EMD Serono Wins FDA Approval for Bavencio

By | April 20, 2017

The FDA has granted EMD Serono accelerated approval for Bavencio (avelumab), a drug for the treatment of metastatic Merkel cell carcinoma (MCC) a rare, aggressive form of skin cancer. This is the first FDA-approved treatment for metastatic MCC.

“While skin cancer is one of the most common cancers, patients with a rare form called Merkel cell cancer have not had an approved treatment option until now,” said Richard Pazdur, M.D., acting director of the Office of Hematology and Oncology Products in the FDA’s Center for Drug Evaluation and Research and director of the FDA’s Oncology Center of Excellence. “The scientific community continues to make advances targeting the body’s immune system mechanisms for the treatment of various types of cancer. These advancements are leading to new therapies—even in rare forms of cancer where treatment options are limited or non-existent.”

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, 23 March, 2017)