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# Priority Review for Gilead Trodelv sBLA
- URL: https://www.fdaweb.com/priority-review-for-gilead-trodelv-sbla/
- Published: 2022-10-11T12:00:00.000Z
- Updated: 2026-09-14T18:02:36.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5152946

FDA has accepted for priority review a Gilead Sciences supplemental BLA for Trodelv (sacituzumab govitecan-hziy) for treating adult patients with unresectable locally advanced or metastatic hormone receptor positive, human epidermal growth factor receptor 2 negative breast cancer who have received endocrine-based therapy and at least two additional systemic therapies in the metastatic setting. The user fee review action target date is set for 2/2023.

The submission is based on data from the Phase 3 TROPiCS-02 study, which met its primary endpoint of progression-free survival (PFS) and key secondary endpoint of overall survival (OS) over comparator chemotherapy, according to the company. Data showed that Trodelvy demonstrated a 34% reduction in risk of disease progression or death (median PFS: 5.5 versus 4 months), and a 21% decrease in the risk of death compared to chemotherapy (median OS: 14.4 months vs. 11.2 months), it says.

Trodelvy is described as a Trop-2 directed antibody-drug conjugate. It is currently approved for treating adult patients with unresectable locally advanced or metastatic triple-negative breast cancer who have received two or more prior systemic therapies, at least one of them for metastatic disease. It also received accelerated approval for treating adults with locally advanced or metastatic urothelial cancer who have previously received a platinum-containing chemotherapy and either programmed death receptor-1 or programmed death-ligand inhibitor.