Regeneron Pharmaceuticals Inc. and Sanofi said FDA has granted Breakthrough Therapy designation status to cemiplimab, an investigational human, monoclonal antibody targeting PD-1– (REGN2810) for the treatment of adults with metastatic cutaneous squamous cell carcinoma and adults with locally advanced and unresectable CSCC.
More than a year after a catastrophic shortage of platinum-based chemotherapy drugs swept through the U.S., FDA on June 28 officially removed carboplatin and cisplatin from the drug shortage list.
