US regulators are undertaking a priority review of Sanofi and Regeneron’s cemiplimab for the treatment of patients with metastatic cutaneous squamous cell carcinoma (CSCC), or those with locally advanced CSCC who are not candidates for surgery.
Advanced CSCC is the deadliest non-melanoma skin cancer, responsible for around 7,000 deaths in the US each year. There are currently no FDA-approved treatments for the condition.
Cemiplimab is an investigational human monoclonal antibody that targets the checkpoint inhibitor PD-1, and was granted Breakthrough Therapy designation status in the US last year.
The drug’s marketing submission contains data from the pivotal Phase II EMPOWER-CSCC 1 study, which showed an overall response rate of 46.3 percent in patients with advanced CSCC.
The FDA should reach a decision on the application by the end of October.