FDA Approves Taletrectinib in TKI-Naive Advanced ROS1+ NSCLC

A supplemental new drug application (sNDA) for taletrectinib (Ibtrozi) has been approved by the FDA for patients with TKI-naive ROS1-positive non–small cell lung cancer, according to a press release from Nuvation Bio.¹

The updated data comes from the the phase 2 TRUST-I (NCT04395677) and TRUST-II trials (NCT04919811).² The press release highlighted a median follow-up of 51 months in the TRUST-I trial and an additional 14 months in the TRUST-I and TRUST-II trials.

"This approval is a significant milestone for [taletrectinib] because this data is now part of the FDA-approved label, something physicians and patients can turn to directly," said David Hung, MD, founder, president, and chief executive officer of Nuvation Bio, said in the press release. "A median duration of response [DOR] of more than 4 years—the longest median DOR reported for an FDA-approved ROS1 TKI—is a remarkable outcome for people living with ROS1+ NSCLC, and having it in the label means something real for patients: a clearer sense of how long they might expect to stay on treatment, and more confidence in what that path could look like at a moment when a new diagnosis can feel overwhelming. It also gives physicians additional evidence to support using [taletrectinib] early in a patient's care, when that choice matters most."

The median duration of response was 49.7 months (95% CI, 41.3-not reached [NR]), the median progression-free survival was 49.6 months (95% CI, 34.5-NR), and the median overall survival (OS) was NR (95% CI, 41.6-NR). The 3-year OS rate was 65.3%.

In June 2025, the FDA gave full approval to taletrectinib for patients with locally advances or metastatic ROS1-positive NSCLC. In May 2026, the FDA accepted the sNDA for this indication, with an original Prescription Drug User Fee Act date of January 4, 2027.

Adverse effects (AEs) associated with taletrectinib included diarrhea (64%), nausea (47%), vomiting (43%), dizziness (22%), rash (22%), constipation (21%), and fatigue (20%). Grade 3/4 AEs reported included increased ALT (13%), increased AST (10%), decreased neutrophils (5%), and increased creatine phosphokinase (5%).

References

1. Nuvation Bio announces FDA approval of supplemental new drug application for IBTROZI® (taletrectinib) with updated duration of response in TKI-naïve advanced ROS1-positive non-small cell lung cancer. News release. September 17, 2026. Accessed Septemeber 17, 2026. https://tinyurl.com/mpbs2z3k
2. Li W, Zhang Y, Fan H, et al. Long-term efficacy and safety of taletrectinib in patients with ROS1+ non–small cell lung cancer: Results from the phase II TRUST-I study. J Clin Oncol. 2026;44(18):1670-1675. doi:10.1200/JCO-26-00434