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See important safety & full prescribing information. Libtayo (cemiplimab) in october 2025, the fda approved an sbla for libtayo as an adjuvant treatment for adults with cscc at high risk of recurrence after surgery and radiation, making libtayo the first and only immunotherapy approved in this setting. The phase i and phase ii studies with cemiplimab showed almost 65% and 61% durable disease control in advanced cutaneous scc patients, respectively [20].

Fda label information for this drug is available at dailymed An additional regulatory application is also under review in the european union, with a decision expected by the first half of 2026. Basal cell carcinoma (bcc) (a type of skin cancer).

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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