{
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    "timestamp_received": "2026-04-24T00:14:25.261447+00:00Z",
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    "github": "https://github.com/vanallenlab/moalmanac-db",
    "name": "Molecular Oncology Almanac",
    "license": "GPL-2.0",
    "release": "draft",
    "url": "https://dev.moalmanac.org",
    "last_updated": "2026-04-09"
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  "data": [
    {
      "id": "ind:ema.kisqali:0",
      "indication": "Kisqali is indicated for the treatment of women with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative locally advanced or metastatic breast cancer in combination with an aromatase inhibitor or fulvestrant as initial endocrine-based therapy, or in women who have received prior endocrine therapy.",
      "initial_approval_date": "2019-01-30",
      "initial_approval_url": "https://www.ema.europa.eu/en/documents/variation-report/kisqali-h-c-4213-ii-0004-epar-assessment-report-variation_en.pdf",
      "description": "The European Medicines Agency (EMA) has authorized ribociclib in combination with an aromatase inhibitor or fulvestrant as an initial endocrine-based therapy for the treatment of patients who are women with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative locally advanced or metastatic breast cancer, or in women who have received prior endocrine therapy. In pre- or perimenopausal women, the endocrine therapy should be combined with a luteinising hormone-releasing hormone (LHRH) agonist. This indication is based on three clinical trials: MONALEESA-2, MONALEESA-3, and MONALEESA-7, and MONALEESA-2 evaluated ribociclib in combination with letrozole, an aromatase inhibitor.",
      "raw_biomarkers": null,
      "raw_cancer_type": "locally advanced or metastatic breast cancer",
      "raw_therapeutics": "Kisqali (ribociclib) in combination with an aromatase inhibitor or fulvestrant",
      "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:ema.kisqali",
        "type": "Document",
        "documentType": "Regulatory approval",
        "name": "Kisqali (ribociclib) [product information]. EMA.",
        "title": null,
        "aliases": [],
        "description": "Novartis Europharm Limited. Kisqali (ribociclib) [product information]. European Medicines Agency website. https://www.ema.europa.eu/en/documents/product-information/kisqali-epar-product-information_en.pdf. Revised April 2025. Accessed September 4, 2025.",
        "urls": [
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          "https://www.ema.europa.eu/en/documents/product-information/kisqali-epar-product-information_en.pdf"
        ],
        "doi": null,
        "pmid": null,
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              "id": "ema",
              "type": "Agent",
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              "name": "European Medicines Agency",
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              "extensions": [
                {
                  "name": "last_updated",
                  "value": "2025-10-01",
                  "description": ""
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                {
                  "name": "url",
                  "value": "https://www.ema.europa.eu/en/medicines",
                  "description": ""
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            },
            "description": "The organization that published this document."
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          {
            "name": "company",
            "value": "Novartis Europharm Limited.",
            "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."
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          {
            "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": "2017-08-31",
            "description": "The publication date for the initial version of this document."
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            "value": null,
            "description": "Identification number used by the publishing organization."
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          {
            "name": "publication_date",
            "value": "2025-04-24",
            "description": "The publication date for the document."
          },
          {
            "name": "status",
            "value": "Active",
            "description": "Whether this document is Active or Deprecated within moalmanac-db."
          }
        ]
      }
    }
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}