Posted by Michael Wonder on 03 Feb 2023
FDA approves sacituzumab govitecan-hziy for HR positive breast cancer
3 February 2023 - Today, the FDA approved sacituzumab govitecan-hziy (Trodelvy, Gilead Sciences) for 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.
Efficacy was evaluated in TROPiCS-02, a multi-centre, open label, randomised trial in 543 patients with unresectable locally advanced or metastatic hormone receptor positive, HER2 negative breast cancer whose disease progressed after the following in any setting: a CDK 4/6 inhibitor, endocrine therapy, and a taxane.
