FDA Grants Accelerated Approval for Gilead Sciences Trodelvy®
The United States Food and Drug Administration (FDA) has granted accelerated approval of Gilead Sciences (GILD) product Trodelvy® (sacituzumab govitecan-hziy). The approval is for use of the product in adult patients with locally advanced or metastatic urothelial cancer (UC) who have previously received platinum-containing chemotherapy and either a programmed death receptor-1 (PD-1) or a programmed death-ligand 1 (PD-L1) inhibitor.
The accelerated approval was based on data from the international Phase 2, single-arm TROPHY study.
Of the 112 patients who were evaluable for efficacy, 27.7% of those treated with Trodelvy responded to treatment, with 5.4% experiencing a complete response and 22.3% experiencing a partial response. The median duration of response was 7.2 months.
A BOXED WARNING for severe or life-threatening neutropenia and severe diarrhea is in the Trodelvy U.S. Prescribing Information.