FDA approves Trodelvy for first-line triple-negative breast cancer

Jun 24, 2026

On June 24, 2026, the FDA approved Gilead Sciences' Trodelvy (sacituzumab govitecan-hziy) as a first-line treatment for adult patients with unresectable locally advanced or metastatic triple-negative breast cancer (mTNBC). The approval covers Trodelvy as a monotherapy for patients ineligible for PD-1/PD-L1 inhibitors, and in combination with Merck's Keytruda (pembrolizumab) for PD-L1 positive tumors. Backed by the Phase 3 ASCENT-03 and ASCENT-04 trials, the regimens significantly reduced the risk of disease progression or death by 38% and 35% respectively, establishing a new standard of care for this aggressive disease.

Trodelvy first-line mTNBC approval

▪The U.S. Food and Drug Administration approved sacituzumab govitecan-hziy, marketed as Trodelvy, on June 24, 2026, as a first-line treatment for adults with unresectable locally advanced or metastatic triple-negative breast cancer.
▪Trodelvy is approved as a single agent for patients who are not candidates for PD-1 or PD-L1 inhibitor-based therapy, and in combination with pembrolizumab or pembrolizumab and berahyaluronidase alfa-pmph for patients whose tumors express PD-L1 with a Combined Positive Score of 10 or higher.

ASCENT-03 trial progression-free survival

▪The Phase 3 ASCENT-03 trial evaluated 558 patients with unresectable locally advanced or metastatic triple-negative breast cancer who had not received previous systemic therapy and were not candidates for immunotherapy.
▪In the ASCENT-03 trial, Trodelvy monotherapy demonstrated a median progression-free survival of 9.7 months compared to 6.9 months with standard chemotherapy, reducing the risk of disease progression or death by 38%.

ASCENT-04 trial combination therapy

▪The Phase 3 ASCENT-04/KEYNOTE-D19 trial evaluated 443 patients with locally advanced or metastatic triple-negative breast cancer whose tumors express PD-L1 with a Combined Positive Score of 10 or higher.

Triple-negative breast cancer epidemiology

▪Triple-negative breast cancer accounts for approximately 15% of all breast cancers and disproportionately impacts younger, premenopausal, and Black and Hispanic women.
▪Among women with metastatic triple-negative breast cancer, the five-year survival rate is 12%, compared with 28% for those with other types of metastatic breast cancer.

Trodelvy global clinical experience

▪Trodelvy is currently approved in more than 60 countries for second-line or later metastatic triple-negative breast cancer and in more than 50 countries for certain patients with pre-treated HR-positive/HER2-negative metastatic breast cancer.
▪More than 75,000 breast cancer patients have been treated with Trodelvy across more than 60 countries over the past six years.

Neutropenia diarrhea safety warnings

▪Trodelvy warnings and precautions include hypersensitivity and infusion-related reactions, nausea and vomiting, increased risk for patients with reduced UGT1A1 activity, and embryo-fetal toxicity.
▪The prescribing information for Trodelvy contains a boxed warning for severe, life-threatening, or fatal neutropenia and severe diarrhea.