FDA has expanded Gilead’s Trodelvy (sacituzumab govitecan-hziy) to a first-line treatment setting for adults with HR-positive, HER2-negative advanced breast cancer?—no, specifically for triple-negative breast cancer (TNBC), strengthening the ADC’s position in a crowded early-line landscape. The label now supports first-line use for TNBC with a slightly broader indication profile aimed at improving differentiation versus other antibody-drug conjugates. The approval arrives after competing TNBC ADCs—AstraZeneca and Daiichi Sankyo’s Datroway (trastuzumab deruxtecan?) and others—secured key breast cancer traction. Trodelvy’s expanded label gives Gilead a clearer path into earlier treatment lines where ADC adoption is increasingly tied to head-to-head clinical evidence. For biotech developers, the decision underscores how regulators are sharpening ADC competition around label scope and sequencing in TNBC rather than limiting differentiation to later-line use. (Article references: MedCity News coverage of the approval and label expansion.)