{
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    "timestamp_received": "2026-04-24T03:10:47.241299+00:00Z",
    "timestamp_returned": "2026-04-24T03:10:47.245967+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": "2026-04-09"
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  "data": [
    {
      "id": "ind:ema.tyverb:0",
      "indication": "Tyverb is indicated for the treatment of adult patients with breast cancer, whose tumours overexpress HER2 (ErbB2) in combination with capecitabine for patients with advanced or metastatic disease with progression following prior therapy, which must have included anthracyclines and taxanes and therapy with trastuzumab in the metastatic setting.",
      "initial_approval_date": "2010-06-09",
      "initial_approval_url": "https://www.ema.europa.eu/en/documents/variation-report/tyverb-h-c-795-ii-0004-epar-assessment-report-variation_en.pdf",
      "description": "The European Medicines Agency (EMA) has authorized laplatinib in combination with capecitabine for the treatment of adult patients with breast cancer, whose tumors overexpress HER2 (ErbB2), with advanced or metastatic disease with progression following prior therapy, which must have included anthracyclines and taxanes and therapy with trastuzumab in the metastatic setting. Lapatinib's product information sheet further defines HER2 (ErbB2) overexpressing tumors as IHC3+, or IHC2+ with gene amplification or gene amplification alone.",
      "raw_biomarkers": null,
      "raw_cancer_type": "Breast cancer",
      "raw_therapeutics": "Tyverb (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:ema.tyverb",
        "type": "Document",
        "documentType": "Regulatory approval",
        "name": "Tyverb (lapatinib) [product information]. EMA.",
        "title": null,
        "aliases": [],
        "description": "Novartis Europharm Limited. Tyverb (lapatinib) [product information]. European Medicines Agency website. https://www.ema.europa.eu/en/documents/product-information/tyverb-epar-product-information_en.pdf. Revised May 2023. Accessed March 25, 2024.",
        "urls": [
          "https://www.ema.europa.eu/en/medicines/human/EPAR/tyverb",
          "https://www.ema.europa.eu/en/documents/product-information/tyverb-epar-product-information_en.pdf"
        ],
        "doi": null,
        "pmid": null,
        "extensions": [
          {
            "name": "agent",
            "value": {
              "id": "ema",
              "type": "Agent",
              "agentType": "organization",
              "name": "European Medicines Agency",
              "description": "Regulatory agency that approves medicines for use in the European Union.",
              "extensions": [
                {
                  "name": "last_updated",
                  "value": "2025-10-01",
                  "description": ""
                },
                {
                  "name": "url",
                  "value": "https://www.ema.europa.eu/en/medicines",
                  "description": ""
                }
              ]
            },
            "description": "The organization that published this document."
          },
          {
            "name": "company",
            "value": "Novartis Europharm Limited.",
            "description": "The company that manufactures the cancer drug. Only applicable to market authorization documents."
          },
          {
            "name": "drug_name_brand",
            "value": "Tyverb",
            "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": "2009-11-17",
            "description": "The publication date for the initial version of this document."
          },
          {
            "name": "identification_number",
            "value": null,
            "description": "Identification number used by the publishing organization."
          },
          {
            "name": "publication_date",
            "value": "2023-05-10",
            "description": "The publication date for the document."
          },
          {
            "name": "status",
            "value": "Active",
            "description": "Whether this document is Active or Deprecated within moalmanac-db."
          }
        ]
      }
    }
  ]
}