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    "timestamp_received": "2026-11-09T16:12:50.297938Z",
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    "name": "Molecular Oncology Almanac",
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    "last_updated": "2026-10-08"
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  "data": [
    {
      "id": "ind:fda:enhertu:2",
      "type": "Indication",
      "description": "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-authorized 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.",
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          "type": "Contribution",
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          "date": "2024-10-30",
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            "type": "Agent",
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            "name": "Van Allen lab",
            "description": "Van Allen lab, Dana-Farber Cancer Institute"
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        {
          "id": "ctrb:fda:2022-08-11:0",
          "type": "Contribution",
          "description": "Indication received accelerated approval.",
          "date": "2022-08-11",
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          "id": "doc:fda:enhertu",
          "type": "Document",
          "documentType": "Regulatory approval",
          "name": "Enhertu (trastuzumab deruxtecan) [package insert]. FDA.",
          "title": null,
          "aliases": [],
          "description": "Daiichi Sankyo. Enhertu (fam-trastuzumab deruxtecan-nxki) [package insert]. U.S. Food and Drug Administration website. https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/761139s041s043lbl.pdf. Revised May 2026. Accessed October 8, 2026.",
          "urls": [
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            "https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=761139"
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              "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."
            },
            {
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              "value": "trastuzumab deruxtecan",
              "description": "The generic name of the cancer drug, per this document. Only applicable to market authorization documents."
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          "id": "doc:fda:enhertu:2022-08-11",
          "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/2022/761139s021lbl.pdf. Revised August 2022. Accessed October 6, 2026.",
          "urls": [
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            "https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=761139"
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          "pmid": null,
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          "value": "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.",
          "description": "The description text for all Statements derived from this Indication."
        }
      ]
    }
  ]
}