Gilead Sciences said on Friday it was voluntarily withdrawing the U.S. approval for Trodelvy in previously treated patients with a type of urothelial cancer after consultation with the regulator.

The move is a blow to Gilead’s cancer portfolio. Trodelvy, an antibody-drug conjugate granted accelerated approval for bladder cancer in 2021, failed its confirmatory trial earlier this year.

Trodelvy’s next big readout is EVOKE-03, which is testing the Gilead drug with Merck’s PD-1 inhibitor Keytruda in PD-L1-high NSCLC. Started in February 2023, the trial currently bears a primary completion date in January 2027.

The antibody drug conjugate didn’t help patients live longer in a confirmatory trial, prompting a review of its conditional approval in that indication.

Sacituzumab govitecan's (Trodelvy) accelerated approval in urothelial cancer will be voluntarily withdrawn, Gilead Sciences announced on Friday. The decision was made in consultation with the FDA and does not affect the antibody-drug conjugate's other indications,

Gilead Sciences is set to withdraw Trodelvy's accelerated approval for metastatic urothelial cancer following unsatisfactory results from the TROPiCS-04 study. However, the decision does not impact Trodelvy's other approved uses.

Bengaluru: Gilead Sciences said on Friday it was voluntarily withdrawing its drug, Trodelvy, for previously treated patients with a type of bladder cancer after consultation with the U.S.