Biotechnology company Regeneron Pharmaceuticals (NASDAQ:REGN) said on Wednesday that the European Commission has approved Libtayo (cemiplimab) in combination with platinum-based chemotherapy for the first-line treatment of adult patients with advanced non-small cell lung cancer (NSCLC) with ≥1% PD-L1 expression.

This includes patients that have no EGFR, ALK or ROS1 aberrations and whose tumours are metastatic or locally advanced and not candidates for definitive chemoradiation.

The Commission's approval was based on positive data from a Phase 3 trial which investigated a first-line combination treatment of Libtayo and platinum-doublet chemotherapy (Libtayo combination), compared to platinum-doublet chemotherapy alone.

Libtayo is currently approved in the EU and other countries for the treatment of certain patients with advanced basal cell carcinoma (BCC), advanced cutaneous squamous cell carcinoma (CSCC), advanced NSCLC and advanced cervical cancer. The Libtayo combination was approved by the US Food and Drug Administration (FDA) for advanced NSCLC regardless of PD-L1 expression in November 2022.