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FDA Approves Avelumab for Merkel Cell Carcinoma

Dr. Richard Pazdur from the FDA's Center for Drug Evaluation and Research

Richard Pazdur, MD

The FDA has granted an accelerated approval to avelumab (Bavencio) for the treatment of adults and pediatric patients 12 years and older with metastatic Merkel cell carcinoma, including those who have not received prior chemotherapy.

The approval is based on data from the phase II JAVELIN Merkel 200 study, which was presented at the 2016 ASCO Annual Meeting and published in the Lancet Oncology. In the open-label trial, the objective response rate (ORR) with avelumab was 31.8%, which included a 9.1% complete response rate. After a median follow-up of 10.4 months, 82% of patients continued to respond to therapy.

“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,” Richard Pazdur, MD, 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 said in a statement. “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.” Click here to read the full article at

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