Nuvalent, Inc. (NUVL) announced positive pivotal data for zidesamtinib, a novel ROS1-selective inhibitor, in TKI pre-treated patients with advanced ROS1-positive non-small cell lung cancer from the global ARROS-1 Phase 1/2 clinical trial.
The company announced progress on front-line development strategies for its parallel lead programs in ROS1-positive and ALK-positive NSCLC.
Nuvalent completed a pre-New Drug Application meeting with the U.S. Food and Drug Administration and aligned on plans to proceed with an NDA submission seeking approval for zidesamtinib in TKI pre-treated patients with locally advanced or metastatic ROS1-positive NSCLC.
Plans include initiating a rolling NDA submission in July 2025, with completion targeted for the third quarter of 2025.
The company continues to engage with the FDA on potential opportunities for line-agnostic expansion.
