Regeneron Pharmaceuticals Inc (NASDAQ:REGN) and its partner Sanofi SA (NASDAQ:SNY) have voluntarily withdrawn their application with the FDA for the expanded use of Libtayo in patients with advanced cervical cancer.
- The application for the monoclonal antibody as the second-line of treatment in the patients was withdrawn "after the companies and the FDA were not able to align on certain post-marketing studies."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.
