The FDA has accepted the Biologics License Application (BLA) 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. The BLA will receive priority review. 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 October 28, 2018.
The BLA submission is based on a Phase 2 pivotal, single-arm, open-label clinical trial of cemiplimab for advanced CSCC (EMPOWER-CSCC 1) in addition to Phase 1 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. Topline results from EMPOWER-CSCC 1 were previously announced in December 2017, and Phase 1 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 congresses. Updated results from both clinical trials will be presented at the 2018 ASCO Annual Meeting.
In the European Union, the European Medicines Agency accepted for review in April 2018 the Marketing Authorization Application for cemiplimab in patients with metastatic CSCC or patients with locally advanced CSCC who are not candidates for surgery.
Advanced CSCC is the deadliest non-melanoma skin cancer.
Cemiplimab is being jointly developed by Sanofi and Regeneron under a global collaboration agreement.