Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) announced on 17 October 2025 that the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion for its PD‑1 inhibitor Libtayo (cemiplimab) as an adjuvant treatment for adult patients with cutaneous squamous cell carcinoma (CSCC) at high risk of recurrence after surgery and radiation.
The CHMP decision is based on the global Phase 3 C‑POST trial, which demonstrated a 68 % reduction in disease recurrence or death (hazard ratio 0.32, 95 % CI 0.20‑0.51, p < 0.0001) and a favorable safety profile consistent with Libtayo’s known tolerability. The European Commission is expected to make a final approval decision in the coming months, potentially adding a new revenue stream for Regeneron in the EU market.
Regeneron’s U.S. FDA had already approved Libtayo for the same adjuvant CSCC indication earlier in October, and the EMA positive opinion positions the company to expand its market share in a high‑growth oncology segment, underscoring the material significance of this regulatory milestone.
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