Breakthrough Therapy Designation status to Cemiplimab (REGN2810) for Advanced Cutaneous Squamous Cell Carcinoma

U.S.Food and Drug Administration has granted breakthrough therapy designation status to the cemiplimab (REGN2801) as announced by Sanofi and Regeneron Pharmaceuticals, Inc.  This drug is used for the treatment of adults with metastatic cutaneous squamous cell carcinoma (CSCC) and adults with locally advanced and unresectable CSCC, which is considered as the second deadliest skin cancer after melanoma.

Cemiplimab is primarily an investigational human, monoclonal antibody targeting PD-1. Sanofi and Regeneron earlier reported positive, preliminary results for cemiplimab from the two expansion cohorts that involved 26 advanced CSC patients in Phase 1 study of around 400 patients at the American Society of Clinical Oncology (ASCO) Annual Meeting in June 2017.

EMPOWER-CSCC 1, a phase 2 potentially pivotal, single-arm, open label clinical trial of cemiplimab is currently enrolling patients for metastatic CSCC and locally advanced unresectable CSCC. Under a global collaboration agreement, Cemiplimab is jointly developed by Sanofi and Regeneron. The companies are planning to submit a biologics license application for cemiplimab with the FDA in the first quarter of 2018.

CSCC is generally considered as the second most common type of skin cancer in the United States. CSCC can be treated on early diagnosis whereas, it is very difficult to treat when the diseases progress to advanced stages. Patients in the advanced stages can be disfigured due to the multiple surgeries for removal of CSCC on different parts of the body like head, neck and other parts. CSCC is mainly responsible for most deaths among the non-melanoma skin cancer patients.

Breakthrough therapy designation is given to expedite the manufacturing and review of the drugs that can target the serious or life-threatening diseases conditions. Drugs that show credible evidence of improvement in patients only is qualified for this designation. Fast Track program features also included for the drugs that designated in breakthrough therapy category.

The drug Cemiplimab is currently under clinical development and its efficacy and safety have not been completely evaluated by any regulatory authority.


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