Everest Medicines announced that the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA) of the People's Republic of China has approved a Clinical Trial Application (CTA) for sacituzumab govitecan-hziy for the treatment of patients with metastatic urothelial cancer (mUC). With this CTA, Everest Medicines plans to enroll patients in China as part of the Phase 3, global, multicenter, open-label randomized controlled TROPiCS-04 trial. The trial will evaluate sacituzumab govitecan-hziy compared with standard of care chemotherapeutic options in subjects with metastatic or locally advanced unresectable urothelial cancer who have progressed after prior therapy with a platinum-based regimen and anti-programmed cell death protein 1 (PD-1)/programmed death-ligand 1 (PD-L1) therapy. Subjects will be randomized to receive either sacituzumab govitecan-hziy or Treatment of Physician's Choice (TPC), including paclitaxel, docetaxel, and vinflunine. Positive results from the pivotal Phase 2 TROPHY U-01 study of sacituzumab govitecan-hziy in 113 mUC patients, presented at the ESMO 2020 annual conference, confirmed earlier study results showing sacituzumab govitecan-hziy has significant activity and is safe in patients with heavily pretreated mUC who progressed on both platinum-based chemotherapy and checkpoint inhibitors (CPI). Results from the study showed that sacituzumab govitecan-hziy achieved a 27% overall response rate (ORR) and a median duration of response (DOR) of 5.9 months in heavily pre-treated patients with mUC. Sacituzumab govitecan-hziy has received Fast Track Designation from the U.S. Food and Drug Administration (FDA) in this indication.