TKI-naïve and TKI-pretreated advanced ROS1-positive (ROS1+) non-small cell lung cancer (NSCLC)
NUVBNuvation BioCatalyst overview
Research summary
This catalyst tracks a PDUFA approval decision for IBTROZI (Taletrectinib) (ROS1 inhibitor) in TKI-naïve and TKI-pretreated advanced ROS1-positive (ROS1+) non-small cell lung cancer (NSCLC) . The expected timing is based on the latest available company guidance and may change.
05/06/26:- FDA accepted sNDA; target action date January 4, 2027. 08/06/26:- sNDA target action date remains January 4, 2027.
Verification
Confirm timing and program details against the company announcement or filing.