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SEP 18 2026
UPCOMING · 107 DAYS TO PDUFA

Nuvalent zidesamtinib $NUVL

for TKI-pretreated advanced ROS1-positive non-small cell lung cancer

NDA · Standard Review

Accepted NOV 19 2025.

About

Non-small cell lung cancer (NSCLC) is the most common form of lung cancer, often resistant to chemotherapy and typically treated with surgery when possible. Zidesamtinib is a next-generation targeted drug that selectively blocks ROS1, a cancer-driving protein, while also reaching tumors in the central nervous system. By inhibiting ROS1 more precisely than older treatments, it may help control advanced NSCLC that has progressed after prior therapy.