Nuvalent Presented Pivotal Data For Zidesamtinib In TKI Pretreated Patients With Advanced Ros1-positive Non-small Cell Lung Cancer From Its Global ARROS-1 Phase 1/2 Trial, On Track To Complete Its Rolling NDA Submission In Q3 2025

Author: Benzinga Newsdesk | September 07, 2025 11:18am

The pivotal data presented today, initially announced in June 2025, serve as the foundation for the company's ongoing rolling New Drug Application (NDA) submission to the U.S. Food and Drug Administration (FDA) for zidesamtinib in TKI pre-treated patients with advanced ROS1-positive NSCLC. The FDA agreed to accept the NDA for participation in the Real-Time Oncology Review (RTOR) program, which facilitates earlier submission of topline efficacy and safety results prior to the submission of the complete application, to support an earlier start to the FDA's evaluation of the application. The company is on track to complete its rolling NDA submission in the third quarter of 2025, and continues to engage with the FDA on potential opportunities for line-agnostic expansion.

Posted In: NUVL