FDA to Conduct Priority Review of Cemiplimab for Advanced CSCC
Posted: Tuesday, July 10, 2018
The U.S. Food and Drug Administration (FDA) accepted for 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. Cemiplimab is an investigational human monoclonal antibody targeting PD-1 and was granted Breakthrough Therapy designation status by the FDA in September 2017.
The submission is based on a phase II single-arm, open-label clinical trial of cemiplimab for advanced CSCC (EMPOWER-CSCC 1) in addition to phase I data from two advanced CSCC expansion cohorts. Both clinical trials enrolled patients with metastatic CSCC and patients with locally advanced CSCC who were not candidates for surgery. The results from EMPOWER-CSCC 1 were previously announced in December 2017, and phase I expansion cohort results were presented at the 2017 American Society of Clinical Oncology (ASCO) Annual Meeting. Updated results from both clinical trials will be presented at upcoming medical meetings.
Cemiplimab is currently under clinical development, and its safety and efficacy have not been fully evaluated by any regulatory authority.
