FDA accepts priority review of BLA for cemiplimab

The US Food and Drug Administration (FDA) has accepted priority review of the biologics licence application (BLA) for cemiplimab for the treatment of patients with metastatic cutaneous squamous cell carcinoma (CSCC) or patients with local advanced CSCC who are not candidates for surgery.

Cemiplimab is an investigational human monoclonal antibody targeting the checkpoint inhibitor PD-1, which was granted breakthrough therapy designation by the FDA in September last year (2017).

This BLA submission has been based on a Phase II clinical trial that evaluated the use of cemiplimab for advanced CSCC (EMPOWER-CSCC 1) as well as Phase I data from two advanced CSCC expansion cohorts. Both these trials enrolled patients with metastatic CSCC and patients with locally advanced CSCC who were not candidates for surgery.

The European Medicines Agency (EMA) accepted the marketing authorisation application for cemiplimab in April this year (2018) in patients with metastatic CSCC or patients with locally advanced CSCC who are not candidates for surgery.

Cemiplimab is being jointly developed by Sanofi and Regeneron under a global collaboration agreement. It is currently under clinical development and as such its safety and efficacy has not yet been fully evaluated by any regulatory authority.