FDA Approves Trodelvy for Two First-Line Indications, Redefining Advanced Triple-Negative Breast Cancer Care

　　On June 24,2026,the U.S.Food and Drug Administration(FDA)granted approval for Gilead Sciences,Inc.’s TROP2-directed antibody-drug conjugate(ADC),sacituzumab govitecan(brand name:Trodelvy),for two distinct first-line indications in adults with unresectable locally advanced or metastatic triple-negative breast cancer(TNBC).This decision provides comprehensive coverage for this patient population:Trodelvy as a monotherapy for patients ineligible for immune checkpoint inhibitors,and in combination with Merck&Co.,Inc.’s pembrolizumab(Keytruda)or its subcutaneous formulation,Keytruda Qlex,for patients with PD-L1-positive(CPS≥10)tumors.Prescribing information for all agents has been updated accordingly.

　　TNBC is characterized by the absence of estrogen,progesterone,and HER2 receptors,presenting high malignancy and limited treatment options.The approval is supported by two pivotal Phase III trials.The ASCENT-03 trial(NCT05382299)demonstrated that in immunotherapy-ineligible patients,Trodelvy monotherapy achieved a median progression-free survival(PFS)of 9.7 months compared to 6.9 months with standard chemotherapy,reducing the risk of disease progression by 38%.The ASCENT-04/KEYNOTE-D19 trial(NCT05382286)showed that in PD-L1 CPS≥10 patients,the combination of Trodelvy and pembrolizumab extended median PFS to 11.2 months,representing a 35%reduction in progression risk versus chemo-immunotherapy,with an objective response rate of 61%.

　　Safety profiles include a Boxed Warning for Trodelvy regarding severe diarrhea and neutropenia;infusion reactions and UGT1A1-mediated toxicity require monitoring.Pembrolizumab carries warnings for immune-mediated adverse reactions.The recommended dosage for Trodelvy is 10 mg/kg administered via intravenous infusion on Days 1 and 8 of a 21-day cycle until disease progression or unacceptable toxicity.As the first ADC approved for both immunotherapy-eligible and ineligible populations in the first-line setting,Trodelvy establishes a new biomarker-driven standard of care,offering a personalized and effective treatment pathway for advanced TNBC.