Regeneron Pharmaceuticals (NSDQ:REGN) and Sanofi (NSDQ:SNY) have voluntarily withdrawn the supplemental Biologics License Application (sBLA) for Libtayo (cemiplimab-rwlc) as a second-line treatment for advanced cervical cancer.
A press release noted that the agency and the sponsors were unable to “align on certain post-marketing studies” that would have been required to greelight the sBLA.
FDA first approved the drug in 2018 for advanced cutaneous squamous cell carcinoma.
The agency approved indications of Libtayo as a first immunotherapy for patients with advanced basal cell carcinoma in 2021 and as a first-line advanced non-small cell lung cancer with PD-L1 expression of ≥50%.
Regeneron and Sanofi are continuing discussions with regulators outside of the U.S. regarding Libtayo’s potential as a second-line advanced cervical cancer therapy.
REGN shares increased 2…