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News Briefs: Gilead Withdraws Trodelvy in Urothelial Cancer

  • Nov 14
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    Nov 14, 2024

    Gilead Sciences Inc. is voluntarily withdrawing the U.S. accelerated approval for Trodelvy (sacituzumab govitecan-hziy) for the treatment of adults with locally advanced or metastatic urothelial cancer who have received a platinum-containing chemotherapy and either a programmed death receptor-1 (PD-1) or programmed death-ligand 1 (PD-L1) inhibitor, the company said on Oct. 18. Other indications for the Trop-2-directed antibody-drug conjugate are not affected. The FDA granted the accelerated approval on April 13, 2021, based on tumor response rate and duration of response in a Phase II single-arm trial. Earlier this year, the company revealed that a Phase III confirmatory trial did not meet the primary endpoint of overall survival in the intention-to-treat population. Read more
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    • Angela Maas

    Angela has an extensive background of editing, reporting and writing for trade and consumer publications. She has written Radar on Specialty Pharmacy since she joined AIS Health in 2005 and has broad knowledge of the various issues at play within the space. She also has written for Spotlight on Market Access since its 2017 launch. Before joining AIS Health, she was managing editor at Employee Benefit News and Employee Benefit News Canada and managing editor at Hem Aware (a hemophilia publication), Lupus Living and Momentum (a multiple sclerosis publication). She has a B.A. in English and an M.A. in British literature from Arizona State University.

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