Regeneron (REGN) Pharmaceuticals announced that the European Commission, EC, has approved the PD-1 inhibitor Libtayo as an adjuvant treatment for adult patients with cutaneous squamous cell carcinoma, CSCC, at high risk of recurrence after surgery and radiation. This expands the existing European Union, EU, indication for Libtayo in advanced CSCC to include patients at high risk of disease recurrence. Libtayo was also recently approved by the U.S. Food and Drug Administration, FDA, in October for the same indication. The approval is supported by data from the global Phase 3 C-POST trial, which evaluated adjuvant Libtayo versus placebo in patients with CSCC at high risk of recurrence following surgery and radiation. Libtayo demonstrated a 68% reduction in the risk of disease recurrence or death compared to placebo. Detailed data were published in the New England Journal of Medicine in May 2025.
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