BioCentury
ARTICLE | Clinical News

EMA accepts MAA for Sanofi's cemiplimab

April 6, 2018 5:48 PM UTC

Sanofi (Euronext:SAN; NYSE:SNY) said EMA accepted for review an MAA for cemiplimab to treat metastatic cutaneous squamous cell carcinoma. 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, Dec. 15, 2017)...