EMA committee backs Trodelvy-Keytruda combo in metastatic TNBC
EMA’s CHMP backed marketing authorization for Gilead’s Trodelvy with Merck’s Keytruda in first-line PD-L1-positive metastatic triple-negative breast cancer.
The opinion covers adults with unresectable locally advanced or metastatic disease, no prior metastatic systemic therapy, and PD-L1 CPS ≥10.
A European Commission decision is expected later in 2026.
The recommendation was based on Phase 3 ASCENT-04/KEYNOTE-D19, which showed a 35% lower risk of progression or death versus chemo plus Keytruda.
GILD•
