{
  "meta": {
    "data_length": 1,
    "message": "Indication id ind:fda.emrelis:0 retrieved successfully",
    "request_url": "http://api.moalmanac.org/indications?indication_id=ind%3Afda.emrelis%3A0",
    "status": "success",
    "status_code": 200,
    "timestamp_elapsed": 0.003749,
    "timestamp_received": "2026-04-23T23:41:49.061122+00:00Z",
    "timestamp_returned": "2026-04-23T23:41:49.064871+00:00Z",
    "trace_id": "0a6a743c-5ce3-41d5-9f66-544a24b321e0"
  },
  "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": "2026-04-09"
  },
  "data": [
    {
      "id": "ind:fda.emrelis:0",
      "indication": "EMRELIS is a c-Met-directed antibody and microtubule inhibitor conjugate indicated for the treatment of adult patients with locally advanced or metastatic non-squamous non-small cell lung cancer (NSCLC) with high c-Met protein overexpression [>=50% of tumor cells with strong (3+) staining], as determined by an FDA-approved test, who have received a prior systemic therapy.",
      "initial_approval_date": "2025-05-14",
      "initial_approval_url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/761384s000lbl.pdf",
      "description": "The U.S. Food and Drug Administration (FDA) granted accelerated approval to telisotuzumab vedotin, a c-Met-directed antibody and microtubule inhibitor conjugate, for the treatment of adult patients with locally advanced or metastatic non-squamous non-small cell lung cancer (NSCLC) with high c-Met protein overexpression [>=50% of tumor cells with strong (3+) staining], as determined by an FDA-approved test, who have received a prior systemic therapy. This indication is approved under accelerated approval based on objective response rate (ORR) and duration of response (DOR). Continued approval for this indication may be contingent upon verification and description of a clinical benefit in a confirmatory trial(s).",
      "raw_biomarkers": "high c-Met protein overexpression [>=50% of tumor cells with strong (3+) staining]",
      "raw_cancer_type": "non-squamous non-small cell lung cancer",
      "raw_therapeutics": "telisotuzumab vedotin",
      "icd10": null,
      "regimen_code": null,
      "reimbursement_category": null,
      "reimbursement_date": null,
      "reimbursement_details": null,
      "date_regular_approval": null,
      "date_accelerated_approval": "2025-05-14",
      "document": {
        "id": "doc:fda.emrelis",
        "type": "Document",
        "documentType": "Regulatory approval",
        "name": "Emrelis (telisotuzumab vedotin-tllv) [package insert]. FDA.",
        "title": null,
        "aliases": [],
        "description": "Abbvie Inc. Emrelis (telisotuzumab vedotin-tllv) [package insert]. U.S. Food and Drug Administration website. https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/761384s000lbl.pdf. Revised May 2025. Accessed June 12, 2025.",
        "urls": [
          "https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/761384s000lbl.pdf",
          "https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=761384"
        ],
        "doi": null,
        "pmid": null,
        "extensions": [
          {
            "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": "2026-04-09",
                  "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": "Abbvie Inc.",
            "description": "The company that manufactures the cancer drug. Only applicable to market authorization documents."
          },
          {
            "name": "drug_name_brand",
            "value": "Emrelis",
            "description": "The brand name of the cancer drug, per this document. Only applicable to market authorization documents."
          },
          {
            "name": "drug_name_generic",
            "value": "telisotuzumab vedotin",
            "description": "The generic name of the cancer drug, per this document. Only applicable to market authorization documents."
          },
          {
            "name": "first_publication_date",
            "value": "2025-05-14",
            "description": "The publication date for the initial version of this document."
          },
          {
            "name": "identification_number",
            "value": 761384,
            "description": "Identification number used by the publishing organization."
          },
          {
            "name": "publication_date",
            "value": "2025-05-14",
            "description": "The publication date for the document."
          },
          {
            "name": "status",
            "value": "Active",
            "description": "Whether this document is Active or Deprecated within moalmanac-db."
          }
        ]
      }
    }
  ]
}