CHMP positive for Bavencio to treat locally advanced or metastatic urothelial carcinoma (bladder cancer). Merck KGaA + Pfizer

Merck KGaA and Pfizer Inc announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) adopted a positive opinion recommending approval of Bavencio (avelumab) as monotherapy for the first-line maintenance treatment of adult patients with locally advanced or metastatic urothelial carcinoma (UC) who are progression-free following platinum-based chemotherapy. The CHMP positive opinion will now be reviewed by the European Commission (EC), with a decision expected in early 2021. The opinion was based on positive findings from the Phase III JAVELIN Bladder 100 trial, results of which were published in The New England Journal of Medicine in September 2020. Bavencio is the only immunotherapy to significantly prolong overall survival (OS) in locally advanced or metastatic UC in the first-line setting in a Phase III trial.