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WASHINGTON -- The granted accelerated approval for the PD-L1 inhibitor avelumab (Bavencio) for treatment of metastatic Merkel cell carcinoma (MCC).

The action made avelumab, distributed by EMD Serono, the first therapy with an approved indication for MCC, a rare, aggressive form of skin cancer. About 1,600 new cases of MCC are diagnosed in the United States each year, and approximately one-third of patients develop metastatic disease.

"The scientific community continues to make advances targeting the body's immune system mechanisms for the treatment of various types of cancer," Richard Pazdur, MD, of the FDA office of hematology and oncology products, said in a statement. "These advancements are leading to new therapies -- even in rare forms of cancer where treatment options are limited or non-existent."

Support for the approval came primarily from a single-arm trial involving 88 patients with MCC previously treated with one or more chemotherapy regimens. About a third of patients achieved objective responses with avelumab, and responses lasted for at least 6 months in 86% of cases. Objective responses lasted for 12 months or longer in a third of cases.

The most common side effects with avelumab are fatigue, musculoskeletal pain, diarrhea, nausea, infusion-related reactions, rash, decreased appetite, and peripheral edema. Typical of the drug class, the most common serious adverse effects of avelumab are immune-mediated effects.

Avelumab is not the only PD-1/PD-L1 agent to demonstrate activity in MCC. Half of patients with advanced MCC had objective responses to pembrolizumab (Keytruda) in a small clinical trial reported last year at the American Association of Cancer Research meeting.

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