Docs ID
          82012
          Application Docs Title
          0
          Application Docs Type ID
          2
          Submission No
          12
          Submission Type
          SUPPL
        official application record
        Appl No
        210861
        Appl Public Notes
        Appl Type
        NDA
        Sponsor Name
        BAYER HLTHCARE
        openfda application present
        true
        products
        1. Active Ingredient
          LAROTRECTINIB SULFATE
          Appl No
          210861
          Drug Name
          VITRAKVI
          Form
          CAPSULE;ORAL
          Product No
          001
          Reference Drug
          1
          Reference Standard
          0
          Strength
          EQ 25MG BASE
          marketing status
          1. Prescription
        2. Active Ingredient
          LAROTRECTINIB SULFATE
          Appl No
          210861
          Drug Name
          VITRAKVI
          Form
          CAPSULE;ORAL
          Product No
          002
          Reference Drug
          1
          Reference Standard
          1
          Strength
          EQ 100MG BASE
          marketing status
          1. Prescription
      2. application number
        NDA211710
        payload
        all indexed label documents
        1. Appl No
          211710
          Application Docs Date
          2018-11-26 00:00:00
          Application Docs ID
          56562
          Application Docs Title
          0
          Application Docs Type ID
          2
          Submission No
          1
          Submission Type
          ORIG
        2. Appl No
          211710
          Application Docs Date
          2021-03-26 00:00:00
          Application Docs ID
          66885
          Application Docs Title
          0
          Application Docs Type ID
          2
          Submission No
          4
          Submission Type
          SUPPL
        3. Appl No
          211710
          Application Docs Date
          2021-03-26 00:00:00
          Application Docs ID
          66887
          Application Docs Title
          0
          Application Docs Type ID
          2
          Submission No
          5
          Submission Type
          SUPPL
        4. Appl No
          211710
          Application Docs Date
          2022-11-28 00:00:00
          Application Docs ID
          72728
          Application Docs Title
          0
          Application Docs Type ID
          2
          Submission No
          8
          Submission Type
          SUPPL
        5. Appl No
          211710
          Application Docs Date
          2023-11-06 00:00:00
          Application Docs ID
          76369
          Application Docs Title
          0
          Application Docs Type ID
          2
          Submission No
          9
          Submission Type
          SUPPL
        6. Appl No
          211710
          Application Docs Date
          2025-04-25 00:00:00
          Application Docs ID
          82013
          Application Docs Title
          0
          Application Docs Type ID
          2
          Submission No
          10
          Submission Type
          SUPPL
        all submission records
        1. Appl No
          211710
          Review Priority
          PRIORITY
          Submission Class Code ID
          12
          Submission No
          1
          Submission Status
          AP
          Submission Status Date
          2018-11-26 00:00:00
          Submission Type
          ORIG
          Submissions Public Notes
        2. Appl No
          211710
          Review Priority
          STANDARD
          Submission Class Code ID
          2
          Submission No
          4
          Submission Status
          AP
          Submission Status Date
          2021-03-25 00:00:00
          Submission Type
          SUPPL
          Submissions Public Notes
        3. Appl No
          211710
          Review Priority
          STANDARD
          Submission Class Code ID
          3
          Submission No
          5
          Submission Status
          AP
          Submission Status Date
          2021-03-25 00:00:00
          Submission Type
          SUPPL
          Submissions Public Notes
        4. Appl No
          211710
          Review Priority
          STANDARD
          Submission Class Code ID
          3
          Submission No
          8
          Submission Status
          AP
          Submission Status Date
          2022-11-23 00:00:00
          Submission Type
          SUPPL
          Submissions Public Notes
        5. Appl No
          211710
          Review Priority
          STANDARD
          Submission Class Code ID
          3
          Submission No
          9
          Submission Status
          AP
          Submission Status Date
          2023-11-03 00:00:00
          Submission Type
          SUPPL
          Submissions Public Notes
        6. Appl No
          211710
          Review Priority
          STANDARD
          Submission Class Code ID
          2
          Submission No
          10
          Submission Status
          AP
          Submission Status Date
          2025-04-09 00:00:00
          Submission Type
          SUPPL
          Submissions Public Notes
        application number
        NDA211710
        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
        2025-04-09
        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
          211710
          Application Docs Date
          2025-04-25 00:00:00
          Application Docs ID
          82013
          Application Docs Title
          0
          Application Docs Type ID
          2
          Submission No
          10
          Submission Type
          SUPPL
        official application record
        Appl No
        211710
        Appl Public Notes
        Appl Type
        NDA
        Sponsor Name
        BAYER HEALTHCARE
        openfda application present
        true
        products
        1. Active Ingredient
          LAROTRECTINIB SULFATE
          Appl No
          211710
          Drug Name
          VITRAKVI
          Form
          SOLUTION;ORAL
          Product No
          001
          Reference Drug
          1
          Reference Standard
          1
          Strength
          EQ 20MG BASE/ML
          marketing status
          1. Prescription

      Source passages and status connections

      Passage classifications are automated and are not treatment recommendations. Connections apply only to their recorded indication scope.

      Passage 1 · positive indication candidate
      application numbers
      1. NDA210861
      2. NDA211710
      brand names
      1. VITRAKVI
      classification reasons
      1. explicit_positive_indication_predicate
      2. tumor_or_malignant_hematology_words_in_positive_statement
      clinical review status
      pending
      content role
      positive_indication_candidate
      context span
      end
      608
      end exclusive
      true
      exact text
      1 INDICATIONS AND USAGE VITRAKVI is indicated for the treatment of adult and pediatric patients with solid tumors that: have a neurotrophic receptor tyrosine kinase ( NTRK ) gene fusion without a known acquired resistance mutation, are metastatic or where surgical resection is likely to result in severe morbidity, and have no satisfactory alternative treatments or that have progressed following treatment. Select patients for therapy based on an FDA-approved test [see Dosage and Administration (2.1) ]. VITRAKVI is a kinase inhibitor indicated for the treatment of adult and pediatric patients with solid
      label id
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      unicode_code_points
      source array index
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      source field
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      source text sha256
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      current approval status
      not_reconciled
      duplicate text group
      dup-b0e5b7cfd0e265f3d648
      extraction review status
      automated_candidate_pending_source_review
      generic names
      1. LAROTRECTINIB
      id
      ind-span-3737132754a6bcb7044e
      label id
      0e3ba6e7-af8d-4840-9409-a537a09e1263
      positive predicate support span
      end
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      end exclusive
      true
      exact text
      is indicated
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      source text sha256
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      qualifier mentions
      1. context exact
        ATIONS AND USAGE VITRAKVI is indicated for the treatment of adult and pediatric patients with solid tumors that: have a neuro
        kind
        age
        polarity
        not_inferred
        span
        end
        72
        end exclusive
        true
        exact text
        adult
        label id
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        offset unit
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        source array index
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        source field
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      2. context exact
        USAGE VITRAKVI is indicated for the treatment of adult and pediatric patients with solid tumors that: have a neurotrophic receptor tyrosi
        kind
        age
        polarity
        not_inferred
        span
        end
        95
        end exclusive
        true
        exact text
        pediatric patients
        label id
        0e3ba6e7-af8d-4840-9409-a537a09e1263
        offset unit
        unicode_code_points
        source array index
        0
        source field
        indications_and_usage_exact
        source text sha256
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      3. context exact
        tumors that: have a neurotrophic receptor tyrosine kinase ( NTRK ) gene fusion without a known acquired resistance mutation, are metastatic or where surgical resect
        kind
        biomarker
        polarity
        not_inferred
        span
        end
        211
        end exclusive
        true
        exact text
        NTRK ) gene fusion without a known acquired
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      4. context exact
        ne fusion without a known acquired resistance mutation, are metastatic or where surgical resection is likely to result in severe morbidity, and have no satisfactor
        kind
        biomarker
        polarity
        not_inferred
        span
        end
        279
        end exclusive
        true
        exact text
        metastatic or where surgical resection is l
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      5. context exact
        ne fusion without a known acquired resistance mutation, are metastatic or where surgical resection is likely to result in severe morbidity, and have no satisfactory
        kind
        stage_or_setting
        polarity
        not_inferred
        span
        end
        281
        end exclusive
        true
        exact text
        metastatic or where surgical resection is lik
        label id
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      6. context exact
        resection is likely to result in severe morbidity, and have no satisfactory alternative treatments or that have progressed following treatment.
        kind
        prior_therapy_or_line
        polarity
        not_inferred
        span
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        true
        exact text
        no satisfactory alternative treatments or that have progressed following treatment
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        0e3ba6e7-af8d-4840-9409-a537a09e1263
        offset unit
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      regulatory links
      1. candidate source span
        end
        408
        end exclusive
        true
        exact text
        1 INDICATIONS AND USAGE VITRAKVI is indicated for the treatment of adult and pediatric patients with solid tumors that: have a neurotrophic receptor tyrosine kinase ( NTRK ) gene fusion without a known acquired resistance mutation, are metastatic or where surgical resection is likely to result in severe morbidity, and have no satisfactory alternative treatments or that have progressed following treatment.
        label id
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        offset unit
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        source array index
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        source field
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        source text sha256
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        fda indication exact
        Treatment of adult and pediatric patients with solid tumors that have a neurotrophic receptor tyrosine kinase (NTRK) gene fusion without a known acquired resistance mutation; are metastatic or where surgical resection is likely to result in severe morbidity; and have no satisfactory alternative treatments or that have progressed following treatment
        fda source row index
        14
        fda source sha256
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        fda status record id
        fda-aa-b2475bfed5391885c422
        interpretation
        Source wording correspondence to a dated FDA status row; current approval not certified
        match method
        whole_indication_literal_normalized_substring
        matching review status
        source_comparison_only_clinical_review_pending
        scope relationship
        whole_fda_indication_text_present
        status category
        verified_clinical_benefit
        status event date
        2025-04-09
        supporting anchor spans
        schema version
        0.1.0
        source batch sha256
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        source defined aliases
          source span
          end
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          end exclusive
          true
          exact text
          1 INDICATIONS AND USAGE VITRAKVI is indicated for the treatment of adult and pediatric patients with solid tumors that: have a neurotrophic receptor tyrosine kinase ( NTRK ) gene fusion without a known acquired resistance mutation, are metastatic or where surgical resection is likely to result in severe morbidity, and have no satisfactory alternative treatments or that have progressed following treatment.
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          source field
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          source text sha256
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          source url
          https://api.fda.gov/drug/label.json?search=id%3A%220e3ba6e7-af8d-4840-9409-a537a09e1263%22
          spl effective date
          2026-05-22
          spl set id
          0c8ca614-58b2-4aa4-83d3-0387a8f782fd
          spl version
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                    Read indication-specific status → · whole_fda_indication_text_present

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                                Preserved source evidence · Not medical advice