Posted by Michael Wonder on 30 Apr 2018
FDA to conduct priority review of cemiplimab as a potential treatment for advanced cutaneous squamous cell carcinoma
30 April 2018 - The U.S. FDA has accepted priority review the biologics license application for cemiplimab for the treatment of patients with metastatic cutaneous squamous cell carcinoma (CSCC) or patients with locally advanced CSCC who are not candidates for surgery.
Advanced CSCC is the deadliest non-melanoma skin cancer . Cemiplimab is an investigational human monoclonal antibody targeting the checkpoint inhibitor PD-1 (programmed death 1) and was granted breakthrough therapy designation status by the FDA in September 2017.
The target action date for the FDA decision is 28 October 2018.
