Priority Review for BMS Lung Cancer Drug

FDA has accepted for priority review a Bristol Myers Squibb NDA for repotrectinib, a next-generation tyrosine kinase inhibitor (TKI) for treating patients with ROS1-positive locally advanced or metastatic non-small cell lung cancer (NSCLC). The agency has set a review action target date of 11/27.

The submission is based on data from the company’s TRIDENT-1 study, which the company says “demonstrated high response rates and clinically meaningful durability of benefit in both TKI-naïve and TKI-pretreated patients, including those with ROS1 resistance mutations.” The study is ongoing to assess long-term outcomes and additional endpoints across patient populations with ROS1-positive locally advanced or metastatic NSCLC and NTRK-positive advanced solid tumors, it says. Repotrectinib’s safety profile is reported by the company as “well characterized and manageable.”