Generic selectors
Exact matches only
Search in title
Search in content
Post Type Selectors
Filter by Categories
Biosimilars Deals 2023
Biosimilars Deals 2024
Chris Vindurampulle
Other Podcasts
Other Updates
Our Awards
Patent Case Summaries
Patent Litigation
Paul Johns
Trade Marks

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).