U.S. FDA Accepts Human Monoclonal Antibody for Priority Review Targeting Advanced Cervical Cancer
New York-based Regeneron Pharmaceuticals, Inc. announced on September 28, 2021, the U.S. Food and Drug Administration (FDA) has accepted for priority review the supplemental Biologics License Application (sBLA) 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 January 30, 2022.
The sBLA is also being reviewed under the FDA's Project Orbis initiative, which will allow for concurrent review by participating health authorities in Australia, Brazil, Canada, and Switzerland. Additional global regulatory submissions are planned, including in the European Union, by the end of 2021.
The use of Libtayo in advanced cervical cancer is investigational, and its safety and efficacy have not been thoroughly evaluated by any regulatory authority.
Libtayo, which was invented using Regeneron's proprietary VelocImmune® technology. Libtayo is a fully human monoclonal antibody targeting the PD-1 immune checkpoint receptor on T-cells. By binding to PD-1, Libtayo has been shown to block cancer cells from using the PD-1 pathway to suppress T-cell activation.
Regeneron and Sanofi jointly develop it under a global collaboration agreement.
Regeneron (NASDAQ: REGN) is a leading biotechnology company that invents life-transforming medicines for people with serious diseases.