FDA Approves Sacituzumab Govitecan-hziy for First-Line Triple-Negative Breast Cancer

On June 24, 2026, the Food and Drug Administration (FDA) expanded the treatment landscape for adults with triple-negative breast cancer (TNBC) by approving sacituzumab govitecan-hziy (Trodelvy) for two separate first-line indications. These approvals provide new therapeutic pathways for patients with unresectable locally advanced or metastatic disease, both as a monotherapy and in combination with immunotherapy.

The first approval identifies sacituzumab govitecan-hziy as a single-agent treatment for adults with unresectable locally advanced or metastatic TNBC who are not eligible for PD-1 or PD-L1 inhibitor-based therapy. The second indication authorizes the drug’s use in combination with pembrolizumab (Keytruda) or pembrolizumab and berahyaluronidase alfa-pmph (Keytruda Qlex). This combination is specifically for patients whose tumors express PD-L1 (CPS ≥ 10) as determined by an FDA-authorized test.

Clinical trial outcomes

The monotherapy approval was supported by the ASCENT-03 trial, a multicenter, open-label, randomized study involving 558 patients. Participants had not received prior systemic therapy for advanced disease and were not candidates for PD-1/PD-L1 inhibitors. Patients were randomized to receive either sacituzumab govitecan-hziy or a treatment of physician’s choice (TPC), which included nab-paclitaxel, paclitaxel, or gemcitabine and carboplatin.

The trial reached its primary efficacy outcome of progression-free survival (PFS), with the sacituzumab govitecan-hziy arm reaching a median PFS of 9.7 months (95% CI: 8.1, 11.1) compared to 6.9 months (95% CI: 5.6, 8.2) in the TPC arm (hazard ratio 0.62; p-value <0.0001). The confirmed objective response rate (ORR) was 50% for the study drug versus 47% for TPC.

The combination therapy was evaluated in the ASCENT-04/KEYNOTE-D19 trial, which enrolled 443 patients with PD-L1-expressing TNBC (CPS ≥ 10). Patients receiving sacituzumab govitecan-hziy plus pembrolizumab showed a median PFS of 11.2 months (95% CI: 9.3, 16.7) compared to 7.8 months (95% CI: 7.3, 9.3) for those receiving TPC plus pembrolizumab (hazard ratio 0.65; p-value 0.0009). The confirmed ORR was 61% in the investigational arm.

Nursing considerations and safety

For oncology nurses, managing the safety profile of these regimens is critical. Sacituzumab govitecan-hziy carries a boxed warning for severe diarrhea and neutropenia. Nurses should also monitor for hypersensitivity, infusion-related reactions, and nausea or vomiting. Additional precautions are necessary for patients with reduced UGT1A1 activity.

When administered with pembrolizumab, clinicians must also monitor for immune-mediated adverse reactions and complications related to allogeneic hematopoietic stem cell transplantation. The recommended dosage for sacituzumab govitecan-hziy is 10 mg/kg administered via intravenous infusion on Days 1 and 8 of each 21-day cycle. Treatment should continue until disease progression or unacceptable toxicity.

Collaborative review

This review was conducted under Project Orbis, an initiative of the FDA Oncology Center of Excellence that facilitates concurrent submissions among international partners, including regulatory agencies in Australia, Brazil, Canada, Israel, and Switzerland. Notably, the FDA approved these applications one month ahead of its goal date.

Reference

1. U.S. Food and Drug Administration. FDA approves sacituzumab govitecan-hziy as monotherapy and in combination with pembrolizumab for first-line treatment of triple-negative breast cancer. June 24, 2026. Accessed June 24, 2026.