BRIEF—Everest Medicines gets China NMPA approval of Trodelvy

Today Everest Medicines announced the approval of its New Drug Application (NDA) for Trodelvy (sacituzumab govitecan) from China’s National Medical Products Administration (NMPA) to treat 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.

This approval marks Everest’s first drug approval in its home market and upcoming commercialization in China. In addition to receiving approval in China and previously in  Singapore, Everest is closely coordinating with regulatory bodies in South Korea, Taiwan, and Hong Kong to review its applications for Trodelvy.

Everest picked up rights to develop the ADC in China and other Asian countries in 2019 from Immunmedics, the therapy’s original developer, before Gilead stepped in and bought the firm for $21 billion.