Posted by Michael Wonder on 11 Dec 2020
Bavencio (avelumab) receives positive CHMP opinion for first-line maintenance treatment of locally advanced or metastatic urothelial carcinoma
11 December 2020 - Merck and Pfizer today announced that the CHMP of the 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 who are progression-free following platinum-based chemotherapy.
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.
