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Avastin Redux? Genentech’s Tecentriq Trial Failure Puts Bladder Cancer Claim At Risk

 
• By Sue Sutter

Confirmatory trial misses overall survival primary endpoint, raising question of whether US FDA will seek to revoke accelerated approval of PD-L1 inhibitor’s second-line bladder cancer indication, as it did with Avastin’s breast cancer claim.

Arrows miss target

With the failed confirmatory trial of Tecentriq (atezolizumab) in second-line bladder cancer, Genentech Inc. is once again facing the potential loss of an accelerated approval indication for one of its cancer medicines.

On May 10, Genentech announced that the Phase III IMvigor211 study evaluating the PD-L1 inhibitor in patients with locally advanced or metastatic urothelial cancer previously treated with platinum-based therapy failed

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