sacituzumab govitecan (Trodelvy): FDA status

Withdrawn Indication: previously treated locally advanced or metastatic urothelial cancer.

Regulatory history

• Nov 6, 2024: Withdrawn. FDA approval of Trodelvy in bladder cancer was withdrawn after confirmatory trial failure. Cure Today
• Oct 29, 2024: Withdrawn. Gilead announced it will withdraw the accelerated approval of sacituzumab govitecan in bladder cancer. CancerNetwork
• Oct 18, 2024: Withdrawn. Gilead pulled Trodelvy's bladder cancer approval after a confirmatory trial failed, following FDA discussions. Fierce Pharma

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