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.

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

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.

Sacituzumab govitecan's (Trodelvy) accelerated approval in urothelial cancer will be voluntarily withdrawn, Gilead Sciences announced on Friday.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, the company said.