Hansoh Pharmaceutical Group Co. Ltd. said aumolertinib mesylate tablets (Ameile in China; Aumseqa outside China) have been approved in the European Union as monotherapy for first-line treatment of adults with advanced EGFR-mutated non-small cell lung cancer (exon 19 deletions or exon 21 L858R) and for treatment of adults with advanced EGFR T790M mutation-positive NSCLC. The company said the European Commission decision followed a positive opinion from the European Medicines Agency’s Committee for Medicinal Products for Human Use.
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