Posted by Michael Wonder on 30 May 2023
US FDA accepts for priority review Bristol Myers Squibb’s application for repotrectinib for the treatment of patients with locally advanced or metastatic ROS1 positive non-small cell lung cancer
30 May 2023 - BMS today announced that the US FDA has accepted the new drug application for repotrectinib, a next generation tyrosine kinase inhibitor, for the treatment of patients with ROS1 positive locally advanced or metastatic non-small cell lung cancer, based on results from the TRIDENT-1 trial.
The FDA granted the application priority review and assigned a PDUFA goal date of 27 November 2023.
