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LABELS · 8f47fb28-9855-4482-b807-e98c425c2a4e

Stivarga

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
2026-02-09
Captured
2026-09-09T23:37:54.830918+00:00
Current indication reconciliation
Not reconciled
Boxed warning in this label
  1. WARNING: HEPATOTOXICITY • Severe and sometimes fatal hepatotoxicity has occurred in clinical trials [see Warnings and Precautions ( 5.1 )] . • Monitor hepatic function prior to and during treatment [see Warnings and Precautions ( 5.1 )]. • Interrupt and then reduce or discontinue STIVARGA for hepatotoxicity as manifested by elevated liver function tests or hepatocellular necrosis, depending upon severity and persistence [see Dosage and Administration ( 2.2 )] . WARNING: HEPATOTOXICITY See full prescribing information for complete boxed warning. • Severe and sometimes fatal hepatotoxicity has occurred in clinical trials. ( 5.1 ) • Monitor hepatic function prior to and during treatment. ( 5.1 ) • Interrupt and then reduce or discontinue STIVARGA for hepatotoxicity as manifested by elevated liver function tests or hepatocellular necrosis, depending upon severity and persistence. ( 2.2 )

Indications and usage: exact source text

  1. 1 INDICATIONS AND USAGE STIVARGA is a kinase inhibitor indicated for the treatment of adult patients with: • Metastatic colorectal cancer (CRC) who have been previously treated with fluoropyrimidine-, oxaliplatin- and irinotecan-based chemotherapy, an anti-VEGF therapy, and, if RAS wild-type, an anti-EGFR therapy. ( 1.1 ) • Locally advanced, unresectable or metastatic gastrointestinal stromal tumor (GIST) who have been previously treated with imatinib mesylate and sunitinib malate. ( 1.2 ) • Hepatocellular carcinoma (HCC) who have been previously treated with sorafenib ( 1.3 ) 1.1 Colorectal Cancer STIVARGA is indicated for the treatment of adult patients with metastatic colorectal cancer (CRC) who have been previously treated with fluoropyrimidine-, oxaliplatin- and irinotecan-based chemotherapy, an anti-VEGF therapy, and, if RAS wild-type, an anti-EGFR therapy. 1.2 Gastrointestinal Stromal Tumors STIVARGA is indicated for the treatment of adult patients with locally advanced, unresectable or metastatic gastrointestinal stromal tumor (GIST) who have been previously treated with imatinib mesylate and sunitinib malate. 1.3 Hepatocellular Carcinoma STIVARGA is indicated for the treatment of adult patients with hepatocellular carcinoma (HCC) who have been previously treated with sorafenib.
Full extracted label fields
application numbers
  1. NDA203085
boxed warning exact
  1. WARNING: HEPATOTOXICITY • Severe and sometimes fatal hepatotoxicity has occurred in clinical trials [see Warnings and Precautions ( 5.1 )] . • Monitor hepatic function prior to and during treatment [see Warnings and Precautions ( 5.1 )]. • Interrupt and then reduce or discontinue STIVARGA for hepatotoxicity as manifested by elevated liver function tests or hepatocellular necrosis, depending upon severity and persistence [see Dosage and Administration ( 2.2 )] . WARNING: HEPATOTOXICITY See full prescribing information for complete boxed warning. • Severe and sometimes fatal hepatotoxicity has occurred in clinical trials. ( 5.1 ) • Monitor hepatic function prior to and during treatment. ( 5.1 ) • Interrupt and then reduce or discontinue STIVARGA for hepatotoxicity as manifested by elevated liver function tests or hepatocellular necrosis, depending upon severity and persistence. ( 2.2 )
brand names
  1. Stivarga
current indication status
not_reconciled
dailymed set url
https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=824f19c9-0546-4a8a-8d8f-c4055c04f7c7
generic names
  1. REGORAFENIB
id
8f47fb28-9855-4482-b807-e98c425c2a4e
indications and usage exact
  1. 1 INDICATIONS AND USAGE STIVARGA is a kinase inhibitor indicated for the treatment of adult patients with: • Metastatic colorectal cancer (CRC) who have been previously treated with fluoropyrimidine-, oxaliplatin- and irinotecan-based chemotherapy, an anti-VEGF therapy, and, if RAS wild-type, an anti-EGFR therapy. ( 1.1 ) • Locally advanced, unresectable or metastatic gastrointestinal stromal tumor (GIST) who have been previously treated with imatinib mesylate and sunitinib malate. ( 1.2 ) • Hepatocellular carcinoma (HCC) who have been previously treated with sorafenib ( 1.3 ) 1.1 Colorectal Cancer STIVARGA is indicated for the treatment of adult patients with metastatic colorectal cancer (CRC) who have been previously treated with fluoropyrimidine-, oxaliplatin- and irinotecan-based chemotherapy, an anti-VEGF therapy, and, if RAS wild-type, an anti-EGFR therapy. 1.2 Gastrointestinal Stromal Tumors STIVARGA is indicated for the treatment of adult patients with locally advanced, unresectable or metastatic gastrointestinal stromal tumor (GIST) who have been previously treated with imatinib mesylate and sunitinib malate. 1.3 Hepatocellular Carcinoma STIVARGA is indicated for the treatment of adult patients with hepatocellular carcinoma (HCC) who have been previously treated with sorafenib.
indications and usage tables exact
    is original packager
    1. true
    manufacturer names
    1. Bayer HealthCare Pharmaceuticals Inc.
    matched search terms
    1. cancer
    2. carcinoma
    3. tumor
    4. tumors
    package ndcs
    1. 50419-171-01
    2. 50419-171-03
    3. 50419-171-00
    4. 50419-171-04
    5. 50419-171-05
    6. 50419-171-06
    product ndcs
    1. 50419-171
    product types
    1. HUMAN PRESCRIPTION DRUG
    recent major changes exact
    1. Warnings and Precautions ( 5.1 ) 2/2026
    record type
    complete_spl_indications_section_candidate
    routes
    1. ORAL
    rxcuis
    1. 1312402
    2. 1312408
    source batch
    file
    /private/tmp/cancer-full-research/indications/raw/labels-00500.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
    500
    total
    830
    sha256
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    url
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    source url
    https://api.fda.gov/drug/label.json?search=id%3A%228f47fb28-9855-4482-b807-e98c425c2a4e%22
    spl effective date
    2026-02-09
    spl effective time
    20260209
    spl set id
    824f19c9-0546-4a8a-8d8f-c4055c04f7c7
    spl version
    36
    substance names
    1. REGORAFENIB
    uniis
    1. MGN125FS9D
    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
      NDA203085
      payload
      all indexed label documents
      1. Appl No
        203085
        Application Docs Date
        2012-09-27 00:00:00
        Application Docs ID
        19416
        Application Docs Title
        0
        Application Docs Type ID
        2
        Submission No
        1
        Submission Type
        ORIG
      2. Appl No
        203085
        Application Docs Date
        2013-06-04 00:00:00
        Application Docs ID
        19417
        Application Docs Title
        0
        Application Docs Type ID
        2
        Submission No
        1
        Submission Type
        SUPPL
      3. Appl No
        203085
        Application Docs Date
        2015-04-14 00:00:00
        Application Docs ID
        40256
        Application Docs Title
        0
        Application Docs Type ID
        2
        Submission No
        4
        Submission Type
        SUPPL
      4. Appl No
        203085
        Application Docs Date
        2016-08-26 00:00:00
        Application Docs ID
        45173
        Application Docs Title
        0
        Application Docs Type ID
        2
        Submission No
        6
        Submission Type
        SUPPL
      5. Appl No
        203085
        Application Docs Date
        2017-04-27 00:00:00
        Application Docs ID
        48129
        Application Docs Title
        0
        Application Docs Type ID
        2
        Submission No
        7
        Submission Type
        SUPPL
      6. Appl No
        203085
        Application Docs Date
        2018-06-21 00:00:00
        Application Docs ID
        54669
        Application Docs Title
        0
        Application Docs Type ID
        2
        Submission No
        8
        Submission Type
        SUPPL
      7. Appl No
        203085
        Application Docs Date
        2019-08-02 00:00:00
        Application Docs ID
        59558
        Application Docs Title
        0
        Application Docs Type ID
        2
        Submission No
        10
        Submission Type
        SUPPL
      8. Appl No
        203085
        Application Docs Date
        2020-02-14 00:00:00
        Application Docs ID
        61889
        Application Docs Title
        0
        Application Docs Type ID
        2
        Submission No
        11
        Submission Type
        SUPPL
      9. Appl No
        203085
        Application Docs Date
        2020-07-22 00:00:00
        Application Docs ID
        63995
        Application Docs Title
        0
        Application Docs Type ID
        2
        Submission No
        13
        Submission Type
        SUPPL
      10. Appl No
        203085
        Application Docs Date
        2020-12-23 00:00:00
        Application Docs ID
        65703
        Application Docs Title
        0
        Application Docs Type ID
        2
        Submission No
        14
        Submission Type
        SUPPL
      11. Appl No
        203085
        Application Docs Date
        2025-02-26 00:00:00
        Application Docs ID
        81375
        Application Docs Title
        0
        Application Docs Type ID
        2
        Submission No
        16
        Submission Type
        SUPPL
      12. Appl No
        203085
        Application Docs Date
        2026-02-05 00:00:00
        Application Docs ID
        84939
        Application Docs Title
        0
        Application Docs Type ID
        2
        Submission No
        18
        Submission Type
        SUPPL
      all submission records
      1. Appl No
        203085
        Review Priority
        STANDARD
        Submission Class Code ID
        3
        Submission No
        18
        Submission Status
        AP
        Submission Status Date
        2026-02-03 00:00:00
        Submission Type
        SUPPL
        Submissions Public Notes
      2. Appl No
        203085
        Review Priority
        STANDARD
        Submission Class Code ID
        3
        Submission No
        16
        Submission Status
        AP
        Submission Status Date
        2025-02-25 00:00:00
        Submission Type
        SUPPL
        Submissions Public Notes
      3. Appl No
        203085
        Review Priority
        STANDARD
        Submission Class Code ID
        4
        Submission No
        14
        Submission Status
        AP
        Submission Status Date
        2020-12-10 00:00:00
        Submission Type
        SUPPL
        Submissions Public Notes
      4. Appl No
        203085
        Review Priority
        STANDARD
        Submission Class Code ID
        3
        Submission No
        13
        Submission Status
        AP
        Submission Status Date
        2020-07-21 00:00:00
        Submission Type
        SUPPL
        Submissions Public Notes
      5. Appl No
        203085
        Review Priority
        STANDARD
        Submission Class Code ID
        3
        Submission No
        12
        Submission Status
        AP
        Submission Status Date
        2020-09-24 00:00:00
        Submission Type
        SUPPL
        Submissions Public Notes
      6. Appl No
        203085
        Review Priority
        STANDARD
        Submission Class Code ID
        3
        Submission No
        11
        Submission Status
        AP
        Submission Status Date
        2020-02-13 00:00:00
        Submission Type
        SUPPL
        Submissions Public Notes
      7. Appl No
        203085
        Review Priority
        STANDARD
        Submission Class Code ID
        3
        Submission No
        10
        Submission Status
        AP
        Submission Status Date
        2019-07-31 00:00:00
        Submission Type
        SUPPL
        Submissions Public Notes
      8. Appl No
        203085
        Review Priority
        STANDARD
        Submission Class Code ID
        2
        Submission No
        8
        Submission Status
        AP
        Submission Status Date
        2018-06-14 00:00:00
        Submission Type
        SUPPL
        Submissions Public Notes
      9. Appl No
        203085
        Review Priority
        PRIORITY
        Submission Class Code ID
        2
        Submission No
        7
        Submission Status
        AP
        Submission Status Date
        2017-04-27 00:00:00
        Submission Type
        SUPPL
        Submissions Public Notes
      10. Appl No
        203085
        Review Priority
        STANDARD
        Submission Class Code ID
        3
        Submission No
        6
        Submission Status
        AP
        Submission Status Date
        2016-08-26 00:00:00
        Submission Type
        SUPPL
        Submissions Public Notes
      11. Appl No
        203085
        Review Priority
        STANDARD
        Submission Class Code ID
        3
        Submission No
        5
        Submission Status
        AP
        Submission Status Date
        2016-06-07 00:00:00
        Submission Type
        SUPPL
        Submissions Public Notes
      12. Appl No
        203085
        Review Priority
        STANDARD
        Submission Class Code ID
        3
        Submission No
        4
        Submission Status
        AP
        Submission Status Date
        2015-04-13 00:00:00
        Submission Type
        SUPPL
        Submissions Public Notes
      application number
      NDA203085
      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
      2026-02-03
      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
        203085
        Application Docs Date
        2026-02-05 00:00:00
        Application Docs ID
        84939
        Application Docs Title
        0
        Application Docs Type ID
        2
        Submission No
        18
        Submission Type
        SUPPL
      official application record
      Appl No
      203085
      Appl Public Notes
      Appl Type
      NDA
      Sponsor Name
      BAYER HLTHCARE
      openfda application present
      true
      products
      1. Active Ingredient
        REGORAFENIB
        Appl No
        203085
        Drug Name
        STIVARGA
        Form
        TABLET;ORAL
        Product No
        001
        Reference Drug
        1
        Reference Standard
        1
        Strength
        40MG
        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. NDA203085
    brand names
    1. Stivarga
    classification reasons
    1. explicit_positive_indication_predicate
    2. no_tumor_directed_keyword_in_positive_statement
    clinical review status
    pending
    content role
    positive_indication_candidate
    context span
    end
    306
    end exclusive
    true
    exact text
    1 INDICATIONS AND USAGE STIVARGA is a kinase inhibitor indicated for the treatment of adult patients with: • Metastatic colorectal cancer (CRC) who have been previously treated with fluoropyrimidine-, oxaliplatin- and irinotecan-based chemotherapy, an anti-VEGF therapy, and, if RAS wild-type, an anti-EGFR
    label id
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    offset unit
    unicode_code_points
    source array index
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    source field
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    source text sha256
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    start
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    current approval status
    not_reconciled
    duplicate text group
    dup-87d38aacb67a42a169be
    extraction review status
    automated_candidate_pending_source_review
    generic names
    1. REGORAFENIB
    id
    ind-span-b1d8f8181862b96dae12
    label id
    8f47fb28-9855-4482-b807-e98c425c2a4e
    positive predicate support span
    end
    64
    end exclusive
    true
    exact text
    is a kinase inhibitor indicated
    label id
    8f47fb28-9855-4482-b807-e98c425c2a4e
    offset unit
    unicode_code_points
    source array index
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    source field
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    source text sha256
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    start
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    qualifier mentions
    1. context exact
      IVARGA is a kinase inhibitor indicated for the treatment of adult patients with:
      kind
      age
      polarity
      not_inferred
      span
      end
      100
      end exclusive
      true
      exact text
      adult patients
      label id
      8f47fb28-9855-4482-b807-e98c425c2a4e
      offset unit
      unicode_code_points
      source array index
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      source field
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      source text sha256
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      start
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    regulatory links
      schema version
      0.1.0
      source batch sha256
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      source defined aliases
      1. abbreviation
        CRC
        definition exact
        colorectal cancer
        definition span
        end
        143
        end exclusive
        true
        exact text
        colorectal cancer (CRC)
        label id
        8f47fb28-9855-4482-b807-e98c425c2a4e
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        start
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      source span
      end
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      end exclusive
      true
      exact text
      1 INDICATIONS AND USAGE STIVARGA is a kinase inhibitor indicated for the treatment of adult patients with:
      label id
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      offset unit
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      source field
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      source text sha256
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      start
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      source url
      https://api.fda.gov/drug/label.json?search=id%3A%228f47fb28-9855-4482-b807-e98c425c2a4e%22
      spl effective date
      2026-02-09
      spl set id
      824f19c9-0546-4a8a-8d8f-c4055c04f7c7
      spl version
      36
      structured fields status
      not_extracted_no_values_inferred_from_mentions
      structured indication
      age
      Source null
      approval pathway
      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
      non_oncology_or_unclear_candidate
      Passage 2 · unclassified context
      application numbers
      1. NDA203085
      brand names
      1. Stivarga
      classification reasons
      1. no_unambiguous_positive_indication_predicate
      clinical review status
      pending
      content role
      unclassified_context
      context span
      end
      515
      end exclusive
      true
      exact text
      1 INDICATIONS AND USAGE STIVARGA is a kinase inhibitor indicated for the treatment of adult patients with: • Metastatic colorectal cancer (CRC) who have been previously treated with fluoropyrimidine-, oxaliplatin- and irinotecan-based chemotherapy, an anti-VEGF therapy, and, if RAS wild-type, an anti-EGFR therapy. ( 1.1 ) • Locally advanced, unresectable or metastatic gastrointestinal stromal tumor (GIST) who have been previously treated with imatinib mesylate and sunitinib malate. ( 1.2 ) • Hepatocellular car
      label id
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      offset unit
      unicode_code_points
      source array index
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      source field
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      source text sha256
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      not_reconciled
      duplicate text group
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      generic names
      1. REGORAFENIB
      id
      ind-span-b960a75a854df69f5ac2
      label id
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      positive predicate support span
      Source null
      qualifier mentions
      1. context exact
        • Metastatic colorectal cancer (CRC) who have been previously treated with fluoropyrimidine-, oxaliplatin
        kind
        biomarker
        polarity
        not_inferred
        span
        end
        152
        end exclusive
        true
        exact text
        Metastatic colorectal cancer (CRC) who have
        label id
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        offset unit
        unicode_code_points
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      2. context exact
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        kind
        biomarker
        polarity
        not_inferred
        span
        end
        314
        end exclusive
        true
        exact text
        EGFR therapy
        label id
        8f47fb28-9855-4482-b807-e98c425c2a4e
        offset unit
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        source array index
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        source field
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        start
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      3. context exact
        • Metastatic colorectal cancer (CRC) who have been previously treated with fluoropyrimidine-, oxaliplatin-
        kind
        stage_or_setting
        polarity
        not_inferred
        span
        end
        154
        end exclusive
        true
        exact text
        Metastatic colorectal cancer (CRC) who have b
        label id
        8f47fb28-9855-4482-b807-e98c425c2a4e
        offset unit
        unicode_code_points
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        source text sha256
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        start
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      4. context exact
        • Metastatic colorectal cancer (CRC) who have been previously treated with fluoropyrimidine-, oxaliplatin- and irinotecan-based chemotherapy, an anti-VEGF therapy, and, if RAS wild-type, an anti-EGFR therapy.
        kind
        prior_therapy_or_line
        polarity
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        span
        end
        314
        end exclusive
        true
        exact text
        previously treated with fluoropyrimidine-, oxaliplatin- and irinotecan-based chemotherapy, an anti-VEGF therapy, and, if RAS wild-type, an anti-EGFR therapy
        label id
        8f47fb28-9855-4482-b807-e98c425c2a4e
        offset unit
        unicode_code_points
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                      previously treated with fluoropyrimidine-, oxaliplatin- and irinotecan-based chemotherapy, an anti-VEGF therapy, and, if RAS wild-type, an anti-EGFR therapy
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                      1.1 Colorectal Cancer STIVARGA is indicated for the treatment of adult patients with metastatic colorectal cancer (CRC) who have been previously treated with fluoropyrimidine-, oxaliplatin- and irinotecan-based chemotherapy, an anti-VEGF therapy, and, if RAS wild-type, an anti-EGFR therapy.
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                      tic colorectal cancer (CRC) who have been previously treated with fluoropyrimidine-, oxaliplatin- and irinotecan-based chemotherapy, an anti-VEGF therapy, and, if RAS wild-type, an anti-EGFR therapy. 1.2 Gastrointestinal Stromal Tumors STIVARGA is indicated for the treatment of adult patients with locally advanced, unresectable or metastatic gastrointestinal stromal tumor (GIST) who have been previously treated with imatinib mesylate and sunitinib malate. 1.3 Hepatocellular Carcinoma STIVARGA is indicated for the treatment of adult patients with hepatocellular carcinoma (HCC) who have been previously treated with sorafenib.
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                        l Stromal Tumors STIVARGA is indicated for the treatment of adult patients with locally advanced, unresectable or metastatic gastroint
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                        nt of adult patients with locally advanced, unresectable or metastatic gastrointestinal stromal tumor (GIST) who have been previously treated with imatinib mesylat
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                        VARGA is indicated for the treatment of adult patients with locally advanced, unresectable or metastatic gastrointestinal stromal tumor
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                        astatic gastrointestinal stromal tumor (GIST) who have been previously treated with imatinib mesylate and sunitinib malate.
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                        1.2 Gastrointestinal Stromal Tumors STIVARGA is indicated for the treatment of adult patients with locally advanced, unresectable or metastatic gastrointestinal stromal tumor (GIST) who have been previously treated with imatinib mesylate and sunitinib malate.
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                        r the treatment of adult patients with locally advanced, unresectable or metastatic gastrointestinal stromal tumor (GIST) who have been previously treated with imatinib mesylate and sunitinib malate. 1.3 Hepatocellular Carcinoma STIVARGA is indicated for the treatment of adult patients with hepatocellular carcinoma (HCC) who have been previously treated with sorafenib.
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                          llular Carcinoma STIVARGA is indicated for the treatment of adult patients with hepatocellular carcinoma (HCC) who have been previousl
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                            end exclusive
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                          1.3 Hepatocellular Carcinoma STIVARGA is indicated for the treatment of adult patients with hepatocellular carcinoma (HCC) who have been previously treated with sorafenib.
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                          Preserved source evidence · Not medical advice