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EMA and Japan accept regulatory filings for review of ORPATHYS plus TAGRISSO in lung cancer
HCMHUTCHMED (China) Ltd
The European Medicines Agency (EMA) and Japan’s Ministry of Health, Labour and Welfare have accepted the Marketing Authorization Application and New Drug Application, respectively, for ORPATHYS (savolitinib) combined with TAGRISSO (osimertinib). The filings seek approval for treating locally advanced or metastatic non-small cell lung cancer in patients with MET overexpression or amplification who progressed on EGFR tyrosine kinase inhibitor therapy. These submissions follow a New Drug Application filed with the US FDA in September 2026 and are supported by positive Phase III SAFFRON trial data showing significant improvements in progression-free and overall survival. HUTCHMED is an innovative biopharmaceutical company focused on discovering and commercializing targeted therapies for cancer.