FDA approves Genentech's PD-L1 for bladder cancer

FDA granted accelerated approval to Tecentriq atezolizumab ( MPDL3280A) from the Genentech Inc. unit of Roche (SIX:ROG; OTCQX:RHHBY) to treat locally advanced or metastatic urothelial carcinoma that has progressed on or after platinum-based chemotherapy. Tecentriq is the first PD-L1 inhibitor to be approved by the agency, and the first drug approved for metastatic bladder cancer in more than 30 years, according to Genentech (see BioCentury, June 9, 2014).

Tecentriq's approval was based on the single-arm Phase II IMvigor 210 study. In January, Roche said median overal survival (OS) was 7.9 months in a cohort of 310 patients in the study who had progressed after receiving platinum-based chemotherapy (see BioCentury Extra, Jan. 8). ...