Nuvation Bio announces FDA approval of IBTROZI (taletrectinib) for ROS1+ NSCLC

Nuvation Bio Inc.

FDA approved IBTROZI for adult patients with locally advanced or metastatic ROS1+ NSCLC.
In TRUST-I, cORR of 90% in TKI-naïve patients; TRUST-II cORR of 85%; median DOR not yet reached.
Intracranial response in 73% of TKI-naïve and 63% of TKI-pretreated patients with brain metastases.
Generally well-tolerated; 7% discontinued due to TEAEs; most common AEs: diarrhea (64%), nausea (47%), vomiting (43%).
Approved dose 600 mg once-daily; half-life ~66 hours enabling sustained CNS exposure.

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