Regeneron, Sanofi withdraw Libtayo application in cervical cancer
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Regeneron Pharmaceuticals (NASDAQ:REGN) and Sanofi (NASDAQ:SNY)
announce 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.
The decision was made after the companies and the FDA were not able to align on certain post-marketing studies.

Discussions with regulatory authorities outside of the U.S. are ongoing.
Libtayo is currently being investigated in trials as a monotherapy, as well as in combination with other therapies for solid tumors and blood cancers. These potential uses are investigational, and their safety and efficacy have not been evaluated by any regulatory authority.
SNY shares down 1% premarket at $52.33.
Recently, FDA accepted for review SNY-REGN's Libtayo application for lung cancer.