Repotrectinib receives approval for the treatment of adult patients with locally advanced or metastatic ROS1-positive non-small cell lung cancer (NSCLC) from the U.S. FDA on November 15, 2023. ROS1 gene is altered in about 1-2% of patients with NSCLC. ROS1-positive lung cancer tends to be aggressive and can spread to the brain and the bones.
Repotrectinib is a highly potent and differentiated small molecule TKI that binds inside the ATP pocket, and is active against both wild-type and resistant mutations, including solvent front and gatekeeper mutations. Repotrectinib is expected to enter the U.S. market in mid-December 2023.