EMD Serono, Pfizer Win FDA Approval for sBLA for BAVENCIO

For the maintenance treatment of patients with locally advanced or metastatic urothelial carcinoma.

By: Contract Pharma

Contract Pharma Staff

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-lin...

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