Posted by Michael Wonder on 20 Nov 2025
Nuvalent announces FDA acceptance of new drug application for zidesamtinib for the treatment of TKI pre-treated patients with advanced ROS1 positive NSCLC
19 November 2025 - Nuvalent today announced the US FDA has accepted for filing its new drug application 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 who received at least 1 prior ROS1 tyrosine kinase inhibitor.
The application has been assigned a PDUFA target action date of 18 September 2026.
