Ibtrozi FDA Approval History
Last updated by Judith Stewart, BPharm on June 11, 2025.
FDA Approved: Yes (First approved June 11, 2025)
Brand name: Ibtrozi
Generic name: taletrectinib
Dosage form: Capsules
Company: Nuvation Bio Inc.
Treatment for: Non Small Cell Lung Cancer
Ibtrozi (taletrectinib) is a kinase inhibitor indicated for the treatment of adult patients with locally advanced or metastatic ROS1-positive non-small cell lung cancer.
- Non-small cell lung cancer (NSCLC) is the most common form of lung cancer. Approximately 2% of patients with NSCLC have ROS1-positive (ROS1+) disease, which occurs when the ROS1 gene fuses together with part of another gene causing uncontrolled cell growth and cancer. ROS1+ NSCLC tends to be aggressive, and brain metastases are common.
- Ibtrozi contains taletrectinib, an inhibitor of tyrosine kinase ROS1, including ROS1 resistance mutations. Ibtrozi works in the treatment of ROS1+ NSCLC by inhibiting the growth of cancer cells expressing ROS1 fusion genes and mutations. Ibtrozi is designed to penetrate the central nervous system and has demonstrated consistent intracranial responses in patients with brain metastases.
- FDA approval was supported by data from the TRUST clinical program in which Ibtrozi demonstrated high, durable response rates and brain-penetrant efficacy.
- Tyrosine kinase inhibitor (TKI)-naive patients: In TRUST-I, Ibtrozi achieved a confirmed overall response rate (cORR) of 90%, and reinforced by the TRUST-II results, with a cORR of 85%. For TRUST-I, the longest DOR was observed at 46.9 months and ongoing, and for TRUST-II, the longest DOR was observed at 30.4 months and ongoing, as of October 2024.
- TKI-pretreated patients: In TRUST-I, Ibtrozi achieved a cORR of 52% and median DOR of 13.2 months, and in TRUST-II, Ibtrozi achieved a cORR of 62%, and a median DOR of 19.4 months, as of October 2024.
- An intracranial response was achieved in 73% of TKI-naive patients (11/15) and 63% of TKI-pretreated patients (15/24). - Ibtrozi capsules are administered orally once daily on an empty stomach until disease progression or unacceptable toxicity.
- Warnings and precautions associated with Ibtrozi include hepatotoxicity, interstitial lung disease (ILD)/pneumonitis, QTc interval prolongation, hyperuricemia, myalgia with creatine phosphokinase (CPK) elevation, skeletal fractures, and embryo-fetal toxicity.
- Frequently reported adverse reactions (≥20%) include diarrhea, nausea, vomiting, dizziness, rash, constipation, and fatigue.
Frequently reported Grade 3 or 4 laboratory abnormalities (≥5%) include increased ALT, increased AST, decreased neutrophils, and increased creatine phosphokinase.
Development timeline for Ibtrozi
Further information
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