Gilead Sciences received a positive opinion from the European Medicines Agency’s expert panel for its drug Trodelvy. The Committee for Medicinal Products for Human Use recommended the therapy in combination with Merck’s Keytruda.
The recommendation covers first-line treatment for adults with PD-L1 expressing metastatic triple-negative breast cancer.
Data from the Phase 3 ASCENT-04 study showed the combination reduced the risk of disease progression or death by 35% compared to Keytruda plus chemotherapy.
The European Commission expects to issue a final marketing authorization decision later in 2026.