After Failed Confirmatory Trial, Gilead Withdraws US Accelerated Approval Of Trodelvy As Bladder Cancer treatment

On Friday, Gilead Sciences, Inc. (NASDAQ:GILD) announced plans to voluntarily withdraw the U.S. accelerated approval for Trodelvy (sacituzumab govitecan-hziy; SG) for adult patients with locally advanced or metastatic urothelial cancer who have previously received platinum-containing chemotherapy and either programmed death receptor-1 (PD-1) or programmed death-ligand 1 (PD-L1) inhibitor.

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The decision was made in consultation with the FDA and does not affect the other approved Trodelvy indications within or outside the U.S.

Trodelvy was granted accelerated approval for metastatic urothelial ...