Regeneron Pharmaceuticals (NSDQ:REGN) and Sanofi (NSDQ:SNY) have voluntarily withdrawn the supplemental Biologics License Application (sBLA) for Libtayo (cemiplimab-rwlc) as a second-line treatment for advanced cervical cancer.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.
Regeneron/Sanofi
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…