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Bristol Myers (BMY) NSCLC Drug Application Gets EMA Validation
Bristol-Myers SquibbBristol-Myers Squibb(US:BMY) Zacks Investment Research·2024-01-04 04:47

Bristol Myers Squibb (BMY) announced that the European Medicines Agency (“EMA”) has validated its marketing authorization application (“MAA”) for the next-generation tyrosine kinase inhibitor (“TKI”) repotrectinib.The MAA is seeking approval of the candidate for the treatment for ROS1 TKI-naïve and pretreated adult patients with ROS1-positive locally advanced or metastatic non-small cell lung cancer (“NSCLC”) and TKI-naïve and -pretreated adult and pediatric patients 12 years and older with NTRK-positive lo ...