FDA Approves Trodelvy for Two Breast Cancer Indications

The FDA approved sacituzumab govitecan-hziy (Trodelvy, Gilead Sciences) for two first-line indications in adults with unresectable locally advanced or metastatic triple-negative breast cancer (TNBC), according to an FDA approval notice.

The first indication covers sacituzumab govitecan-hziy as monotherapy for adults who are not candidates for PD-1 or PD-L1 inhibitor-based therapy. The second indication covers sacituzumab govitecan-hziy in combination with pembrolizumab (Keytruda, Merck & Co., Inc.) or pembrolizumab and berahyaluronidase alfa-pmph (Keytruda Qlex, Merck & Co., Inc.) for adults whose tumors express PD-L1 with a combined positive score (CPS) of at least 10, as determined by an FDA-authorized test.

The monotherapy approval was supported by ASCENT-03, a multicenter, open-label, randomized trial. The FDA notice described ASCENT-03 as enrolling 558 patients with unresectable locally advanced or metastatic TNBC who had not received prior systemic therapy for advanced disease and were not candidates for PD-1 or PD-L1 inhibitor therapy. Patients were randomly assigned to sacituzumab govitecan-hziy or treatment of physician’s choice. Median progression-free survival (PFS) by blinded independent central review was 9.7 months with sacituzumab govitecan-hziy compared with 6.9 months in the comparator arm (hazard ratio [HR], 0.62; P<.0001). Confirmed objective response rates (ORRs) were 50% and 47%, respectively, and overall survival (OS) data were immature.

The combination approval was supported by ASCENT-04/KEYNOTE-D19, a multicenter, open-label, randomized trial involving 443 patients with locally advanced or metastatic TNBC whose tumors expressed PD-L1 and who had not received previous systemic therapy for advanced disease. Median PFS was 11.2 months with sacituzumab govitecan-hziy plus pembrolizumab and 7.8 months with treatment of physician’s choice plus pembrolizumab (HR, 0.65; P=.0009). Confirmed ORRs were 61% and 55%, respectively, and OS data were immature.

The prescribing information for sacituzumab govitecan-hziy includes a boxed warning for diarrhea and neutropenia. It also includes warnings and precautions for hypersensitivity and infusion-related reactions, nausea and vomiting, reduced UGT1A1 activity, and embryo-fetal toxicity. The recommended dose is 10 mg/kg administered as an intravenous infusion on days 1 and 8 of each 21-day cycle until disease progression or unacceptable 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. Published June 24, 2026. Accessed July 1, 2026.