FDA Grants Priority Review to Cemiplimab in CSCC

April 30, 2018 – The FDA has granted a priority review to a biologics license application (BLA) for the PD-1 inhibitor cemiplimab for the treatment of patients with metastatic cutaneous squamous cell carcinoma (CSCC) or patients with locally advanced CSCC who are not eligible for surgery. The BLA was submitted based on data from the phase II EMPOWER-CSCC 1 study (NCT02760498), in which the overall response rate (ORR) was 46.3% in patients with advanced CSCC … (leggi tutto)