EC approves Gilead’s Trodelvy for pre-treated HR+/HER2- metastatic breast cancer

Gilead Sciences announced that the European Commission, or EC, approved Trodelvy as a monotherapy for the treatment of adult patients with unresectable or metastatic hormone receptor-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 3 TROPiCS-02 study, in which Trodelvy demonstrated a statistically significant and clinically meaningful overall survival, or OS, benefit of 3.2 months versus comparator single-agent chemotherapy. Trodelvy also demonstrated a 34% reduction in risk of disease progression or death. Three times as many people treated with Trodelvy were progression-free at one year versus those treated with chemotherapy. In the TROPiCS-02 study, Trodelvy also significantly improved additional secondary endpoint measures, including objective response rate and time to deterioration assessed by the Global Health Status/Quality of Life and Fatigue scale per EORTC-QLQ-C30. No statistically significant difference in TTD in Pain Scale was observed. The safety profile for Trodelvy is well-characterized and consistent with prior studies, with no new safety signals identified in this patient population. In the TROPiCS-02 study, the discontinuation rate due to adverse reactions was 6% for Trodelvy and 4% for patients on single-agent chemotherapy.