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FDA Grants Cemiplimab Breakthrough Designation for CSCC

Jason Harris
Published: Friday, Sep 08, 2017

Kyriakos P. Papadopoulos, MD

Kyriakos P. Papadopoulos, MD
The FDA has granted a breakthrough therapy designation to cemiplimab (REGN2810) for the treatment of adults with metastatic cutaneous squamous cell carcinoma (CSCC) and adults with locally advanced and unresectable CSCC, according to Regeneron Pharmaceuticals, the manufacturer of the anti–PD-1 monoclonal antibody. 

Investigators are currently recruiting patients with metastatic CSCC and locally advanced and unresectable CSCC for EMPOWER-CSCC 1, a phase II, single-arm, open-label clinical trial of cemiplimab. Regeneron and its global partner Sanofi hope to submit a biologics license application to the FDA based on data from that trial early next year.
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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