{
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    "timestamp_received": "2026-04-24T03:26:16.594181+00:00Z",
    "timestamp_returned": "2026-04-24T03:26:16.598752+00:00Z",
    "trace_id": "b66d55d6-4adc-4165-b1f0-099f036680ec"
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    "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:ema.rozlytrek:1",
      "indication": "Rozlytrek as monotherapy is indicated for the treatment of adult and paediatric patients older than one month with solid tumours expressing a neurotrophic tyrosine receptor kinase (NTRK) gene fusion (i) who have a disease that is locally advanced, metastatic or where surgical resection is likely to result in severe morbidity, and (ii) who have not received a prior NTRK inhibitor, (iii) who have no satisfactory treatment options.",
      "initial_approval_date": "2024-07-03",
      "initial_approval_url": "https://www.ema.europa.eu/en/documents/variation-report/rozlytrek-h-c-004936-x-0017-g-epar-assessment-report-variation_en.pdf",
      "description": "The European Medicines Agency (EMA) has conditionally authorized entrectinib for the treatment of adult and pediatric patients 12 years of age and older with solid tumors expressing a neuotrophic tyrosine receptor kinase (NTRK) gene fusion who have a disease that is locally advanced, metastatic, or where surgical resection is likely to result in severe morbidity, and who have not received a prior NTRK inhibitor, and who have no satisfactory treatment options.",
      "raw_biomarkers": null,
      "raw_cancer_type": "Any solid tumor",
      "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:ema.rozlytrek",
        "type": "Document",
        "documentType": "Regulatory approval",
        "name": "Rozlytrek (entrectinib) [product information]. EMA.",
        "title": null,
        "aliases": [],
        "description": "Roche Registration GmbH. Rozlytrek (entrectinib) [product information]. European Medicines Agency website. https://www.ema.europa.eu/en/documents/product-information/rozlytrek-epar-product-information_en.pdf. Revised July 2023. Accessed March 22, 2024.",
        "urls": [
          "https://www.ema.europa.eu/en/medicines/human/EPAR/rozlytrek",
          "https://www.ema.europa.eu/en/documents/product-information/rozlytrek-epar-product-information_en.pdf"
        ],
        "doi": null,
        "pmid": null,
        "extensions": [
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            "value": {
              "id": "ema",
              "type": "Agent",
              "agentType": "organization",
              "name": "European Medicines Agency",
              "description": "Regulatory agency that approves medicines for use in the European Union.",
              "extensions": [
                {
                  "name": "last_updated",
                  "value": "2025-10-01",
                  "description": ""
                },
                {
                  "name": "url",
                  "value": "https://www.ema.europa.eu/en/medicines",
                  "description": ""
                }
              ]
            },
            "description": "The organization that published this document."
          },
          {
            "name": "company",
            "value": "Roche Registration GmbH.",
            "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": "2020-09-11",
            "description": "The publication date for the initial version of this document."
          },
          {
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            "value": null,
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          },
          {
            "name": "publication_date",
            "value": "2024-07-03",
            "description": "The publication date for the document."
          },
          {
            "name": "status",
            "value": "Active",
            "description": "Whether this document is Active or Deprecated within moalmanac-db."
          }
        ]
      }
    }
  ]
}