FDA Approves Avelumab for Rare Skin Cancer

On March 23, 2017, FDA approved Bavencio (avelumab) for the treatment of adults and pediatric patients with Merkel cell carcinoma (MCC). MCC is a rare, aggressive form of skin cancer for which avelumab is the first FDA-approved treatment. The drug is marketed by Pfizer and EMD Serono, the biopharmaceutical business of Merck KGaA, Darmstadt Germany in the United States and Canada.

Bavencio targets the PD-1/PD-L1 pathway, and by blocking these interactions, Bavencio may help the body’s immune system attack cancer cells, FDA said in a statement. The drug received accelerated approval and FDA said further clinical trials are needed to confirm its clinical benefit. The drug is also currently being investigated as a treatment for bladder cancer.

FDA said the approval of avelumab was based on data from a single-arm trial of 88 patients with MCC, who had previously been treated with at least one prior chemotherapy. The trial found that 33% of patients experienced complete or partial tumor shrinkage. The response lasted more than six months in 86% of responding patients and more than 12 months in 45% of responding patients.