EC approval for Libtayo as adjuvant treatment of high-risk CSCC

20 November 2025

Regeneron Pharmaceuticals (Nasdaq: REGN) has announced that the European Commission (EC) has approved the 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. 

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 US Food and Drug Administration (FDA) in October for the same indication.

This is the sixth approval for Libtayo in the European Union

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