Posted by Michael Wonder on 19 Jan 2022
FDA accepts for review Libtayo (cemiplimab-rwlc) in combination with chemotherapy for first-line treatment of advanced NSCLC
19 January 2022 - Regulatory filing recently submitted in the European Union.
Regeneron Pharmaceuticals today announced that the U.S. FDA has accepted for review the supplemental biologics license application for PD-1 inhibitor Libtayo (cemiplimab-rwlc) in combination with chemotherapy as first-line treatment in advanced non-small-cell lung cancer.
The target action date for the FDA decision is 19 September 2022.
