Application based on results from the registrational TRIDENT-1 trial, in which repotrectinib demonstrated high response rates and durable responses in patients with ROS1-positive locally advanced or metastatic non-small cell lung cancer
If approved, repotrectinib will provide a potential best-in-class option for patients with ROS1-positive NSCLC who are TKI-naïve and a potential first-in-class treatment for patients who have been treated with prior TKI
The U.S. Food and Drug Administration assigned a target action date of November 27, 2023
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