Drug updated on 7/15/2025
| Dosage Form | Capsule (oral; 200 mg) |
| Drug Class | Kinase inhibitors |
| Ongoing and Completed Studies | ClinicalTrials.gov |
Indication
- Indicated for the treatment of adult patients with locally advanced or metastatic ROS1-positive non-small cell lung cancer (NSCLC).
Latest News
Summary
- This summary is based on the review of one systematic review/meta-analysis. [1]
- Ibtrozi (taletrectinib) is indicated for the treatment of adult patients with locally advanced or metastatic ROS1-positive non-small cell lung cancer (NSCLC).
- In treatment-naive patients with ROS1-positive NSCLC, taletrectinib demonstrated an overall response rate (ORR) of up to 90.6%.
- In crizotinib-pretreated patients with ROS1-positive NSCLC, taletrectinib achieved an ORR of 51.5%.
- Effectiveness outcomes were reported specifically for treatment-naive and crizotinib-pretreated ROS1-positive NSCLC patients; no subgroup data by age, gender, or comorbidities were provided.
- In a population of 234 ROS1-positive NSCLC patients (102 males, 132 females), taletrectinib was associated with manageable adverse events, including mild liver enzyme elevations and gastrointestinal symptoms.
- No significant safety concerns or adverse effects were reported for specific subgroups, including treatment-naive and crizotinib-pretreated patients.
Product Monograph / Prescribing Information
| Document Title | Year | Source |
|---|---|---|
| Ibtrozi (taletrectinib) Prescribing Information | 2025 | Nuvation Bio Inc., Burlington, MA |
Systematic Reviews / Meta-Analyses
| Document Title | Year | Source |
|---|---|---|
| Efficacy and safety of taletrectinib for treatment of ROS1 positive non-small cell lung cancer: A systematic review | 2025 | Expert Opinion on Pharmacotherapy |