Express Pharma

Gilead gets US FDA Accelerated Approval for Trodelvy to treat metastatic urothelial cancer

New indication marks second FDA approval for Trodelvy in 2021

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Gilead Sciences announced that the US Food and Drug Administration (FDA) has granted accelerated approval of Trodelvy (sacituzumab govitecan-hziy) for use 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 per cent of those treated with Trodelvy responded to treatment, with 5.4 per cent experiencing a complete response and 22.3 per cent experiencing a partial response. The median duration of response was 7.2 months (95% CI: 4.7-8.6).

Trodelvy’s safety profile in the TROPHY study is consistent with previous observations in metastatic UC and other tumor types. Among all evaluable treated metastatic UC patients (n=113), the most common (≥25%) adverse reactions were diarr