Express Pharma

Gilead gets US FDA nod for Trodelvy to treat metastatic triple-negative breast cancer

Trodelvy significantly reduced the risk of death by 49 per cent compared with single-agent chemotherapy in the Phase 3 ASCENT Study

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Gilead Sciences announced that the US Food and Drug Administration (FDA) has granted full approval to Trodelvy (sacituzumab govitecan-hziy) for adult patients with unresectable locally advanced or metastatic triple-negative breast cancer (TNBC) who have received two or more prior systemic therapies, at least one of them for metastatic disease. The approval is supported by data from the Phase 3 ASCENT study, in which Trodelvy demonstrated a statistically significant and clinically meaningful 57 per cent reduction in the risk of disease worsening or death (progression-free survival (PFS)), extending median PFS to 4.8 months from 1.7 months with chemotherapy (HR: 0.43; 95% CI: 0.35-0.54; p<0.0001). Trodelvy also extended median ove