FDA Approval

FDA Approves Sacituzumab Govitecan (Trodelvy) for First-Line Treatment of Locally Advanced or Metastatic Triple-Negative Breast Cancer

Anthony Calabro, MA

Key Highlights

  • The FDA approved sacituzumab govitecan-hziy (Trodelvy) for 2 first-line indications in adults with unresectable locally advanced or metastatic triple-negative breast cancer.
  • Sacituzumab govitecan-hziy monotherapy is indicated for patients who are not candidates for PD-1 or PD-L1 inhibitor-based therapy.
  • Sacituzumab govitecan-hziy plus pembrolizumab-based therapy is indicated for patients with PD-L1–expressing tumors, defined as CPS ≥10 by an FDA-authorized test.
  • Approval was supported by progression-free survival results from ASCENT-03 and ASCENT-04/KEYNOTE-D19.

On June 24, the FDA approved sacituzumab govitecan-hziy (Trodelvy, Gilead Sciences, Inc) for 2 first-line indications in adults with unresectable locally advanced or metastatic triple-negative breast cancer (TNBC). Sacituzumab govitecan-hziy was approved as monotherapy for adults who are not candidates for PD-1 or PD-L1 inhibitor-based therapy and, in combination with pembrolizumab or with pembrolizumab and berahyaluronidase alfa-pmph, for adults whose tumors express PD-L1, defined as CPS ≥10 by an FDA-authorized test.

The monotherapy indication was supported by ASCENT-03, a multicenter, open-label, randomized trial involving 558 patients who had not previously received systemic therapy for advanced disease and were not candidates for PD-1 or PD-L1 inhibitor therapy. The median progression-free survival rate was 9.7 months with sacituzumab govitecan-hziy vs 6.9 months with treatment of the physician’s choice (hazard ratio, 0.62; 95% CI, 0.50-0.77; P < .0001).

The combination indication was supported by ASCENT-04/KEYNOTE-D19, a multicenter, open-label, randomized trial of 443 patients with PD-L1–expressing locally advanced or metastatic TNBC. The median progression-free survival rate was 11.2 months with sacituzumab govitecan-hziy plus pembrolizumab vs 7.8 months with treatment of the physician’s choice plus pembrolizumab (hazard ratio, 0.65; 95% CI, 0.51-0.84; P < .0009). The overall survival data were immature in both studies.

The prescribing information for sacituzumab govitecan-hziy contains a boxed warning for diarrhea and neutropenia. Warnings and precautions include hypersensitivity and infusion-related reactions, nausea/vomiting, reduced UGT1A1 activity, and embryo-fetal toxicity. Pembrolizumab prescribing information includes warnings and precautions for immune-mediated adverse reactions, infusion-related reactions, complications of allogeneic hematopoietic stem cell transplantation, and embryo-fetal toxicity.

The recommended sacituzumab govitecan-hziy dose, as monotherapy or in combination with pembrolizumab, is 10 mg/kg administered as an intravenous infusion on days 1 and 8 of each 21-day cycle. Treatment should continue until disease progression or unacceptable toxicity. Refer to the prescribing information for dosing information for pembrolizumab or pembrolizumab and berahyaluronidase alfa-pmph.

Reference
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 25, 2026. https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-sacituzumab-govitecan-hziy-monotherapy-and-combination-pembrolizumab-first-line