European Commission approves Trodelvy for first-line metastatic TNBC

CAR-T Digest - August 2020

Weekly Digest - June 2026

23 June 2026: European Commission approves Trodelvy for first-line metastatic TNBC

Gilead Sciences has received European Commission approval for Trodelvy as a first-line treatment for adult patients with unresectable locally advanced or metastatic triple-negative breast cancer who are not candidates for PD-1/PD-L1 inhibitor therapy, expanding access to the TROP2-directed ADC across the European Union
The approval was supported by results from the phase 3 ASCENT-03 trial, where Trodelvy reduced the risk of disease progression or death by 38% versus standard chemotherapy, achieving a median progression-free survival of 9.7 months compared with 6.9 months and demonstrating a clinically meaningful benefit in a patient population with limited frontline treatment options
The decision addresses a significant unmet need for the majority of metastatic TNBC patients who are ineligible for immunotherapy and have historically relied on chemotherapy-based regimens associated with poor long-term outcomes and rapid disease progression
Trodelvy is a TROP2-directed antibody-drug conjugate that delivers the active metabolite SN-38, a topoisomerase I inhibitor, directly to tumor cells, enabling targeted cytotoxic activity while leveraging the broad expression of TROP2 across triple-negative breast cancer
Strategically, the European approval further expands Trodelvy’s presence in the first-line metastatic breast cancer setting, strengthens Gilead’s position in the rapidly growing TROP2-targeted ADC market, and intensifies competition with other next-generation ADCs as targeted therapies increasingly replace conventional chemotherapy in TNBC treatment paradigms