FDA Approves Updated IBTROZI (Taletrectinib) Label Reporting a 49.7-Month Median Duration of Response in TKI-Naive ROS1-Positive Lung Cancer
Nuvation Bio announced on Thursday, September 17, 2026 that the FDA approved a supplemental New Drug Application updating the IBTROZI (taletrectinib) label for locally advanced or metastatic ROS1-positive non-small cell lung cancer. The label now reports a median duration of response of 49.7 months in TKI-naive patients in the Phase 2 TRUST-I study, based on a median follow-up of 51 months and an August 2025 data cutoff that added 14 months of data from TRUST-I and TRUST-II. Nuvation said the approval came four months ahead of the PDUFA date and brought no changes to the label's safety sections. IBTROZI, which Nuvation describes as a CNS-active next-generation ROS1 inhibitor, was first approved on June 11, 2025; Innovent Biologics markets it in China as DOVBLERON.