Gilead Pulls Trodelvy in Bladder Cancer After Trial Failures and FDA Discussions

Gilead Sciences has opted to withdraw Trodelvy from the bladder cancer market in the U.S. after the TROPiCS-04 trial failed to show a survival benefit over standard chemotherapy[1][2]. The decision followed discussions with the FDA and is part of a broader trend of withdrawing accelerated approvals when confirmatory trials do not meet expectations[3]. Despite this setback, Trodelvy remains approved for treating breast cancer, where it continues to contribute significantly to Gilead's oncology revenue[1]. Though the loss in bladder cancer highlights competitive pressures, especially from companies like AstraZeneca, Gilead is focusing on expanding Trodelvy's application in other cancer types, including ongoing trials in breast and lung cancer[2].