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...
Despite following the path of the popular Project Orbis, the cell and gene therapy international collaborative review pilot is being reconsidered by the FDA's new management.
It appears that the European Medicines Agency is making progress on its re-examination of Eli Lilly’s Alzheimer’s disease drug Kisunla, following an initial rejection in March based on safety concerns.
Key expert panel go-ahead with a trial waiver put’s Eisai's Alzheimer's therapy on track for a debut in India where tailored pricing will be pivotal. Lilly’s Kisunla is also under regulatory review.
