Posted by Michael Wonder on 29 Oct 2020
FDA accepts for priority review Libtayo (cemiplimab-rwlc) for advanced non-small cell lung cancer with PD-L1 expression of ≥50%
29 October 2020 - Regeneron Pharmaceuticals today announced that the U.S. FDA has accepted for priority review the supplemental biologics license application for PD-1 inhibitor Libtayo (cemiplimab-rwlc) to treat patients with first-line locally advanced or metastatic non-small cell lung cancer with ≥50% PD-L1 expression.
The target action date for the FDA decision is 28 February 2021.
