Gilead pulls Trodelvy’s approval in bladder cancer after trial flop, FDA discussions

CAR-T Digest - August 2020

18 Oct 2024: Gilead pulls Trodelvy’s approval in bladder cancer after trial flop, FDA discussions

Gilead Sciences has announced the withdrawal of Trodelvy as a treatment for bladder cancer in the U.S. after the confirmatory TROPiCS-04 clinical trial failed to meet its primary endpoint
The TROP2-directed ADC did not outperform chemotherapy in extending survival for bladder cancer patients who had previously received a PD-1/L1 therapy and chemotherapy
The accelerated approval in bladder cancer was granted on Phase II data from the single-arm TROPHY-U-01 study
Trodelvy retains its U.S. indication for breast cancer, where it remains a significant part of Gilead’s portfolio, despite the setback in bladder cancer
The bladder cancer flop came on the back of another more important trial failure (EVOKE-01), in which Trodelvy failed to move the needle in second-line NSCLC when pitted against chemo. Following the setback in that study, Gilead recognized an impairment charge of $2.4 billion