{
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    "timestamp_received": "2026-04-24T16:06:29.011757+00:00Z",
    "timestamp_returned": "2026-04-24T16:06:29.016009+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"
  },
  "data": [
    {
      "id": "ind:fda.orserdu:0",
      "indication": "ORSERDU is an estrogen receptor antagonist indicated for treatment of postmenopausal women or adult men, with ER-positive, HER2-negative, ESR1-mutated advanced or metastatic breast cancer with disease progression following at least one line of endocrine therapy.",
      "initial_approval_date": "2023-01-27",
      "initial_approval_url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/217639Orig1s000correctedlbl.pdf",
      "description": "The U.S. Food and Drug Administration granted approval to elacestrant for the treatment of patients who are postmenopausal women or adult men with ER-positive, HER2-negative, ESR1-mutated advanced or metastatic breast cancer with disease progression following at least one line of endocrine therapy.",
      "raw_biomarkers": "ER-positive, HER2-negative, ESR1-mutated",
      "raw_cancer_type": "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:fda.orserdu",
        "type": "Document",
        "documentType": "Regulatory approval",
        "name": "Orserdu (elacestrant) [package insert]. FDA.",
        "title": null,
        "aliases": [],
        "description": "Stemline Therapeutics, Inc. Orserdu (elacestrant) [package insert]. U.S. Food and Drug Administration website. https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/217639Orig1s001lbl.pdf. Revised May 2023. Accessed October 30, 2024.",
        "urls": [
          "https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/217639Orig1s001lbl.pdf",
          "https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=217639"
        ],
        "doi": null,
        "pmid": null,
        "extensions": [
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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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            "description": "The organization that published this document."
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          {
            "name": "company",
            "value": "Stemline Therapeutics, Inc.",
            "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."
          },
          {
            "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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            "value": null,
            "description": "The publication date for the initial version of this document."
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          {
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            "value": 217639,
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          },
          {
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            "value": "2023-11-09",
            "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."
          }
        ]
      }
    }
  ]
}