27 July 2023 - Approval based on clinically meaningful overall survival benefit demonstrated in the TROPiCS-02 study in pre-treated HR+/HER2- (IHC 0, IHC 1+ or IHC 2+/ISH–) metastatic breast cancer versus physician’s choice of chemotherapy.
Gilead today announced that the European Commission approved Trodelvy (sacituzumab govitecan) as a monotherapy for the treatment of adult patients with unresectable or metastatic hormone receptor positive, HER2 negative breast cancer who have received endocrine-based therapy, and at least two additional systemic therapies in the advanced setting.