Posted by Michael Wonder on 28 Sep 2021
FDA accepts Libtayo (cemiplimab-rwlc) for priority review for advanced cervical cancer
28 September 2021 - European Union regulatory submission planned by end of 2021.
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 recurrent or metastatic cervical cancer whose disease progressed on or after chemotherapy.
The target action date for the FDA decision is 30 January 2022.
