Gilead Sciences has voluntarily withdrawn cancer drug Trodelvy from the U.S. market for the treatment of advanced urothelial carcinoma after a failed confirmatory study. The drug, an antibody drug conjugate targeting the TROP-2 protein, had received accelerated FDA approval in 2021. Despite its success in breast cancer indications, Trodelvy failed to meet the primary endpoint for overall survival in urothelial carcinoma. The company plans to present the data at a future medical meeting. Trodelvy accounted for over $1 billion in sales in 2023 and is approved in over 50 countries for various cancer types. Clinical trials are ongoing in additional populations.
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Gilead Sciences Voluntarily Pulls Drug for Bladder Cancer After Trial Failure
