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Oct 9, 2025 4:00 PM

Regeneron's Libtayo Gains FDA Approval To Reduce Recurrence Risk In Skin Cancer Patients

On Wednesday, the U.S. Food and Drug Administration (FDA) approved Regeneron Pharmaceuticals Inc.’s (NASDAQ:REGN) PD-1 inhibitor Libtayo (cemiplimab-rwlc) as an adjuvant treatment for adult patients with cutaneous squamous cell carcinoma (CSCC) at high risk of recurrence after surgery and radiation.

The FDA evaluated Libtayo under Priority Review. An additional regulatory application is also under review in the European Union, with a decision expected by the first half of 2026.

The FDA approval is based on pivotal Phase 3 C-POST trial data.

Also Read: Regeneron Touts Positive Data From Phase 3 Study In Patients With Ultra-Rare Genetic Disorder

Data

The study showed that Libtayo demonstrated ...