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).