EMA to consider expanding use of Merck/Pfizer's Bavencio

The European Medicines Agency has validated for review Merck and Pfizer's application to market Bavencio (avelumab) for first-line maintenance treatment of patients with locally advanced or metastatic urothelial carcinoma (UC).

Every year in the European union nearly 200,000 people are diagnosed with bladder cancer and 60,000 lose their lives to the disease, highlighting the remaining unmet need despite available therapies.

Urothelial carcinoma, which accounts for around 90% of bladder cancers, becomes harder to treat as it advances, spreading through the layers of the bladder wall. When metastatic, the disease has a five-year survival rate of just 5%

Data from the Phase III JAVELIN Bladder 100 study in patients with previously untreated locally advanced or metastatic urothelial carcinoma (UC) show that Bavencio significantly improved overall survival in patients with PD-L1-positive tumours, raising hopes for a new first-line treatment option.

In Europe, the drug is already approved in combination with axitinib for the first-line treatment of adults with advanced renal cell carcinoma (RCC), and as monotherapy for Merkel Cell Carcinoma.