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FDA Grants Priority Review to Cemiplimab in CSCC

Jason M. Broderick @jasoncology
Published: Monday, Apr 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.

Two patients died within 30 days of the final dose, but these were not attributed to cemiplimab.
Papadopoulos KP, Owonikoko TK, Johnson ML, et al. REGN2810: A fully human anti-PD-1 monoclonal antibody, for patients with unresectable locally advanced or metastatic cutaneous squamous cell carcinoma (CSCC)—Initial safety and efficacy from expansion cohorts (ECs) of phase I study. J Clin Oncol 35, 2017 (suppl; abstr 9503)

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