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LABELS · 9466e642-f230-43f3-b78e-5a432fa040ee

KISQALI

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
2026-07-01
Captured
2026-09-09T23:37:54.830918+00:00
Current indication reconciliation
Not reconciled

Indications and usage: exact source text

  1. 1 INDICATIONS AND USAGE KISQALI is a kinase inhibitor indicated: in combination with an aromatase inhibitor for the adjuvant treatment of adults with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative stage II and III early breast cancer at high risk of recurrence. ( 1 ) for the treatment of adults with HR-positive, HER2-negative advanced or metastatic breast cancer in combination with: an aromatase inhibitor as initial endocrine-based therapy; or fulvestrant as initial endocrine-based therapy or following disease progression on endocrine therapy. ( 1 ) 1.1 Early Breast Cancer KISQALI is indicated in combination with an aromatase inhibitor for the adjuvant treatment of adults with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative stage II and III early breast cancer at high risk of recurrence. 1.2 Advanced or Metastatic Breast Cancer KISQALI is indicated for the treatment of adults with HR-positive, HER2-negative advanced or metastatic breast cancer in combination with: an aromatase inhibitor as initial endocrine-based therapy; or fulvestrant as initial endocrine-based therapy or following disease progression on endocrine therapy.
Full extracted label fields
application numbers
  1. NDA209092
boxed warning exact
    brand names
    1. KISQALI
    current indication status
    not_reconciled
    dailymed set url
    https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=aaeaef94-f3f5-4367-8ea2-b181d7be2da8
    generic names
    1. RIBOCICLIB
    id
    9466e642-f230-43f3-b78e-5a432fa040ee
    indications and usage exact
    1. 1 INDICATIONS AND USAGE KISQALI is a kinase inhibitor indicated: in combination with an aromatase inhibitor for the adjuvant treatment of adults with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative stage II and III early breast cancer at high risk of recurrence. ( 1 ) for the treatment of adults with HR-positive, HER2-negative advanced or metastatic breast cancer in combination with: an aromatase inhibitor as initial endocrine-based therapy; or fulvestrant as initial endocrine-based therapy or following disease progression on endocrine therapy. ( 1 ) 1.1 Early Breast Cancer KISQALI is indicated in combination with an aromatase inhibitor for the adjuvant treatment of adults with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative stage II and III early breast cancer at high risk of recurrence. 1.2 Advanced or Metastatic Breast Cancer KISQALI is indicated for the treatment of adults with HR-positive, HER2-negative advanced or metastatic breast cancer in combination with: an aromatase inhibitor as initial endocrine-based therapy; or fulvestrant as initial endocrine-based therapy or following disease progression on endocrine therapy.
    indications and usage tables exact
      is original packager
      1. true
      manufacturer names
      1. Novartis Pharmaceuticals Corporation
      matched search terms
      1. cancer
      package ndcs
      1. 0078-0860-01
      2. 0078-0867-14
      3. 0078-0867-42
      4. 0078-0874-21
      5. 0078-0874-63
      product ndcs
      1. 0078-0860
      2. 0078-0867
      3. 0078-0874
      product types
      1. HUMAN PRESCRIPTION DRUG
      recent major changes exact
        record type
        complete_spl_indications_section_candidate
        routes
        1. ORAL
        rxcuis
        1. 1873983
        2. 1873989
        3. 1873990
        4. 1873991
        5. 1873992
        6. 1873993
        7. 1873994
        8. 1873995
        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
        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=500&sort=id%3Aasc
        source url
        https://api.fda.gov/drug/label.json?search=id%3A%229466e642-f230-43f3-b78e-5a432fa040ee%22
        spl effective date
        2026-07-01
        spl effective time
        20260701
        spl set id
        aaeaef94-f3f5-4367-8ea2-b181d7be2da8
        spl version
        28
        substance names
        1. RIBOCICLIB SUCCINATE
        uniis
        1. BG7HLX2919
        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
        4. fda_label_posted_after_spl_effective_date_requires_version_review
        Drugs@FDA application source records
        1. application number
          NDA209092
          payload
          all indexed label documents
          1. Appl No
            209092
            Application Docs Date
            2017-03-13 00:00:00
            Application Docs ID
            47529
            Application Docs Title
            0
            Application Docs Type ID
            2
            Submission No
            1
            Submission Type
            ORIG
          2. Appl No
            209092
            Application Docs Date
            2018-08-29 00:00:00
            Application Docs ID
            55355
            Application Docs Title
            0
            Application Docs Type ID
            2
            Submission No
            1
            Submission Type
            SUPPL
          3. Appl No
            209092
            Application Docs Date
            2019-09-11 00:00:00
            Application Docs ID
            59973
            Application Docs Title
            0
            Application Docs Type ID
            2
            Submission No
            4
            Submission Type
            SUPPL
          4. Appl No
            209092
            Application Docs Date
            2020-01-22 00:00:00
            Application Docs ID
            61616
            Application Docs Title
            0
            Application Docs Type ID
            2
            Submission No
            3
            Submission Type
            SUPPL
          5. Appl No
            209092
            Application Docs Date
            2020-07-07 00:00:00
            Application Docs ID
            63813
            Application Docs Title
            0
            Application Docs Type ID
            2
            Submission No
            5
            Submission Type
            SUPPL
          6. Appl No
            209092
            Application Docs Date
            2021-09-20 00:00:00
            Application Docs ID
            68644
            Application Docs Title
            0
            Application Docs Type ID
            2
            Submission No
            9
            Submission Type
            SUPPL
          7. Appl No
            209092
            Application Docs Date
            2021-12-13 00:00:00
            Application Docs ID
            69529
            Application Docs Title
            0
            Application Docs Type ID
            2
            Submission No
            8
            Submission Type
            SUPPL
          8. Appl No
            209092
            Application Docs Date
            2022-10-07 00:00:00
            Application Docs ID
            72263
            Application Docs Title
            0
            Application Docs Type ID
            2
            Submission No
            13
            Submission Type
            SUPPL
          9. Appl No
            209092
            Application Docs Date
            2023-08-29 00:00:00
            Application Docs ID
            75307
            Application Docs Title
            0
            Application Docs Type ID
            2
            Submission No
            16
            Submission Type
            SUPPL
          10. Appl No
            209092
            Application Docs Date
            2024-07-24 00:00:00
            Application Docs ID
            79159
            Application Docs Title
            0
            Application Docs Type ID
            2
            Submission No
            19
            Submission Type
            SUPPL
          11. Appl No
            209092
            Application Docs Date
            2024-10-15 00:00:00
            Application Docs ID
            79891
            Application Docs Title
            0
            Application Docs Type ID
            2
            Application Docs URL
            https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/209092Orig1s020, 209935Orig1s028lbl.pdf
            Submission No
            20
            Submission Type
            SUPPL
          12. Appl No
            209092
            Application Docs Date
            2024-10-25 00:00:00
            Application Docs ID
            79998
            Application Docs Title
            0
            Application Docs Type ID
            2
            Submission No
            18
            Submission Type
            SUPPL
          all submission records
          1. Appl No
            209092
            Review Priority
            PRIORITY
            Submission Class Code ID
            2
            Submission No
            27
            Submission Status
            AP
            Submission Status Date
            2026-07-01 00:00:00
            Submission Type
            SUPPL
            Submissions Public Notes
          2. Appl No
            209092
            Review Priority
            N/A
            Submission Class Code ID
            4
            Submission No
            25
            Submission Status
            AP
            Submission Status Date
            2025-09-16 00:00:00
            Submission Type
            SUPPL
            Submissions Public Notes
          3. Appl No
            209092
            Review Priority
            STANDARD
            Submission Class Code ID
            3
            Submission No
            24
            Submission Status
            AP
            Submission Status Date
            2025-07-28 00:00:00
            Submission Type
            SUPPL
            Submissions Public Notes
          4. Appl No
            209092
            Review Priority
            STANDARD
            Submission Class Code ID
            3
            Submission No
            23
            Submission Status
            AP
            Submission Status Date
            2025-02-11 00:00:00
            Submission Type
            SUPPL
            Submissions Public Notes
          5. Appl No
            209092
            Review Priority
            N/A
            Submission Class Code ID
            4
            Submission No
            20
            Submission Status
            AP
            Submission Status Date
            2024-09-03 00:00:00
            Submission Type
            SUPPL
            Submissions Public Notes
          6. Appl No
            209092
            Review Priority
            STANDARD
            Submission Class Code ID
            2
            Submission No
            19
            Submission Status
            AP
            Submission Status Date
            2024-07-22 00:00:00
            Submission Type
            SUPPL
            Submissions Public Notes
          7. Appl No
            209092
            Review Priority
            PRIORITY
            Submission Class Code ID
            2
            Submission No
            18
            Submission Status
            AP
            Submission Status Date
            2024-09-17 00:00:00
            Submission Type
            SUPPL
            Submissions Public Notes
          8. Appl No
            209092
            Review Priority
            STANDARD
            Submission Class Code ID
            3
            Submission No
            16
            Submission Status
            AP
            Submission Status Date
            2023-08-24 00:00:00
            Submission Type
            SUPPL
            Submissions Public Notes
          9. Appl No
            209092
            Review Priority
            STANDARD
            Submission Class Code ID
            2
            Submission No
            13
            Submission Status
            AP
            Submission Status Date
            2022-10-03 00:00:00
            Submission Type
            SUPPL
            Submissions Public Notes
          10. Appl No
            209092
            Review Priority
            STANDARD
            Submission Class Code ID
            3
            Submission No
            9
            Submission Status
            AP
            Submission Status Date
            2021-09-15 00:00:00
            Submission Type
            SUPPL
            Submissions Public Notes
          11. Appl No
            209092
            Review Priority
            STANDARD
            Submission Class Code ID
            2
            Submission No
            8
            Submission Status
            AP
            Submission Status Date
            2021-12-10 00:00:00
            Submission Type
            SUPPL
            Submissions Public Notes
          12. Appl No
            209092
            Review Priority
            STANDARD
            Submission Class Code ID
            2
            Submission No
            5
            Submission Status
            AP
            Submission Status Date
            2020-07-06 00:00:00
            Submission Type
            SUPPL
            Submissions Public Notes
          application number
          NDA209092
          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
          2026-07-01
          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
            209092
            Application Docs Date
            2026-07-10 00:00:00
            Application Docs ID
            86520
            Application Docs Title
            0
            Application Docs Type ID
            2
            Submission No
            27
            Submission Type
            SUPPL
          official application record
          Appl No
          209092
          Appl Public Notes
          Appl Type
          NDA
          Sponsor Name
          NOVARTIS
          openfda application present
          true
          products
          1. Active Ingredient
            RIBOCICLIB SUCCINATE
            Appl No
            209092
            Drug Name
            KISQALI
            Form
            TABLET;ORAL
            Product No
            001
            Reference Drug
            1
            Reference Standard
            1
            Strength
            EQ 200MG BASE
            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. NDA209092
        brand names
        1. KISQALI
        classification reasons
        1. explicit_positive_indication_predicate
        2. tumor_or_malignant_hematology_words_in_positive_statement
        3. positive_statement_also_contains_qualification_review_required
        clinical review status
        pending
        content role
        positive_indication_candidate
        context span
        end
        503
        end exclusive
        true
        exact text
        1 INDICATIONS AND USAGE KISQALI is a kinase inhibitor indicated: in combination with an aromatase inhibitor for the adjuvant treatment of adults with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative stage II and III early breast cancer at high risk of recurrence. ( 1 ) for the treatment of adults with HR-positive, HER2-negative advanced or metastatic breast cancer in combination with: an aromatase inhibitor as initial endocrine-based therapy; or fulvestrant a
        label id
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        duplicate text group
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        extraction review status
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        generic names
        1. RIBOCICLIB
        id
        ind-span-d9d1424644be6465eb19
        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
          n with an aromatase inhibitor for the adjuvant treatment of adults with hormone receptor (HR)-positive, human epidermal growth
          kind
          age
          polarity
          not_inferred
          span
          end
          144
          end exclusive
          true
          exact text
          adults
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        2. context exact
          or (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative stage II and III early breast cancer at high risk of recurrence.
          kind
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          polarity
          not_inferred
          span
          end
          268
          end exclusive
          true
          exact text
          HER2)-negative stage II and III early breast
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        3. context exact
          dicated: in combination with an aromatase inhibitor for the adjuvant treatment of adults with hormone receptor (HR)-positive, human epidermal growth factor recepto
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          not_inferred
          span
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          end exclusive
          true
          exact text
          adjuvant treatment of adults with hormone r
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        4. context exact
          ICATIONS AND USAGE KISQALI is a kinase inhibitor indicated: in combination with an aromatase inhibitor for the adjuvant treatment of adults with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative stage II and III early breast cancer at high risk of recurrence.
          kind
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          polarity
          not_inferred
          span
          end
          244
          end exclusive
          true
          exact text
          in combination with an aromatase inhibitor for the adjuvant treatment of adults with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative stage
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        regulatory links
          schema version
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          source defined aliases
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            exact text
            1 INDICATIONS AND USAGE KISQALI is a kinase inhibitor indicated: in combination with an aromatase inhibitor for the adjuvant treatment of adults with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative stage II and III early breast cancer at high risk of recurrence.
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            source url
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            spl effective date
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            spl set id
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            spl version
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            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
            tumor_directed_candidate
            Passage 2 · positive indication candidate
            application numbers
            1. NDA209092
            brand names
            1. KISQALI
            classification reasons
            1. inherited_predicate_from_same_label_section_requires_review
            2. tumor_or_malignant_hematology_words_in_positive_statement
            clinical review status
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            content role
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            exact text
            tor for the adjuvant treatment of adults with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative stage II and III early breast cancer at high risk of recurrence. ( 1 ) for the treatment of adults with HR-positive, HER2-negative advanced or metastatic breast cancer in combination with: an aromatase inhibitor as initial endocrine-based therapy; or fulvestrant as initial endocrine-based therapy or following disease progression on endocrine therapy. ( 1 ) 1.1 Early Breast Cancer KISQALI is indicated in combination with an aromatase inhibitor for the adjuvant treatment of adults with hormone receptor (HR)-positive, human epidermal growth factor r
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            current approval status
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            duplicate text group
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            generic names
            1. RIBOCICLIB
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            is a kinase inhibitor indicated
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            1. context exact
              ( 1 ) for the treatment of adults with HR-positive, HER2-negative advanced or metastatic brea
              kind
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              not_inferred
              span
              end
              337
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              exact text
              adults
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            2. context exact
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              exact text
              HER2-negative advanced or metastatic breast
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                              Preserved source evidence · Not medical advice