03:05 PM EDT, 10/08/2025 (MT Newswires) -- Regeneron Pharmaceuticals ( REGN ) said Wednesday the US Food and Drug Administration approved Libtayo as an adjuvant treatment for adults with skin cancer cutaneous squamous cell carcinoma at high risk of recurrence after surgery and radiation.

The FDA assessed Libtayo under Priority Review. Another regulatory application is under review in the European Union, with a decision expected by H1 2026, according to the company.

The FDA approval is based on data from a phase 3 trial of Libtayo. The immunotherapy treatment showcased a 68% reduction in the risk of disease recurrence or death compared with the placebo group, according to a statement.

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