FDA approves sacituzumab govitecan-hziy for HR-positive breast cancer
Regulatory approval: On Feb 3, 2023, the FDA approved sacituzumab govitecan-hziy (Trodelvy) for unresectable locally advanced or metastatic HR-positive, HER2-negative breast cancer after endocrine-based therapy and at least two additional systemic therapies in the metastatic setting. Approval was supported by the phase 3 TROPiCS-02 trial, which showed improved PFS and OS versus investigator’s choice single-agent chemotherapy.
FDA approval: sacituzumab govitecan-hziy in HR-positive/HER2-negative breast cancer (Feb 3, 2023)
Type: Regulatory approval
Agency/date: US FDA, 2023-02-03
The FDA approved sacituzumab govitecan-hziy (Trodelvy; Gilead Sciences) for patients with unresectable locally advanced or metastatic hormone receptor (HR)-positive, HER2-negative (IHC 0, IHC 1+, or IHC 2+/ISH−) breast cancer who have received endocrine-based therapy and at least two additional systemic therapies in the metastatic setting.
Key evidence (TROPiCS-02; NCT03901339)
TROPiCS-02 was a multicenter, open-label, randomized trial (n=543) in patients with unresectable locally advanced or metastatic HR-positive/HER2-negative breast cancer whose disease progressed after a CDK4/6 inhibitor, endocrine therapy, and a taxane (in any setting). Patients had received ≥2 prior chemotherapies in the metastatic setting.
Patients were randomized 1:1 to sacituzumab govitecan-hziy 10 mg/kg IV on days 1 and 8 every 21 days (n=272) or investigator’s choice single-agent chemotherapy (eribulin, vinorelbine, gemcitabine, or capecitabine; n=271) until progression or unacceptable toxicity.
- Median PFS (primary; BICR): 5.5 vs 4.0 months (HR 0.661; 95% CI 0.529–0.826; p=0.0003)
- Median OS (key secondary): 14.4 vs 11.2 months (HR 0.789; 95% CI 0.646–0.964; p=0.0200)
Safety
Most common adverse events (≥25%) included decreased leukocytes (88%), decreased neutrophils (83%), decreased hemoglobin (73%), diarrhea (62%), fatigue (60%), nausea (59%), and alopecia (48%).
Regulatory notes
Review occurred under Project Orbis; reviews were ongoing at partner agencies at the time of the FDA decision. The application received priority review.