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STATUS · fda-aa-b86c12dadbbbf05b6c82

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 and pediatric patients 12 years of age and older with advanced or metastatic RET fusion-positive thyroid cancer who require systemic therapy and who are radioactive iodine-refractory (if radioactive iodine is appropriate)

Source status category
ongoing
Event date
2020-12-01
Meaning of this date
Original accelerated approval date; ongoing status observed at source retrieval
accelerated approval date
2020-12-01
accelerated approval date source text
12/1/2020
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-b86c12dadbbbf05b6c82
indication exact
Treatment of adult and pediatric patients 12 years of age and older with advanced or metastatic RET fusion-positive thyroid cancer who require systemic therapy and who are radioactive iodine-refractory (if radioactive iodine is appropriate)
original projected completion source text
6/30/2025
post marketing requirement exact
3959-2: Submit the final report of integrated studies and datasets, to verify and further characterize the clinical benefit of pralsetinib for the treatment of patients with RET fusion-positive thyroid cancer who have received radioactive iodine (if appropriate for their tumor histology) to provide a more precise estimation of the BICR-assessed ORR and DOR in at least 50 patients in a variety of histologies after all responding patients have been followed for 12 months following onset of response or until disease progression, whichever comes first.
record type
fda_accelerated_approval_status_row
related fda urls
    source cells exact
    1. links
        text
        Gavreto (pralsetinib)
      1. links
          text
          Treatment of adult and pediatric patients 12 years of age and older with advanced or metastatic RET fusion-positive thyroid cancer who require systemic therapy and who are radioactive iodine-refractory (if radioactive iodine is appropriate)
        1. links
            text
            12/1/2020
          1. links
              text
              3959-2: Submit the final report of integrated studies and datasets, to verify and further characterize the clinical benefit of pralsetinib for the treatment of patients with RET fusion-positive thyroid cancer who have received radioactive iodine (if appropriate for their tumor histology) to provide a more precise estimation of the BICR-assessed ORR and DOR in at least 50 patients in a variety of histologies after all responding patients have been followed for 12 months following onset of response or until disease progression, whichever comes first.
            1. links
                text
                6/30/2025
              source provenance
              bytes
              102185
              file
              /private/tmp/cancer-full-research/indications/raw/accelerated-ongoing.html
              http status
              200
              retrieved at
              2026-09-09T23:35:15.160724+00:00
              sha256
              8df28be8da28c19a2d63f9c7ada45adf8aa0a5f11be1a2b4df67ce8eea572def
              source page date Modified text
              Wed, 09/09/2026 - 00:00
              source page date Published text
              Wed, 09/09/2026 - 12:45
              source row index
              42
              source table headers
              1. Drug Name
              2. Accelerated Approval (AA) Indication
              3. AA Date
              4. AA Post-Marketing Requirement
              5. Original Projected Completion 1
              source table index
              0
              source url
              https://www.fda.gov/drugs/resources-information-approved-drugs/ongoing-cancer-accelerated-approvals
              status applies to
              This exact indication and regimen, not every use of this drug
              status category
              ongoing
              status event date
              2020-12-01
              status event date meaning
              Original accelerated approval date; ongoing status observed at source retrieval
              traditional approval date
              Source null
              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-b86c12dadbbbf05b6c82
                indication exact
                Treatment of adult and pediatric patients 12 years of age and older with advanced or metastatic RET fusion-positive thyroid cancer who require systemic therapy and who are radioactive iodine-refractory (if radioactive iodine is appropriate)
                match status
                source_correspondence_found_clinical_review_pending
                matched candidate ids
                1. ind-span-c21e1fd77ea6003c98df
                2. ind-span-753a9986d6eeba64ec8a
                source provenance
                bytes
                102185
                file
                /private/tmp/cancer-full-research/indications/raw/accelerated-ongoing.html
                http status
                200
                retrieved at
                2026-09-09T23:35:15.160724+00:00
                sha256
                8df28be8da28c19a2d63f9c7ada45adf8aa0a5f11be1a2b4df67ce8eea572def
                source page date Modified text
                Wed, 09/09/2026 - 00:00
                source page date Published text
                Wed, 09/09/2026 - 12:45
                status category
                ongoing
                unmatched meaning
                Source null
                links
                1. package id
                  fda-label-library-8184721b7b3bb86692f8276c
                  correspondence id
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                  span id
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                  status id
                  fda-aa-b86c12dadbbbf05b6c82
                  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
                  1269
                  end exclusive
                  true
                  exact text
                  1.2 RET Fusion-Positive Thyroid Cancer GAVRETO is indicated for the treatment of adult and pediatric patients 12 years of age and older with advanced or metastatic RET fusion-positive thyroid cancer who require systemic therapy and who are radioactive iodine-refractory (if radioactive iodine is appropriate).
                  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
                  960
                  fda indication exact
                  Treatment of adult and pediatric patients 12 years of age and older with advanced or metastatic RET fusion-positive thyroid cancer who require systemic therapy and who are radioactive iodine-refractory (if radioactive iodine is appropriate)
                  fda source row index
                  42
                  fda source sha256
                  8df28be8da28c19a2d63f9c7ada45adf8aa0a5f11be1a2b4df67ce8eea572def
                  fda status record id
                  fda-aa-b86c12dadbbbf05b6c82
                  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
                  ongoing
                  status event date
                  2020-12-01
                  supporting anchor spans
                  1. package id
                    fda-label-library-8184721b7b3bb86692f8276c
                    correspondence id
                    correspondence-938667dbecbd8c19c032b1f9
                    span id
                    ind-span-c21e1fd77ea6003c98df
                    status id
                    fda-aa-b86c12dadbbbf05b6c82
                    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
                    1269
                    end exclusive
                    true
                    exact text
                    1.2 RET Fusion-Positive Thyroid Cancer GAVRETO is indicated for the treatment of adult and pediatric patients 12 years of age and older with advanced or metastatic RET fusion-positive thyroid cancer who require systemic therapy and who are radioactive iodine-refractory (if radioactive iodine is appropriate).
                    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
                    960
                    fda indication exact
                    Treatment of adult and pediatric patients 12 years of age and older with advanced or metastatic RET fusion-positive thyroid cancer who require systemic therapy and who are radioactive iodine-refractory (if radioactive iodine is appropriate)
                    fda source row index
                    42
                    fda source sha256
                    8df28be8da28c19a2d63f9c7ada45adf8aa0a5f11be1a2b4df67ce8eea572def
                    fda status record id
                    fda-aa-b86c12dadbbbf05b6c82
                    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
                    ongoing
                    status event date
                    2020-12-01
                    supporting anchor spans

                    Preserved source evidence · Not medical advice