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LABELS · af2c2115-cb7d-4679-935a-c2200487b965

Gavreto

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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
2025-12-30
Captured
2026-09-09T23:37:58.719708+00:00
Current indication reconciliation
Not reconciled
Boxed warning in this label
  1. WARNING: SERIOUS INFECTIONS, INCLUDING OPPORTUNISTIC INFECTIONS GAVRETO may increase the risk for serious infections, including bacterial, fungal, viral and opportunistic infections, which can lead to hospitalization or death. Withhold, reduce the dose or permanently discontinue GAVRETO based on severity [see Dosage and Administration (2.3) , Warnings and Precautions (5.1) ] . WARNING: SERIOUS INFECTIONS, INCLUDING OPPORTUNISTIC INFECTIONS See full prescribing information for complete boxed warning. GAVRETO may increase the risk for serious infections, including bacterial, fungal, viral and opportunistic infections, which can lead to hospitalization or death. Withhold, reduce the dose or permanently discontinue GAVRETO based on severity. ( 2.3 , 5.1 )

Indications and usage: exact source text

  1. 1 INDICATIONS AND USAGE GAVRETO is a kinase inhibitor indicated for treatment of: Adult patients with metastatic rearranged during transfection (RET ) fusion-positive non-small cell lung cancer as detected by an FDA approved test (NSCLC). ( 1.1 ) 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). This indication is approved under accelerated approval based on overall response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trial(s). ( 1.2 ) 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. 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). This indication is approved under accelerated approval based on overall response rate and duration of response [see Clinical Studies (14.2) ] . Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trial(s).
Full extracted label fields
application numbers
  1. NDA213721
boxed warning exact
  1. WARNING: SERIOUS INFECTIONS, INCLUDING OPPORTUNISTIC INFECTIONS GAVRETO may increase the risk for serious infections, including bacterial, fungal, viral and opportunistic infections, which can lead to hospitalization or death. Withhold, reduce the dose or permanently discontinue GAVRETO based on severity [see Dosage and Administration (2.3) , Warnings and Precautions (5.1) ] . WARNING: SERIOUS INFECTIONS, INCLUDING OPPORTUNISTIC INFECTIONS See full prescribing information for complete boxed warning. GAVRETO may increase the risk for serious infections, including bacterial, fungal, viral and opportunistic infections, which can lead to hospitalization or death. Withhold, reduce the dose or permanently discontinue GAVRETO based on severity. ( 2.3 , 5.1 )
brand names
  1. Gavreto
current indication status
not_reconciled
dailymed set url
https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=16edd46e-28b8-f06d-e063-6394a90ae31b
generic names
  1. PRALSETINIB
id
af2c2115-cb7d-4679-935a-c2200487b965
indications and usage exact
  1. 1 INDICATIONS AND USAGE GAVRETO is a kinase inhibitor indicated for treatment of: Adult patients with metastatic rearranged during transfection (RET ) fusion-positive non-small cell lung cancer as detected by an FDA approved test (NSCLC). ( 1.1 ) 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). This indication is approved under accelerated approval based on overall response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trial(s). ( 1.2 ) 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. 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). This indication is approved under accelerated approval based on overall response rate and duration of response [see Clinical Studies (14.2) ] . Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trial(s).
indications and usage tables exact
    is original packager
    1. true
    manufacturer names
    1. Rigel Pharmaceuticals, Inc.
    matched search terms
    1. cancer
    package ndcs
    1. 71332-006-60
    2. 71332-006-90
    3. 71332-006-12
    product ndcs
    1. 71332-006
    product types
    1. HUMAN PRESCRIPTION DRUG
    recent major changes exact
    1. Boxed Warning 12/2025 Warning and Precautions - ( 5.1 ) 12/2025 Warning and Precautions - ( 5.2 ) ( 6.1 ) 2/2025
    record type
    complete_spl_indications_section_candidate
    routes
    1. ORAL
    rxcuis
    1. 2394941
    2. 2394947
    source batch
    file
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    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
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    limit
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    sha256
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    url
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    source url
    https://api.fda.gov/drug/label.json?search=id%3A%22af2c2115-cb7d-4679-935a-c2200487b965%22
    spl effective date
    2025-12-30
    spl effective time
    20251230
    spl set id
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    spl version
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    substance names
    1. PRALSETINIB
    uniis
    1. 1WPE73O1WV
    verification flags
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    Drugs@FDA application source records
    1. application number
      NDA213721
      payload
      all indexed label documents
      1. Appl No
        213721
        Application Docs Date
        2020-09-08 00:00:00
        Application Docs ID
        64520
        Application Docs Title
        0
        Application Docs Type ID
        2
        Submission No
        1
        Submission Type
        SUPPL
      2. Appl No
        213721
        Application Docs Date
        2021-11-12 00:00:00
        Application Docs ID
        69300
        Application Docs Title
        0
        Application Docs Type ID
        2
        Submission No
        4
        Submission Type
        SUPPL
      3. Appl No
        213721
        Application Docs Date
        2022-02-04 00:00:00
        Application Docs ID
        70069
        Application Docs Title
        0
        Application Docs Type ID
        2
        Submission No
        5
        Submission Type
        SUPPL
      4. Appl No
        213721
        Application Docs Date
        2022-10-11 00:00:00
        Application Docs ID
        72280
        Application Docs Title
        0
        Application Docs Type ID
        2
        Submission No
        7
        Submission Type
        SUPPL
      5. Appl No
        213721
        Application Docs Date
        2023-07-03 00:00:00
        Application Docs ID
        74682
        Application Docs Title
        0
        Application Docs Type ID
        2
        Submission No
        11
        Submission Type
        SUPPL
      6. Appl No
        213721
        Application Docs Date
        2023-07-21 00:00:00
        Application Docs ID
        74854
        Application Docs Title
        0
        Application Docs Type ID
        2
        Submission No
        14
        Submission Type
        SUPPL
      7. Appl No
        213721
        Application Docs Date
        2023-08-10 00:00:00
        Application Docs ID
        75037
        Application Docs Title
        0
        Application Docs Type ID
        2
        Submission No
        9
        Submission Type
        SUPPL
      8. Appl No
        213721
        Application Docs Date
        2024-03-25 00:00:00
        Application Docs ID
        77931
        Application Docs Title
        0
        Application Docs Type ID
        2
        Submission No
        15
        Submission Type
        SUPPL
      9. Appl No
        213721
        Application Docs Date
        2026-01-06 00:00:00
        Application Docs ID
        84660
        Application Docs Title
        0
        Application Docs Type ID
        2
        Submission No
        16
        Submission Type
        SUPPL
      all submission records
      1. Appl No
        213721
        Review Priority
        STANDARD
        Submission Class Code ID
        3
        Submission No
        16
        Submission Status
        AP
        Submission Status Date
        2025-12-22 00:00:00
        Submission Type
        SUPPL
        Submissions Public Notes
      2. Appl No
        213721
        Review Priority
        STANDARD
        Submission Class Code ID
        3
        Submission No
        15
        Submission Status
        AP
        Submission Status Date
        2024-03-22 00:00:00
        Submission Type
        SUPPL
        Submissions Public Notes
      3. Appl No
        213721
        Review Priority
        STANDARD
        Submission Class Code ID
        3
        Submission No
        14
        Submission Status
        AP
        Submission Status Date
        2023-07-20 00:00:00
        Submission Type
        SUPPL
        Submissions Public Notes
      4. Appl No
        213721
        Review Priority
        STANDARD
        Submission Class Code ID
        3
        Submission No
        11
        Submission Status
        AP
        Submission Status Date
        2023-06-30 00:00:00
        Submission Type
        SUPPL
        Submissions Public Notes
      5. Appl No
        213721
        Review Priority
        STANDARD
        Submission Class Code ID
        2
        Submission No
        9
        Submission Status
        AP
        Submission Status Date
        2023-08-09 00:00:00
        Submission Type
        SUPPL
        Submissions Public Notes
      6. Appl No
        213721
        Review Priority
        STANDARD
        Submission Class Code ID
        3
        Submission No
        7
        Submission Status
        AP
        Submission Status Date
        2022-09-28 00:00:00
        Submission Type
        SUPPL
        Submissions Public Notes
      7. Appl No
        213721
        Review Priority
        STANDARD
        Submission Class Code ID
        3
        Submission No
        5
        Submission Status
        AP
        Submission Status Date
        2022-02-02 00:00:00
        Submission Type
        SUPPL
        Submissions Public Notes
      8. Appl No
        213721
        Review Priority
        STANDARD
        Submission Class Code ID
        3
        Submission No
        4
        Submission Status
        AP
        Submission Status Date
        2021-11-10 00:00:00
        Submission Type
        SUPPL
        Submissions Public Notes
      9. Appl No
        213721
        Review Priority
        PRIORITY
        Submission Class Code ID
        7
        Submission No
        1
        Submission Status
        AP
        Submission Status Date
        2020-09-04 00:00:00
        Submission Type
        SUPPL
        Submissions Public Notes
      10. Appl No
        213721
        Review Priority
        PRIORITY
        Submission Class Code ID
        7
        Submission No
        1
        Submission Status
        AP
        Submission Status Date
        2020-09-04 00:00:00
        Submission Type
        ORIG
        Submissions Public Notes
      application number
      NDA213721
      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
      2025-12-22
      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
        213721
        Application Docs Date
        2026-01-06 00:00:00
        Application Docs ID
        84660
        Application Docs Title
        0
        Application Docs Type ID
        2
        Submission No
        16
        Submission Type
        SUPPL
      official application record
      Appl No
      213721
      Appl Public Notes
      Appl Type
      NDA
      Sponsor Name
      RIGEL PHARMS
      openfda application present
      true
      products
      1. Active Ingredient
        PRALSETINIB
        Appl No
        213721
        Drug Name
        GAVRETO
        Form
        CAPSULE;ORAL
        Product No
        001
        Reference Drug
        1
        Reference Standard
        1
        Strength
        100MG
        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. NDA213721
    brand names
    1. Gavreto
    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
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    438
    end exclusive
    true
    exact text
    1 INDICATIONS AND USAGE GAVRETO is a kinase inhibitor indicated for treatment of: Adult patients with metastatic rearranged during transfection (RET ) fusion-positive non-small cell lung cancer as detected by an FDA approved test (NSCLC). ( 1.1 ) 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 (i
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    current approval status
    not_reconciled
    duplicate text group
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    extraction review status
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    generic names
    1. PRALSETINIB
    id
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    label id
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    positive predicate support span
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    exact text
    is a kinase inhibitor indicated
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    qualifier mentions
    1. context exact
      E GAVRETO is a kinase inhibitor indicated for treatment of: Adult patients with metastatic rearranged during transfection (RET ) fusio
      kind
      age
      polarity
      not_inferred
      span
      end
      96
      end exclusive
      true
      exact text
      Adult patients
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    2. context exact
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      kind
      biomarker
      polarity
      not_inferred
      span
      end
      145
      end exclusive
      true
      exact text
      metastatic rearranged during transfection (
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    3. context exact
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      RET ) fusion-positive non-small cell lung c
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    4. context exact
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      kind
      stage_or_setting
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      span
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      exact text
      metastatic rearranged during transfection (RE
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    regulatory links
      schema version
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      source batch sha256
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      source defined aliases
      1. abbreviation
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        definition exact
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        definition span
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        exact text
        non-small cell lung cancer (NSCLC)
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      1 INDICATIONS AND USAGE GAVRETO is a kinase inhibitor indicated for treatment of: Adult patients with metastatic rearranged during transfection (RET ) fusion-positive non-small cell lung cancer as detected by an FDA approved test (NSCLC).
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      source url
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      spl effective date
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      spl set id
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      structured fields status
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      Source null
      biomarker and test
      Source null
      disease stage
      Source null
      limitations
      Source null
      line
      Source null
      prior therapy
      Source null
      regimen
      Source null
      tumor histology
      Source null
      use intent
      tumor_directed_candidate
      Passage 2 · unclassified context
      application numbers
      1. NDA213721
      brand names
      1. Gavreto
      classification reasons
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      clinical review status
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      nase inhibitor indicated for treatment of: Adult patients with metastatic rearranged during transfection (RET ) fusion-positive non-small cell lung cancer as detected by an FDA approved test (NSCLC). ( 1.1 ) 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 radioa
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      duplicate text group
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      extraction review status
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      generic names
      1. PRALSETINIB
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      positive predicate support span
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          source batch sha256
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            definition exact
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          ( 1.1 )
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          source url
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          spl effective date
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          spl set id
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          Source null
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                          ositive 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. 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). This indication is approved under accelerated approval based on overall response rate and duration of response [see Clinical Studies (14.2) ] . Continued approval for this indication may be contingen
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                                    Preserved source evidence · Not medical advice