{
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    "message": "Indication id ind:fda.hernexeos:0 retrieved successfully",
    "request_url": "http://api.moalmanac.org/indications?indication_id=ind%3Afda.hernexeos%3A0",
    "status": "success",
    "status_code": 200,
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    "timestamp_received": "2026-04-06T16:09:20.868223+00:00Z",
    "timestamp_returned": "2026-04-06T16:09:20.871695+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": "2026-03-05"
  },
  "data": [
    {
      "id": "ind:fda.hernexeos:0",
      "indication": "HERNEXEOS is a kinase inhibitor indicated for the treatment of adult patients with unresectable or metastatic non-squamous non-small cell lung cancer (NSCLC) whose tumors have HER2 (ERBB2) tyrosine kinase domain activating mutations, as detected by an FDA-approved test. This indication is approved under accelerated approval based on objective 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": "2025-08-08",
      "initial_approval_url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/219042s000lbl.pdf",
      "description": "The U.S. Food and Drug Administration (FDA) granted accelerated approval to zongertinib for the treatment of adult patients with unresectable or metastatic non-squamous non-small cell lung cancer (NSCLC) whose tumors have HER2 (ERBB2) tyrosine kinase domain activating mutations, as detected by an FDA-approved test. This indication is approved under accelerated approval based on objective 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).",
      "raw_biomarkers": "HER2 (ERBB2) tyrosine kinase domain activating mutations",
      "raw_cancer_type": "non-squamous non-small cell lung cancer",
      "raw_therapeutics": "Hernexeos (zongertinib)",
      "icd10": null,
      "regimen_code": null,
      "reimbursement_category": null,
      "reimbursement_date": null,
      "reimbursement_details": null,
      "date_regular_approval": null,
      "date_accelerated_approval": "2025-08-08",
      "document": {
        "id": "doc:fda.hernexeos",
        "type": "Document",
        "documentType": "Regulatory approval",
        "name": "Hernexeos (zongertinib) [package insert]. FDA.",
        "title": null,
        "aliases": [],
        "description": "Boehringer Ingelheim Pharmaceuticals, Inc. Hernexeos (zongertinib) [package insert]. U.S. Food and Drug Administration website. https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/219042s001lbl.pdf. Revised February 2026. Accessed March 2, 2026.",
        "urls": [
          "https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/219042s001lbl.pdf",
          "https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=219042"
        ],
        "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": "Boehringer Ingelheim Pharmaceuticals, Inc.",
            "description": "The company that manufactures the cancer drug. Only applicable to market authorization documents."
          },
          {
            "name": "drug_name_brand",
            "value": "Hernexeos",
            "description": "The brand name of the cancer drug, per this document. Only applicable to market authorization documents."
          },
          {
            "name": "drug_name_generic",
            "value": "sunvozertinib",
            "description": "The generic name of the cancer drug, per this document. Only applicable to market authorization documents."
          },
          {
            "name": "first_publication_date",
            "value": "2025-08-08",
            "description": "The publication date for the initial version of this document."
          },
          {
            "name": "identification_number",
            "value": 219042,
            "description": "Identification number used by the publishing organization."
          },
          {
            "name": "publication_date",
            "value": "2026-02-26",
            "description": "The publication date for the document."
          },
          {
            "name": "status",
            "value": "Active",
            "description": "Whether this document is Active or Deprecated within moalmanac-db."
          }
        ]
      }
    }
  ]
}