Pharmaceutical manufacturer Sanofi has announced that the U.S. Food and Drug Administration (FGA) has granted Breakthrough Therapy Designation to Cemiplimab (REGN2810) as a treatment for adults with metastatic cutaneous squamous cell carcinoma (CSCC) and adults with locally advanced and unresectable CSCC.
Breakthrough Therapy Designation is granted to drugs aimed at treating serious or life-threatening conditions, either alone or in combination with another medication, with the aim of speeding up the development of these vital medicines. It may also be granted when preliminary clinical evidence suggests the drug may be substantially more effective than existing treatments. Other drugs to be granted this status in 2017 include Nivolumab for the treatment of urothelial carcinoma, Pembrolizumab for the treatment of Hodgkin Lymphoma, and Dupilumab, used for treating atopic dermatitis.
Cemiplimab is an investigation human monoclonal antibody targeting PD-1 and is currently in the second phase of clinical trials. Following a Phase 1 study of around 400 patients, Sanofi and Regeneron reported positive preliminary results and are in the process of enrolling patients for a Phase 2 trial.
In a statement announcing the latest development, Sanofi asserted: "Although CSCC has a good prognosis when caught early, it can prove especially difficult to treat when it progresses to advanced stages."
According to the American Cancer Society, skin cancer is the most commonly diagnosed form of cancer in the United States. CSCC is one of the main forms of skin cancer and usually manifests as a hard lump with a scaly top. The highest risk factor is exposure to ultraviolet radiation from the sun. It is often treated with surgical removal, radiation therapy, and chemotherapy. CSCC is the second most common form of skin cancer after nonmelanoma skin cancer.