HUTCHMED Announces Regulatory Filings Accepted in Europe and Japan for ORPATHYS® plus TAGRISSO® in Lung Cancer
HUTCHMED has announced that regulatory filings for the combination of ORPATHYS® (savolitinib) and TAGRISSO® (osimertinib) have been accepted for review by the European Medicines Agency (EMA) and submitted in Japan. The applications seek approval for the treatment of patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) whose tumors have MET overexpression or amplification and who have progressed on or after EGFR tyrosine kinase inhibitor therapy. These filings follow a submission to the U.S. FDA in September 2026 and are supported by positive results from the SAFFRON global Phase III trial.
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