EMD Serono, Pfizer Win FDA Approval for sBLA for BAVENCIO

EMD Serono and Pfizer received FDA approval for its 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.

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 vs. 14.3 months. This statistically significant improvement in OS represents a 31% reduction in the risk of death in the overall population. OS was measured from the time of randomization, after patients were treated with four to six cycles of gemcitabine plus cisplatin or carboplatin over a period of approximately four months.