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    "name": "Molecular Oncology Almanac",
    "license": "GPL-2.0",
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    "last_updated": "2026-04-09"
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  "data": [
    {
      "id": "ind:ema.tyverb:1",
      "indication": "Tyverb is indicated for the treatment of adult patients with breast cancer, whose tumours overexpress HER2 (ErbB2) in combination with trastuzumab for patients with hormone receptor-negative metastatic disease that has progressed on prior trastuzumab therapy(ies) in combination with chemotherapy.",
      "initial_approval_date": "2013-08-14",
      "initial_approval_url": "https://www.ema.europa.eu/en/documents/variation-report/tyverb-h-c-795-ii-0022-epar-assessment-report-variation_en.pdf",
      "description": "The European Medicines Agency (EMA) has authorized laplatinib in combination with trastuzumab for the treatment of adult patients with breast cancer, whose tumors overexpress HER2 (ErbB2), with hormone receptor-negative metastatic disease that has progressed on prior trastuzumab therapy in combination with chemotherapy. 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 trastuzumab and chemotherapy",
      "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",
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        "pmid": null,
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              "id": "ema",
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              "agentType": "organization",
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              "description": "Regulatory agency that approves medicines for use in the European Union.",
              "extensions": [
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                  "name": "last_updated",
                  "value": "2025-10-01",
                  "description": ""
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                {
                  "name": "url",
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            "description": "The organization that published this document."
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          {
            "name": "company",
            "value": "Novartis Europharm Limited.",
            "description": "The company that manufactures the cancer drug. Only applicable to market authorization documents."
          },
          {
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            "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."
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          {
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            "value": null,
            "description": "Identification number used by the publishing organization."
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          {
            "name": "publication_date",
            "value": "2023-05-10",
            "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."
          }
        ]
      }
    }
  ]
}