Posted by Michael Wonder on 26 Jun 2023
Gilead receives CHMP positive opinion for Trodelvy in pre-treated HR+/HER2- metastatic breast cancer
23 June 2023 - Recommendation based on the TROPiCS-02 study showing Trodelvy demonstrated statistically significant and clinically meaningful overall survival in pre-treated HR+/HER2- (IHC 0, IHC 1+ or IHC 2+/ISH–) metastatic breast cancer vs. physician’s choice of chemotherapy.
Gilead Sciences today announced that the CHMP of the EMA adopted a positive opinion for Trodelvy (sacituzumab govitecan) as 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.
