FDA Accepts Cemiplimab-Rwlc for Priority Review for Advanced Cervical Cancer

The FDA has accepted for priority review the supplemental Biologics License Application (sBLA) for programmed cell death protein 1 (PD-1) inhibitor cemiplimab-rwlc (Libtayo, Regeneron) to treat patients with recurrent or metastatic cervical cancer whose disease progressed on or after chemotherapy. The FDA has set a target action date for decision on January 30, 2022, according to a Regeneron press release.

The sBLA is also under review as part of the FDA’s Project Orbis initiative, which allows for concurrent review by participating health authorities in Australia, Brazil, Canada, and Switzerland.

This review is supported by results from a phase 3 trial that enrolled patients irrespective of PD-L1 expression status and is being conducted with The GOG Foundation, Inc, the European Network for Gynecological Oncological Trial groups, and NRG Oncology-Japan, according to the press release.

Cemiplimab-rwlc is being developed by Regeneron and Sanofi under a global collaboration agreement. The use of the drug for advanced cervical cancer is investigational, with its safety and efficacy not being fully evaluated by any regulatory authority.

REFERENCE

FDA accepts Libtayo (cemiplimab-rwlc) for priority review for advanced cervical cancer. Regeneron. September 28, 2021. Accessed September 28, 2021. https://investor.regeneron.com/index.php/news-releases/news-release-details/fda-accepts-libtayor-cemiplimab-rwlc-priority-review-advanced