U.S. FDA approves Trodelvy for first-line treatment of metastatic TNBC

CAR-T Digest - August 2020

Weekly Digest - June 2026

24 June 2026: U.S. FDA approves Trodelvy for first-line treatment of metastatic TNBC

Gilead Sciences has received U.S. FDA approval for Trodelvy as a first-line treatment for adults with unresectable locally advanced or metastatic triple-negative breast cancer, establishing the TROP2-directed ADC as a new frontline treatment option across both PD-L1-negative and PD-L1-positive patient populations
The approval was supported by results from two pivotal phase 3 studies: ASCENT-03, where Trodelvy monotherapy reduced the risk of disease progression or death by 38% versus chemotherapy in patients not eligible for PD-1/PD-L1 inhibitor therapy and achieved a median PFS of 9.7 months versus 6.9 months; and ASCENT-04/KEYNOTE-D19, where Trodelvy combined with pembrolizumab demonstrated statistically significant and clinically meaningful improvements in progression-free survival compared with chemotherapy plus pembrolizumab in previously untreated PD-L1-positive mTNBC
The approval addresses a major unmet need for metastatic TNBC patients ineligible for immunotherapy, a population that historically relied on chemotherapy and often experiences rapid disease progression with limited treatment alternatives
Trodelvy is a TROP2-directed antibody-drug conjugate that delivers the topoisomerase I inhibitor SN-38 directly to tumor cells, enabling targeted cytotoxic activity while reducing exposure of healthy tissues compared with conventional chemotherapy
Strategically, the approval expands Trodelvy from a later-line therapy into the first-line metastatic setting, strengthening Gilead’s leadership in TROP2-targeted oncology and intensifying competition with emerging ADCs such as Datroway, while reinforcing ADCs as a new backbone of care for metastatic triple-negative breast cancer