{
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    "message": "Indication id ind:fda.kisqali:2 retrieved successfully",
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    "timestamp_received": "2026-04-16T17:56:20.181368+00:00Z",
    "timestamp_returned": "2026-04-16T17:56:20.185298+00:00Z",
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  "service": {
    "github": "https://github.com/vanallenlab/moalmanac-db",
    "name": "Molecular Oncology Almanac",
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    "url": "https://dev.moalmanac.org",
    "last_updated": "2026-04-09"
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  "data": [
    {
      "id": "ind:fda.kisqali:2",
      "indication": "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.",
      "initial_approval_date": "2024-09-17",
      "initial_approval_url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/209092Orig1s018lbl.pdf",
      "description": "The U.S. Food and Drug Administration granted approval to ribociclib in combination with an aromatase inhibitor for the adjuvant treatment of adult patients 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. This indication is based on NATALEE (NCT03701334) was a randomized (1:1), open-label, multicenter study, where participants received goserelin and either letrozole or anastrozole, in addition to ribociclib.",
      "raw_biomarkers": "hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative",
      "raw_cancer_type": "early breast cancer",
      "raw_therapeutics": "ribociclib in combination with an aromatase inhibitor",
      "icd10": null,
      "regimen_code": null,
      "reimbursement_category": null,
      "reimbursement_date": null,
      "reimbursement_details": null,
      "date_regular_approval": null,
      "date_accelerated_approval": null,
      "document": {
        "id": "doc:fda.kisqali",
        "type": "Document",
        "documentType": "Regulatory approval",
        "name": "Kisqali (ribociclib) [package insert]. FDA.",
        "title": null,
        "aliases": [],
        "description": "Novartis Pharmaceuticals Corporation. Kisqali (ribociclib) [package insert]. U.S. Food and Drug Administration website. https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/209092Orig1s018lbl.pdf. Revised September 2024. Accessed October 30, 2024.",
        "urls": [
          "https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/209092Orig1s018lbl.pdf",
          "https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=209092"
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        "doi": null,
        "pmid": null,
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              "description": "Regulatory agency that approves drugs for use in the United States.",
              "extensions": [
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                  "description": ""
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                  "value": "https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm",
                  "description": ""
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            },
            "description": "The organization that published this document."
          },
          {
            "name": "company",
            "value": "Novartis Pharmaceuticals Corporation.",
            "description": "The company that manufactures the cancer drug. Only applicable to market authorization documents."
          },
          {
            "name": "drug_name_brand",
            "value": "Kisqali",
            "description": "The brand name of the cancer drug, per this document. Only applicable to market authorization documents."
          },
          {
            "name": "drug_name_generic",
            "value": "ribociclib",
            "description": "The generic name of the cancer drug, per this document. Only applicable to market authorization documents."
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          {
            "name": "first_publication_date",
            "value": "2017-03-13",
            "description": "The publication date for the initial version of this document."
          },
          {
            "name": "identification_number",
            "value": 209092,
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            "value": "2024-09-17",
            "description": "The publication date for the document."
          },
          {
            "name": "status",
            "value": "Active",
            "description": "Whether this document is Active or Deprecated within moalmanac-db."
          }
        ]
      }
    }
  ]
}