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    "name": "Molecular Oncology Almanac",
    "license": "GPL-2.0",
    "release": "draft",
    "url": "https://dev.moalmanac.org",
    "last_updated": "2026-04-09"
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  "data": [
    {
      "id": "ind:fda.keytruda:15",
      "indication": "KEYTRUDA is a programmed death receptor-1 (PD-1)-blocking antibody indicated in combination with chemotherapy, for the treatment of patients with locally recurrent unresectable or metastatic TNBC whose tumors express PD-L1 (CPS >=10) as determined by an FDA approved test.",
      "initial_approval_date": null,
      "initial_approval_url": null,
      "description": "The U.S. Food and Drug Administration granted approval to pembrolizumab in combination with chemotherapy for the treatment of patients with locally recurrent unresectable or metastatic triple negative breast cancer (TNBC) whose tumors express PD-L1 (CPS >= 10), as determined by an FDA approved test. This indication is based on KEYNOTE-355 (NCT02819518), a multicenter, double-blind, randomized, placebo-controlled trial where patients received either paclitaxel and paclitaxel protein-bound, or gemcitabine and carboplatin.",
      "raw_biomarkers": "triple-negative, PD-L1 (CPS >= 10)",
      "raw_cancer_type": "locally recurrent unresectable or metastatic triple-negative breast cancer",
      "raw_therapeutics": "Keytruda (pembrolizumab) in combination with chemotherapy",
      "icd10": null,
      "regimen_code": null,
      "reimbursement_category": null,
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      "date_regular_approval": null,
      "date_accelerated_approval": null,
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        "id": "doc:fda.keytruda",
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        "documentType": "Regulatory approval",
        "name": "Keytruda (pembrolizumab) [package insert]. FDA.",
        "title": null,
        "aliases": [],
        "description": "Merck Sharp & Dohme Corp. Keytruda (pembrolizumab) [package insert]. U.S. Food and Drug Administration website. https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/125514Orig1s186lbl.pdf. Revised February 2026. Accessed March 2, 2026.",
        "urls": [
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            "name": "company",
            "value": "Merck Sharp & Dohme Corp.",
            "description": "The company that manufactures the cancer drug. Only applicable to market authorization documents."
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            "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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          {
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            "value": "2014-09-04",
            "description": "The publication date for the initial version of this document."
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            "description": "The publication date for the document."
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            "name": "status",
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            "description": "Whether this document is Active or Deprecated within moalmanac-db."
          }
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      }
    }
  ]
}