The US FDA has approved a supplemental New Drug Application for Ibtrozi (taletrectinib), updating the label for New York-based Nuvation Bio (NYSE: NUVB)'s ROS1 inhibitor to include a median duration of response (DOR) of 49.7 months in tyrosine kinase inhibitor (TKI)-naïve patients with locally advanced or metastatic ROS1-positive (ROS1+) non-small cell lung cancer (NSCLC). The approval arrived four months ahead of the Prescription Drug User Fee Act date.
The updated label reflects longer follow-up from the Phase II TRUST-I and TRUST-II studies, including a median follow-up of 51 months in TRUST-I and an additional 14 months of data based on an August 2025 cutoff. Nuvation Bio said no new safety signals emerged and no changes were made to the safety sections of the label. The updated data showed a median DOR of 49.7 months in TKI-naïve patients.
Taletrectinib is an oral, CNS-active, selective next-generation ROS1 inhibitor designed to retain activity against resistance mutations that limit earlier-generation agents. Its CNS penetration is clinically relevant given that approximately 35% of patients newly diagnosed with metastatic ROS1+ NSCLC present with brain metastases, and around 50% of previously treated patients develop central nervous system metastases.