U.S. FDA Approves Trodelvy® for First-Line Treatment of Metastatic Triple-Negative Breast Cancer

Trodelvy earns FDA approval as first-line treatment for triple-negative breast cancer

The FDA has approved sacituzumab govitecan-hziy as first-line therapy for adults with unresectable locally advanced or metastatic triple-negative breast cancer across PD-L1 status. Sacituzumab govitecan-hziy (Trodelvy, Gilead Sciences) — a TROP2-directed antibody-drug conjugate — received approval as a single agent for patients who are not eligible for PD-1 or PD-L1 inhibitors, and in

TROP2 Drug Wins Two New Indications in Triple-Negative Breast Cancer

(MedPage Today) -- The FDA approved sacituzumab govitecan (Trodelvy) for two indications in patients with metastatic triple-negative breast cancer (TNBC). The first indication for the TROP2-targeting antibody-drug conjugate, supported by the ASCENT...

U.S. FDA Approves Trodelvy® for First-Line Treatment of Metastatic Triple-Negative Breast Cancer

FOSTER CITY, Calif.--(BUSINESS WIRE)--Jun 24, 2026-

FDA Approves Trodelvy for Metastatic Triple-Negative Breast Cancer

Results from the Breast Cancer Research Foundation investigator-led clinical trials underpin approvals Key takeaways These approvals give doctors more treatment options for patients with mTNBC. Because mTNBC is aggressive and fast-growing, choosing a powerful first-line treatment is critical. Trodelvy’s efficacy as a first-line treatment may improve outcomes, providing a profound impact on patients’ lives. This targeted ADC outperforms chemoth…

Sacituzumab Govitecan Receives FDA Approval Across 2 TNBC Indications

Results from the phase 3 ASCENT-03 and ASCENT-04 trials supported the FDA approval across both locally advanced or metastatic TNBC indications.

FDA backs Gilead’s Trodelvy for first-line, triple-negative breast cancer

One month after Daiichi Sankyo and AstraZeneca’s drug Datroway received a key breast cancer approval from the FDA, the agency has granted Gilead two approvals for its competing therapy Trodelvy. The FDA's Wednesday