Gilead's sacituzumab govitecan (Trodelvy) has secured European Commission marketing authorization as a first-line monotherapy for metastatic triple-negative breast cancer (TNBC) in patients who are not candidates for PD-1 or PD-L1 inhibitor therapy — making it the first ADC approved in the EU for first-line metastatic TNBC and the first new treatment option in this setting in Europe in two decades. The approval covers all 27 EU member states plus Norway, Iceland, and Liechtenstein.
The authorization is based on data from the Phase III ASCENT-03 study, in which Trodelvy demonstrated a statistically significant and clinically meaningful improvement in progression-free survival versus standard chemotherapy, reducing the risk of disease progression or death by 38% in patients ineligible for PD-1/PD-L1 inhibitor therapy. The ASCENT-03 trial used a patient-centered crossover design allowing patients in the chemotherapy arm to receive Trodelvy after progression. The CHMP had issued a positive opinion on May 21, 2026, preceding the Commission's formal decision.
Trodelvy is a Trop-2-directed ADC that delivers SN-38, a topoisomerase I inhibitor, via a proprietary hydrolyzable linker. The construct is designed to act on Trop-2-expressing tumor cells and neighboring cells through a bystander effect. Trop-2 is highly expressed in more than 90% of breast and lung cancers, making it a validated target in TNBC. The newly authorized indication addresses a clinically distinct and underserved subgroup: patients who are PD-L1-negative or otherwise ineligible for checkpoint inhibitor therapy, for whom cytotoxic chemotherapy had remained the only first-line option.
Gilead has also submitted a supplemental application to the European Medicines Agency for Trodelvy in combination with Keytruda (pembrolizumab) for PD-L1-positive first-line metastatic TNBC, based on the Phase III ASCENT-04/KEYNOTE-D19 study, which reported a 35% reduction in the risk of disease progression or death versus Keytruda plus chemotherapy. If approved, Trodelvy would span the full PD-L1 spectrum in first-line metastatic TNBC in Europe. In the US, Gilead has filed supplemental applications for both the monotherapy and combination settings. The asset has now been used in more than 75,000 breast cancer patients globally since 2020 and holds approvals in more than 60 countries for later-line TNBC.