FDA Approves Trodelvy for First-Line Treatment of Triple-Negative Breast Cancer

The U.S. Food and Drug Administration (FDA) has approved Trodelvy (sacituzumab govitecan-hziy) for two first-line indications in adults with unresectable locally advanced or metastatic triple-negative breast cancer (TNBC). This includes use as monotherapy for immunotherapy-ineligible patients and in combination with Keytruda (pembrolizumab) for those with PD-L1–positive disease. Clinical trials demonstrated improved progression-free survival with Trodelvy, though it carries a boxed warning for potential severe side effects like diarrhea and low white blood cell counts.