{
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    "message": "Indication id ind:fda:bizengri:1 retrieved successfully",
    "request_url": "https://api.moalmanac.org/indications?indication_id=ind%3Afda%3Abizengri%3A1",
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    "timestamp_received": "2026-11-09T16:13:12.163531Z",
    "timestamp_returned": "2026-11-09T16:13:12.165103Z",
    "trace_id": "28991876-e15a-4b79-a24b-8c108e1554cf"
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    "name": "Molecular Oncology Almanac",
    "license": "GPL-2.0",
    "release": "draft",
    "url": "https://moalmanac.org",
    "last_updated": "2026-10-08"
  },
  "data": [
    {
      "id": "ind:fda:bizengri:1",
      "type": "Indication",
      "description": "BIZENGRI is a bispecific HER2- and HER3-directed antibody indicated for the treatment of adults with advanced, unresectable or metastatic pancreatic adenocarcinoma harboring a neuregulin 1 (NRG1) gene fusion with disease progression on or after prior systemic therapy. 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).",
      "contributions": [
        {
          "id": "ctrb:vanallenlab:2025-01-10:0",
          "type": "Contribution",
          "description": "Additional FDA approvals for initial version",
          "date": "2025-01-10",
          "contributor": {
            "id": "agent:user:vanallenlab",
            "type": "Agent",
            "agentType": "contributor",
            "name": "Van Allen lab",
            "description": "Van Allen lab, Dana-Farber Cancer Institute"
          }
        },
        {
          "id": "ctrb:fda:2024-12-04:0",
          "type": "Contribution",
          "description": "Indication received accelerated approval.",
          "date": "2024-12-04",
          "contributor": {
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            "type": "Agent",
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            "name": "Food and Drug Administration",
            "description": "Regulatory agency that approves drugs for use in the United States."
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          "id": "doc:fda:bizengri",
          "type": "Document",
          "documentType": "Regulatory approval",
          "name": "Bizengri (zenocutuzumab-zbco) [package insert]. FDA.",
          "title": null,
          "aliases": [],
          "description": "Merus N.V. Bizengri (zenocutuzumab) [package insert]. U.S. Food and Drug Administration website. https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/761352s010lbl.pdf. Revised May 2026. Accessed October 8, 2026.",
          "urls": [
            "https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/761352s010lbl.pdf",
            "https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=761352"
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              "description": "The organization that published this document."
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            {
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              "value": "Merus N.V.",
              "description": "The company that manufactures the cancer drug. Only applicable to market authorization documents."
            },
            {
              "name": "drug_name_brand",
              "value": "Bizengri",
              "description": "The brand name of the cancer drug, per this document. Only applicable to market authorization documents."
            },
            {
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              "value": "zenocutuzumab-zbco",
              "description": "The generic name of the cancer drug, per this document. Only applicable to market authorization documents."
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              "name": "first_publication_date",
              "value": "2024-12-04",
              "description": "The publication date for the initial version of this document."
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              "value": "2026-05-08",
              "description": "The publication date for the document."
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              "name": "status",
              "value": "Active",
              "description": "Whether this document is Active or Deprecated within moalmanac-db."
            }
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          "id": "doc:fda:bizengri:2024-12-04",
          "type": "Document",
          "documentType": "Regulatory approval",
          "name": "Bizengri (zenocutuzumab-zbco) [package insert]. FDA.",
          "title": null,
          "aliases": [],
          "description": "Merus N.V. Bizengri (zenocutuzumab-zbco) [package insert]. U.S. Food and Drug Administration website. https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/761352s001lbl.pdf. Revised December 2024. Accessed October 6, 2026.",
          "urls": [
            "https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/761352s001lbl.pdf",
            "https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=761352"
          ],
          "doi": null,
          "pmid": null,
          "extensions": [
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              "name": "agent",
              "value": {
                "id": "agent:org:fda",
                "type": "Agent",
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              "description": "The organization that published this document."
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              "value": "Bizengri",
              "description": "The brand name of the cancer drug, per this document. Only applicable to market authorization documents."
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              "value": "zenocutuzumab-zbco",
              "description": "The generic name of the cancer drug, per this document. Only applicable to market authorization documents."
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            {
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              "value": "2024-12-04",
              "description": "The publication date for the initial version of this document."
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              "value": "2024-12-04",
              "description": "The publication date for the document."
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              "description": "Identifier assigned by the regulatory agency, such as an FDA application number (e.g. NDA208716, BLA125427) or an EMA product number (e.g. EMEA/H/C/006184)."
            },
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              "value": "Deprecated",
              "description": "Whether this document is Active or Deprecated within moalmanac-db."
            }
          ]
        }
      ],
      "extensions": [
        {
          "name": "status",
          "value": "Accelerated",
          "description": "Current approval status."
        },
        {
          "name": "statement description",
          "value": "The U.S. Food and Drug Administration (FDA) granted accelerated approval to zenocutuzumab for the treatment of adult patients with advanced, unresectable or metastatic pancreatic adenocarcinoma harboring a neuregulin 1 (NRG1) gene fusion with disease progression on or after prior systemic therapy. The package insert notes 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).",
          "description": "The description text for all Statements derived from this Indication."
        }
      ]
    }
  ]
}