Benzinga | Jan 28, 2022 07:03AM EST

Regeneron And Sanofi Provide Regulatory Update On Libtayo In Advanced Cervical Cancer

Regeneron Pharmaceuticals, Inc. (NASDAQ:REGN) and Sanofi today announced the voluntary withdrawal of the supplemental Biologics License Application (sBLA) for Libtayo(r) (cemiplimab-rwlc) as a second-line treatment for patients with advanced cervical cancer. The decision was made after the companies and the U.S. Food and Drug Administration (FDA) were not able to align on certain post-marketing studies. Discussions with regulatory authorities outside of the U.S. are ongoing.

About Cervical Cancer

It is estimated that approximately 570,000 people are diagnosed with cervical cancer worldwide each year, with deaths exceeding 250,000. In the U.S. there are 14,500 new cases diagnosed annually and approximately 4,000 die each year. Since we filed our sBLA, another PD-1 inhibitor was approved as first-line treatment for patients with persistent, recurrent or metastatic cervical tumors that express PD-L1. The use of Libtayo in advanced cervical cancer is not approved by the FDA.