FDA approves Regeneron, Sanofi skin cancer immuno-oncology drug

Tarrytown-based Regeneron Pharmaceuticals Inc. and French pharma company Sanofi have received U.S. Food and Drug Administration approval for an immuno-oncology drug to treat skin cancer in patients who do not respond to surgery or radiation.

Regeneron announced jointly with Paris-based Sanofi that the drug Libtayo received FDA approvals on Sept. 28. The drug is the first FDA-approved treatment for patients with advanced forms of a skin cancer known as cutaneous squamous cell carcinoma. CSCC represents about a fifth of all skin cancer diagnoses in the U.S. and is the second most common form of skin cancer, according to the FDA. The cancer is responsible for an estimated 7,000 deaths each year in the U.S.

Libtayo, also known as cemiplimab, targets PD-1, a protein present on immune cells that may help some patients better fight off cancers.

The drug was evaluated by the FDA under Priority Review, which is reserved for medicines that represent significant improvements  in treating serious conditions.

The wholesale price for the drug is $9,100 per three-week treatment cycle, not including insurance or other forms financial assistance.

In 2015, Sanofi and Regeneron announced a partnership and planned investment of $2 billion to discover and bring new antibody cancer drugs to market.

Libtayo was invented by Regeneron using the company’s proprietary VelocImmune technology that yields optimized fully-human antibodies. The company will market the drug jointly in the U.S. with Sanofi Genzyme, the specialty care global business unit of Sanofi.

Dr. Israel Lowy, Regeneron’s vice president of global clinical development and head of translational science and clinical oncology, said the company remains “focused on advancing our clinical research investigating Libtayo as a potential monotherapy and combination therapy in other cancer types.”