European Medicines Agency validates for review licence extension application for avelumab as first-line maintenance treatment of patients with locally advanced or metastatic urothelial carcinoma

Results from Phase III JAVELIN Bladder 100 study show that avelumab significantly improved overall survival in patients with PD-L1-positive tumours, raising hopes for a new first-line treatment option.

SPS commentary:

In the UK and EU, avelumab (an anti PD-L1 antibody) is already approved in combination with axitinib for the first-line treatment of adults with advanced renal cell carcinoma, and as monotherapy for Merkel Cell Carcinoma.