Gilead's Trodelvy Under FDA Review For Pre-Treated HR+/HER2- Metastatic Breast Cancer

The FDA has accepted for review Gilead Sciences Inc's GILD Trodelvy (sacituzumab govitecan-hziy) for unresectable locally advanced or metastatic hormone receptor (HR) positive, human epidermal growth factor receptor 2 (HER2) negative breast cancer.
The supplemental application covers patients who have received endocrine-based therapy and at least two additional systemic therapies in the metastatic setting.
The target action date of the Prescription Drug User Fee Act (PDUFA) is February 2023.
Related: Gilead's Trodelvy Shows Improved Overall Survival In Pretreated Breast Cancer Settings.
The application is based on data from the registrational Phase 3 TROPiCS-02 study. In the study, Trodelvy demonstrated a 34% reduction in the risk of disease progression or death and a 21% decrease in the risk of death compared to chemo.
The safety profile for Trodelvy in TROPiCS-02 was consistent with prior studies, with no new safety concerns identified in this population.
Any regulatory agency has not approved Trodelvy for HR+/HER2- metastatic breast cancer.
Price Action: GILD shares are up 2.34% at $65.97 on the last check Tuesday.