The European Commission has granted marketing authorization for Trodelvy® (sacituzumabgovitecan) as an initial treatment for adults with unresectable or metastatic triple-negative breast cancer (mTNBC) who are ineligible for PD-1/PD-L1 checkpoint inhibitor therapy.
The decision marks a watershed moment: Trodelvy becomes the first antibody-drug conjugate cleared for frontline use in mTNBC across the EU’s 27 member states, plus Norway, Iceland, and Liechtenstein — and the first genuinely new treatment option in this setting in roughly two decades.
Regulatory clearance rested on Phase 3 ASCENT-03 trial data showing Trodelvy reduced the risk of disease progression or death by 38% compared with standard chemotherapy among patients ineligible for immunotherapy.
Metastatic TNBC — which disproportionately affects younger, premenopausal, Black, and Hispanic women — carries a five-year survival rate of just 12%, making earlier access to effective therapy critically important.
Gilead Sciences has also submitted applications to the U.S. FDA covering both single-agent and combination uses of Trodelvy in the first-line mTNBC setting.
Written By: Sayan Das
Graphics by: Pramit Hazra
