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.
As the Galleri test is advancing toward becoming the first multi-cancer detection test to secure FDA approval, cancer care providers are coming up with strategies for using these tests responsibly.
