{
  "meta": {
    "data_length": 1,
    "message": "Indication id ind:fda:datroway:0 retrieved successfully",
    "request_url": "http://api.moalmanac.org/indications?indication_id=ind%3Afda%3Adatroway%3A0",
    "status": "success",
    "status_code": 200,
    "timestamp_elapsed": 0.001757,
    "timestamp_received": "2026-09-25T00:11:57.676367+00:00Z",
    "timestamp_returned": "2026-09-25T00:11:57.678124+00:00Z",
    "trace_id": "eb2599a7-59e9-44ea-8c50-fb6330077fc6"
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  "service": {
    "github": "https://github.com/vanallenlab/moalmanac-db",
    "name": "Molecular Oncology Almanac",
    "license": "GPL-2.0",
    "release": "draft",
    "url": "https://dev.moalmanac.org",
    "last_updated": "2026-08-02"
  },
  "data": [
    {
      "id": "ind:fda:datroway:0",
      "type": "Indication",
      "description": "DATROWAY is a Trop-2-directed antibody and topoisomerase inhibitor conjugate indicated for the treatment of adult patients with locally advanced or metastatic epidermal growth factor (EGFR)-mutated non-small cell lung cancer (NSCLC) who have received prior EGFR-directed therapy and platinum-based chemotherapy. This indication is 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 the confirmatory trial.",
      "contributions": [
        {
          "id": "ctrb:vanallenlab:2025-09-02:1",
          "type": "Contribution",
          "description": "The US FDA approved datopotamab deruxtecan for the treatment of adult patients with locally advanced or metastatic EGFR mutated non-small cell lung cancer who have received prior EGFR-directed therapy and platinum-based chemotherapy.",
          "date": "2025-09-02",
          "contributor": {
            "id": "agent:user:vanallenlab",
            "type": "Agent",
            "agentType": "contributor",
            "name": "Van Allen lab",
            "description": "Van Allen lab, Dana-Farber Cancer Institute"
          }
        },
        {
          "id": "ctrb:fda:2025-06-23:0",
          "type": "Contribution",
          "description": "Indication received accelerated approval.",
          "date": "2025-06-23",
          "contributor": {
            "id": "agent:org:fda",
            "type": "Agent",
            "agentType": "organization",
            "name": "Food and Drug Administration",
            "description": "Regulatory agency that approves drugs for use in the United States."
          }
        }
      ],
      "reportedIn": [
        {
          "id": "doc:fda:datroway",
          "type": "Document",
          "documentType": "Regulatory approval",
          "name": "Datroway (datopotamab deruxtecan-dlnk) [package insert]. FDA.",
          "title": null,
          "aliases": [],
          "description": "Daiichi Sankyo, Inc. Datroway (datopotamab deruxtecan-dlnk) [package insert]. U.S. Food and Drug Administration website. https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/761464s000lbl.pdf. Revised June 2025. Accessed September 2, 2025.",
          "urls": [
            "https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/761464s000lbl.pdf",
            "https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=761464"
          ],
          "doi": null,
          "pmid": null,
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                "type": "Agent",
                "agentType": "organization",
                "name": "Food and Drug Administration",
                "description": "Regulatory agency that approves drugs for use in the United States."
              },
              "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": "Datroway",
              "description": "The brand name of the cancer drug, per this document. Only applicable to market authorization documents."
            },
            {
              "name": "drug_name_generic",
              "value": "datopotamab deruxtecan-dlnk",
              "description": "The generic name of the cancer drug, per this document. Only applicable to market authorization documents."
            },
            {
              "name": "first_publication_date",
              "value": "2025-06-23",
              "description": "The publication date for the initial version of this document."
            },
            {
              "name": "identification_number",
              "value": 761464,
              "description": "Identification number used by the publishing organization."
            },
            {
              "name": "publication_date",
              "value": "2025-06-23",
              "description": "The publication date for the document."
            },
            {
              "name": "status",
              "value": "Active",
              "description": "Whether this document is Active or Deprecated within moalmanac-db."
            }
          ]
        }
      ],
      "extensions": [
        {
          "name": "status",
          "value": "Accelerated",
          "description": "Current approval status."
        }
      ]
    }
  ]
}