On November 8, 2022, the FDA approved cemiplimab-rwlc in combination with platinum-based chemotherapy as first line therapy for patients with advanced non-small cell lung cancer (NSCLC) with no EGFR, ALK, or ROS1 aberrations and irrespective of PDL-1 status. The approval was based on a multi-centre, randomized, phase III trial, in which the addition of cemiplimab-rwlc to platinum based chemotherapy resulted in statistically significant and clinically meaningful improvement in OS compared to placebo plus chemotherapy (HR = 0.71, p-value = 0.0140).