{
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    "message": "Indication id ind:fda.augtyro:1 retrieved successfully",
    "request_url": "http://api.moalmanac.org/indications?indication_id=ind%3Afda.augtyro%3A1",
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    "timestamp_received": "2026-04-24T00:23:27.558072+00:00Z",
    "timestamp_returned": "2026-04-24T00:23:27.562412+00:00Z",
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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"
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  "data": [
    {
      "id": "ind:fda.augtyro:1",
      "indication": "AUGTYRO is a kinase inhibitor indicated for the treatment of adult and pediatric patients 12 years of age and older with solid tumors that (i) have a neurotrophic tyrosine receptor kinase (NTRK) gene fusion and (ii) are locally advanced or metastatic or where surgical resection is likely to result in severe morbidity, and (iii) have progressed following treatment or have no satisfactory alternative therapy. This indication is approved under accelerated approval based on overall response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials.",
      "initial_approval_date": "2024-06-13",
      "initial_approval_url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/218213s001lbl.pdf",
      "description": "The U.S. Food and Drug Administration granted accelerated approval to repotrectinib for the treatment of adult and pediatric patients 12 years of age and older with solid tumors that (i) have a neurotrophic tyrosine receptor kinase (NTRK) gene fusion and (ii) are locally advanced or metastatic or where surgical resection is likely to result in severe morbidity, and (iii) have progressed following treatment or have no satisfactory alternative therapy. The product label notes that this indication is approved under accelerated approval based on overall response rate and duration of response and that continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials.",
      "raw_biomarkers": "NTRK gene fusions",
      "raw_cancer_type": "solid tumors",
      "raw_therapeutics": "Augtyro (repotrectinib)",
      "icd10": null,
      "regimen_code": null,
      "reimbursement_category": null,
      "reimbursement_date": null,
      "reimbursement_details": null,
      "date_regular_approval": null,
      "date_accelerated_approval": "2024-06-13",
      "document": {
        "id": "doc:fda.augtyro",
        "type": "Document",
        "documentType": "Regulatory approval",
        "name": "Augtyro (repotrectinib) [package insert]. FDA.",
        "title": null,
        "aliases": [],
        "description": "Bristol-Myers Squibb. Augtyro (repotrectinib) [package insert]. U.S. Food and Drug Administration website. https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/218213s001lbl.pdf. Revised June 2024. Accessed October 30, 2024.",
        "urls": [
          "https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/218213s001lbl.pdf",
          "https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=218213"
        ],
        "doi": null,
        "pmid": null,
        "extensions": [
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            "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": ""
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                  "name": "url",
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                  "description": ""
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            },
            "description": "The organization that published this document."
          },
          {
            "name": "company",
            "value": "Bristol-Myers Squibb.",
            "description": "The company that manufactures the cancer drug. Only applicable to market authorization documents."
          },
          {
            "name": "drug_name_brand",
            "value": "Augtyro",
            "description": "The brand name of the cancer drug, per this document. Only applicable to market authorization documents."
          },
          {
            "name": "drug_name_generic",
            "value": "repotrectinib",
            "description": "The generic name of the cancer drug, per this document. Only applicable to market authorization documents."
          },
          {
            "name": "first_publication_date",
            "value": null,
            "description": "The publication date for the initial version of this document."
          },
          {
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            "value": 218213,
            "description": "Identification number used by the publishing organization."
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          {
            "name": "publication_date",
            "value": "2024-06-13",
            "description": "The publication date for the document."
          },
          {
            "name": "status",
            "value": "Active",
            "description": "Whether this document is Active or Deprecated within moalmanac-db."
          }
        ]
      }
    }
  ]
}