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LABELS · 142c8672-a552-4d20-9226-2a92aa9773d1

QINLOCK

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
2025-05-12
Captured
2026-09-09T23:37:39.774134+00:00
Current indication reconciliation
Not reconciled

Indications and usage: exact source text

  1. 1 INDICATIONS AND USAGE QINLOCK is indicated for the treatment of adult patients with advanced gastrointestinal stromal tumor (GIST) who have received prior treatment with 3 or more kinase inhibitors, including imatinib. QINLOCK is a kinase inhibitor indicated for the treatment of adult patients with advanced gastrointestinal stromal tumor (GIST) who have received prior treatment with 3 or more kinase inhibitors, including imatinib. ( 1 )
Full extracted label fields
application numbers
  1. NDA213973
boxed warning exact
    brand names
    1. QINLOCK
    current indication status
    not_reconciled
    dailymed set url
    https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=9f18e462-03dd-4296-a02a-a0577e3ee78d
    generic names
    1. RIPRETINIB
    id
    142c8672-a552-4d20-9226-2a92aa9773d1
    indications and usage exact
    1. 1 INDICATIONS AND USAGE QINLOCK is indicated for the treatment of adult patients with advanced gastrointestinal stromal tumor (GIST) who have received prior treatment with 3 or more kinase inhibitors, including imatinib. QINLOCK is a kinase inhibitor indicated for the treatment of adult patients with advanced gastrointestinal stromal tumor (GIST) who have received prior treatment with 3 or more kinase inhibitors, including imatinib. ( 1 )
    indications and usage tables exact
      is original packager
      1. true
      manufacturer names
      1. Deciphera Pharmaceuticals, LLC
      matched search terms
      1. tumor
      package ndcs
      1. 73207-101-30
      2. 73207-101-31
      product ndcs
      1. 73207-101
      product types
      1. HUMAN PRESCRIPTION DRUG
      recent major changes exact
        record type
        complete_spl_indications_section_candidate
        routes
        1. ORAL
        rxcuis
        1. 2369397
        2. 2369403
        source batch
        file
        /private/tmp/cancer-full-research/indications/raw/labels-00000.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
        0
        total
        830
        sha256
        0dba7a040bbbf460aa9f482c5b67c9f28f75fc9df775ee1e7b345b758f780e07
        url
        https://api.fda.gov/drug/label.json?search=%28indications_and_usage%3Acancer+OR+indications_and_usage%3Acarcinoma+OR+indications_and_usage%3Acarcinomas+OR+indications_and_usage%3Alymphoma+OR+indications_and_usage%3Alymphomas+OR+indications_and_usage%3Aleukemia+OR+indications_and_usage%3Aleukaemia+OR+indications_and_usage%3Asarcoma+OR+indications_and_usage%3Asarcomas+OR+indications_and_usage%3Amelanoma+OR+indications_and_usage%3Amyeloma+OR+indications_and_usage%3Atumor+OR+indications_and_usage%3Atumors+OR+indications_and_usage%3Atumour+OR+indications_and_usage%3Atumours+OR+indications_and_usage%3Aneoplasm+OR+indications_and_usage%3Aneoplasms+OR+indications_and_usage%3Amalignant+OR+indications_and_usage%3Amalignancy+OR+indications_and_usage%3Amyelodysplastic+OR+indications_and_usage%3Amyelofibrosis+OR+indications_and_usage%3Amastocytosis+OR+indications_and_usage%3Aglioma+OR+indications_and_usage%3Aglioblastoma+OR+indications_and_usage%3Aneuroblastoma+OR+indications_and_usage%3Aretinoblastoma+OR+indications_and_usage%3Apheochromocytoma+OR+indications_and_usage%3Aparaganglioma+OR+indications_and_usage%3Amyeloproliferative+OR+indications_and_usage%3Awaldenstrom+OR+indications_and_usage%3Apolycythemia+OR+indications_and_usage%3Athrombocythemia+OR+indications_and_usage%3Adesmoid+OR+indications_and_usage%3Aneurofibromatosis+OR+indications_and_usage%3Ahistiocytosis%29+AND+%28openfda.application_number%3ANDA%2A+OR+openfda.application_number%3ABLA%2A%29&limit=100&skip=0&sort=id%3Aasc
        source url
        https://api.fda.gov/drug/label.json?search=id%3A%22142c8672-a552-4d20-9226-2a92aa9773d1%22
        spl effective date
        2025-05-12
        spl effective time
        20250512
        spl set id
        9f18e462-03dd-4296-a02a-a0577e3ee78d
        spl version
        9
        substance names
        1. RIPRETINIB
        uniis
        1. 9XW757O13D
        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
          NDA213973
          payload
          all indexed label documents
          1. Appl No
            213973
            Application Docs Date
            2020-05-15 00:00:00
            Application Docs ID
            63053
            Application Docs Title
            0
            Application Docs Type ID
            2
            Submission No
            1
            Submission Type
            ORIG
          2. Appl No
            213973
            Application Docs Date
            2021-06-22 00:00:00
            Application Docs ID
            67853
            Application Docs Title
            0
            Application Docs Type ID
            2
            Submission No
            1
            Submission Type
            SUPPL
          3. Appl No
            213973
            Application Docs Date
            2022-09-19 00:00:00
            Application Docs ID
            72109
            Application Docs Title
            0
            Application Docs Type ID
            2
            Submission No
            3
            Submission Type
            SUPPL
          4. Appl No
            213973
            Application Docs Date
            2023-01-04 00:00:00
            Application Docs ID
            73076
            Application Docs Title
            0
            Application Docs Type ID
            2
            Submission No
            4
            Submission Type
            SUPPL
          5. Appl No
            213973
            Application Docs Date
            2023-10-27 00:00:00
            Application Docs ID
            75978
            Application Docs Title
            0
            Application Docs Type ID
            2
            Submission No
            7
            Submission Type
            SUPPL
          6. Appl No
            213973
            Application Docs Date
            2025-05-06 00:00:00
            Application Docs ID
            82209
            Application Docs Title
            0
            Application Docs Type ID
            2
            Submission No
            10
            Submission Type
            SUPPL
          all submission records
          1. Appl No
            213973
            Review Priority
            PRIORITY
            Submission Class Code ID
            7
            Submission No
            1
            Submission Status
            AP
            Submission Status Date
            2020-05-15 00:00:00
            Submission Type
            ORIG
            Submissions Public Notes
          2. Appl No
            213973
            Review Priority
            STANDARD
            Submission Class Code ID
            3
            Submission No
            1
            Submission Status
            AP
            Submission Status Date
            2021-06-17 00:00:00
            Submission Type
            SUPPL
            Submissions Public Notes
          3. Appl No
            213973
            Review Priority
            STANDARD
            Submission Class Code ID
            3
            Submission No
            3
            Submission Status
            AP
            Submission Status Date
            2022-09-15 00:00:00
            Submission Type
            SUPPL
            Submissions Public Notes
          4. Appl No
            213973
            Review Priority
            STANDARD
            Submission Class Code ID
            3
            Submission No
            4
            Submission Status
            AP
            Submission Status Date
            2022-12-29 00:00:00
            Submission Type
            SUPPL
            Submissions Public Notes
          5. Appl No
            213973
            Review Priority
            STANDARD
            Submission Class Code ID
            3
            Submission No
            7
            Submission Status
            AP
            Submission Status Date
            2023-10-26 00:00:00
            Submission Type
            SUPPL
            Submissions Public Notes
          6. Appl No
            213973
            Review Priority
            STANDARD
            Submission Class Code ID
            3
            Submission No
            10
            Submission Status
            AP
            Submission Status Date
            2025-05-06 00:00:00
            Submission Type
            SUPPL
            Submissions Public Notes
          application number
          NDA213973
          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
          2025-05-06
          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
            213973
            Application Docs Date
            2025-05-06 00:00:00
            Application Docs ID
            82209
            Application Docs Title
            0
            Application Docs Type ID
            2
            Submission No
            10
            Submission Type
            SUPPL
          official application record
          Appl No
          213973
          Appl Public Notes
          Appl Type
          NDA
          Sponsor Name
          DECIPHERA PHARMS
          openfda application present
          true
          products
          1. Active Ingredient
            RIPRETINIB
            Appl No
            213973
            Drug Name
            QINLOCK
            Form
            TABLET;ORAL
            Product No
            001
            Reference Drug
            1
            Reference Standard
            1
            Strength
            50MG
            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. NDA213973
        brand names
        1. QINLOCK
        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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        420
        end exclusive
        true
        exact text
        1 INDICATIONS AND USAGE QINLOCK is indicated for the treatment of adult patients with advanced gastrointestinal stromal tumor (GIST) who have received prior treatment with 3 or more kinase inhibitors, including imatinib. QINLOCK is a kinase inhibitor indicated for the treatment of adult patients with advanced gastrointestinal stromal tumor (GIST) who have received prior treatment with 3 or more kinase inhibitors, inc
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        duplicate text group
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        extraction review status
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        generic names
        1. RIPRETINIB
        id
        ind-span-c6a038f24c9a70dbe31d
        label id
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        positive predicate support span
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        end exclusive
        true
        exact text
        is indicated
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        qualifier mentions
        1. context exact
          CATIONS AND USAGE QINLOCK is indicated for the treatment of adult patients with advanced gastrointestinal stromal tumor (GIST) who hav
          kind
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          polarity
          not_inferred
          span
          end
          80
          end exclusive
          true
          exact text
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        2. context exact
          NLOCK is indicated for the treatment of adult patients with advanced gastrointestinal stromal tumor (GIST) who have received prior treatment with 3 or more kinase
          kind
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          polarity
          not_inferred
          span
          end
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          end exclusive
          true
          exact text
          advanced gastrointestinal stromal tumor (GI
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        3. context exact
          atients with advanced gastrointestinal stromal tumor (GIST) who have received prior treatment with 3 or more kinase inhibitors, including imatinib.
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          not_inferred
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          end exclusive
          true
          exact text
          who have received prior treatment with 3 or more kinase inhibitors, including imatinib
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        regulatory links
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            exact text
            1 INDICATIONS AND USAGE QINLOCK is indicated for the treatment of adult patients with advanced gastrointestinal stromal tumor (GIST) who have received prior treatment with 3 or more kinase inhibitors, including imatinib.
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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
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            Source null
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            Source null
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            tumor histology
            Source null
            use intent
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            Passage 2 · positive indication candidate
            application numbers
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            brand names
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            classification reasons
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            clinical review status
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            content role
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            442
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            true
            exact text
            GE QINLOCK is indicated for the treatment of adult patients with advanced gastrointestinal stromal tumor (GIST) who have received prior treatment with 3 or more kinase inhibitors, including imatinib. QINLOCK is a kinase inhibitor indicated for the treatment of adult patients with advanced gastrointestinal stromal tumor (GIST) who have received prior treatment with 3 or more kinase inhibitors, including imatinib. ( 1 )
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            is a kinase inhibitor indicated
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            qualifier mentions
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              kind
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              end
              296
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            2. context exact
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                QINLOCK is a kinase inhibitor indicated for the treatment of adult patients with advanced gastrointestinal stromal tumor (GIST) who have received prior treatment with 3 or more kinase inhibitors, including imatinib.
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                exact text
                ase inhibitor indicated for the treatment of adult patients with advanced gastrointestinal stromal tumor (GIST) who have received prior treatment with 3 or more kinase inhibitors, including imatinib. ( 1 )
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                      source url
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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
                      unclear

                      Preserved source evidence · Not medical advice