{
  "meta": {
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    "message": "Indication id ind:fda.tafinlar:5 retrieved successfully",
    "request_url": "http://api.moalmanac.org/indications?indication_id=ind%3Afda.tafinlar%3A5",
    "status": "success",
    "status_code": 200,
    "timestamp_elapsed": 0.003791,
    "timestamp_received": "2026-04-24T17:04:02.428985+00:00Z",
    "timestamp_returned": "2026-04-24T17:04:02.432776+00:00Z",
    "trace_id": "0e642363-a2a1-4564-ac71-b0beceab6d7f"
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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.tafinlar:5",
      "indication": "TAFINLAR is indicated, in combination with trametinib, for the treatment of adult and pediatric patients 1 year of age and older with unresectable or metastatic solid tumors with BRAF V600E mutation who have progressed following prior treatment and have no satisfactory alternative treatment options. This indication is approved under accelerated approval based on overall response rate (ORR) and duration of response (DoR). Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s).",
      "initial_approval_date": "2022-06-22",
      "initial_approval_url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/202806s022lbl.pdf",
      "description": "The U.S. Food and Drug Administration granted accelerated approval to dabrafenib in combination with trametinib for the treatment of adult and pediatric patients 1 year of age and older with unresectable or metastatic solid tumors with BRAF V600E mutation who have progressed following prior treatment and have no satisfactory alternative treatment options.",
      "raw_biomarkers": "BRAF V600E",
      "raw_cancer_type": "unresectable or metastatic solid tumors",
      "raw_therapeutics": "Tafinlar (dabrafenib) in combination with trametinib",
      "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.tafinlar",
        "type": "Document",
        "documentType": "Regulatory approval",
        "name": "Tafinlar (dabrafenib) [package insert]. FDA.",
        "title": null,
        "aliases": [],
        "description": "Novartis Pharmaceuticals Corporation. Tafinlar (dabrafenib) [package insert]. U.S. Food and Drug Administration website. https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/202806s030lbl.pdf. Revised March 2024. Accessed October 30, 2024.",
        "urls": [
          "https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/202806s030lbl.pdf",
          "https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=202806"
        ],
        "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": [
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                  "name": "last_updated",
                  "value": "2026-04-09",
                  "description": ""
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                  "description": ""
                }
              ]
            },
            "description": "The organization that published this document."
          },
          {
            "name": "company",
            "value": "Novartis Pharmaceuticals Corporation.",
            "description": "The company that manufactures the cancer drug. Only applicable to market authorization documents."
          },
          {
            "name": "drug_name_brand",
            "value": "Tafinlar",
            "description": "The brand name of the cancer drug, per this document. Only applicable to market authorization documents."
          },
          {
            "name": "drug_name_generic",
            "value": "dabrafenib",
            "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."
          },
          {
            "name": "identification_number",
            "value": 202806,
            "description": "Identification number used by the publishing organization."
          },
          {
            "name": "publication_date",
            "value": "2024-03-29",
            "description": "The publication date for the document."
          },
          {
            "name": "status",
            "value": "Active",
            "description": "Whether this document is Active or Deprecated within moalmanac-db."
          }
        ]
      }
    }
  ]
}