Updated label reflects TRUST-I TKI-naïve median duration of response of nearly 50 months
No changes to the safety sections of labeling with longer follow-up and no new safety signals identified
Approval comes four months ahead of PDUFA date
NEW YORK, Sept. 16, 2026 /PRNewswire/ -- Nuvation Bio Inc. (NYSE:NUVB), a global oncology company focused on tackling some of the toughest challenges in cancer treatment, today announced that the U.S. Food and Drug Administration (FDA) has approved a supplemental New Drug Application (sNDA) for IBTROZI® (taletrectinib), a ROS1 inhibitor approved for the treatment of locally advanced or metastatic ROS1-positive (ROS1+) non-small cell lung cancer (NSCLC).
The updated IBTROZI label now reflects updated median duration of response (DOR) for the TRUST-I study, with a median DOR of 49.7 months in TKI-naïve patients in TRUST-I, reflecting more than four years of sustained clinical benefit. This update came with no changes to the safety sections of labeling, with no new signals identified with longer follow-up, confirming the safety profile.
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 studies as of an August 2025 data cutoff. Many patients remained on therapy for extended periods with a continued response—some for multiple years—highlighting the long-term durability and tolerability of IBTROZI and reinforcing its importance as a treatment option for advanced ROS1+ NSCLC. These data were also presented at the American Association for Cancer Research (AACR) Annual Meeting 2026 and simultaneously published in the Journal of Clinical Oncology.