PARIS, Sept 8 (Reuters) - Sanofi and Regeneron Pharmaceuticals said on Friday that the U.S. Food and Drug Administration (FDA) has granted “Breakthrough Therapy” designation status to their skin cancer treatment Cemiplimab.
“Breakthrough Therapy” designation serves to accelerate the development and review of drugs that target serious or life-threatening conditions, the companies said in a joint statement.
Pending data results, the two companies anticipate submitting a biologics license application for cemiplimab with the FDA in the first quarter of 2018.
Cemiplimag would be used to treat adults with metastatic cutaneous squamous cell carcinoma (CSCC) and adults with locally advanced and unresectable CSCC, the second deadliest skin cancer after melanoma. CSCC is the second most common type of skin cancer in the United States. (Reporting by Dominique Vidalon; Editing by Leigh Thomas)