FDA Approves Sacituzumab Govitecan for First-Line Treatment of Metastatic Triple-Negative Breast Cancer

Clinical Summary:

• This FDA approval was based on the phase 3 ASCENT-03 and ASCENT-04/KEYNOTE-D19 trials evaluating sacituzumab govitecan in patients with previously untreated unresectable locally advanced or metastatic triple-negative breast cancer. 
• In these randomized studies, sacituzumab govitecan significantly improved progression-free survival compared with standard chemotherapy in both PD-L1–negative or immunotherapy-ineligible disease and in PD-L1–positive disease when combined with pembrolizumab.
• These approvals expand the role of sacituzumab govitecan into the first-line setting across biomarker-defined triple-negative breast cancer populations.

On June 24, 2026, the US Food and Drug Administration (FDA) approved sacituzumab govitecan (Trodelvy, Gilead) for the first-line treatment of patients with unresectable locally advanced or metastatic triple-negative breast cancer (TNBC), both as monotherapy for patients ineligible for PD-1/PD-L1 inhibitor–based therapy and in combination with pembrolizumab (Keytruda, Merck) for patients with PD-L1–positive disease. 

These approvals were based on results from the ASCENT-03 and the ASCENT-04/ KEYNOTE-D19 trials. 

In the multicenter, open-label ASCENT-03 trial, 558 patients who had not received prior systemic therapy for advanced disease and were not candidates for PD-1 or PD-L1 inhibitor therapy were randomized 1:1 to receive either sacituzumab govitecan or physician’s choice chemotherapy (nab-paclitaxel, paclitaxel, or gemcitabine plus carboplatin). The primary end point was progression-free survival (PFS), assessed via blinded review. Key secondary end points included overall survival (OS) and objective response rate (ORR).

At analysis, median PFS was 9.7 months in the sacituzumab govitecan arm and 6.9 months in the chemotherapy arm (hazard ratio [HR], 0.62; 95% confidence interval [CI], 0.50 to 0.77; P < .0001). Confirmed ORRs were 50% and 47%, respectively. OS data were immature.

In the multicenter, open-label ASCENT-04 trial, 443 previously untreated patients with PD-L1-positive disease (CPS ≥ 10) were randomized 1:1 to receive either sacituzumab govitecan plus pembrolizumab or physician’s choice chemotherapy plus pembrolizumab. The primary end point was PFS, assessed via blinded review. Key secondary end points included OS and ORR. 

At analysis, median PFS was 11.2 months in the sacituzumab govitecan plus pembrolizumab arm and 7.8 months in the chemotherapy plus pembrolizumab arm (HR, 0.65; 95% CI, 0.51 to 0.84; P = .0009). Confirmed ORRs were 61% and 55%, respectively. OS data were immature.

The recommended dose of sacituzumab govitecan is 10 mg/kg administered intravenously on days 1 and 8 of each 21-day cycle as monotherapy or in combination with pembrolizumab until disease progression or unacceptable toxicity.

The prescribing information includes a boxed warning for neutropenia and diarrhea, and warnings and precautions for hypersensitivity and infusion-related reactions, nausea and vomiting, reduced UGT1A1 activity, and embryo-fetal toxicity. 

The prescribing information for pembrolizumab includes warnings and precautions for immune-mediated adverse reactions, infusion-related reactions, complications of allogeneic hematopoietic stem cell transplantation, and embryo-fetal toxicity.

Source:

US 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. Accessed June 24, 2026. https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-sacituzumab-govitecan-hziy-monotherapy-and-combination-pembrolizumab-first-line