{
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    "message": "Indication id ind:fda.tykerb:0 retrieved successfully",
    "request_url": "http://api.moalmanac.org/indications?indication_id=ind%3Afda.tykerb%3A0",
    "status": "success",
    "status_code": 200,
    "timestamp_elapsed": 0.003794,
    "timestamp_received": "2026-04-23T23:24:26.662695+00:00Z",
    "timestamp_returned": "2026-04-23T23:24:26.666489+00:00Z",
    "trace_id": "3240ab23-527c-4f4b-8196-e5ba077fa125"
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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.tykerb:0",
      "indication": "TYKERB is a kinase inhibitor indicated in combination with capecitabine for the treatment of patients with advanced or metastatic breast cancer whose tumors overexpress human epidermal growth factor receptor 2 (HER2) and who have received prior therapy, including an anthracycline, a taxane, and trastuzumab. Limitations of Use: Patients should have disease progression on trastuzumab prior to initiation of treatment with TYKERB in combination with capecitabine. TYKERB in combination with an aromatase inhibitor has not been compared to a trastuzumab-containing chemotherapy regimen for the treatment of metastatic breast cancer.",
      "initial_approval_date": "2007-03-13",
      "initial_approval_url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/022059lbl.pdf",
      "description": "The U.S. Food and Drug Administration granted approval to lapatinib in combination with capecitabine for the treatment of patients with advanced or metastatic breast cancer whose tumors overexpress human epidermal growth factor 2 (HER2) and who have received prior therapy, including an anthracycline, a taxane, a trastuzumab.",
      "raw_biomarkers": "HER2 overexpression",
      "raw_cancer_type": "advanced or metastatic breast cancer",
      "raw_therapeutics": "Tykerb (lapatinib) in combination with capecitabine",
      "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.tykerb",
        "type": "Document",
        "documentType": "Regulatory approval",
        "name": "Tykerb (lapatinib) [package insert]. FDA.",
        "title": null,
        "aliases": [],
        "description": "Novartis Pharmaceuticals Corporation. Tykerb (lapatinib) [package insert]. U.S. Food and Drug Administration website. https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/022059s031lbl.pdf. Revised March 2022. Accessed October 30, 2024.",
        "urls": [
          "https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/022059s031lbl.pdf",
          "https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=022059"
        ],
        "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": "Novartis Pharmaceuticals Corporation.",
            "description": "The company that manufactures the cancer drug. Only applicable to market authorization documents."
          },
          {
            "name": "drug_name_brand",
            "value": "Tykerb",
            "description": "The brand name of the cancer drug, per this document. Only applicable to market authorization documents."
          },
          {
            "name": "drug_name_generic",
            "value": "lapatinib",
            "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": 22059,
            "description": "Identification number used by the publishing organization."
          },
          {
            "name": "publication_date",
            "value": "2022-03-27",
            "description": "The publication date for the document."
          },
          {
            "name": "status",
            "value": "Active",
            "description": "Whether this document is Active or Deprecated within moalmanac-db."
          }
        ]
      }
    }
  ]
}