Regeneron, Sanofi Withdraw FDA Application For Libtayo's Expanded Use

Regeneron Pharmaceuticals Inc REGN and its partner Sanofi SA SNY have voluntarily withdrawn their application with the FDA for the expanded use of Libtayo in patients with advanced cervical cancer.

• The application for the monoclonal antibody as the second-line of treatment in the patients was withdrawn "after the companies and the FDA were not able to align on certain post-marketing studies."
• The FDA had accepted the supplemental application for priority review in September, with the target action date for the decision on January 30, 2022.
• Related: Sanofi, Regeneron, Share Competitive Libtayo Survival Data in 1L NSCLC.
• Regeneron and Sanofi are still discussing marketing applications with regulatory authorities outside the U.S, the companies said.
• Related content: Benzinga's Full FDA Calendar.
• The drug is already approved for some types of skin and lung cancer.
• Price Action: REGN stock is down 0.43% at $606.09, and SNY is lower by 0.93% at $52.37 on the last check Friday.