Gilead to withdraw Trodelvy accelerated approval for bladder cancer
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Gilead Sciences announced its intention to voluntarily withdraw the accelerated approval for sacituzumab govitecan-hziv for treatment of certain patients with advanced bladder cancer.
The indication applied to use of the agent for treatment of adults with locally advanced or metastatic urothelial cancer who previously received a platinum-containing chemotherapy plus either a PD-1 or PD-L1 inhibitor.
Sacituzumab govitecan-hziv (Trodelvy, Gilead Sciences) is a TROP-2-directed antibody-drug conjugate.
The FDA granted accelerated approval for the urothelial cancer indication in 2021.
However, Gilead Sciences announced in May that results of the confirmatory TROPiCS-04 study showed no survival benefit with sacituzumab govitecan-hziv compared with chemotherapy. Complete data from TROPiCS-04 will be presented at a medical meeting.
The company’s decision to withdraw the bladder cancer indication does not affect other indications for the drug, which is approved in the United States for treatment of certain patients with advanced triple-negative or hormone receptor-positive, HER2-negative breast cancer.
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