Posted by Michael Wonder on 28 Jun 2021
Libtayo (cemiplimab) approved by the European Commission for first-line treatment of patients with advanced non-small cell lung cancer with ≥50% PD-L1 expression
25 June 2021 - Approval based on a Phase 3 trial demonstrating Libtayo significantly improved overall survival compared to chemotherapy in advanced NSCLC that included challenging-to-treat patient populations.
The European Commission has approved Sanofi and Regeneron’s PD-1 inhibitor Libtayo (cemiplimab) for the first-line treatment of adults with non-small cell lung cancer whose tumour cells have ≥50% PD-L1 expression and no EGFR, ALK or ROS1 aberrations. Patients must have metastatic non-small cell lung cancer or locally advanced non-small cell lung cancer and not be a candidate for definitive chemoradiation.
