“Specifically, the CHMP recommended the Libtayo combination be approved in the European Union (EU) for 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 European Commission is expected to make a final decision on the application in the coming months. In November 2022, the Libtayo combination was approved by the U.S. Food and Drug Administration (FDA) for advanced NSCLC regardless of PD-L1 expression.
