FDA Approves Augtyro for ROS1-Positive Non-Small Cell Lung Cancer

The FDA approved repotrectinib (Augtyro, Bristol Myers Squibb) for locally advanced or metastatic ROS1-positive non-small cell lung cancer (NSCLC).

This is the first FDA approval that includes patients with ROS1-positive NSCLC who have previously received a ROS1 tyrosine kinase inhibitor (TKI), in addition to patients who are TKI naive.

Approval was based on TRIDENT-1, a global, multicenter, single-arm, open-label, multi-cohort clinical trial that included patients with ROS1-positive locally