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FDA statement on Trodelvy withdrawal by end of 2024?
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Official FDA press releases or announcements
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Gilead to Withdraw US Approval for Trodelvy in Urothelial Cancer on Friday
Oct 18, 2024, 01:00 PM
Gilead Sciences has announced its decision to voluntarily withdraw the U.S. accelerated approval for Trodelvy (sacituzumab govitecan-hziy) for the treatment of adults with locally advanced or metastatic urothelial cancer. This decision, announced on Friday, follows consultations with the FDA and the results from the TROPiCS-04 study, which did not meet the overall survival endpoint. The withdrawal specifically affects patients who have previously received a platinum-containing chemotherapy and either programmed death receptor-1 (PD-1) or programmed death-ligand 1 (PD-L1) inhibitor. Other indications for Trodelvy remain unaffected. The drug was used in previously treated bladder cancer patients.
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