IBTROZI sNDA cleared with 49.7-month median duration of response in TKI-naïve ROS1+ NSCLC

What this means

Non-small cell lung cancer (NSCLC) with a ROS1 gene rearrangement is a rare but distinct form of lung cancer, affecting about 1-2% of NSCLC patients. IBTROZI (taletrectinib) is an oral targeted therapy from Nuvation Bio that blocks the ROS1 protein driving these tumors. The FDA originally approved it in June 2025 for adults with locally advanced or metastatic ROS1-positive NSCLC. On September 16, 2026 - approximately four months ahead of the FDA's target decision date - the FDA approved a supplemental application that updates the IBTROZI label with much longer follow-up data from the two pivotal trials, TRUST-I (NCT04395677) and TRUST-II (NCT04919811). The most striking new figure is a 49.7-month median duration of response - more than four years of sustained tumor control - in patients who had not previously received a ROS1-targeted therapy (TKI-naïve), based on 51 months of median follow-up in TRUST-I. There were no changes to the safety sections of the label and no new safety signals identified with longer follow-up, confirming the drug's established tolerability profile. IBTROZI is commercialized globally through partners: Nippon Kayaku in Japan, Innovent Biologics in China (as DOVBLERON), and Eisai in Europe.