FDA Approves Avelumab for Rare Skin Cancer

March 24, 2017

FDA approved avelumab for the treatment of patients with Merkel cell carcinoma.

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.  

Source: FDA, Pfizer