Nuvation Bio Secures FDA Label Update for IBTROZI (Taletrectinib) in ROS1-Positive Advanced NSCLC Citing 49.7-Month Median Duration of Response in TRUST-I TKI-Naive Population After 51 Months of Follow-Up
Nuvation Bio (NYSE: NUVB) announced Thursday September 17, 2026 an FDA label update for IBTROZI (taletrectinib, next-generation ROS1 tyrosine kinase inhibitor with intracranial and G2032R-resistance-mutation activity) in adults with locally advanced or metastatic ROS1-positive non-small cell lung cancer (NSCLC). The updated label incorporates 51-month follow-up data from the Phase 2 TRUST-I trial in ROS1-TKI-naive patients: median duration of response 49.7 months (4+ years), a durability benchmark that has not previously been reported in this population. IBTROZI was FDA-approved in June 2025 for TKI-naive and TKI-pretreated ROS1+ metastatic NSCLC based on ORR and DOR from TRUST-I and TRUST-II. Taletrectinib is co-developed with Innovent Biologics in Greater China. The label update lands two months after competitor Nuvalent's zidesamtinib (Jideytro, GSK) received FDA approval July 22, 2026 for TKI-pretreated ROS1+ NSCLC ahead of its Friday September 18 PDUFA action date, setting up a two-way durability contest in the ROS1+ NSCLC market.