Nuvalent Inc. Announces FDA's Acceptance of NDA for Zidesamtinib in ROS1-Positive NSCLC Under Real-Time Oncology Review Program
Nuvalent Inc. announced on June 24, 2025, that it has reached a significant milestone in its regulatory journey with the U.S. Food and Drug Administration (FDA). The company has successfully completed a pre-New Drug Application (NDA) meeting with the FDA for its novel ROS1-selective inhibitor, zidesamtinib, intended for the treatment of tyrosine kinase inhibitor (TKI) pre-treated patients with advanced ROS1-positive non-small cell lung cancer (NSCLC). The FDA has agreed to accept the NDA under the Real-Time Oncology Review (RTOR) pilot program, allowing for an earlier evaluation of the application. Nuvalent plans to begin a rolling NDA submission in July 2025, with completion targeted for the third quarter of the year. This development marks a pivotal step forward in bringing zidesamtinib to market for patients in need.
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