FDA announcements and Gilead Sciences press releases

Gilead Sciences Withdraws Trodelvy Approval for Bladder Cancer

Oct 18, 2024, 04:01 PM

Gilead Sciences announced on Friday that it will voluntarily withdraw the U.S. accelerated approval for its drug Trodelvy (sacituzumab govitecan-hziy) for the treatment of adult patients with locally advanced or metastatic urothelial cancer, specifically in previously treated bladder cancer. The decision follows the results of the TROPiCS-04 study, which failed to meet its primary endpoint of overall survival. Despite this withdrawal, other indications for Trodelvy remain unaffected. The withdrawal comes after consultation with the FDA.