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Skin Cancer Drug Designated as Breakthrough Therapy

Sept. 14, 2017

The FDA has designated cemiplimab as a breakthrough therapy for the treatment of adults with metastatic cutaneous squamous cell carcinoma (CSCC) and adults with locally advanced and unresectable CSCC.

The drug’s developers, Sanofi and Regeneron Pharmaceuticals, said they expect to apply to the FDA for a biologics license for cemiplimab — an investigational human, monoclonal antibody — by April 2018.

CSCC is the second deadliest skin cancer after melanoma.

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