By granting an approval four months ahead of schedule of Roche AG's and Genentech Inc.'s anti-PD-LI cancer immunotherapy Tecentriq (atezolizumab), the FDA may have helped the companies secure a better lead in the bladder cancer marketplace than the firms otherwise would have held. But already established immunotherapies, Merck & Co. Inc.'s Keytruda (pembrolizumab) and Bristol-Myer Squibb Co.'s Opdivo (nivolumab), are in hot pursuit.
Roche AG and its US unit Genentech Inc. on May 18 gained an earlier-than-expected approval of Tecentriq (atezolizumab), the first and only anti-PD-L1 cancer immunotherapy approved by the FDA for locally advanced or metastatic urothelial carcinoma (mUC), the most common form of bladder cancer.
Tecentriq, which is the first drug approved for mUC in more than three decades and the first targeted therapy for...