{
  "meta": {
    "data_length": 1,
    "message": "Indication id ind:fda.tibsovo:3 retrieved successfully",
    "request_url": "http://api.moalmanac.org/indications?indication_id=ind%3Afda.tibsovo%3A3",
    "status": "success",
    "status_code": 200,
    "timestamp_elapsed": 0.003893,
    "timestamp_received": "2026-04-06T14:48:19.041543+00:00Z",
    "timestamp_returned": "2026-04-06T14:48:19.045436+00:00Z",
    "trace_id": "a22cd4d7-6d51-4420-a643-5d7425d71843"
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  "service": {
    "github": "https://github.com/vanallenlab/moalmanac-db",
    "name": "Molecular Oncology Almanac",
    "license": "GPL-2.0",
    "release": "draft",
    "url": "https://dev.moalmanac.org",
    "last_updated": "2026-03-05"
  },
  "data": [
    {
      "id": "ind:fda.tibsovo:3",
      "indication": "TIBSOVO is an isocitrate dehydrogenase-1 (IDH1) inhibitor indicated for patients with a susceptible IDH1 mutation as detected by an FDA-approved test with for the treatment of adult patients with locally advanced or metastatic cholangiocarcinoma who have been previously treated.",
      "initial_approval_date": "2021-08-25",
      "initial_approval_url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/211192_s008lbl.pdf",
      "description": "The U.S. Food and Drug Administration granted approval to ivosidenib for the treatment adult patients with locally advanced or metastatic cholangiocarcinoma who have been previously treated with a susceptible IDH1 mutation, as detected by an FDA-approved test. This indication is based on Study AG120-C-005 (NCT02989857), a randomized, multicenter, double-blind, placebo-controlled clinical trial consisting of 185 adult patients with locally advanced or metastatic cholangiocarcinoma with an IDH1 mutation. The product label notes that, across both arms of the trial, patients primarily had R132 variants: R132C (70% of patients), R132L (15%), R132G (12%), R132H (1.1%), and R132S (1.6%).",
      "raw_biomarkers": "susceptible IDH1 mutation",
      "raw_cancer_type": "locally advanced or metastatic cholangiocarcinoma",
      "raw_therapeutics": "Tibsovo (ivosidenib)",
      "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.tibsovo",
        "type": "Document",
        "documentType": "Regulatory approval",
        "name": "Tibsovo (ivosidenib) [package insert]. FDA.",
        "title": null,
        "aliases": [],
        "description": "Agios Pharmaceuticals, Inc. Tibsovo (ivosidenib) [package insert]. U.S. Food and Drug Administration website. https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/211192s011lbl.pdf. Revised October 2023. Accessed October 30, 2024.",
        "urls": [
          "https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/211192s011lbl.pdf",
          "https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=211192"
        ],
        "doi": null,
        "pmid": null,
        "extensions": [
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            "name": "agent",
            "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": "2026-03-02",
                  "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": "Agios Pharmaceuticals, Inc.",
            "description": "The company that manufactures the cancer drug. Only applicable to market authorization documents."
          },
          {
            "name": "drug_name_brand",
            "value": "Tibsovo",
            "description": "The brand name of the cancer drug, per this document. Only applicable to market authorization documents."
          },
          {
            "name": "drug_name_generic",
            "value": "ivosidenib",
            "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": 211192,
            "description": "Identification number used by the publishing organization."
          },
          {
            "name": "publication_date",
            "value": "2023-10-24",
            "description": "The publication date for the document."
          },
          {
            "name": "status",
            "value": "Active",
            "description": "Whether this document is Active or Deprecated within moalmanac-db."
          }
        ]
      }
    }
  ]
}