Official announcements from Gilead Sciences or clinical trial registries

Gilead to Withdraw US Approval for Trodelvy in Urothelial Cancer on Friday

Oct 18, 2024, 01:00 PM

Gilead Sciences has announced its decision to voluntarily withdraw the U.S. accelerated approval for Trodelvy (sacituzumab govitecan-hziy) for the treatment of adults with locally advanced or metastatic urothelial cancer. This decision, announced on Friday, follows consultations with the FDA and the results from the TROPiCS-04 study, which did not meet the overall survival endpoint. The withdrawal specifically affects patients who have previously received a platinum-containing chemotherapy and either programmed death receptor-1 (PD-1) or programmed death-ligand 1 (PD-L1) inhibitor. Other indications for Trodelvy remain unaffected. The drug was used in previously treated bladder cancer patients.