European Commission approves Trodelvy to treat unresectable or metastatic hormone receptor (HR)-positive, HER2-negative breast cancer patients who have received endocrine-based therapy – Gilead Sciences

Gilead Sciences, Inc. announced that the European Commission (EC) approved Trodelvy (sacituzumab govitecan) as a monotherapy for the treatment of adult patients with unresectable or metastatic hormone receptor (HR)-positive, HER2-negative breast cancer who have received endocrine-based therapy, and at least two additional systemic therapies in the advanced setting.

The approval by the European Commission follows the positive opinion of the Committee for Medicinal Products and is based on the Phase III TROPiCS-02 study, in which Trodelvy demonstrated a statistically significant and clinically meaningful overall survival (OS) benefit of 3.2 months versus comparator single-agent chemotherapy (treatment of physician’s choice; TPC) (median OS: 14.4 months vs. 11.2 months; hazard ratio [HR]=0.79; 95% CI: 0.65-0.96; p=0.02). Trodelvy also demonstrated a 34% reduction in risk of disease progression or death (median PFS: 5.5 versus 4.0 months; HR: 0.66; 95% CI: 0.53-0.83; p=0.0003). Three times as many people treated with Trodelvy were progression-free at one year versus those treated with chemotherapy (21% versus 7%).