FDA accepts Priority Review for BMS’s NDA for repotrectinib for NSCLC

May 30, 2023

BMS announced that the FDA accepted its New Drug Application for repotrectinib, a tyrosine kinase inhibitor for the treatment of ROS1-positive locally advanced or metastatic non-small cell lung cancer (NSCLC).  The FDA granted the application Priority Review and a decision is expected by 27 November 2023.  If approved, it could potentially be a best-in-class option for TKI-naïve patients and a first-in-class option for previously treated patients with ROS1-positive NSCLC.   

BMS recently announced that the FDA has accepted its sBLA, and the EMA has validated its Type II Variation Application, for Reblozyl® (luspatercept-aamt). 

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