On June 11, 2025, the U.S. Food and Drug Administration (FDA) approved taletrectinib (Ibtrozi, Nuvation Bio Inc.), a new kinase inhibitor. FDA approval of taletrectinib for ROS1-positive NSCLC is a significant advancement. This treatment is for adults with locally advanced or metastatic ROS1-positive non-small cell lung cancer (NSCLC). Meanwhile, this is big news for patients with this rare lung cancer type.
How Was Taletrectinib Tested?
The FDA evaluated taletrectinib using data from two clinical trials: TRUST-I (NCT04395677) and TRUST-II (NCT04919811). These were multicenter, single-arm, open-label studies. In addition, FDA’s approval of taletrectinib for ROS1-positive NSCLC included 157 treatment-naive patients (103 in TRUST-I, 54 in TRUST-II) and 113 patients who had prior ROS1 tyrosine kinase inhibitor (TKI) treatment (66 in TRUST-I, 47 in TRUST-II). Furthermore, some patients also had prior chemotherapy.
What Were the Results?
Treatment-Naive Patient Outcomes
The main measures of success were confirmed overall response rate (ORR) and duration of response (DOR), checked by blinded independent review using RECIST v1.1. For treatment-naive patients, ORR was 90% (95% CI: 83, 95) in TRUST-I and 85% (95% CI: 73, 93) in TRUST-II. Additionally, 72% (TRUST-I) and 63% (TRUST-II) had a DOR of 12 months or more. Therefore, FDA approves taletrectinib for ROS1-positive NSCLC, and these results highlight taletrectinib’s effectiveness for new patients.
TKI-Pretreated Patient Outcomes
However, for TKI-pretreated patients, ORR was 52% (95% CI: 39, 64) in TRUST-I and 62% (95% CI: 46, 75) in TRUST-II. Furthermore, 74% (TRUST-I) and 83% (TRUST-II) had a DOR of 6 months or more. As a result, these findings suggest taletrectinib offers hope even for those with prior treatments.
Safety and Side Effects
Taletrectinib comes with warnings. Possible side effects include hepatotoxicity, interstitial lung disease/pneumonitis, QTc interval prolongation, hyperuricemia, myalgia with creatine phosphokinase elevation, skeletal fractures, and embryo-fetal toxicity. In addition, patients should discuss these with their doctor.
How to Take Taletrectinib
The recommended dose is 600 mg orally once daily. Take it on an empty stomach—no food for 2 hours before or after. Meanwhile, continue until disease progression or if side effects become too severe.
Fast-Track Approval Process
This approval used the Assessment Aid, a tool from the applicant to speed up FDA review. Taletrectinib received priority review, breakthrough designation, and orphan drug designation. Furthermore, learn more about these programs in the FDA’s Guidance for Industry.
Reporting Side Effects
Healthcare providers must report serious side effects to the FDA’s MedWatch system or by calling 1-800-FDA-1088. As a result, this helps ensure patient safety.
Simple Language Overview for Patients
If you or a loved one has ROS1-positive lung cancer, taletrectinib might be a new option. This medicine comes as a pill you take once a day on an empty stomach. In addition, it works by targeting the cancer in a special way, helping many people feel better. Tests showed 9 out of 10 new patients and over half of those who tried other treatments had their cancer shrink. Furthermore, some felt good for over a year! However, it can cause side effects like liver or lung problems, so your doctor will watch you closely. Therefore, talk to them to see if this treatment fits your needs.
Final Thoughts
The FDA approval of taletrectinib offers hope for ROS1-positive NSCLC patients. This news that the FDA approves taletrectinib for ROS1-positive NSCLC provides a breakthrough in treatment. With strong trial results and a streamlined review, it’s a step forward in cancer treatment. In addition, consult your healthcare provider to see if this is right for you.
Realted Links:
https://oncologytube.com/tag/fda-approval