{
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    "github": "https://github.com/vanallenlab/moalmanac-db",
    "name": "Molecular Oncology Almanac",
    "license": "GPL-2.0",
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    "url": "https://dev.moalmanac.org",
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  "data": [
    {
      "id": "ind:ema.keytruda:11",
      "indication": "KEYTRUDA, in combination with chemotherapy, is indicated for the treatment of locally recurrent unresectable or metastatic triple-negative breast cancer in adults whose tumours express PD-L1 with a CPS >= 10 and who have not received prior chemotherapy for metastatic disease.",
      "initial_approval_date": "2021-10-28",
      "initial_approval_url": "https://www.ema.europa.eu/en/documents/variation-report/keytruda-h-c-3820-ii-0099-epar-assessment-report-variation_en.pdf",
      "description": "The European Medicines Agency (EMA) has authorized pembrolizumab in combination with chemotherapy for the treatment of adult patients with locally recurrent unresectable or metastatic triple-negative breast cancer whose tumors express PD-L1 with a combined positive score (CPS) >= 10 and who have not received prior chemotherapy for metastatic disease. This indication is based on KEYNOTE-355, a phase 3, randomizewd, double-blind, multi-center, placebo-controlled study where the efficacy of pembrolizumab in combination with: (i) paclitaxel, (ii) nab-paclitaxel, or (iii) gemcitabine and carboplatin were investigated for the treatment of patients with TNBC who were previously untreated for metastatic disease.",
      "raw_biomarkers": null,
      "raw_cancer_type": "Triple-negative breast cancer",
      "raw_therapeutics": "Keytruda (pembrolizumab) in combination with 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.keytruda",
        "type": "Document",
        "documentType": "Regulatory approval",
        "name": "Keytruda (pembrolizumab) [product information]. EMA.",
        "title": null,
        "aliases": [],
        "description": "Merck Sharp & Dohme B.V. Keytruda (pembrolizumab) [product information]. European Medicines Agency website. https://www.ema.europa.eu/en/documents/product-information/keytruda-epar-product-information_en.pdf. Revised January 2024. Accessed March 10, 2024.",
        "urls": [
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          "https://www.ema.europa.eu/en/documents/product-information/keytruda-epar-product-information_en.pdf"
        ],
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        "pmid": null,
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              "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": "Merck Sharp & Dohme B.V.",
            "description": "The company that manufactures the cancer drug. Only applicable to market authorization documents."
          },
          {
            "name": "drug_name_brand",
            "value": "Keytruda",
            "description": "The brand name of the cancer drug, per this document. Only applicable to market authorization documents."
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            "value": "pembrolizumab",
            "description": "The generic name of the cancer drug, per this document. Only applicable to market authorization documents."
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            "value": "2015-07-30",
            "description": "The publication date for the initial version of this document."
          },
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            "value": null,
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            "value": "2024-01-11",
            "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."
          }
        ]
      }
    }
  ]
}