{
  "meta": {
    "data_length": 1,
    "message": "Indication id ind:ema.kisqali:1 retrieved successfully",
    "request_url": "http://api.moalmanac.org/indications?indication_id=ind%3Aema.kisqali%3A1",
    "status": "success",
    "status_code": 200,
    "timestamp_elapsed": 0.004343,
    "timestamp_received": "2026-04-24T00:14:41.561165+00:00Z",
    "timestamp_returned": "2026-04-24T00:14:41.565508+00:00Z",
    "trace_id": "622bbaf2-8556-42c0-b121-503c8d3062b5"
  },
  "service": {
    "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"
  },
  "data": [
    {
      "id": "ind:ema.kisqali:1",
      "indication": "Kisqali in combination with an aromatase inhibitor for the adjuvant treatment of patients with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative early breast cancer at high risk of recurrence. In pre- or perimenopausal women, or in men, the aromatase inhibitor should be combined with a luteinising hormone-releasing hormone (LHRH) agonist.",
      "initial_approval_date": "2024-12-16",
      "initial_approval_url": "https://www.ema.europa.eu/en/documents/variation-report/kisqali-h-c-004213-ii-0045-epar-assessment-report-variation_en.pdf",
      "description": "The European Medicines Agency (EMA) has authorized ribociclib in combination with an aromatase inhibitor for the adjuvant treatment of patients with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative early breast cancer at high risk of recurrence. In pre- or perimenopausal women, the endocrine therapy should be combined with a luteinising hormone-releasing hormone (LHRH) agonist. 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": "(HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative",
      "raw_cancer_type": "breast cancer",
      "raw_therapeutics": "Kisqali (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: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": [
          "https://www.ema.europa.eu/en/medicines/human/EPAR/kisqali",
          "https://www.ema.europa.eu/en/documents/product-information/kisqali-epar-product-information_en.pdf"
        ],
        "doi": null,
        "pmid": null,
        "extensions": [
          {
            "name": "agent",
            "value": {
              "id": "ema",
              "type": "Agent",
              "agentType": "organization",
              "name": "European Medicines Agency",
              "description": "Regulatory agency that approves medicines for use in the European Union.",
              "extensions": [
                {
                  "name": "last_updated",
                  "value": "2025-10-01",
                  "description": ""
                },
                {
                  "name": "url",
                  "value": "https://www.ema.europa.eu/en/medicines",
                  "description": ""
                }
              ]
            },
            "description": "The organization that published this document."
          },
          {
            "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."
          },
          {
            "name": "drug_name_generic",
            "value": "ribociclib",
            "description": "The generic name of the cancer drug, per this document. Only applicable to market authorization documents."
          },
          {
            "name": "first_publication_date",
            "value": "2017-08-31",
            "description": "The publication date for the initial version of this document."
          },
          {
            "name": "identification_number",
            "value": null,
            "description": "Identification number used by the publishing organization."
          },
          {
            "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."
          }
        ]
      }
    }
  ]
}