Nuvalent Inc. Advances with FDA's Real-Time Oncology Review for Zidesamtinib in ROS1-Positive NSCLC Patients

Reuters
Aug 14
Nuvalent Inc. Advances with FDA's Real-Time Oncology Review for Zidesamtinib in ROS1-Positive NSCLC Patients

Nuvalent Inc., a clinical-stage biopharmaceutical company, has initiated its rolling New Drug Application (NDA) submission for zidesamtinib, a novel ROS1-selective inhibitor, for TKI pre-treated patients with advanced ROS1-positive non-small cell lung cancer (NSCLC). The U.S. Food and Drug Administration (FDA) has agreed to accept the NDA for participation in the Real-Time Oncology Review (RTOR) pilot program. This program allows for earlier submission of topline efficacy and safety results, potentially expediting the FDA's evaluation process. Completion of the NDA submission is targeted for the third quarter of 2025. Nuvalent continues to engage with the FDA on potential line-agnostic expansion opportunities, marking a significant step in advancing treatment options for patients with ROS1-positive NSCLC.

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