Lack of late-stage data no barrier to Regeneron and Sanofi scoring priority review

Data from Phase II and Phase I studies was enough for the US Food and Drug Administration (FDA) to accept for priority review the Biologics License Application (BLA) for cemiplimab for metastatic cutaneous squamous cell carcinoma (CSCC) or locally advanced CSCC patients who are not candidates for surgery.

The investigational human monoclonal antibody targeting the checkpoint inhibitor PD-1 is being jointly developed by US biotech Regeneron (Nasdaq: REGN) and French pharma major Sanofi (Euronext: SAN).

Advanced CSCC is the deadliest non-melanoma skin cancer and cemiplimab was granted Breakthrough Therapy designation status by the FDA in September 2017.