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    "name": "Molecular Oncology Almanac",
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    "release": "draft",
    "url": "https://dev.moalmanac.org",
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  "data": [
    {
      "id": "ind:fda.keytruda:2",
      "indication": "KEYTRUDA is a programmed death receptor-1 (PD-1)-blocking antibody indicated as a single agent for the treatment of patients with metastatic NSCLC whose tumors express PD-L1 (TPS >=1%) as determined by an FDA-approved test, with disease progression on or after platinum containing chemotherapy. Patients with EGFR or ALK genomic tumor aberrations should have disease progression on FDA-approved therapy for these aberrations prior to receiving KEYTRUDA.",
      "initial_approval_date": null,
      "initial_approval_url": null,
      "description": "The U.S. Food and Drug Administration granted approval to pembrolizumab for the treatment of patients with metastatic non-small cell lung cancer (NSCLC) whose tumors express PD-L1 [Tumor Proportion Score (TPS) >=1%], as determined by an FDA-approved test, with disease progression on or after platinum containing chemotherapy. The product label further states that patients with EGFR or ALK genomic tumor aberrations should have disease progression on FDA-approved therapy for these aberrations prior to receiving KEYTRUDA.",
      "raw_biomarkers": "PD-L1 [Tumor Proportion Score (TPS) >= 1%",
      "raw_cancer_type": "metastatic non-small cell lung cancer",
      "raw_therapeutics": "Keytruda (pembrolizumab)",
      "icd10": null,
      "regimen_code": null,
      "reimbursement_category": null,
      "reimbursement_date": null,
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      "date_regular_approval": null,
      "date_accelerated_approval": null,
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        "id": "doc:fda.keytruda",
        "type": "Document",
        "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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          "https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=125514"
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        "pmid": null,
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                  "description": ""
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            "description": "The organization that published this document."
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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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            "value": "Active",
            "description": "Whether this document is Active or Deprecated within moalmanac-db."
          }
        ]
      }
    }
  ]
}