The European Commission has granted marketing authorization for Gilead Sciences’ Trodelvy in combination with Merck’s Keytruda to treat adult patients with unresectable, locally advanced, or metastatic triple-negative breast cancer (TNBC).
The approval covers patients who have not received prior systemic therapy for metastatic disease and whose tumors express PD-L1 with a combined positive score of 10 or higher. The decision follows Phase 3 ASCENT-04/KEYNOTE-D19 trial data showing a 35% reduction in the risk of disease progression or death compared with standard chemotherapy plus Keytruda.
TNBC accounts for approximately 15% of all breast cancer cases and carries a five-year survival rate of just 12% in metastatic settings, compared with 28% for other metastatic breast cancer subtypes. The combination is positioned as a first-line treatment option in this high-risk patient population.
Gilead noted that more than 75,000 patients worldwide have been treated with Trodelvy since its initial approval in 2020. The drug is already approved in the U.S. and Europe for use as monotherapy in similar TNBC indications. The European authorization extends across all 27 EU member states, as well as Norway, Iceland, and Liechtenstein.
Merck Sharp & Dohme LLC, a subsidiary of Merck & Co, holds the trademark for Keytruda, which is widely used across oncology indications. The combination therapy expands treatment options for TNBC, an aggressive subtype that disproportionately affects younger, premenopausal, and minority women.
