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.
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
A US Supreme Court ruling in favor of the agency in an e-cigarette case has implications for drugs and other medical products as the justices decided not to disturb the FDA’s ‘change in position’ authority, while also creating a complex new landscape.
Deputy FDA Commissioner Grace Graham acknowledged the importance of user fees, while also calling for restructuring. She also said part of MAHA's mission is to reexamine uses of drugs not supported by data.
Patients from Asia saw a differential treatment effect versus non-Asian regions in the Phase III multiregional study, with an adverse survival trend seen in the latter group, the FDA said about the lymphoma drug.
