{
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    "message": "Indication id ind:fda.lytgobi:0 retrieved successfully",
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    "status": "success",
    "status_code": 200,
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    "timestamp_received": "2026-04-24T17:04:03.629115+00:00Z",
    "timestamp_returned": "2026-04-24T17:04:03.633019+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"
  },
  "data": [
    {
      "id": "ind:fda.lytgobi:0",
      "indication": "LYTGOBI is a kinase inhibitor indicated for the treatment of adult patients with previously treated, unresectable, locally advanced or metastatic intrahepatic cholangiocarcinoma harboring fibroblast growth factor receptor 2 (FGFR2) gene fusions or other rearrangements. 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 a confirmatory trial(s).",
      "initial_approval_date": "2022-09-30",
      "initial_approval_url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/214801Orig1s000lbledt.pdf",
      "description": "The U.S. Food and Drug Administration granted accelerated approval to futibatinib for the treatment of adult patients with previously treated, unresectable, locally advanced or metastatic intrahepatic cholangiocarcinoma harboring fibroblast growth factor receptor 2 (FGFR2) gene fusions or other rearrangements. Futibatinib's package insert states that this indication is approved under accelerated approval based on overall response rate and duration of response. Furthermore, continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s).",
      "raw_biomarkers": "FGFR2 gene fusions or other rearrangements",
      "raw_cancer_type": "unresectable, locally or metastatic intrahepatic cholangiocarcinoma",
      "raw_therapeutics": "Lytgobi (futibatinib)",
      "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.lytgobi",
        "type": "Document",
        "documentType": "Regulatory approval",
        "name": "Lytgobi (futibatinib) [package insert]. FDA.",
        "title": null,
        "aliases": [],
        "description": "Taiho Pharmaceutical Co., Ltd. Lytgobi (futibatinib) [package insert]. U.S. Food and Drug Administration website. https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/214801s002lbl.pdf. Revised April 2024. Accessed October 30, 2024.",
        "urls": [
          "https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/214801s002lbl.pdf",
          "https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=214801"
        ],
        "doi": null,
        "pmid": null,
        "extensions": [
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            "value": {
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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": ""
                },
                {
                  "name": "url",
                  "value": "https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm",
                  "description": ""
                }
              ]
            },
            "description": "The organization that published this document."
          },
          {
            "name": "company",
            "value": "Taiho Pharmaceutical Co., Ltd.",
            "description": "The company that manufactures the cancer drug. Only applicable to market authorization documents."
          },
          {
            "name": "drug_name_brand",
            "value": "Lytgobi",
            "description": "The brand name of the cancer drug, per this document. Only applicable to market authorization documents."
          },
          {
            "name": "drug_name_generic",
            "value": "futibatinib",
            "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": 214801,
            "description": "Identification number used by the publishing organization."
          },
          {
            "name": "publication_date",
            "value": "2024-04-17",
            "description": "The publication date for the document."
          },
          {
            "name": "status",
            "value": "Active",
            "description": "Whether this document is Active or Deprecated within moalmanac-db."
          }
        ]
      }
    }
  ]
}