EMA accepts MAA for Sanofi’s anti-PD-1 mAb

Sanofi (Euronext:SAN; NYSE:SNY) said EMA accepted for review an MAA for cemiplimab to treat metastatic cutaneous squamous cell carcinoma. The pharma is developing the therapy in partnership with Regeneron Pharmaceuticals Inc. (NASDAQ:REGN).

Cemiplimab is a human mAb against PD-1. The MAA is based on data from the single-arm, open-label Phase II EMPOWER-CSCC 1 trial, in which cemiplimab led to an overall response rate (ORR) of 46.3% (see BioCentury Extra, Dec. 13, 2017)...