SN-38

Gilead voluntarily withdrew the US accelerated approval of sacituzumab govitecan-hziy (Trodelvy) for locally advanced or metastatic urothelial cancer after the TROPiCS-04 trial failed to meet the primary end point of overall survival vs single-agent chemotherapy. The withdrawal follows negative data from the trial and does not affect other approved Trodelvy indications.

Gilead Sciences plans to withdraw U.S. accelerated approval for sacituzumab govitecan (Trodelvy) in metastatic urothelial cancer, after TROPiCS-04 study failed to meet primary endpoint of overall survival. Decision made in consultation with FDA; other approved indications unaffected.

Gilead Sciences is withdrawing cancer drug Trodelvy from the U.S. market for metastatic urothelial carcinoma after its failure in a confirmatory study. The withdrawal does not affect Trodelvy's status in other approved indications. Trodelvy, an antibody drug conjugate, has generated over $1 billion in sales in 2023 and $628 million in the first half of 2024, driven by higher demand in breast cancer indications.

Gilead is withdrawing Trodelvy from the market in bladder cancer after the TROPiCS-04 trial failed to meet its primary endpoint. Trodelvy remains on the market for other indications, including advanced breast cancer. The withdrawal does not affect its traditional approvals in different types of advanced breast cancer. Gilead intends to report full TROPiCS-04 trial results at an upcoming medical meeting.

Gilead withdraws Trodelvy for bladder cancer after negative trial results, impacting less than 10% of sales; focuses on breast cancer, with $1 billion sales forecast by 2030; faces challenges in lung cancer expansion; awaits Phase 3 trial data for triple-negative breast cancer.

Gilead Sciences to withdraw U.S. accelerated approval for Trodelvy in metastatic urothelial cancer, not affecting other indications. Decision based on TROPiCS-04 study not meeting overall survival endpoint.

Gilead plans to withdraw Trodelvy's U.S. accelerated approval for metastatic urothelial cancer after the TROPiCS-04 study failed to meet the primary endpoint of overall survival. This decision does not affect other Trodelvy indications. Healthcare providers will be notified, and patients currently receiving Trodelvy for this condition should consult their healthcare provider.