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STATUS · fda-aa-b2475bfed5391885c422

Vitrakvi (larotrectinib)

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This status concerns only the indication wording below. It must not be applied to other uses of the same drug. It is not reconciled against the current label.

Exact indication

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

Source status category
verified clinical benefit
Event date
2025-04-09
Meaning of this date
FDA table traditional approval date
accelerated approval date
2018-11-26
accelerated approval date source text
11/26/2018
brand name hint
Vitrakvi
date change comparison status
no_previous_normalized_snapshot_supplied
date change from prior snapshot
Source null
drug name exact
Vitrakvi (larotrectinib)
generic name hint
larotrectinib
id
fda-aa-b2475bfed5391885c422
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
original projected completion source text
Source null
post marketing requirement exact
Source null
record type
fda_accelerated_approval_status_row
related fda urls
  1. https://www.fda.gov/drugs/fda-approves-larotrectinib-solid-tumors-ntrk-gene-fusions-0
source cells exact
  1. links
      text
      Vitrakvi (larotrectinib)
    1. links
      1. /drugs/fda-approves-larotrectinib-solid-tumors-ntrk-gene-fusions-0
      text
      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
    2. links
        text
        11/26/2018
      1. links
          text
          4/09/2025
        source provenance
        bytes
        74315
        file
        /private/tmp/cancer-full-research/indications/raw/accelerated-verified.html
        http status
        200
        retrieved at
        2026-09-09T23:35:16.058704+00:00
        sha256
        91f921503728c2afb0ec500d9c6034553e0b81d5af260a20c5478686c1127a7e
        source page date Modified text
        Wed, 07/15/2026 - 00:00
        source page date Published text
        Wed, 07/15/2026 - 07:11
        source row index
        14
        source table headers
        1. Drug Name
        2. Accelerated Approval (AA) Indication
        3. Accelerated Approval Date
        4. Traditional Approval Date
        source table index
        0
        source url
        https://www.fda.gov/drugs/resources-information-approved-drugs/verified-clinical-benefit-cancer-accelerated-approvals
        status applies to
        This exact indication and regimen, not every use of this drug
        status category
        verified_clinical_benefit
        status event date
        2025-04-09
        status event date meaning
        FDA table traditional approval date
        traditional approval date
        2025-04-09
        verification flags
          verification status
          official_fda_status_table_extracted_indication_matching_not_clinically_reviewed
          withdrawal date
          Source null
          Source correspondence records
          matching
          drug name exact
          Vitrakvi (larotrectinib)
          fda status record id
          fda-aa-b2475bfed5391885c422
          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
          match status
          source_correspondence_found_clinical_review_pending
          matched candidate ids
          1. ind-span-3737132754a6bcb7044e
          2. ind-span-1add9807511eed81de70
          source provenance
          bytes
          74315
          file
          /private/tmp/cancer-full-research/indications/raw/accelerated-verified.html
          http status
          200
          retrieved at
          2026-09-09T23:35:16.058704+00:00
          sha256
          91f921503728c2afb0ec500d9c6034553e0b81d5af260a20c5478686c1127a7e
          source page date Modified text
          Wed, 07/15/2026 - 00:00
          source page date Published text
          Wed, 07/15/2026 - 07:11
          status category
          verified_clinical_benefit
          unmatched meaning
          Source null
          links
          1. package id
            fda-label-library-8184721b7b3bb86692f8276c
            correspondence id
            correspondence-2eb2326e229c1d40d26275fc
            span id
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            status id
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            match method
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            whole_fda_indication_text_present
            matching review status
            source_comparison_only_clinical_review_pending
            payload
            candidate source span
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            910
            end exclusive
            true
            exact text
            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.
            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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            start
            507
            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
            91f921503728c2afb0ec500d9c6034553e0b81d5af260a20c5478686c1127a7e
            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
            1. package id
              fda-label-library-8184721b7b3bb86692f8276c
              correspondence id
              correspondence-8d3b8b9f86273359b0a7e01a
              span id
              ind-span-3737132754a6bcb7044e
              status id
              fda-aa-b2475bfed5391885c422
              match method
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              scope relationship
              whole_fda_indication_text_present
              matching review status
              source_comparison_only_clinical_review_pending
              payload
              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
              0e3ba6e7-af8d-4840-9409-a537a09e1263
              offset unit
              unicode_code_points
              source array index
              0
              source field
              indications_and_usage_exact
              source text sha256
              ba79fac05181ce778636c7b11865f1a2cae992782c1cde866c95c07ffd290d75
              start
              0
              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
              91f921503728c2afb0ec500d9c6034553e0b81d5af260a20c5478686c1127a7e
              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

              Preserved source evidence · Not medical advice