FDA grants accelerated approval for Bavencio (avelumab) to treat Merkel cell carcinoma .-Merck KgAA + Pfizer

Merck and Pfizer Inc. announced that the FDA has approved Bavencio (avelumab) Injection 20 mg/mL, for intravenous use, for the treatment of adults and pediatric patients 12 years and older with metastatic Merkel cell carcinoma (mMCC). This indication is approved under accelerated approval based on tumor response and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials.

Bavencio, a human anti-PD-L1 antibody, is the first FDA-approved therapy for patients with mMCC. Metastatic MCC is a rare and aggressive skin cancer, with fewer than half of patients surviving more than one year and fewer than 20% surviving beyond five years.

Comment: Bavencio will be co-commercialized by EMD Serono, the biopharmaceutical business of Merck in the US and Canada, and Pfizer..