Pfizer’s Bavencio Approved for Bladder Cancer

The FDA has approved Pfizer’s Bavencio (avelumab) as a maintenance treatment for patients with locally advanced or metastatic urothelial carcinoma that has not responded to first-line platinum-containing chemotherapy.

The approval is based on the results of a phase 3 trial, in which patients treated with Bavencio along with best supportive care demonstrated a median survival of 21.4 months compared to 14.3 months for those given best supportive care alone.

Bavencio received a Breakthrough Therapy designation and a streamlined review under the FDA’s Real-Time Oncology Review pilot program.