Zidesamtinib PDUFA Date (Nuvalent)
FDA PDUFA decision date for Zidesamtinib is September 18, 2026. Developed by Nuvalent. Indication: ROS1-positive NSCLC (CNS-active). Current status: Approved.
Indication
ROS1-positive NSCLC (CNS-active)
Notes
Breakthrough therapy designation. CNS-active ROS1 inhibitor addresses unmet need.
Regulatory details
- Company: Nuvalent
- Therapeutic area: Oncology
- Application type: NDA
- Review type: Priority
- PDUFA date: 2026-09-18
- Outcome: Approved