New York, New York, September 17, 2026
Nuvation Bio Inc. has announced that the U.S. Food and Drug Administration (FDA) has approved a supplemental New Drug Application (sNDA) for IBTROZI® (taletrectinib), updating the product labeling with longer-term efficacy data for patients with TKI-naïve advanced ROS1-positive non-small cell lung cancer (NSCLC). The updated label incorporates extended follow-up from the pivotal TRUST-I study, showing a median duration of response (DOR) of 49.7 months in TKI-naïve patients. The regulatory decision comes approximately four months ahead of the FDA’s previously assigned PDUFA target date and adds mature long-term efficacy information to the U.S. prescribing information for IBTROZI.
Updated Data Show Nearly Four Years of Response
The FDA’s sNDA approval is based on additional follow-up from the TRUST-I and TRUST-II clinical studies, with the updated analysis incorporating an August 2025 data cutoff. In TRUST-I, the median follow-up for TKI-naïve patients reached approximately 51 months, while the updated median DOR was 49.7 months. This means that the median duration of response was nearly four years and two months, providing additional information about the durability of treatment benefit with taletrectinib. Nuvation Bio reported that many patients remained on therapy for extended periods, with some maintaining responses for multiple years. The updated findings were presented at the 2026 American Association for Cancer Research (AACR) Annual Meeting and were simultaneously published in the Journal of Clinical Oncology. The updated label focuses on the TKI-naïve population and does not represent a new indication for IBTROZI. The FDA originally granted full approval for taletrectinib in June 2025 for adults with locally advanced or metastatic ROS1-positive NSCLC across lines of therapy. The latest regulatory action incorporates additional clinical follow-up into the approved product information, giving healthcare professionals access to longer-term efficacy data within the FDA-approved label.
IBTROZI Demonstrates Durable Activity in ROS1+ NSCLC
IBTROZI is a ROS1 tyrosine kinase inhibitor (TKI) developed for patients whose tumors harbor ROS1 alterations. ROS1-positive disease represents a molecularly defined subset of NSCLC, and targeted therapies are an important component of treatment for these patients. Earlier long-term analyses from TRUST-I and TRUST-II showed a confirmed objective response rate of 89.8% and median progression-free survival of 46.1 months among TKI-naïve patients in the pooled analysis. The same analysis reported intracranial activity in patients with brain metastases, an important consideration because central nervous system involvement can occur in advanced ROS1-positive NSCLC. Additional analyses presented at the 2026 World Conference on Lung Cancer showed that responses remained consistent across selected patient subgroups. Among TKI-naïve patients, the objective response rate was 90.0% in those who had previously received chemotherapy and 89.8% in those without prior chemotherapy. Median DOR was 48.3 months and 54.3 months, respectively. These subgroup findings add to the broader clinical evidence supporting taletrectinib’s activity across different patient characteristics.
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No New Safety Signals With Longer Follow-Up
Alongside the updated efficacy information, Nuvation Bio reported that no changes were made to the safety sections of the IBTROZI labeling. Longer follow-up did not identify new safety signals, and the overall safety profile remained consistent with previously reported clinical data. This is relevant because extended treatment duration provides additional opportunity to characterize the tolerability of targeted therapies used for chronic disease control in advanced cancer. IBTROZI is already approved for advanced ROS1-positive NSCLC in the United States, Japan and China, where it is marketed under different commercial arrangements and brand names. Nuvation Bio and its partner Eisai are also pursuing regulatory reviews in additional markets, including Europe and the United Kingdom. The FDA’s latest sNDA approval therefore strengthens the U.S. product label with long-term evidence while the companies continue broader international regulatory activities.
The updated 49.7-month median duration of response provides additional long-term clinical information for IBTROZI in TKI-naïve advanced ROS1-positive NSCLC. Continued follow-up from the TRUST clinical program will further characterize the treatment’s efficacy and safety as patients are monitored over longer periods.
Source: Nuvation Bio press release
