FDAnews
www.fdanews.com/articles/175833-fda-grants-genentech-priority-review-for-atezolizumab

FDA Grants Genentech Priority Review for Atezolizumab

March 21, 2016

Roche’s Genentech unit has won FDA priority review of its atezolizumab BLA to treat a type of bladder cancer.

The company is studying the candidate in locally advanced or metastatic urothelial carcinoma in patients whose disease had progressed during or following platinum-based chemotherapy. An FDA decision is expected by Sept. 12.

Atezolizumab received breakthrough therapy designation in May 2014. It also is being assessed in other cancers.