{
  "meta": {
    "data_length": 1,
    "message": "Indication id ind:fda.tazverik:0 retrieved successfully",
    "request_url": "http://api.moalmanac.org/indications?indication_id=ind%3Afda.tazverik%3A0",
    "status": "success",
    "status_code": 200,
    "timestamp_elapsed": 0.004353,
    "timestamp_received": "2026-04-24T03:54:07.030683+00:00Z",
    "timestamp_returned": "2026-04-24T03:54:07.035036+00:00Z",
    "trace_id": "9853560c-e2b2-41a8-a827-7b491e700764"
  },
  "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": "2026-04-09"
  },
  "data": [
    {
      "id": "ind:fda.tazverik:0",
      "indication": "TAZVERIK is a methyltransferase inhibitor indicated for the treatment of adult patients with relapsed or refractory follicular lymphoma whose tumors are positive for an EZH2 mutation as detected by an FDA-approved test and who have received at least 2 prior systemic therapies. These indications are approved under accelerated approval based on overall response rate and duration of response. Continued approval for these indications may be contingent upon verification and description of clinical benefit in a confirmatory trial(s).",
      "initial_approval_date": "2023-11-16",
      "initial_approval_url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/211723s004lbl.pdf",
      "description": "The U.S. Food and Drug Administration granted accelerated approval to tazemetostat for the treatment of adult patients with relapsed or refractory follicular lymphoma whose tumors are positive for an EZH2 mutation, as detected by an FDA-approved test, and who have received at least 2 prior systemic therapies. The product label states that this indication is approved under accelerated approval based on overall response rate and duration of response and that continued approval for this indications may be contingent upon verification and description of clinical benefit in a confirmatory trial(s).",
      "raw_biomarkers": "EZH2 mutation positive",
      "raw_cancer_type": "follicular lymphoma",
      "raw_therapeutics": "Tazverik (tazemetostat)",
      "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.tazverik",
        "type": "Document",
        "documentType": "Regulatory approval",
        "name": "Tazverik (tazemetostat) [package insert]. FDA.",
        "title": null,
        "aliases": [],
        "description": "Epizyme, Inc. Tazverik (tazemetostat) [package insert]. U.S. Food and Drug Administration website. https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/211723s004lbl.pdf. Revised November 2023. Accessed October 30, 2024.",
        "urls": [
          "https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/211723s004lbl.pdf",
          "https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=211723"
        ],
        "doi": null,
        "pmid": null,
        "extensions": [
          {
            "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": "2026-04-09",
                  "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": "Epizyme, Inc.",
            "description": "The company that manufactures the cancer drug. Only applicable to market authorization documents."
          },
          {
            "name": "drug_name_brand",
            "value": "Tazverik",
            "description": "The brand name of the cancer drug, per this document. Only applicable to market authorization documents."
          },
          {
            "name": "drug_name_generic",
            "value": "tazemetostat",
            "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": 211723,
            "description": "Identification number used by the publishing organization."
          },
          {
            "name": "publication_date",
            "value": "2023-11-16",
            "description": "The publication date for the document."
          },
          {
            "name": "status",
            "value": "Active",
            "description": "Whether this document is Active or Deprecated within moalmanac-db."
          }
        ]
      }
    }
  ]
}