The U.S. Food and Drug Administration on June 24, 2026, approved Trodelvy (sacituzumab govitecan-hziy), Gilead Sciences’ first-in-class Trop-2-directed antibody-drug conjugate (ADC), for the first-line treatment of adults with unresectable locally advanced or metastatic triple-negative breast cancer (TNBC). The decision clears two distinct uses: Trodelvy as a single agent for patients who are not candidates for PD-1 or PD-L1 inhibitor-based therapy, and Trodelvy in combination with Merck’s Keytruda (pembrolizumab), or its subcutaneous formulation, Keytruda Qlex, for patients whose tumors express PD-L1 (combined positive score, or CPS, of at least 10). It is the first ADC cleared in first-line metastatic TNBC, and the first to span the population regardless of PD-L1 status.