FDA Accepts New Drug Application for Zidesamtinib—A Potential New Option for ROS1-Positive NSCLC Patients

On November 19, 2025, Nuvalent, Inc. announced that the U.S. Food and Drug Administration (FDA) has accepted for filing a New Drug Application (NDA) for zidesamtinib, an investigational ROS1-selective inhibitor. This NDA is based on data from the global ARROS-1 Phase 1/2 clinical trial in patients with advanced ROS1-positive NSCLC who have previously received at least one ROS1 tyrosine kinase inhibitor (TKI). The planned date for the FDA to make a decision regarding the drug's approval is September 18, 2026.

Zidesamtinib is designed to penetrate the central nervous system and may help address some of the limitations seen with existing ROS1 inhibitors, particularly for patients with brain metastases or resistance mutations. The acceptance of this NDA represents an important step forward in the regulatory process and signals potential new treatment options for our community.

As always, patient experiences and access to emerging therapies remain central to The ROS1ders’ mission. We’ll continue to share updates as the FDA review progresses.

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