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As first and only immunotherapy for adjuvant treatment of cutaneous squamous cell carcinoma (cscc) with a high risk of recurrence after surgery and radiation The fda evaluated libtayo under priority review, which is reserved for medicines that represent potentially significant improvements in efficacy or safety in the treatment of serious conditions. Libtayo fda approval history last updated by judith stewart, bpharm on oct 9, 2025

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Yes (first approved september 28, 2018) brand name Findings showed cemiplimab reduced the risk of disease recurrence or death by 68% compared with placebo See important safety & full prescribing information.