EU regulator backs Trodelvy plus Keytruda for first-line PD-L1-positive breast cancer

The EMA's CHMP recommended Trodelvy combined with Keytruda for adults with unresectable or metastatic triple-negative breast cancer who have not had prior systemic therapy for metastatic disease and whose tumors are PD-L1 positive (CPS 10 or higher). The recommendation is based on the Phase 3 ASCENT-04/KEYNOTE-D19 study. It is a committee opinion, not a final approval, and the European Commission decision is expected later in 2026.

• Indication: first-line metastatic TNBC, PD-L1 CPS of 10 or higher, with Keytruda
• Trial: Phase 3 ASCENT-04/KEYNOTE-D19
• Opinion is a recommendation; European Commission decision expected later in 2026
• Follows the May 2026 CHMP opinion for Trodelvy alone in first-line TNBC