European Medicines Agency Validates Application for Bavenico® 

Merck announced that the European Medicines Agency (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 (UC). 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. The data were presented at the ASCO 2020 Virtual Scientific Meeting.

In the European Union alone, nearly 200,000 people are diagnosed each year with bladder cancer.1 Urothelial carcinoma accounts for approximately 90 percent of bladder cancers.2 Urothelial carcinoma becomes harder to treat as it advances, spreading through the layers of the bladder wall.3 Despite available therapies, more than 60,000 Europeans die from bladder cancer each year.1

Earlier this year, the US Food and Drug Administration (FDA) accepted a supplemental Biologics License Application (sBLA) for first-line maintenance treatment of patients with locally advanced or metastatic UC for Priority Review under the agency’s Real-Time Oncology Review (RTOR) pilot program. The FDA also granted Breakthrough Therapy Designation to BAVENCIO for this indication.

In addition, a supplemental new drug application has also been accepted by Japan’s Ministry of Health, Labour and Welfare for BAVENCIO as a first-line maintenance therapy for locally advanced or metastatic UC.

ABOUT JAVELIN BLADDER 100

JAVELIN Bladder 100 is a Phase III, multicenter, multinational, randomized, open-label, parallel-arm study investigating first-line maintenance treatment with BAVENCIO plus BSC versus BSC alone in patients with locally advanced or metastatic UC. A total of 700 patients whose disease had not progressed after platinum-based induction chemotherapy as per RECIST v1.1 were randomly assigned to receive either BAVENCIO plus BSC or BSC alone. The primary endpoint was OS in the two primary populations of all patients and patients with PD-L1+ tumors defined by the Ventana SP263 assay.



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