{
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    "message": "Indication id ind:fda.enhertu:2 retrieved successfully",
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    "timestamp_received": "2026-04-06T16:09:20.366274+00:00Z",
    "timestamp_returned": "2026-04-06T16:09:20.370071+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": "2026-03-05"
  },
  "data": [
    {
      "id": "ind:fda.enhertu:2",
      "indication": "ENHERTU is a HER2-directed antibody and topoisomerase inhibitor conjugate indicated for the treatment of adult patients with unresectable or metastatic non-small cell lung cancer (NSCLC) whose tumors have activating HER2 (ERBB2) mutations, as detected by an FDA-approved test, and who have received a prior systemic therapy. These indications are approved under accelerated approval based on objective response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial.",
      "initial_approval_date": "2022-08-11",
      "initial_approval_url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/761139s021lbl.pdf",
      "description": "The U.S. Food and Drug Administration granted accelerated approval to trastuzumab deruxtecan for the treatment of adult patients with unresectable or metastatic non-small cell lung cancer (NSCLC) whose tumors have activating HER2 (ERBB2) mutations, as detected by an FDA-approved test, and who have received a prior systemic therapy. The product label states that these indications are approved under accelerated approval based on objective response rate and duration of response and that continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial.",
      "raw_biomarkers": "HER2 (ERBB2) mutations",
      "raw_cancer_type": "unresectable or metastatic non-small cell lung cancer",
      "raw_therapeutics": "Enhertu (trastuzumab deruxtecan)",
      "icd10": null,
      "regimen_code": null,
      "reimbursement_category": null,
      "reimbursement_date": null,
      "reimbursement_details": null,
      "date_regular_approval": null,
      "date_accelerated_approval": "2022-08-11",
      "document": {
        "id": "doc:fda.enhertu",
        "type": "Document",
        "documentType": "Regulatory approval",
        "name": "Enhertu (trastuzumab deruxtecan) [package insert]. FDA.",
        "title": null,
        "aliases": [],
        "description": "Daiichi Sankyo, Inc. Enhertu (trastuzumab deruxtecan) [package insert]. U.S. Food and Drug Administration website. https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/761139s038s042lbl.pdf. Revised December 2025. Accessed December 24, 2025.",
        "urls": [
          "https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/761139s038s042lbl.pdf",
          "https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=761139"
        ],
        "doi": null,
        "pmid": null,
        "extensions": [
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            "name": "agent",
            "value": {
              "id": "fda",
              "type": "Agent",
              "agentType": "organization",
              "name": "Food and Drug Administration",
              "description": "Regulatory agency that approves drugs for use in the United States.",
              "extensions": [
                {
                  "name": "last_updated",
                  "value": "2026-03-02",
                  "description": ""
                },
                {
                  "name": "url",
                  "value": "https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm",
                  "description": ""
                }
              ]
            },
            "description": "The organization that published this document."
          },
          {
            "name": "company",
            "value": "Daiichi Sankyo, Inc.",
            "description": "The company that manufactures the cancer drug. Only applicable to market authorization documents."
          },
          {
            "name": "drug_name_brand",
            "value": "Enhertu",
            "description": "The brand name of the cancer drug, per this document. Only applicable to market authorization documents."
          },
          {
            "name": "drug_name_generic",
            "value": "trastuzumab deruxtecan",
            "description": "The generic name of the cancer drug, per this document. Only applicable to market authorization documents."
          },
          {
            "name": "first_publication_date",
            "value": "2019-12-20",
            "description": "The publication date for the initial version of this document."
          },
          {
            "name": "identification_number",
            "value": 761139,
            "description": "Identification number used by the publishing organization."
          },
          {
            "name": "publication_date",
            "value": "2025-12-15",
            "description": "The publication date for the document."
          },
          {
            "name": "status",
            "value": "Active",
            "description": "Whether this document is Active or Deprecated within moalmanac-db."
          }
        ]
      }
    }
  ]
}