The U.S. Food & Drug Administration declined to approve two China-tested cancer treatments on Monday, saying one of the companies – Hutchmed Ltd. – needs to test its drug for the U.S. population in a diverse multi-regional trial.
Junshi’s Checkpoint Inhibitor Ready to Head to Regulators for Throat Cancer
Biologics License Application (BLA), Checkpoint Inhibitors, China, China National Medical Products Administration (NMPA), Clinical Trials, Conditional Approval, FDA/Regulatory, Interim Analysis, Nasopharyngeal Carcinoma (NPC), Progression-Free Survival (PFS), R&D, Throat CancerJunshi Biosciences, based in Shanghai, China, announced that an Independent Monitoring Committee (IDMC) decided the company’s Phase III JUPITER-02 trial had met the pre-specified primary endpoint at the interim analysis.