EMD Serono Wins FDA Approval for Drug to Treat Skin Cancer

The FDA has granted accelerated approval to Bavencio (avelumab) for the treatment of metastatic Merkel cell carcinoma (MCC). This is the first FDA-approved treatment for metastatic MCC, a rare, aggressive form of skin cancer, and EMD Serono’s first cancer drug launch. The drug has been approved for adults and pediatric patients 12 years and older, including those who have not received prior chemotherapy.

According to the National Cancer Institute, approximately 1,600 people in the United States are diagnosed with MCC every year. While the majority of patients present with localized tumors that can be treated with surgical resection, approximately half of all patients will experience recurrence, and more than 30 percent will eventually develop metastatic disease.

Bavencio targets the PD-1/PD-L1 pathway (proteins found on the body’s immune cells and some cancer cells). By blocking these interactions, Bavencio may help the body’s immune system attack cancer cells. Bavencio received an Accelerated Approval, which enables the FDA to approve drugs for serious conditions to fill an unmet medical need using clinical trial data that is thought to predict a clinical benefit to patients. Further clinical trials are required to confirm Bavencio’s clinical benefit and the sponsor is currently conducting these studies.

The FDA granted this application Priority Review and Breakthrough Therapy designation. Bavencio also received Orphan Drug designation, which provides incentives to assist and encourage the development of drugs for rare diseases. (Source: FDA Website, March 23, 2017)

For more information visit: https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm548278.htm