The Skin Cancer Foundation Comments on FDA Approval of Bavencio (Avelumab) for the Treatment of Merkel Cell Carcinoma

New York, NY (March 29, 2017) – On March 23, 2017, the US Food and Drug Administration (FDA) approved Bavencio (avelumab) for the treatment of adults and pediatric patients 12 years and older with Merkel cell carcinoma, a rare, aggressive skin cancer. Merkel cell carcinoma (MCC) has a high risk of recurring and metastasizing (spreading) throughout the body, with most recurrences taking place within two years after diagnosis of the primary tumor.

While the disease is 40 times rarer than melanoma, it kills about one in three patients compared with one in nine for melanoma. FDA approval of Bavencio was based on data from a clinical trial in which 33 percent of patients with metastatic MCC experienced complete or partial shrinkage of their tumors. The response lasted for more than six months in 86 percent of responding patients and more than 12 months in 45 percent of responding patients.

Bavencio works by blocking PD-1/PD-L1 proteins that normally keep the immune system in check. Blocking these proteins allows the immune system to mass-produce T cells to fight the cancer.

“As the first FDA-approved therapy for patients with metastatic Merkel cell carcinoma, Bavencio is a significant medical advancement in the fight against this disease,” said Deborah S. Sarnoff, MD, President of The Skin Cancer Foundation. “The approval of this drug gives new hope for people and their families touched by this rare form of skin cancer.”

Bavencio was co-developed by EMD Serono, the biopharmaceutical business of Merck KGaA, Darmstadt, Germany in the US and Canada and Pfizer, Inc. EMD Serono and Pfizer awarded a patient education grant to The Skin Cancer Foundation in 2016.


About The Skin Cancer Foundation
The Skin Cancer Foundation is the only global organization solely devoted to the prevention, early detection and treatment of skin cancer. The mission of the Foundation is to decrease the incidence of skin cancer through public and professional education and research. Since its inception in 1979, the Foundation has recommended following a complete sun protection regimen that includes seeking shade and covering up with clothing, including a wide-brimmed hat and UV-blocking sunglasses, in addition to daily sunscreen use. For more information, visit

Becky Kamowitz
Director, Marketing Communications