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See important safety & full prescribing information. Review important safety info & full prescribing information including med guide. 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. • for the treatment of patients with metastatic cutaneous squamous cell carcinoma (cscc)(mcscc) or locally advanced cscc (lacscc) who are not candidates for curative surgery or curative radiation. Findings showed cemiplimab reduced the risk of disease recurrence or death by 68% compared with placebo

View full prescribing information for libtayo.

Fda approved indication(s) libtayo is indicated