{
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    "data_length": 1,
    "message": "Indication id ind:fda:datroway:0 retrieved successfully",
    "request_url": "https://api.moalmanac.org/indications?indication_id=ind%3Afda%3Adatroway%3A0",
    "status": "success",
    "status_code": 200,
    "timestamp_elapsed": 0.001699,
    "timestamp_received": "2026-11-09T16:11:56.130561Z",
    "timestamp_returned": "2026-11-09T16:11:56.132260Z",
    "trace_id": "81c82ad9-53e0-4216-9399-b5681e64cc65"
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    "github": "https://github.com/vanallenlab/moalmanac-db",
    "name": "Molecular Oncology Almanac",
    "license": "GPL-2.0",
    "release": "draft",
    "url": "https://moalmanac.org",
    "last_updated": "2026-10-08"
  },
  "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,
          "extensions": [
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              "name": "agent",
              "value": {
                "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."
              },
              "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": "publication_date",
              "value": "2025-06-23",
              "description": "The publication date for the document."
            },
            {
              "name": "regulatory_identifier",
              "value": "BLA761464",
              "description": "Identifier assigned by the regulatory agency, such as an FDA application number (e.g. NDA208716, BLA125427) or an EMA product number (e.g. EMEA/H/C/006184)."
            },
            {
              "name": "status",
              "value": "Active",
              "description": "Whether this document is Active or Deprecated within moalmanac-db."
            }
          ]
        },
        {
          "id": "doc:fda:datroway:2025-06-23",
          "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 October 6, 2026.",
          "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,
          "extensions": [
            {
              "name": "agent",
              "value": {
                "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."
              },
              "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."
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              "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": "publication_date",
              "value": "2025-06-23",
              "description": "The publication date for the document."
            },
            {
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              "value": "BLA761464",
              "description": "Identifier assigned by the regulatory agency, such as an FDA application number (e.g. NDA208716, BLA125427) or an EMA product number (e.g. EMEA/H/C/006184)."
            },
            {
              "name": "status",
              "value": "Deprecated",
              "description": "Whether this document is Active or Deprecated within moalmanac-db."
            }
          ]
        }
      ],
      "extensions": [
        {
          "name": "status",
          "value": "Accelerated",
          "description": "Current approval status."
        },
        {
          "name": "statement description",
          "value": "The U.S. Food and Drug Administration (FDA) granted accelerated approval to datopotamab deruxtecan-dlnk 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. This approval is based on two clinical studies: TROPION-Lung05 and TROPION-Lung01, where efficacy was assessed in 114 patients with EGFR-mutated NSCLC. Fifty-three percent (53%) of patients had exon 19 deletions, 34% had exon 21 L858R mutations, 28% had T790M mutations, 2.6% had exon 20 insertion mutations, and 14% had other EGFR mutations.",
          "description": "The description text for all Statements derived from this Indication."
        }
      ]
    }
  ]
}