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      "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.",
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          "name": "Keytruda (pembrolizumab) [package insert]. FDA.",
          "title": null,
          "aliases": [],
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          "description": "Placeholder. Cat-VRS does not yet support sets of categorical variants. See the 'biomarkers' extension for biomarkers associated with this Proposition."
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              "description": "Type of cancer treatment from cancer.gov: https://www.cancer.gov/about-cancer/treatment/types"
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            "description": "The biomarkers associated with this Proposition, each with a `present` flag indicating if the biomarker is present (true) or absent (false). Multiple biomarkers are combined with implied AND logic."
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          "description": "Whether this Statement is Active, Superseded, or Deprecated within moalmanac-db."
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          "name": "indication",
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            "id": "ind:fda:keytruda:13",
            "type": "Indication",
            "description": "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.",
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                "name": "Keytruda (pembrolizumab) [package insert]. FDA.",
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