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STATUS · fda-aa-f1bd2f76ea52efe6c081

Gavreto (pralsetinib)

Open original source → · Download preserved record

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 patients with metastatic RET fusion-positive non-small cell lung cancer (NSCLC) as detected by an FDA approved test

Source status category
verified clinical benefit
Event date
2023-08-09
Meaning of this date
FDA table traditional approval date
accelerated approval date
2020-09-04
accelerated approval date source text
9/4/2020
brand name hint
Gavreto
date change comparison status
no_previous_normalized_snapshot_supplied
date change from prior snapshot
Source null
drug name exact
Gavreto (pralsetinib)
generic name hint
pralsetinib
id
fda-aa-f1bd2f76ea52efe6c081
indication exact
Treatment of adult patients with metastatic RET fusion-positive non-small cell lung cancer (NSCLC) as detected by an FDA approved test
original projected completion source text
Source null
post marketing requirement exact
Source null
record type
fda_accelerated_approval_status_row
related fda urls
    source cells exact
    1. links
        text
        Gavreto (pralsetinib)
      1. links
          text
          Treatment of adult patients with metastatic RET fusion-positive non-small cell lung cancer (NSCLC) as detected by an FDA approved test
        1. links
            text
            9/4/2020
          1. links
              text
              8/9/2023
            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
            32
            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
            2023-08-09
            status event date meaning
            FDA table traditional approval date
            traditional approval date
            2023-08-09
            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
              Gavreto (pralsetinib)
              fda status record id
              fda-aa-f1bd2f76ea52efe6c081
              indication exact
              Treatment of adult patients with metastatic RET fusion-positive non-small cell lung cancer (NSCLC) as detected by an FDA approved test
              match status
              source_correspondence_found_clinical_review_pending
              matched candidate ids
              1. ind-span-72fd477c23412081c39f
              2. ind-span-9849f4cf0bb1ff821363
              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
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                span id
                ind-span-72fd477c23412081c39f
                status id
                fda-aa-f1bd2f76ea52efe6c081
                match method
                whole_indication_literal_normalized_substring
                scope relationship
                whole_fda_indication_text_present
                matching review status
                source_comparison_only_clinical_review_pending
                payload
                candidate source span
                end
                959
                end exclusive
                true
                exact text
                1.1 Metastatic RET Fusion-Positive Non-Small Cell Lung Cancer GAVRETO is indicated for the treatment of adult patients with metastatic RET fusion-positive non-small cell lung cancer (NSCLC) as detected by an FDA approved test.
                label id
                af2c2115-cb7d-4679-935a-c2200487b965
                offset unit
                unicode_code_points
                source array index
                0
                source field
                indications_and_usage_exact
                source text sha256
                a136bc103db4e1681d77160b9ab5e4b852f4718c14a33403471c1713c3af3e9d
                start
                733
                fda indication exact
                Treatment of adult patients with metastatic RET fusion-positive non-small cell lung cancer (NSCLC) as detected by an FDA approved test
                fda source row index
                32
                fda source sha256
                91f921503728c2afb0ec500d9c6034553e0b81d5af260a20c5478686c1127a7e
                fda status record id
                fda-aa-f1bd2f76ea52efe6c081
                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
                2023-08-09
                supporting anchor spans
                1. package id
                  fda-label-library-8184721b7b3bb86692f8276c
                  correspondence id
                  correspondence-85148c534fa23bb6b9fd1c5b
                  span id
                  ind-span-9849f4cf0bb1ff821363
                  status id
                  fda-aa-f1bd2f76ea52efe6c081
                  match method
                  whole_indication_literal_normalized_substring
                  scope relationship
                  whole_fda_indication_text_present
                  matching review status
                  source_comparison_only_clinical_review_pending
                  payload
                  candidate source span
                  end
                  959
                  end exclusive
                  true
                  exact text
                  1.1 Metastatic RET Fusion-Positive Non-Small Cell Lung Cancer GAVRETO is indicated for the treatment of adult patients with metastatic RET fusion-positive non-small cell lung cancer (NSCLC) as detected by an FDA approved test.
                  label id
                  202f12fc-4f57-4e69-bf7b-73d7c1d1ed0c
                  offset unit
                  unicode_code_points
                  source array index
                  0
                  source field
                  indications_and_usage_exact
                  source text sha256
                  a136bc103db4e1681d77160b9ab5e4b852f4718c14a33403471c1713c3af3e9d
                  start
                  733
                  fda indication exact
                  Treatment of adult patients with metastatic RET fusion-positive non-small cell lung cancer (NSCLC) as detected by an FDA approved test
                  fda source row index
                  32
                  fda source sha256
                  91f921503728c2afb0ec500d9c6034553e0b81d5af260a20c5478686c1127a7e
                  fda status record id
                  fda-aa-f1bd2f76ea52efe6c081
                  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
                  2023-08-09
                  supporting anchor spans

                  Preserved source evidence · Not medical advice