The European Medicines Agency is currently reviewing the Marketing Authorisation Application for cemiplimap as a potential treatment for advanced cutaneous squamous cell carcinoma (CCSC).
Cemiplimab is being jointly developed by Sanofi and Regeneron under a global collaboration agreement.
Advanced CCSC is the deadliest non-melanoma skin cancer. Cemiplimab is an investigational human monoclonal antibody targeting the checkpoint inhibitor PD-1 (programmed cell death protein-1).
The Marketing Authorisation Application for cemiplimab is based on a Phase 2 pivotal, single-arm, open-label clinical trial of cemiplimab for advanced CSCC in addition to Phase 1 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.
The treatment is currently under clinical development, and its safety and efficacy have not been fully evaluated by any regulatory authority.