Regulatory Filings Accepted for Review for ORPATHYS® plus TAGRISSO® in MET-Driven EGFR-Mutated Lung Cancer in Europe and Japan
In Europe, the European Medicines Agency (EMA) has validated and accepted for regulatory review the Marketing Authorization Application (MAA) submitted by AstraZeneca, seeking approval for the combination 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 had disease progression on or after an epidermal growth factor receptor (“EGFR”) tyrosine kinase inhibitor (“TKI”) therapy. In Japan, AstraZeneca has submitted a New Drug Application (“NDA”) to the Ministry of Health, Labour and Welfare (MHLW), which has also been accepted for review, seeking approval in patients with unresectable, advanced or recurrent NSCLC whose tumors have MET overexpression or amplification, and who had disease progression following EGFR-TKI therapy.
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