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    "message": "Indication id ind:fda.keytruda:13 retrieved successfully",
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    "timestamp_received": "2026-04-24T00:41:16.599518+00:00Z",
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    "name": "Molecular Oncology Almanac",
    "license": "GPL-2.0",
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    "url": "https://dev.moalmanac.org",
    "last_updated": "2026-04-09"
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  "data": [
    {
      "id": "ind:fda.keytruda:13",
      "indication": "KEYTRUDA is a programmed death receptor-1 (PD-1)-blocking antibody indicated for the treatment of adult and pediatric patients with unresectable or metastatic tumor mutational burden-high (TMB-H) [>=10 mutations/megabase (mut/Mb)] solid tumors, as determined by an FDA-approved test, that have progressed following prior treatment and who have no satisfactory alternative treatment options. The safety and effectiveness of KEYTRUDA in pediatric patients with TMB-H central nervous system cancers have not been established. This indication is approved under accelerated approval based on tumor response rate and durability of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trials.",
      "initial_approval_date": null,
      "initial_approval_url": null,
      "description": "The U.S. Food and Drug Administration granted accelerated approval to pembrolizumab for the treatment of adult and pediatric patients with unresectable or metastatic tumor mutational burden-high (TMB-H) [>=10 mutations/megabase (mut/Mb)] solid tumors, as determined by an FDA-approved test, that have progressed following prior treatment and who have no satisfactory alternative treatment options. The product label states that the safety and effectiveness of pembrolizumab in pediatric patients with TMB-H central nervous system cancers have not been established and that this indication is approved under accelerated approval based on tumor response rate and durability of response. Furthermore, it states that continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trials.",
      "raw_biomarkers": "TMB-H [>= 10 mutations / megabase]",
      "raw_cancer_type": "unresectable or metastatic ... solid tumors",
      "raw_therapeutics": "Keytruda (pembrolizumab)",
      "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: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": [
          "https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/125514Orig1s186lbl.pdf",
          "https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=125514"
        ],
        "doi": null,
        "pmid": null,
        "extensions": [
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              "id": "fda",
              "type": "Agent",
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              "name": "Food and Drug Administration",
              "description": "Regulatory agency that approves drugs for use in the United States.",
              "extensions": [
                {
                  "name": "last_updated",
                  "value": "2026-04-09",
                  "description": ""
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                  "name": "url",
                  "value": "https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm",
                  "description": ""
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            },
            "description": "The organization that published this document."
          },
          {
            "name": "company",
            "value": "Merck Sharp & Dohme Corp.",
            "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."
          },
          {
            "name": "drug_name_generic",
            "value": "pembrolizumab",
            "description": "The generic name of the cancer drug, per this document. Only applicable to market authorization documents."
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          {
            "name": "first_publication_date",
            "value": "2014-09-04",
            "description": "The publication date for the initial version of this document."
          },
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            "value": 125514,
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            "name": "publication_date",
            "value": "2026-02-10",
            "description": "The publication date for the document."
          },
          {
            "name": "status",
            "value": "Active",
            "description": "Whether this document is Active or Deprecated within moalmanac-db."
          }
        ]
      }
    }
  ]
}