FDA Approves Bavencio for Merkel Cell Carcinoma

The US Food and Drug Administration granted accelerated approval to Bavencio (avelumab) for the treatment of adults and pediatric patients 12 years and older with metastatic Merkel cell carcinoma (MCC), including patients who have not received prior chemotherapy treatment.

Bavencio is the first FDA-approved drug for the treatment of metastatic MCC and works by blocking interactions at the PD-1/PD-L1 pathway, which may help the immune system attack cancer cells.
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The approval of Bavencio was based on a single-arm trial that included 88 patients with metastatic MCC who had been previously treated with at least 1 chemotherapy regimen before initiating treatment with Bavencio. The trial showed that 33% of patients taking Bavencio experienced complete or partial tumor shrinkage, which lasted for more than 6 months in 86% of responding patients and for more than 12 months in 45% of responding patients.

The most common adverse effects associated with Bavencio included fatigue, musculoskeletal pain, diarrhea, nausea, infusion-related reactions, rash, decreased appetite, and peripheral edema.

—Melissa Weiss

Reference:

FDA approves first treatment for rare form of skin cancer [press release]. FDA. March 23, 2017. https://www.fda.gov.