Everest Medicines Announces CTA Approval by China NMPA for P

Everest Medicines Announces CTA Approval by China NMPA for Phase 3 Trial of Sacituzumab Govitecan-Hziy for Metastatic Urothelial Cancer


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SHANGHAI, Jan. 6, 2021 /PRNewswire/ -- Everest Medicines (HKEX 1952.HK), a biopharmaceutical company focused on developing and commercializing transformative pharmaceutical products that address critical unmet medical needs for patients in Greater China and other parts of Asia, today 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.

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