FDA Approves Ibtrozi for Locally Advanced or Metastatic ROS1+ NSCLC

The Food and Drug Administration (FDA) has approved an updated supplemental New Drug Application for Ibtrozi (taletrectinib), adding longer-term data on how long patients with ROS1-positive non-small cell lung cancer (NSCLC) responded to treatment.

The updated label reflects data from the TRUST-I study showing a median duration of response of 49.7 months among patients who had not previously received a ROS1-targeted tyrosine kinase inhibitor (TKI). The update does not include any changes to the drug’s safety information or any newly identified safety signals.

What Is Ibtrozi?

Ibtrozi is an oral ROS1-targeted treatment approved for adults with locally advanced or metastatic ROS1-positive NSCLC. The FDA first granted full approval for this indication in June 2025.

ROS1-positive NSCLC is a type of lung cancer driven by changes involving the ROS1 gene. Although ROS1-positive disease accounts for an estimated 2% of NSCLC cases, the cancer can spread to the brain. About 35% of people newly diagnosed with metastatic ROS1-positive NSCLC have tumors that have spread to the brain, according to the company.

What the Updated Data Shows

The updated approval incorporates longer follow-up from the TRUST clinical program. For patients in TRUST-I who had not previously received a ROS1 TKI, the median duration of response was 49.7 months.

In other words, half of the patients in this group had their cancer response last at least that long, while the other half had responses that lasted for a shorter period. The company reported that some patients remained on treatment and continued to respond for multiple years.

The updated information is based on a median follow-up of 51 months for patients in TRUST-I and includes an additional 14 months of data from the TRUST-I and TRUST-II studies, using an August 2025 data cutoff.

What This Means for Patients

For people living with advanced ROS1-positive NSCLC, the updated information provides additional insight into how long responses to Ibtrozi may last.

The FDA-approved indication remains the same: Ibtrozi is indicated for adults with locally advanced or metastatic ROS1-positive NSCLC. The updated approval primarily adds longer-term information about the durability of treatment response.

Ibtrozi does carry important risks. The prescribing information includes warnings for liver toxicity, interstitial lung disease or pneumonitis, QTc interval prolongation, hyperuricemia, muscle pain with creatine phosphokinase elevation, skeletal fractures and embryo-fetal toxicity. Common adverse reactions include diarrhea, nausea, vomiting, dizziness, rash, constipation and fatigue.

Patients taking Ibtrozi should discuss potential side effects, drug interactions and monitoring with their health care team.

Looking Ahead

The TRUST clinical program continues to evaluate Ibtrozi in ROS1-positive NSCLC. Studies include research in patients who have previously received ROS1 TKIs, as well as a Phase 3 study evaluating Ibtrozi as an adjuvant treatment after surgery for early-stage ROS1-positive NSCLC.

For patients with advanced ROS1-positive NSCLC, the updated FDA label provides longer-term data that can help doctors and patients better understand the potential durability of response with Ibtrozi.

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.” Sept. 17, 2026. PR Newswire

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