FDA to Conduct Priority Review of Cemiplimab as a Potential Treatment for Advanced Cutaneous Squamous Cell Carcinoma

On April 30, the U.S. Food and Drug Administration (FDA) accepted for priority review the biologics license application (BLA) for cemiplimab for the treatment of patients with metastatic cutaneous squamous cell carcinoma or patients with locally advanced cutaneous squamous cell carcinoma who are not candidates for surgery. 

Cemiplimab is an investigational human monoclonal antibody targeting programmed cell death protein 1 (PD-1) and was granted Breakthrough Therapy designation status by the FDA in September 2017. The target action date for the FDA decision is October 28, 2018. 

The BLA submission is based on a phase II single-arm, open-label clinical trial of cemiplimab for advanced cutaneous squamous cell carcinoma (EMPOWER-CSCC 1) in addition to phase I data from two advanced cutaneous squamous cell carcinoma expansion cohorts. Both clinical trials enrolled patients with metastatic disease and patients with locally advanced disease who were not candidates for surgery.

Topline results from EMPOWER-CSCC 1 were previously announced in December 2017, and phase I expansion cohort results were presented at the 2017 ASCO Annual Meeting. Updated results from both clinical trials will be presented at upcoming medical congresses and at the 2018 ASCO Annual Meeting.

In the European Union, the European Medicines Agency accepted for review in April 2018 the marketing authorization application for cemiplimab in patients with metastatic cutaneous squamous cell carcinoma or patients with locally advanced cutaneous squamous cell carcinoma who are not candidates for surgery.

Cemiplimab is currently under clinical development, and its safety and efficacy has not been fully evaluated by any regulatory authority.

The content in this post has not been reviewed by the American Society of Clinical Oncology, Inc. (ASCO®) and does not necessarily reflect the ideas and opinions of ASCO®.




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