Gilead Sciences has voluntarily withdrawn Trodelvy from the U.S. market

Gilead Sciences announced the voluntary withdrawal of its drug Trodelvy for bladder cancer after it failed to meet survival goals in a confirmatory trial.

This decision, made in consultation with the FDA, follows the TROPiCS-04 study, which revealed a higher death rate from complications compared to alternative treatments.

Trodelvy remains approved for other indications, including advanced breast cancer, and is involved in over 20 ongoing trials for various cancers. The withdrawal impacts about 10% of Trodelvy’s $1 billion sales in 2023.

Guru Sonpavde:

“Bladder cancer update – Following the recent news of the Phase III trial TROPICS-04 that failed to show improved overall survival for sacituzumab govitecan (Trodelvy) over chemotherapy (taxane or vinflunine) in previously treated advanced urothelial carcinoma patients, Gilead Sciences has voluntarily withdrawn this drug from the U.S. market for this indication.”

Paolo Tarantino:

“Negative OS from TROPiCS04 prompts voluntary withdrawal of sacituzumab govitecan for bladder cancer. Remains approved for metastatic TNBC and HR+/HER2- MBC.”

Tom Powles:

“Voluntary withdrawal of sacituzumab govitecan in pretreated advanced bladder cancer occurred today. Accelerated approval relied on TROPICS4 which was negative for OS. The May 30th press release stated activity but also a toxicity signal. Details awaited.”

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Guru Sonpavde is the Oncology and Phase I Clinical Trials Director at AdventHealth Central Florida and the Chair of Bladder Cancer Research. He is also a Professor of Medicine at the University of Central Florida.

Dr. Paolo Tarantino, MD, is pursuing an advanced research fellowship at Dana-Farber Cancer Institute and Harvard Medical School, concurrently working towards a PhD in clinical research at the University of Milan.

Professor Thomas Powles, specializing in urology cancer, holds the position of Professor at the University of London since 2012 and serves as the Director of Barts Cancer Centre, a CRUK Major Cancer Centre. With a role in biomarker development and drug strategies, he has secured multiple EMA and FDA approvals.