{
  "meta": {
    "data_length": 1,
    "message": "Indication id ind:fda:elahere:0 retrieved successfully",
    "request_url": "https://api.moalmanac.org/indications?indication_id=ind%3Afda%3Aelahere%3A0",
    "status": "success",
    "status_code": 200,
    "timestamp_elapsed": 0.001609,
    "timestamp_received": "2026-11-09T16:12:00.174515Z",
    "timestamp_returned": "2026-11-09T16:12:00.176124Z",
    "trace_id": "2f2fa4af-d424-4b0a-810a-514b1731e80f"
  },
  "service": {
    "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:elahere:0",
      "type": "Indication",
      "description": "ELAHERE is a folate receptor alpha (FRalpha)-directed antibody and microtubule inhibitor conjugate indicated for the treatment of adult patients with FR-alpha positive, platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal cancer, who have received one to three prior systemic treatment regimens. Select patients for therapy based on an FDA-approved test.",
      "contributions": [
        {
          "id": "ctrb:vanallenlab:2024-10-30:0",
          "type": "Contribution",
          "description": "Initial access of FDA approvals",
          "date": "2024-10-30",
          "contributor": {
            "id": "agent:user:vanallenlab",
            "type": "Agent",
            "agentType": "contributor",
            "name": "Van Allen lab",
            "description": "Van Allen lab, Dana-Farber Cancer Institute"
          }
        },
        {
          "id": "ctrb:fda:2024-03-22:0",
          "type": "Contribution",
          "description": "Indication received traditional approval.",
          "date": "2024-03-22",
          "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:elahere",
          "type": "Document",
          "documentType": "Regulatory approval",
          "name": "Elahere (mirvetuximab soravtansine-gynx) [package insert]. FDA.",
          "title": null,
          "aliases": [],
          "description": "ImmunoGen, Inc. Elahere (mirvetuximab soravtansine-gynx) [package insert]. U.S. Food and Drug Administration website. https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/761310Origs005lbl.pdf. Revised March 2024. Accessed October 30, 2024.",
          "urls": [
            "https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/761310Origs005lbl.pdf",
            "https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=761310"
          ],
          "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": "ImmunoGen, Inc.",
              "description": "The company that manufactures the cancer drug. Only applicable to market authorization documents."
            },
            {
              "name": "drug_name_brand",
              "value": "Elahere",
              "description": "The brand name of the cancer drug, per this document. Only applicable to market authorization documents."
            },
            {
              "name": "drug_name_generic",
              "value": "mirvetuximab soravtansine-gynx",
              "description": "The generic name of the cancer drug, per this document. Only applicable to market authorization documents."
            },
            {
              "name": "first_publication_date",
              "value": "2022-11-14",
              "description": "The publication date for the initial version of this document."
            },
            {
              "name": "publication_date",
              "value": "2024-03-22",
              "description": "The publication date for the document."
            },
            {
              "name": "regulatory_identifier",
              "value": "BLA761310",
              "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:elahere:2024-03-22",
          "type": "Document",
          "documentType": "Regulatory approval",
          "name": "Elahere (mirvetuximab soravtansine-gynx) [package insert]. FDA.",
          "title": null,
          "aliases": [],
          "description": "ImmunoGen, Inc. Elahere (mirvetuximab soravtansine-gynx) [package insert]. U.S. Food and Drug Administration website. https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/761310Origs005lbl.pdf. Revised March 2024. Accessed October 6, 2026.",
          "urls": [
            "https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/761310Origs005lbl.pdf",
            "https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=761310"
          ],
          "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": "ImmunoGen, Inc.",
              "description": "The company that manufactures the cancer drug. Only applicable to market authorization documents."
            },
            {
              "name": "drug_name_brand",
              "value": "Elahere",
              "description": "The brand name of the cancer drug, per this document. Only applicable to market authorization documents."
            },
            {
              "name": "drug_name_generic",
              "value": "mirvetuximab soravtansine-gynx",
              "description": "The generic name of the cancer drug, per this document. Only applicable to market authorization documents."
            },
            {
              "name": "first_publication_date",
              "value": "2022-11-14",
              "description": "The publication date for the initial version of this document."
            },
            {
              "name": "publication_date",
              "value": "2024-03-22",
              "description": "The publication date for the document."
            },
            {
              "name": "regulatory_identifier",
              "value": "BLA761310",
              "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": "Approved",
          "description": "Current approval status."
        },
        {
          "name": "statement description",
          "value": "The U.S. Food and Drug Administration granted approval to mirvetuximab soravtansine-gynx for the treatment of adult patients with folate receptor-alpha positive, platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal cancer, who have received one to three prior systemic treatment regimens. The package insert states to select patients for therapy based on an FDA-approved test and, furthermore, that folate receptor-alpha tumor positive is defined as the presence of folate receptor-alpha tumor expression.",
          "description": "The description text for all Statements derived from this Indication."
        }
      ]
    }
  ]
}