Gilead to voluntarily withdraw U.S. accelerated approval for Trodelvy in mUC

Gilead (GILD) Sciences announced plans to voluntarily withdraw the U.S. accelerated approval for Trodelvy for the treatment of adult patients with locally advanced or metastatic urothelial cancer, or mUC, who have previously received a platinum-containing chemotherapy and either programmed death receptor-1 or programmed death-ligand 1 inhibitor. This decision was made in consultation with the U.S. Food and Drug Administration and does not affect the other approved Trodelvy indications within or outside of the U.S., the company stated. “Trodelvy was granted accelerated approval for metastatic urothelial cancer in 2021 based on tumor response rate and duration of response data from the global Phase 2, single-arm TROPHY-U-01 study. Continued approval for this indication was contingent on verification and description of clinical benefit in the confirmatory TROPiCS-04 study. As previously announced, the TROPiCS-04 study did not meet the primary endpoint of overall survival in the intention-to-treat population. These data will be presented at an upcoming medical meeting,” the company said.