FDA Approves Taletrectinib Label Update With Longer-Term Response Data in ROS1-Positive Non-Small Cell Lung Cancer

Clinical Summary:

• Design/Population: The TRUST clinical program evaluated taletrectinib in adults with advanced ROS1-positive NSCLC, including TKI-naive and previously treated patients across the pivotal TRUST-I and TRUST-II studies.
• Key Outcomes: The updated FDA label includes longer-term TRUST-I data showing a median duration of response of 49.7 months in TKI-naive patients, with continued responses observed in some patients for multiple years.
• Clinical Relevance: The label update supports the long-term durability of taletrectinib in ROS1-positive NSCLC, with no new safety signals identified after extended follow-up.

The US Food and Drug Administration (FDA) has approved a supplemental New Drug Application for taletrectinib (IBTROZI; Nuvation Bio), a ROS1 inhibitor approved for adults with locally advanced or metastatic ROS1-positive non-small cell lung cancer (NSCLC). 

The updated label now includes longer-term duration of response data from the phase 2 TRUST-I study, with a median duration of response of 49.7 months in TKI-naive patients. The update reflects a median follow-up of 51 months in TRUST-I and incorporates an additional 14 months of data from the pivotal TRUST-I and TRUST-II studies as of an August 2025 data cutoff. 

TRUST-I and TRUST-II are phase 2 single-arm trials with confirmed objective response rate as assessed by an independent review committee serving as the primary end point. The updated data showed that many patients remained on therapy with continued responses for extended periods, including some for multiple years.

No new safety signals were identified with longer follow-up. The most frequently reported adverse reactions with taletrectinib include diarrhea, nausea, vomiting, dizziness, rash, constipation, and fatigue. Warnings and precautions include hepatotoxicity, interstitial lung disease/pneumonitis, QTc interval prolongation, hyperuricemia, myalgia with creatine phosphokinase elevation, skeletal fractures, and embryo-fetal toxicity.

The FDA previously granted full approval to taletrectinib in June 2025 for adults with locally advanced or metastatic ROS1-positive NSCLC across lines of therapy. 

“This approval is a significant milestone for IBTROZI because this data is now part of the FDA-approved label, something physicians and patients can turn to directly,” stated David Hung, MD, founder, president, and chief executive officer of Nuvation Bio. “A median duration of response of more than four 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.”

Source:

Nuvation Bio. 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. Accessed on: September 17, 2026. https://investors.nuvationbio.com/news/news-details/2026/Nuvation-Bio-Announces-FDA-Approval-of-Supplemental-New-Drug-Application-for-IBTROZI-taletrectinib-with-Updated-Duration-of-Response-in-TKI-Nave-Advanced-ROS1-Positive-Non-Small-Cell-Lung-Cancer/default.aspx