Gilead’s Trodelvy Faces Setback with Bladder Cancer Trial Failure and Concerns over Early Deaths

CAR-T Digest - August 2020

30 May 2024: Gilead’s Trodelvy Faces Setback with Bladder Cancer Trial Failure and Concerns over Early Deaths

Following a major setback in NSCLC in January, Gilead announced that Trodelvy also failed to show significant results in a bladder cancer study
The TROP2-directed ADC failed to surpass single-agent chemotherapy in extending survival for urothelial cancer patients previously treated with chemotherapy and PD-1/L1 therapy
The TROPiCS-04 study’s negative outcome may prompt Gilead to retract Trodelvy’s accelerated approval in previously treated bladder cancer, granted in 2021
Gilead is analyzing data and discussing next steps with the FDA amidst ongoing disappointments and impairment charges