EU - EC Decision for Regeneron's Libtayo extension of indication in 1L advanced PD-L1+ NSCLC

Regeneron has announced that the European Commission (EC) has issued its Decision for Libtayo (cemiplimab) extension of indication 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 tumors are metastatic or locally advanced and not candidates for definitive chemoradiation.

The approval is based on data from the global Phase 3 EMPOWER-Lung 3 trial (NCT03409614), a randomized, multicenter trial investigating a first-line combination treatment of Libtayo and platinum-doublet chemotherapy (Libtayo combination), compared to platinum-doublet chemotherapy alone.

A a reminder, Libtayo extension of indication got a positive CHMP Opinion in February 2023 (cf. previous alert).

Reference link: Regeneron press release