Gilead Withdraws Trodelvy for Bladder Cancer in US After Confirmatory Trial Failure

Withdrawal Decision:
Gilead Sciences has voluntarily withdrawn Trodelvy from the US market as a treatment for advanced urothelial carcinoma, a type of bladder cancer, following a failed confirmatory trial.

Reason for Withdrawal:
The drug failed to show a survival benefit in the TROPiCS-04 study, which was required to confirm its accelerated approval granted in 2021.

Impact on Other Indications:
The withdrawal does not affect Trodelvy’s status in its other approved indications, including certain types of breast cancer.

Clinical Development:
Trodelvy is still being evaluated in various clinical trials for other cancers, including lung, head and neck, and gynecological cancers.

Market Performance:
Despite the setback, Trodelvy generated significant revenue, with over $1 billion in sales in 2023 and a 30% increase in the first half of 2024 compared to the same period in 2023.

Regulatory Status:
Trodelvy has approvals in more than 50 countries for various indications, and its clinical development program continues to explore its potential in different cancer types.