Nuvalent (NUVL) announced the FDA has accepted for filing its New Drug Application, or NDA, for zidesamtinib, an investigational ROS1-selective inhibitor, for the treatment of adult patients with locally advanced or metastatic ROS1-positive non-small cell lung cancer – or NSCLC – who received at least 1 prior ROS1 tyrosine kinase inhibitor. The application has been assigned a Prescription Drug User Fee Act target action date of September 18, 2026.
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