FDA D.I.S.C.O. Burst Edition: FDA approval of Trodelvy (sacituzumab govitecan-hziy) for HR-positive breast cancer
Regulatory approval: On Feb 3, 2023, the FDA approved sacituzumab govitecan-hziy (Trodelvy) for patients with unresectable locally advanced or metastatic hormone receptor–positive, HER2-negative breast cancer after endocrine-based therapy and at least two additional systemic therapies in the metastatic setting. Approval was supported by TROPiCS-02 (n=543), where median PFS was 5.5 vs 4.0 months and median OS was 14.4 vs 11.2 months versus single-agent chemotherapy.
FDA approval (Feb 3, 2023): sacituzumab govitecan-hziy for HR+/HER2- metastatic breast cancer
The FDA approved sacituzumab govitecan-hziy (Trodelvy) on 2023-02-03 for unresectable locally advanced or metastatic hormone receptor–positive, HER2-negative breast cancer in patients who have received endocrine-based therapy and at least two additional systemic therapies in the metastatic setting.
Evidence base
Efficacy was evaluated in TROPiCS-02, a multicenter, open-label, randomized trial enrolling 543 patients with unresectable locally advanced or metastatic HR+/HER2- breast cancer whose disease progressed after a CDK4/6 inhibitor, endocrine therapy, and a taxane (in any setting). Patients had received at least two prior chemotherapies in the metastatic setting. Patients were randomized 1:1 to sacituzumab govitecan-hziy or single-agent chemotherapy, with stratification by prior chemotherapy regimens for metastatic disease, visceral metastasis, and duration of endocrine therapy in the metastatic setting.
Primary endpoint: PFS by blinded independent central review (RECIST v1.1). Key secondary endpoint: OS.
- Median PFS: 5.5 months vs 4.0 months (single-agent chemotherapy)
- Median OS: 14.4 months vs 11.2 months
Safety
Most common adverse events (>25%; including lab abnormalities): decreased leukocyte, neutrophil, hemoglobin, and lymphocyte counts; diarrhea; fatigue; nausea; alopecia; increased glucose; constipation; decreased albumin.
The review was conducted under Project Orbis; reviews at other agencies were ongoing at the time of the FDA update.