Biopharmaceutical company Gilead Sciences Inc (Nasdaq:GILD) announced on Friday that the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) has recommended marketing authorisation for Trodelvy (sacituzumab govitecan-hziy) in combination with Keytruda (pembrolizumab) for adults with unresectable locally advanced or metastatic triple-negative breast cancer whose tumours are PD-L1-positive (CPS ≥10) and who have not received prior systemic therapy for metastatic disease.

A European Commission decision is expected later in 2026.

This recommendation is based on the Phase 3 ASCENT-04/KEYNOTE-D19 study, which showed a highly statistically significant and clinically meaningful improvement in progression-free survival versus standard-of-care chemotherapy plus Keytruda. The combination reduced the risk of disease progression or death by 35% in patients with PD-L1-positive metastatic triple-negative breast cancer.

Trodelvy is already approved in the European Union as a monotherapy for adults with unresectable or metastatic triple-negative breast cancer who are not candidates for PD-1 or PD-L1 inhibitor therapy. In the United States, the therapy is approved both as a single agent for eligible patients and in combination with Keytruda for patients with PD-L1-positive tumours.