Posted by Michael Wonder on 11 Oct 2022
U.S. FDA accepts for priority review the supplemental biologics license application for Gilead’s Trodelvy for pre-treated HR+/HER2- metastatic breast cancer
11 October 2022 - Supplemental biologics license application based on statistically significant and clinically meaningful overall survival and progression-free survival results from the Phase 3 TROPiCS-02 study.
Gilead Sciences today announced the US FDA has accepted for priority review the supplemental biologics license application for Trodelvy (sacituzumab govitecan-hziy) for the treatment of adult patients with unresectable locally advanced or metastatic hormone receptor positive, human epidermal growth factor receptor 2 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.
