The European Commission has granted marketing authorization for Gilead Sciences’ Trodelvy (sacituzumab govitecan-hziy) in combination with Merck’s Keytruda (pembrolizumab) for adult patients with unresectable, locally advanced, or metastatic triple-negative breast cancer (TNBC) who have not received prior systemic therapy for metastatic disease and whose tumors express PD-L1 with a combined positive score of 10 or higher.
The approval follows positive results from the Phase 3 ASCENT-04/KEYNOTE-D19 study, which demonstrated a 35% reduction in the risk of disease progression or death compared with standard chemotherapy plus Keytruda. The combination is now cleared for use across the European Union’s 27 member states, as well as Norway, Iceland, and Liechtenstein.
Separately, the European Commission also recently approved Trodelvy as a monotherapy for patients with unresectable locally advanced or metastatic TNBC who are ineligible for PD-1 or PD-L1 inhibitor therapy and have not received prior systemic treatment for metastatic disease. Since its initial U.S. and EU approvals in 2020, Trodelvy has been administered to more than 75,000 breast cancer patients globally.
Triple-negative breast cancer accounts for approximately 15% of all breast cancer cases and is characterized by the absence of estrogen, progesterone, and HER2 receptors, making it particularly aggressive. The condition disproportionately affects younger, premenopausal women, as well as Black and Hispanic populations. Survival rates for metastatic TNBC remain low, with a five-year survival rate of just 12%, compared with 28% for other metastatic breast cancer subtypes.
