{
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    "name": "Molecular Oncology Almanac",
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    "url": "https://dev.moalmanac.org",
    "last_updated": "2026-04-09"
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  "data": [
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      "id": "ind:ema.herceptin:7",
      "indication": "Herceptin is indicated for the treatment of adult patients with HER2 positive early breast cancer (EBC) in combination with neoadjuvant chemotherapy followed by adjuvant Herceptin therapy, for locally advanced (including inflammatory) disease or tumours > 2 cm in diameter.",
      "initial_approval_date": "2012-05-07",
      "initial_approval_url": "https://www.ema.europa.eu/en/documents/variation-report/herceptin-h-c-278-ii-0057-epar-assessment-report-variation_en.pdf",
      "description": "The European Medicines Agency (EMA) has authorized trastuzumab in combination with neoadjuvant chemotherapy followed by adjuvant trastuzumab for the treatment of adult patients with HER2 positive early breast cancer (EBC) whose tumors are locally advanced (including inflammatory) disease or > 2 cm in diameter. This indication is based on the multicenter randomized trial MO16432 which used doxorubicin in combination with paclitaxel for the neoadjuvant chemotherapy. 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) in combination with neoadjuvant chemotherapy",
      "icd10": null,
      "regimen_code": null,
      "reimbursement_category": null,
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      "reimbursement_details": null,
      "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.",
        "urls": [
          "https://www.ema.europa.eu/en/medicines/human/EPAR/herceptin",
          "https://www.ema.europa.eu/en/documents/product-information/herceptin-epar-product-information_en.pdf"
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        "pmid": null,
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              "extensions": [
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                  "description": ""
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                  "name": "url",
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                  "description": ""
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            "description": "The organization that published this document."
          },
          {
            "name": "company",
            "value": "Roche Registration GmbH.",
            "description": "The company that manufactures the cancer drug. Only applicable to market authorization documents."
          },
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            "value": "Herceptin",
            "description": "The brand name of the cancer drug, per this document. Only applicable to market authorization documents."
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            "value": "trastuzumab",
            "description": "The generic name of the cancer drug, per this document. Only applicable to market authorization documents."
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            "value": "2010-03-01",
            "description": "The publication date for the initial version of this document."
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            "value": "2023-03-17",
            "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."
          }
        ]
      }
    }
  ]
}