Nuvalent Announces FDA Acceptance of New Drug Application for Zidesamtinib in TKI Pre-treated Advanced ROS1-positive NSCLC
The FDA has accepted Nuvalent's New Drug Application (NDA) for zidesamtinib, a novel investigational ROS1-selective inhibitor, for adults with locally advanced or metastatic ROS1-positive non-small cell lung cancer (NSCLC) who have received at least one prior ROS1 tyrosine kinase inhibitor (TKI) treatment3567.
The NDA is supported by results from the global ARROS-1 Phase 1/2 clinical trial, showing a 44% objective response rate (ORR) in TKI pre-treated advanced ROS1-positive NSCLC patients13.
The application is part of the FDA’s Real-Time Oncology Review (RTOR) program, with a Prescription Drug User Fee Act (PDUFA) target action date set for September 18, 202613.
Data supporting the NDA, including CNS (central nervous system) penetration and activity against resistance mutations, were presented at the IASLC 2025 World Conference on Lung Cancer13.
Zidesamtinib has received Breakthrough Therapy designation for ROS1-positive metastatic NSCLC previously treated with two or more ROS1 TKIs, and Orphan Drug designation for ROS1-positive NSCLC3.
While the NDA acceptance is a significant regulatory milestone, final FDA approval will require successful completion of ongoing and possibly post-marketing confirmatory trials to confirm survival or clinical benefit outcomes13.
Sources:
1. https://www.ainvest.com/news/nuvalent-zidesamtinib-fda-milestone-growth-catalyst-analysis-biotech-investors-2511/
3. https://www.prnewswire.com/news-releases/nuvalent-announces-fda-acceptance-of-new-drug-application-for-zidesamtinib-for-the-treatment-of-tki-pre-treated-patients-with-advanced-ros1-positive-nsclc-302620883.html
5. https://www.cancernetwork.com/view/fda-accepts-nda-for-zidesamtinib-in-pretreated-advanced-ros1-nsclc
6. https://investors.nuvalent.com/2025-11-19-Nuvalent-Announces-FDA-Acceptance-of-New-Drug-Application-for-Zidesamtinib-for-the-Treatment-of-TKI-Pre-treated-Patients-with-Advanced-ROS1-positive-NSCLC
7. https://www.nasdaq.com/articles/fda-accepts-nuvalents-nda-zidesamtinib-ros1-positive-non-small-cell-lung-cancer