FDA Approves First Treatment for Merkel Cell Carcinoma
The FDA granted accelerated approval to Bavencio (avelumab), developed by EMD Serono, as the first approved treatment for metastatic Merkel cell carcinoma, an aggressive skin cancer. The immunotherapy treatment was approved for adults and pediatric patients 12 years and older, including those who have not received prior chemotherapy.
The approval was based on a single-arm trial of 88 patients, measuring overall response rate and duration of response. One-third of patients experienced complete or partial shrinkage of their tumors, with responses lasting for more than six months in 86 percent of responding patients, and more than 12 months in 45 percent.
Additional clinical trials are underway to confirm Bavencio’s clinical benefit. The FDA previously granted Serono’s application priority review and a breakthrough therapy designation, as well as an orphan drug designation.