Blow for Sanofi and Regeneron over Libtayo in cervical cancer

French pharma major Sanofi (Euronext: SAN) and its US partner Regeneron (Nasdaq: REGN) have announced the voluntary withdrawal of the supplemental Biologics License Application (sBLA) for Libtayo (cemiplimab-rwlc) as a second-line treatment for patients with advanced cervical cancer.

According to a Sanofi statement, the decision was made after the companies and the US Food and Drug Administration (FDA) were not able to align on certain post-marketing studies. Discussions with regulatory authorities outside of the USA are ongoing, the statement added.

Libtayo is a fully human monoclonal antibody targeting the immune checkpoint receptor PD-1 on T-cells. By binding to PD-1, it has been shown to block cancer cells from using the PD-1 pathway to suppress T-cell activation.