Regeneron and Sanofi announced the voluntary withdrawal of the supplemental Biologics License Application (sBLA) for cemiplimab-rwlc as a second-line treatment for patients with advanced cervical cancer.

In September 2021, the Food and Drug Administration (FDA) accepted for Priority Review the sBLA for cemiplimab-rwlc, a programmed death receptor-1 (PD-1) blocking antibody, for the treatment of patients with recurrent or metastatic cervical cancer whose disease progressed on or after chemotherapy. The application included positive overall survival data from an open-label, randomized, multicenter phase 3 trial (ClinicalTrials.gov Identifier: NCT03257267).

The decision was made to withdraw the application after the Companies and the FDA were not able to align on certain postmarketing studies.

Cemiplimab-rwlc is currently marketed under the brand name Libtayo and is approved for advanced basal cell carcinoma, advanced cutaneous squamous cell carcinoma, and advanced non-small cell lung cancer.

References

  1. Regeneron and Sanofi provide regulatory update on Libtayo® (cemiplimab-rwlc) in advanced cervical cancer. News release. Regeneron Pharmaceuticals, Inc. and Sanofi. Accessed January 28, 2022. https://www.prnewswire.com/news-releases/regeneron-and-sanofi-provide-regulatory-update-on-libtayo-cemiplimab-rwlc-in-advanced-cervical-cancer-301470298.html.
  2. FDA accepts Libtayo® (cemiplimab-rwlc) for priority review for advanced cervical cancer. News release. Regeneron Pharmaceuticals, Inc. September 28, 2021. Accessed January 28, 2022. https://newsroom.regeneron.com/news-releases/news-release-details/fda-accepts-libtayor-cemiplimab-rwlc-priority-review-advanced.