{
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    "timestamp_received": "2026-04-24T03:23:20.788279+00:00Z",
    "timestamp_returned": "2026-04-24T03:23:20.792085+00:00Z",
    "trace_id": "437040cd-73e9-4c4e-96f0-a793f57d62be"
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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.orserdu:0",
      "indication": "ORSERDU monotherapy is indicated for the treatment of postmenopausal women, and men, with estrogen receptor (ER)-positive, HER2-negative, locally advanced or metastatic breast cancer with an activating ESR1 mutation who have disease progression following at least one line of endocrine therapy including a CDK 4/6 inhibitor.",
      "initial_approval_date": "2023-10-09",
      "initial_approval_url": "https://www.ema.europa.eu/en/documents/assessment-report/orserdu-epar-public-assessment-report_en.pdf",
      "description": "The European Medicines Agency (EMA) has authorized elacestrant for the treatment of postmenopausal women and men with estrogen receptor (ER)-positive, HER2-negative, locally advanced or metastatic breast cancer with an activating ESR1 mutation who have disease progression following at least one line of endocrine therapy including a CDK 4/6 inhibitor.",
      "raw_biomarkers": null,
      "raw_cancer_type": "locally advanced or metastatic breast cancer",
      "raw_therapeutics": "Orserdu (elacestrant)",
      "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.orserdu",
        "type": "Document",
        "documentType": "Regulatory approval",
        "name": "Orserdu (elacestrant) [product information]. EMA.",
        "title": null,
        "aliases": [],
        "description": "Stemline Therapeutics B.V. Orserdu (elacestrant) [product information]. European Medicines Agency website. https://www.ema.europa.eu/en/documents/product-information/orserdu-epar-product-information_en.pdf. Revised February 2024. Accessed March 22, 2024.",
        "urls": [
          "https://www.ema.europa.eu/en/medicines/human/EPAR/orserdu",
          "https://www.ema.europa.eu/en/documents/product-information/orserdu-epar-product-information_en.pdf"
        ],
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        "pmid": null,
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              "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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                  "value": "https://www.ema.europa.eu/en/medicines",
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            "value": "Stemline Therapeutics B.V.",
            "description": "The company that manufactures the cancer drug. Only applicable to market authorization documents."
          },
          {
            "name": "drug_name_brand",
            "value": "Orserdu",
            "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": "elacestrant",
            "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": "2023-11-27",
            "description": "The publication date for the initial version of this document."
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            "value": "2024-02-14",
            "description": "The publication date for the document."
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          {
            "name": "status",
            "value": "Active",
            "description": "Whether this document is Active or Deprecated within moalmanac-db."
          }
        ]
      }
    }
  ]
}