{
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    "message": "Indication id ind:fda.vitrakvi:0 retrieved successfully",
    "request_url": "http://api.moalmanac.org/indications?indication_id=ind%3Afda.vitrakvi%3A0",
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    "timestamp_received": "2026-04-24T15:54:50.250932+00:00Z",
    "timestamp_returned": "2026-04-24T15:54:50.254792+00:00Z",
    "trace_id": "5ae30cff-a862-4584-b8f0-47c06a336e9e"
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    "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.vitrakvi:0",
      "indication": "VITRAKVI is a kinase inhibitor indicated for the treatment of adult and pediatric patients with solid tumors that: have a neurotrophic receptor tyrosine kinase (NTRK) gene fusion without a known acquired resistance mutation, are metastatic or where surgical resection is likely to result in severe morbidity, and have no satisfactory alternative treatments or that have progressed following treatment. Select patients for therapy based on an FDA-approved test.",
      "initial_approval_date": "2018-11-26",
      "initial_approval_url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/210861s000lbl.pdf",
      "description": "The U.S. Food and Drug Administration granted approval to larotrectinib for the treatment of adult and pediatric patients with solid tumors that: have a neurotrophic receptor tyrosine kinase (NTRK) gene fusion without a known acquired resistance mutation, are metastatic or where surgical resection is likely to result in severe morbidity, and have no satisfactory alternative treatments or that have progressed following treatment. Larotrectinib's product label specifies to select patients for therapy based on an FDA-approved test.",
      "raw_biomarkers": "NTRK gene fusion",
      "raw_cancer_type": "solid tumors",
      "raw_therapeutics": "Vitrakvi (larotrectinib)",
      "icd10": null,
      "regimen_code": null,
      "reimbursement_category": null,
      "reimbursement_date": null,
      "reimbursement_details": null,
      "date_regular_approval": "2025-04-09",
      "date_accelerated_approval": "2018-11-26",
      "document": {
        "id": "doc:fda.vitrakvi",
        "type": "Document",
        "documentType": "Regulatory approval",
        "name": "Vitrakvi (larotrectinib) [package insert]. FDA.",
        "title": null,
        "aliases": [],
        "description": "Loxo Oncology, Inc. Vitrakvi (larotrectinib) [package insert]. U.S. Food and Drug Administration website. https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/210861s012lbl.pdf. Revised April 2025. Accessed April 30, 2025.",
        "urls": [
          "https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/210861s012lbl.pdf",
          "https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=210861"
        ],
        "doi": null,
        "pmid": null,
        "extensions": [
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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.",
              "extensions": [
                {
                  "name": "last_updated",
                  "value": "2026-04-09",
                  "description": ""
                },
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                  "value": "https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm",
                  "description": ""
                }
              ]
            },
            "description": "The organization that published this document."
          },
          {
            "name": "company",
            "value": "Loxo Oncology, Inc.",
            "description": "The company that manufactures the cancer drug. Only applicable to market authorization documents."
          },
          {
            "name": "drug_name_brand",
            "value": "Vitrakvi",
            "description": "The brand name of the cancer drug, per this document. Only applicable to market authorization documents."
          },
          {
            "name": "drug_name_generic",
            "value": "larotrectinib",
            "description": "The generic name of the cancer drug, per this document. Only applicable to market authorization documents."
          },
          {
            "name": "first_publication_date",
            "value": "2018-11-26",
            "description": "The publication date for the initial version of this document."
          },
          {
            "name": "identification_number",
            "value": 210861,
            "description": "Identification number used by the publishing organization."
          },
          {
            "name": "publication_date",
            "value": "2025-04-09",
            "description": "The publication date for the document."
          },
          {
            "name": "status",
            "value": "Active",
            "description": "Whether this document is Active or Deprecated within moalmanac-db."
          }
        ]
      }
    }
  ]
}