- First and only FDA-approved immunotherapy to demonstrate a significant overall survival benefit in the first-line setting in a Phase III study
- In JAVELIN Bladder 100, BAVENCIO maintenance treatment extended median overall survival by 50% over standard of care
- Priority review completed under FDA’s Real-Time Oncology Review (RTOR) pilot program, following receipt of Breakthrough Therapy Designation
San Francisco, CA (UroToday.com) – EMD Serono, the biopharmaceutical business of Merck KGaA, Darmstadt, Germany in the US and Canada, and Pfizer Inc. announced that the US Food and Drug Administration (FDA) has approved the supplemental Biologics License Application (sBLA) for BAVENCIO® (avelumab) for the maintenance treatment of patients with locally advanced or metastatic urothelial carcinoma (UC) that has not progressed with first-line platinum-containing chemotherapy.