FDA Brief: Priority Review for Sacituzumab Govitecan in HR-Positive, HER2-Negative Metastatic Breast Cancer

By: JNCCN 360 Staff
Posted: Thursday, October 13, 2022

On October 11, Gilead Sciences announced that the U.S. Food and Drug Administration (FDA) has accepted for priority review the supplemental biologics license application for sacituzumab govitecan-hziy (Trodelvy) for the treatment of adults 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. This Trop2-directed antibody and topoisomerase inhibitor conjugate was granted accelerated approval in 2020 for the treatment of adults with metastatic triple-negative breast cancer who have received at least two prior therapies for metastatic disease.

This recent application is based on data from the registrational phase III TROPiCS-02 study, which met its primary endpoint of progression-free survival and the secondary endpoint of overall survival over comparator chemotherapy. In the study, sacituzumab govitecan demonstrated a 34% reduction in the risk of disease progression or death (median progression-free survival: 5.5 vs. 4 months; hazard ratio [HR] = 0.66; 95% confidence interval [CI] = 0.53–0.83; P = .0003) and a 21% decrease in the risk of death compared with treatment of physician’s choice (median overall survival: 14.4 months vs. 11.2 months; HR = 0.789; 95% CI = 0.646–0.964; P = .02).

The safety profile for this agent in TROPiCS-02 was consistent with prior studies, with no new safety concerns identified in this population. Sacituzumab govitecan has a boxed warning for severe or life-threatening neutropenia and severe diarrhea. For full prescribing information, visit accessdata.fda.gov.

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