FDA Approves Bavencio (Avelumab) for Bladder Cancer

The US Food and Drug Administration (FDA) has approved the immunotherapy drug Bavencio (avelumab) to treat people with advanced urothelial carcinoma, the most common type of bladder cancer. The new drug is approved for use in people whose cancer got worse after they had chemotherapy.

Bavencio is part of a new class of immunotherapy drugs called checkpoint inhibitors. It’s the fourth checkpoint inhibitor to be approved for bladder cancer. The others are Tecentriq (atezolizumab), Imfinzi (durvalumab), and Opdivo (nivolumab), which were already on the market for advanced melanoma, lung, and kidney cancers. Bavencio, given as an infusion, targets the PD-L1 protein, which some cancer cells use to evade the immune system. By blocking PD-L1, it helps immune cells recognize and attack cancer cells.

The FDA also recently approved Bavencio for Merkel cell carcinoma, a type of skin cancer.

The new approval was based on a clinical trial of 242 people with advanced bladder cancer that grew or spread despite chemotherapy. Among 30 people who were followed for at least 13 weeks, 13.3% saw their tumors shrink. Among 26 people who were followed for at least 6 months, 16.1% saw their tumors shrink. However, 6% of study participants died from an adverse reaction. The study is still ongoing.

Serious reactions or side effects were reported in 41% of people in the study. The most common were urinary tract infection or bleeding, abdominal pain, muscle and bone pain, kidney failure, dehydration, intestinal obstruction, and fever.

More common side effects included fatigue, infusion-related reaction, pain, nausea, and decreased appetite.

Bavencio was evaluated using accelerated approval and priority review status – FDA programs designed to speed up the availability of drugs to treat serious diseases. As a condition of accelerated approval, the company that makes the drug must submit additional clinical information after approval, to demonstrate its benefit.

Bavencio is marketed by EMD Serono, Inc.

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