Posted by Michael Wonder on 22 Jun 2020
European Medicines Agency validates application for Bavencio (avelumab) for first-line maintenance treatment of locally advanced or metastatic urothelial carcinoma
22 June 2020 - Merck and Pfizer today announced that the EMA has validated for review the Type II variation application for Bavencio (avelumab) for first-line maintenance treatment of patients with locally advanced or metastatic urothelial carcinoma.
With this validation, the application is complete, and the EMA will now begin the review procedure.
The application is based on results from the Phase III JAVELIN Bladder 100 study, which showed a statistically significant improvement in overall survival (OS) for BAVENCIO plus best supportive care (BSC) as first-line maintenance treatment following induction chemotherapy versus BSC alone in patients with locally advanced or metastatic UC.
