Posted by Michael Wonder on 01 Jul 2020
FDA approves Bavencio as first-line maintenance treatment for patients with locally advanced or metastatic urothelial carcinoma
30 June 2020 - First and only FDA approved immunotherapy to demonstrate a significant overall survival benefit in the first-line setting in a Phase III study.
Merck and Pfizer today announced that the US FDA has approved the supplemental biologics license application for Bavencio (avelumab) for the maintenance treatment of patients with locally advanced or metastatic urothelial carcinoma that has not progressed with first-line platinum-containing chemotherapy.
The approval is based on results from the Phase III JAVELIN Bladder 100 study, which demonstrated a significant 7.1 month improvement in median overall survival (OS) with BAVENCIO as first-line maintenance plus best supportive care (BSC) compared with BSC alone: 21.4 months (95% CI: 18.9 to 26.1) vs. 14.3 months (95% CI: 12.9 to 17.9).
