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See important safety & full prescribing information. Yes (first approved september 28, 2018) brand name 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
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An additional regulatory application is also under review in the european union, with a decision expected by the first half of 2026. Libtayo fda approval history last updated by judith stewart, bpharm on oct 9, 2025 Findings showed cemiplimab reduced the risk of disease recurrence or death by 68% compared with placebo
Food and drug administration approved adjuvant cemiplimab (libtayo) for adults with cutaneous squamous cell carcinoma who are at a high risk for recurrence after surgery and radiation.
