{
  "meta": {
    "data_length": 1,
    "message": "Indication id ind:ema.tyverb:2 retrieved successfully",
    "request_url": "http://api.moalmanac.org/indications?indication_id=ind%3Aema.tyverb%3A2",
    "status": "success",
    "status_code": 200,
    "timestamp_elapsed": 0.003762,
    "timestamp_received": "2026-04-24T00:56:18.302159+00:00Z",
    "timestamp_returned": "2026-04-24T00:56:18.305921+00:00Z",
    "trace_id": "d5de5f2e-548f-48fe-b1b5-81f7da140640"
  },
  "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:ema.tyverb:2",
      "indication": "Tyverb is indicated for the treatment of adult patients with breast cancer, whose tumours overexpress HER2 (ErbB2) in combination with an aromatase inhibitor for postmenopausal women with hormone receptor positive metastatic disease, not currently intended for chemotherapy. The patients in the registration study were not previously treated with trastuzumab or an aromatase inhibitor. No data are available on the efficacy of this combination relative to trastuzumab in combination with an aromatase inhibitor in this patient population.",
      "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 an aromatase inhibitor for postmenopausal women with hormone receptor positive metastatic disease, not currently intended for chemotherapy. This indication states that the patients in the registration study were not previosuly treated with trastuzumab or an aromatase inhibitor and that no data are available on the efficacy of this combination relative to trastuzumab in combination with an aromatase inhibitor in this patient population. This indication is based on the randomized, double-blind, and placebo controlled phase 3 study EGF30008, which used Letrozole as an aromatase inhibitor. 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 an aromataste inhibitor",
      "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."
          }
        ]
      }
    }
  ]
}