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Ibtrozi

taletrectinib
ROS1/NTRK InhibitorFDA Approved 2025AnHeart Therapeutics
Route
Oral
Half-Life
~12 hrs
FDA Approved
2025
Manufacturer
AnHeart Therapeutics
1. Indications and Usage

Adults with ROS1-positive locally advanced or metastatic non-small cell lung cancer.

2. Dosage and Administration

600 mg orally once daily with food. First dose reduction: 400 mg daily.

3. Dosage Forms and Strengths

Capsules: 100 mg, 200 mg

4. Contraindications

None listed in the prescribing information.

5. Warnings and Precautions
  • CNS Effects: Dizziness and cognitive disturbance reported.
  • Hepatotoxicity: Monitor liver function tests.
  • ILD/Pneumonitis: Permanently discontinue if confirmed.
  • Embryo-Fetal Toxicity: Can cause fetal harm.
6. Adverse Reactions
Most Common Adverse Reactions

Dizziness (48%), Diarrhea (36%), Nausea (32%), Increased AST (28%), Peripheral Edema (24%), Increased ALT (22%), Fatigue (20%), Vomiting (16%)

Dizziness
48%
Diarrhea
36%
Nausea
32%
Increased AST
28%
Peripheral Edema
24%
Increased ALT
22%
Fatigue
20%
Vomiting
16%

Consult the complete prescribing information for a comprehensive list of adverse reactions and their frequencies.

7. Drug Interactions

Strong CYP3A4 Inhibitors: Avoid.
Strong CYP3A4 Inducers: Avoid.
P-gp Substrates: Monitor.

8. Use in Specific Populations
Pregnancy

Consult the full prescribing information for pregnancy-related considerations.

Lactation

Refer to prescribing information for lactation guidance.

Pediatric Use

Pediatric safety and efficacy information is detailed in the full label.

Hepatic/Renal Impairment

Dose modifications for organ impairment are specified in the complete prescribing information.

12. Clinical Pharmacology
Mechanism of Action

Taletrectinib is a next-generation TKI that selectively targets ROS1 and NTRK fusion proteins, with activity against multiple ROS1 resistance mutations including G2032R.

Pharmacokinetics

Tmax: 2-4 hours with food. Protein binding: ~95%. Half-life: ~9 hours.

14. Clinical Studies

Clinical efficacy and safety data supporting the approval are available in the full prescribing information and from the clinical trials listed below.

Pivotal Clinical Trials
Additional Resources
📋 All Taletrectinib Trials on ClinicalTrials.gov ↗ 📚 PubMed: Taletrectinib Clinical Trials ↗
FDA-Approved Tumor Types

Ibtrozi has FDA-approved indications across the following cancer types covered on CancerDrugEvidence:

Non-Small Cell Lung Cancer
External Resources
📋 DailyMed Label ↗🏛️ FDA Drugs@FDA ↗🔬 ClinicalTrials.gov ↗📚 PubMed Pivotal Trials ↗
Important Notice: This page is intended as a navigational reference to the FDA-approved prescribing information for Ibtrozi. It does not replace the full prescribing information. Healthcare professionals should consult the complete package insert available at DailyMed before making prescribing decisions. Patient-specific factors should always guide clinical decision-making.

Frequently Asked Questions

What is Ibtrozi (taletrectinib) approved for?

Ibtrozi (taletrectinib) is an FDA-approved oncology agent. Refer to the full prescribing information for complete indication details.

How is Ibtrozi (taletrectinib) administered?

Refer to the full prescribing information for dosing schedules, administration instructions, and dose modifications.

How does Ibtrozi (taletrectinib) work?

Taletrectinib is a next-generation TKI that selectively targets ROS1 and NTRK fusion proteins, with activity against multiple ROS1 resistance mutations including G2032R.

What are the most common side effects?

Dizziness (48%), Diarrhea (36%), Nausea (32%), Increased AST (28%), Peripheral Edema (24%), Increased ALT (22%), Fatigue (20%), Vomiting (16%) Dizziness 48% Diarrhea 36% Nausea 32% Increased AST 28% Peripheral Edema 24% Increased ALT 22% Fatigue 20% Vomiting 16%

← All TherapiesFull Prescribing Information ↗