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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 is not chemotherapy or radiation therapy. An additional regulatory application is also under review in the european union, with a decision expected by the first half of 2026.

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See important safety & full prescribing information. Libtayo is the first medicine approved by the food and drug administration (fda) to treat cscc that has spread or cannot be cured by surgery or radiation Regeneron pharmaceuticals) for the adjuvant treatment of adults with cutaneous squamous cell carcinoma (cscc) who are at a high risk of recurrence following surgery and radiation.