{
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    "message": "Indication id ind:fda.rozlytrek:1 retrieved successfully",
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    "status_code": 200,
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    "timestamp_received": "2026-04-23T21:59:15.954261+00:00Z",
    "timestamp_returned": "2026-04-23T21:59:15.958596+00:00Z",
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    "name": "Molecular Oncology Almanac",
    "license": "GPL-2.0",
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    "url": "https://dev.moalmanac.org",
    "last_updated": "2026-04-09"
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  "data": [
    {
      "id": "ind:fda.rozlytrek:1",
      "indication": "ROZLYTREK is a kinase inhibitor indicated for the treatment of adult and pediatric patients older than 1 month of age with solid tumors that: (i) have a neurotrophic tyrosine receptor kinase (NTRK) gene fusion, as detected by an FDA-approved test without a known acquired resistance mutation, (ii) are 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 tumor response rate and durability of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trials.",
      "initial_approval_date": "2023-10-20",
      "initial_approval_url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/212725Orig1s009Correctedlbl.pdf",
      "description": "The U.S. Food and Drug Administration granted accelerated approval to entrectinib for the treatment of adult and pediatric patients older than 1 month of age with solid tumors that: (i) have a neurotrophic tyrosine receptor kinase (NTRK) gene fusion, as detected by an FDA-approved test without a known acquired resistance mutation, (ii) are metastatic or where surgical resection is likely to result in severe morbidity, and (iii) have progressed following treatment or have no satisfactory alternative therapy. Entrectinib's package insert further states that this indication is approved under accelerated approval based on tumor response rate and durability of response. Furthermore, continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trials.",
      "raw_biomarkers": "NTRK gene fusion",
      "raw_cancer_type": "solid tumors",
      "raw_therapeutics": "Rozlytrek (entrectinib)",
      "icd10": null,
      "regimen_code": null,
      "reimbursement_category": null,
      "reimbursement_date": null,
      "reimbursement_details": null,
      "date_regular_approval": null,
      "date_accelerated_approval": null,
      "document": {
        "id": "doc:fda.rozlytrek",
        "type": "Document",
        "documentType": "Regulatory approval",
        "name": "Rozlytrek (entrectinib) [package insert]. FDA.",
        "title": null,
        "aliases": [],
        "description": "Genentech, Inc. Rozlytrek (entrectinib) [package insert]. U.S. Food and Drug Administration website. https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/212725s011lbl.pdf. Revised January 2024. Accessed October 30, 2024.",
        "urls": [
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          "https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=212725"
        ],
        "doi": null,
        "pmid": null,
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              "id": "fda",
              "type": "Agent",
              "agentType": "organization",
              "name": "Food and Drug Administration",
              "description": "Regulatory agency that approves drugs for use in the United States.",
              "extensions": [
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                  "name": "last_updated",
                  "value": "2026-04-09",
                  "description": ""
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                {
                  "name": "url",
                  "value": "https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm",
                  "description": ""
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            },
            "description": "The organization that published this document."
          },
          {
            "name": "company",
            "value": "Genentech, Inc.",
            "description": "The company that manufactures the cancer drug. Only applicable to market authorization documents."
          },
          {
            "name": "drug_name_brand",
            "value": "Rozlytrek",
            "description": "The brand name of the cancer drug, per this document. Only applicable to market authorization documents."
          },
          {
            "name": "drug_name_generic",
            "value": "entrectinib",
            "description": "The generic name of the cancer drug, per this document. Only applicable to market authorization documents."
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          {
            "name": "first_publication_date",
            "value": null,
            "description": "The publication date for the initial version of this document."
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          {
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            "value": 212725,
            "description": "Identification number used by the publishing organization."
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          {
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            "value": "2024-01-26",
            "description": "The publication date for the document."
          },
          {
            "name": "status",
            "value": "Active",
            "description": "Whether this document is Active or Deprecated within moalmanac-db."
          }
        ]
      }
    }
  ]
}