Gilead Sciences to withdraw Trodelvy (sacituzumab govitecan-hziy) for bladder cancer in the US

After falling short in a confirmatory clinical trial, Gilead Sciences has decided to withdraw Trodelvy (sacituzumab goviteca-hziy) as a bladder cancer treatment in the U.S.

Gilead Sciences announced the decision following its discussions with the FDA. The move affects the accelerated approval for Trodelvy in advanced urothelial cancer patients who have previously received a PD-1/L1 inhibitor and chemotherapy. The drug’s other U.S. indications in breast cancer remain in place,.

The withdrawal wasn’t unexpected. The TROPiCS-04 study, which was meant to serve as the confirmatory trial for the accelerated bladder cancer approval, did not hit its goal. The TROP2-directed antibody-drug conjugate failed to improve on chemotherapy at extending the lives of bladder cancer patients who had tried a PD-1/L1 therapy and chemo.

Trodelvy secured its bladder cancer approval in 2021 based on single-arm, phase II data showing the drug triggered a tumor response in 27.7% of patients, including 5.4% who experienced a complete response. The median duration of response was 7.2 months.