Gilead’s Trodelvy won an expanded FDA approval for first-line triple-negative breast cancer, enabling use regardless of PD-L1 status. The expanded label supports both monotherapy and combination use with Merck’s Keytruda depending on tumor biomarker status. The update sets up a new competitive phase in the TROP2 ADC landscape shortly after other front-line TNBC approvals in the category. Gilead’s label positioning is backed by two phase 3 studies described by the reporting outlet, spanning PD-(L)1 treatment-ineligible and PD-L1-positive populations. This approval broadens clinical positioning for Trodelvy as sponsors race to define the most durable first-line ADC standards.