The U.S. Food and Drug Administration (FDA) has approved updated labeling of taletrectinib (Ibtrozi), an oral, CNS-active, selective next-generation ROS1 inhibitor therapy for non–small cell lung cancer (NSCLC), reflecting a median duration of response of 49.7 months in tyrosine kinase inhibitor (TKI)-naive patients in the TRUST-I trial, and validating more than 4 years of sustained clinical benefit. No changes were made to the safety sections of labeling, and no new signals were identified with longer follow-up.
These data were presented at the American Association for Cancer Research (AACR) Annual Meeting 2026 and simultaneously published in the Journal of Clinical Oncology.
Full FDA approval for taletrectinib was granted in June 2025 for the treatment of locally advanced or metastatic ROS1-positive NSCLC across lines of therapy.
The sNDA approval reflects a median follow-up of 51 months for patients from the TRUST-I study and incorporates an additional 14 months of data from both of the pivotal TRUST-I and TRUST-II (Clinical Trials ID NCT04919811) studies as of an August 2025 data cutoff, according to a news statement from Nuvation Bio, which announced today’s approval.
Acccording to the statement, many patients remained on therapy for extended periods with a continued response highlighting the long-term durability and tolerability of taletrectinib and reinforcing its role as a treatment option for patients with advanced ROS1-positive NSCLC.
To learn more, see a video interview with investigator Lyudmila A. Bazhenova, MD, of the University of California, San Diego, who presented the updated data from the phase II TRUST-I and TRUST-II trials at the 2026 AACR Annual Meeting.
