IBTROZI (taletrectinib)

Sept. 16, 2026: Nuvation Bio (NYSE: NUVB) said the FDA approved a supplemental NDA for IBTROZI (taletrectinib) to update the U.S. label for adults with locally advanced or metastatic ROS1-positive NSCLC. The revised label adds longer-term efficacy data from the pivotal TRUST-I/TRUST-II studies; in TRUST-I, TKI-naïve patients had a median duration of response of 49.7 months with 51 months median follow-up, based on an August 2025 data cutoff. The company said the approval came four months before the PDUFA date.

The company said the safety sections of the label were unchanged and no new safety signals were identified with longer follow-up. These updated data were presented at AACR 2026 and published in the Journal of Clinical Oncology.

Prior milestones/current status: IBTROZI received full FDA approval on June 11, 2025 for ROS1-positive advanced NSCLC across lines of therapy. Nuvation Bio and partner Eisai also reported that taletrectinib’s MAA was validated by EMA in March 2026 for standard review and by the UK MHRA in June 2026.

Pipeline/trial updates mentioned: TRUST-III is a randomized Phase 3 trial versus crizotinib in 194 China patients with advanced ROS1-positive NSCLC who are ROS1 TKI-naïve; TRUST-IV is a placebo-controlled Phase 3 adjuvant study in resected early-stage ROS1-positive NSCLC, with primary completion estimated in 2030.