Paris and Tarrytown, NY – April 30, 2018 – The U.S. Food and Drug Administration (FDA) has accepted priority review the Biologics License Application (BLA) for cemiplimab for the treatment of patients with metastatic cutaneous squamous cell carcinoma (CSCC) or patients with locally advanced CSCC who are not candidates for surgery. Advanced CSCC is the deadliest non-melanoma skin cancer . Cemiplimab is an investigational human monoclonal antibody targeting the checkpoint inhibitor PD-1 (programmed death 1) and was granted Breakthrough Therapy designation status by the FDA in September 2017. The target action date for the FDA decision is October 28, 2018.
The BLA submission is based on a Phase 2 pivotal, single-arm, open-label clinical trial of cemiplimab for advanced CSCC (EMPOWER-CSCC 1) in addition to Phase 1 data from two advanced CSCC expansion cohorts. Both clinical trials enrolled patients with metastatic CSCC and patients with locally advanced CSCC who were not candidates for surgery. Topline results from EMPOWER-CSCC 1 were previously announced in December 2017, and Phase 1 expansion cohort results were presented at the 2017 American Society of Clinical Oncology (ASCO) Annual Meeting. Updated results from both clinical trials will be presented at upcoming medical congresses. Updated results from both clinical trials will be presented at the 2018 ASCO Annual Meeting.
In the European Union, the European Medicines Agency accepted for review in April 2018 the Marketing Authorization Application for cemiplimab in patients with metastatic CSCC or patients with locally advanced CSCC who are not candidates for surgery.
Cemiplimab is being jointly developed by Sanofi and Regeneron under a global collaboration agreement.
Cemiplimab is currently under clinical development, and its safety and efficacy has not been fully evaluated by any regulatory authority.
Cutaneous squamous cell carcinoma (CSCC) is the second most common type of skin cancer in the U.S., with the number of newly diagnosed cases expected to rise annually. Although CSCC has a good prognosis when caught early, the cancer can prove especially difficult to treat effectively when it is advanced, and patients can experience reduced quality of life due to the impact of the disease as it progresses . Advanced CSCC is the deadliest non-melanoma skin cancer, responsible for approximately 7,000 deaths in the U.S. each year. There are currently no FDA-approved treatments for advanced CSCC.
About Regeneron Pharmaceuticals, Inc.
Regeneron (NASDAQ: REGN) is a leading biotechnology company that invents life-transforming medicines for people with serious diseases. Founded and led for 30 years by physician-scientists, our unique ability to repeatedly and consistently translate science into medicine has led to six FDA-approved treatments and numerous product candidates in development, all of which were homegrown in our laboratories. Our medicines and pipeline are designed to help patients with eye disease, heart disease, allergic and inflammatory diseases, pain, cancer, infectious diseases and rare diseases.
Regeneron is accelerating and improving the traditional drug development process through our proprietary VelociSuite® technologies, such as VelocImmune® which produces optimized fully-human antibodies, and ambitious research initiatives such as the Regeneron Genetics Center, which is conducting one of the largest genetics sequencing efforts in the world.
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