Sanofi and Regeneron Pharmaceuticals have revealed that the US Food and Drug Administration (FDA) has granted breakthrough therapy designation status to cemiplimab (REGN2810), an investigational human, monoclonal antibody.
Breakthrough medicine
Cemiplimab is being developed jointly by the companies under a global collaboration agreement. It has been granted breakthrough status for the treatment of adults with metastatic cutaneous squamous cell carcinoma (CSCC) and adults with locally advanced and unresectable CSCC.
Earlier this year, the companies reported positive preliminary results for cemiplimab at the American Society of Clinical Oncology (ASCO) Annual Meeting. These expansion cohorts included 26 advanced CSCC patients in a Phase I study of nearly 400 patients. The Phase II trial (EMPOWER-CSCC 1) is currently enrolling patients.
Depending on the results of the trials, Sanofi and Regeneron are anticipating submission of a biologics licence application for cemiplimab with the FDA early next year.