Gilead Withdraws Trodelvy in Bladder Cancer After Confirmatory Trial Failures

Gilead Sciences has decided to pull Trodelvy from the bladder cancer market after a confirmatory trial, TROPiCS-04, failed to show improved survival rates, leading to discussions with the FDA and the drug’s withdrawal[1][2]. Originally granted accelerated approval in 2021, Trodelvy was found lacking in efficacy compared to chemotherapy in advanced urothelial cancer patients, resulting in safety concerns due to adverse events[3][1]. Despite this setback, Trodelvy remains on the market for other indications, such as breast cancer, and is projected to contribute significantly to Gilead's future revenues.
References
Explore Further
What specific factors led to the failure of the TROPiCS-04 trial for Trodelvy in bladder cancer?
How does the withdrawal of Trodelvy from the bladder cancer market impact Gilead's financial outlook?
What are the potential future applications for Trodelvy in other cancer types according to Gilead?
How does Gilead plan to address the competition from AstraZeneca and Merck in the oncology sector?
What lessons can be learned from the withdrawal of Trodelvy regarding accelerated drug approvals?