{
  "meta": {
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    "message": "Indication id ind:fda.ziihera:0 retrieved successfully",
    "request_url": "http://api.moalmanac.org/indications?indication_id=ind%3Afda.ziihera%3A0",
    "status": "success",
    "status_code": 200,
    "timestamp_elapsed": 0.003865,
    "timestamp_received": "2026-04-23T21:47:52.001037+00:00Z",
    "timestamp_returned": "2026-04-23T21:47:52.004902+00:00Z",
    "trace_id": "be7079cd-cc66-4914-85e1-0a799d70eddc"
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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": "2026-04-09"
  },
  "data": [
    {
      "id": "ind:fda.ziihera:0",
      "indication": "ZIHERA is a bispecific HER2-directed antibody indicated for the treatment of adults with previously treated, unresectable or metastatic HER2-positive (IHC 3+) biliary tract cancer (BTC), as detected by an FDA-approved test. 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": "2024-11-20",
      "initial_approval_url": "https://www.accessdata.fda.gov/drugsatfda_docs/nda/2024/761416Orig1s000Lbl.pdf",
      "description": "The U.S. Food and Drug Administration (FDA) granted accelerated approval to zanitdatamab for the treatment of adult patients with previously treated, unresectable or metastatic HER2-positive (IHC 3+) biliary tract cancer (BTC), as detected by an FDA-approved test. The package insert states that this indication is approved under accelerated approval based on overall response rate and duration of response and that continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s).",
      "raw_biomarkers": "HER2-positive (IHC 3+)",
      "raw_cancer_type": "biliary tract cancer (BTC)",
      "raw_therapeutics": "zanidatamab",
      "icd10": null,
      "regimen_code": null,
      "reimbursement_category": null,
      "reimbursement_date": null,
      "reimbursement_details": null,
      "date_regular_approval": null,
      "date_accelerated_approval": "2024-11-20",
      "document": {
        "id": "doc:fda.ziihera",
        "type": "Document",
        "documentType": "Regulatory approval",
        "name": "Ziihera (zanidatamab-hrii) [package insert]. FDA.",
        "title": null,
        "aliases": [],
        "description": "Astellas Pharma US, Inc. Ziihera (zanidatamab-hrii) [package insert]. U.S. Food and Drug Administration website. https://www.accessdata.fda.gov/drugsatfda_docs/nda/2024/761416Orig1s000Lbl.pdf. Revised November 2024. Accessed January 10, 2025.",
        "urls": [
          "https://www.accessdata.fda.gov/drugsatfda_docs/nda/2024/761416Orig1s000Lbl.pdf",
          "https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=761416"
        ],
        "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": "Astellas Pharma US, Inc.",
            "description": "The company that manufactures the cancer drug. Only applicable to market authorization documents."
          },
          {
            "name": "drug_name_brand",
            "value": "Ziihera",
            "description": "The brand name of the cancer drug, per this document. Only applicable to market authorization documents."
          },
          {
            "name": "drug_name_generic",
            "value": "zanidatamab-hrii",
            "description": "The generic name of the cancer drug, per this document. Only applicable to market authorization documents."
          },
          {
            "name": "first_publication_date",
            "value": "2024-11-20",
            "description": "The publication date for the initial version of this document."
          },
          {
            "name": "identification_number",
            "value": 761416,
            "description": "Identification number used by the publishing organization."
          },
          {
            "name": "publication_date",
            "value": "2024-11-20",
            "description": "The publication date for the document."
          },
          {
            "name": "status",
            "value": "Active",
            "description": "Whether this document is Active or Deprecated within moalmanac-db."
          }
        ]
      }
    }
  ]
}