Taletrectinib

(Ibtrozi®)

Taletrectinib

Drug updated on 7/15/2025

Dosage FormCapsule (oral; 200 mg)
Drug ClassKinase 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)

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Summary
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  • 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 TitleYearSource
Ibtrozi (taletrectinib) Prescribing Information2025Nuvation Bio Inc., Burlington, MA

Systematic Reviews / Meta-Analyses