Nuvalent New Drug Application For Zidesamtinib ROS1-Selective Inhibitor Reeives FDA's Approval To Treat Locally Advanced Or Metastatic Ros1-positive Non-small Cell Lung Cancer

Nuvalent, Inc. (NASDAQ:NUVL), a clinical-stage biopharmaceutical company focused on creating precisely targeted therapies for clinically proven kinase targets in cancer, today announced the U.S. Food and Drug Administration (FDA) has accepted for filing its New Drug Application (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 (NSCLC) who received at least 1 prior ROS1 tyrosine kinase inhibitor (TKI). The application has been assigned a Prescription Drug User Fee Act (PDUFA) target action date of September 18, 2026.

Nuvalent's NDA submission is based on results for TKI pre-treated patients with advanced ROS1-positive NSCLC enrolled in the global registrational ARROS-1 Phase 1/2 clinical trial. These data were reported along with preliminary data from the ongoing Phase 2 TKI-naïve cohort of ARROS-1, and presented as part of the Presidential Symposium at the IASLC 2025 World Conference on Lung Cancer in September 2025.