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    "name": "Molecular Oncology Almanac",
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  "data": [
    {
      "id": "ind:ema.herceptin:4",
      "indication": "Herceptin is indicated for the treatment of adult patients with HER2 positive early breast cancer (EBC) following surgery, chemotherapy (neoadjuvant or adjuvant) and radiotherapy (if applicable).",
      "initial_approval_date": "2006-06-09",
      "initial_approval_url": "https://www.ema.europa.eu/en/documents/scientific-discussion-variation/herceptin-h-c-278-ii-0026-epar-scientific-discussion-variation_en.pdf",
      "description": "The European Medicines Agency (EMA) has authorized trastuzumab for the treatment of adult patients with HER2 positive early breast cancer (EBC) following surgery, chemotherapy (neoadjuvant or adjuvant), and radiotherapy (if applicable). The production information for trastuzumab notes that trastuzumab should only be used in patients with metastatic or early breast cancer whose tumors have either HER2 overexpression or HER2 gene amplification as determined by an accurate and validated assay.",
      "raw_biomarkers": null,
      "raw_cancer_type": "breast cancer",
      "raw_therapeutics": "Herceptin (trastuzumab)",
      "icd10": null,
      "regimen_code": null,
      "reimbursement_category": null,
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      "date_regular_approval": null,
      "date_accelerated_approval": null,
      "document": {
        "id": "doc:ema.herceptin",
        "type": "Document",
        "documentType": "Regulatory approval",
        "name": "Herceptin (trastuzumab) [product information]. EMA.",
        "title": null,
        "aliases": [],
        "description": "Roche Registration GmbH. Herceptin (trastuzumab) [product information]. European Medicines Agency website. https://www.ema.europa.eu/en/documents/product-information/herceptin-epar-product-information_en.pdf. Revised March 2023. Accessed March 12, 2024.",
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            "description": "The company that manufactures the cancer drug. Only applicable to market authorization documents."
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            "description": "The brand name of the cancer drug, per this document. Only applicable to market authorization documents."
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            "value": "2010-03-01",
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    }
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}