{
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    "message": "Indication id ind:ema.xospata:0 retrieved successfully",
    "request_url": "http://api.moalmanac.org/indications?indication_id=ind%3Aema.xospata%3A0",
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    "timestamp_received": "2026-04-24T01:52:28.865197+00:00Z",
    "timestamp_returned": "2026-04-24T01:52:28.868959+00:00Z",
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    "github": "https://github.com/vanallenlab/moalmanac-db",
    "name": "Molecular Oncology Almanac",
    "license": "GPL-2.0",
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    "url": "https://dev.moalmanac.org",
    "last_updated": "2026-04-09"
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  "data": [
    {
      "id": "ind:ema.xospata:0",
      "indication": "Xospata is indicated as monotherapy for the treatment of adult patients who have relapsed or refractory acute myeloid leukaemia (AML) with a FLT3 mutation.",
      "initial_approval_date": "2019-11-08",
      "initial_approval_url": "https://www.ema.europa.eu/en/documents/assessment-report/xospata-epar-public-assessment-report_en.pdf",
      "description": "The European Medicines Agency (EMA) has authorized gilteritinib for the treatment of adult patients with relapsed or refractory acute myeloid leukemia (AML) with a FLT3 mutation. Gilteritinib's product information states that, before taking gilteritinib, relapsed or refactory AML patients must have confirmation of FMS-like tyrosine kinase 3 (FLT3) mutation (internal tandem duplication [ITD] or tyrosine kinase domain [TKD]) using a validated test. The product information describes the mechanism of action for gilteritinib as inhibiting FLT3 receptor signaling and proliferation in cells exogenously expressing FLT3 including FLT3-ITD, FLT3-D835Y, and FLT3-ITD-D835Y, and that it induces apoptosis in leukemic cells expressing FLT3-ITD.",
      "raw_biomarkers": null,
      "raw_cancer_type": "Acute myeloid leukaemia",
      "raw_therapeutics": "Xospata (gilteritinib)",
      "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.xospata",
        "type": "Document",
        "documentType": "Regulatory approval",
        "name": "Xospata (gilteritinib) [product information]. EMA.",
        "title": null,
        "aliases": [],
        "description": "Astellas Pharma Europe B.V. Xospata (gilteritinib) [product information]. European Medicines Agency website. https://www.ema.europa.eu/en/documents/product-information/xospata-epar-product-information_en.pdf. Revised November 2023. Accessed March 26, 2024.",
        "urls": [
          "https://www.ema.europa.eu/en/medicines/human/EPAR/xospata",
          "https://www.ema.europa.eu/en/documents/product-information/xospata-epar-product-information_en.pdf"
        ],
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        "pmid": null,
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              "name": "European Medicines Agency",
              "description": "Regulatory agency that approves medicines for use in the European Union.",
              "extensions": [
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                  "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": "Astellas Pharma Europe B.V.",
            "description": "The company that manufactures the cancer drug. Only applicable to market authorization documents."
          },
          {
            "name": "drug_name_brand",
            "value": "Xospata",
            "description": "The brand name of the cancer drug, per this document. Only applicable to market authorization documents."
          },
          {
            "name": "drug_name_generic",
            "value": "gilteritinib",
            "description": "The generic name of the cancer drug, per this document. Only applicable to market authorization documents."
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          {
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            "value": "2019-11-08",
            "description": "The publication date for the initial version of this document."
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            "value": "2023-11-07",
            "description": "The publication date for the document."
          },
          {
            "name": "status",
            "value": "Active",
            "description": "Whether this document is Active or Deprecated within moalmanac-db."
          }
        ]
      }
    }
  ]
}