EMA accepts marketing authorisation application for cemiplimab

The marketing authorisation application (MAA) for cemiplimab as a potential treatment for advanced cutaneous squamous cell carcinoma (CSCC) has been accepted for review by the European Medicines Agency (EMA).

Cemiplimab is an investigational human monoclonal antibody targeting the checkpoint inhibitor PD-1 (programmed cell death protein-1) that is being jointly developed by Sanofi and Regeneron under a global collaboration agreement. It is currently under clinical development and its safety and efficacy have not been fully evaluated by any regulatory authority.

This MAA is based on a Phase II clinical trial of cemiplimab for the treatment of advanced CSCC (EMPOWER-CSCC 1) in addition to Phase I data from two advanced CSCC expansion cohorts. Both clinical trials enrolled patients with metastatic CSCC and patients with locally advanced CSCC who were not candidates for surgery.

Topline results from these studies were announced at the end of last year (2017) and some of them were presented at the 2017 American Society of Clinical Oncology Annual Meeting. Updated results from both trials are being submitted for presentation at upcoming medical congresses.