China NMPA accepts BLA for sacituzumab govitecan-hziy in breast cancer

The China National Medical Products Administration (NMPA) has accepted for review the Biologics License Application (BLA) for sacituzumab govitecan-hziy (SG), an investigational therapy for the treatment of adult patients with unresectable locally advanced or metastatic triple-negative breast cancer (TNBC) who have received two or more prior systemic therapies, at least one of them for metastatic disease, submitted by Chinese biotech Everest Medicines (HK: 1952).

"This aggressive and difficult-to-treat disease has historically had very limited treatment options, with overall survival remaining unchanged among patients for nearly two decades," said Yang Shi, chief medical officer for oncology at Everest Medicines. "The outstanding and robust efficacy and safety results from the global Phase III ASCENT study demonstrate SG is an important potential new treatment option for people in China with metastatic TNBC," he noted.

Already approved in USA as Trodelvy