The US regulator has granted a priority review for Trodelvy (sacituzumab govitecan) as a treatment for adults with unresectable locally advanced or metastatic HR+/HER2- breast cancer who have progressed on endocrine-based therapy and at least two additional systemic therapies, based on the results of the recently-reported TROPiCs-02 trial.
It has set a target date of 23 February to complete its review, which if positive would see the patient population eligible for Trodelvy expand significantly from its current use in triple-negative breast cancer (TNBC) and urothelial cancer.
