Posted by Michael Wonder on 28 Jan 2022
Regeneron and Sanofi provide regulatory update on Libtayo (cemiplimab-rwlc) in advanced cervical cancer
28 January 2022 - Regeneron Pharmaceuticals and Sanofi today announced the voluntary withdrawal of the supplemental biologics license application for Libtayo (cemiplimab-rwlc) as a second-line treatment for patients with advanced cervical cancer.
The decision was made after the companies and the U.S. FDA were not able to align on certain post-marketing studies. Discussions with regulatory authorities outside of the U.S. are on-going.
