Bavencio approval hailed as major paradigm shift

Germany’s Merck KGaA (MRK: DE)) and US drug giant Pfizer (NYSE: PFE) have received US approval to market Bavencio (avelumab) for the maintenance treatment of locally-advanced or metastatic urothelial carcinoma (UC) that has not progressed with first-line platinum-containing chemotherapy.

The drug is the first and only US Food and Drug Administration (FDA)-approved immunotherapy to demonstrate a significant overall survival benefit in the first-line setting in a Phase III study.

In the JAVELIN Bladder 100 study, Bavencio maintenance treatment extended median overall survival by 50% over standard of care.