EMA Accepts Regulatory Review for ORPATHYS® Plus TAGRISSO® in Lung Cancer Treatment

HUTCHMED announced that the European Medicines Agency (EMA) has validated and accepted for regulatory review a Marketing Authorization Application (MAA) for the combination therapy of ORPATHYS® (savolitinib) and TAGRISSO® (osimertinib). This combination is proposed for the treatment of patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) whose tumors exhibit MET overexpression or amplification and who have progressed on or after EGFR tyrosine kinase inhibitor therapy. Similar regulatory filings have also been made in Japan and previously with the US FDA.