Brand Name

Ibtrozi

Generic Name
Taletrectinib
View Brand Information
FDA approval date: June 11, 2025
Form: Capsule

What is Ibtrozi (Taletrectinib)?

IBTROZI ™ is indicated for the treatment of adult patients with locally advanced or metastatic ROS1 -positive non-small cell lung cancer [see Dosage and Administration.
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Related Clinical Trials

A Phase 3 Multicenter Double-blind Randomized Study of Taletrectinib Versus Placebo in Patients With ROS1-Fusion Positive Stage IB-IIIA Non-Small Cell Lung Cancer Who Have Undergone Complete Tumor Resection

Summary: The purpose of this phase 3 multicenter double-blind randomized study is to assess the use of taletrectinib in the early-stage non-small cell lung cancer (NSCLC). The study compares taletrectinib (study drug) versus placebo (sugar pill) in patients with ROS1-fusion positive stage IB, II, IIIA NSCLC. The study will evaluate if taletrectinib is better than placebo at preventing the participant's dis...

A Multicenter, Non-interventional, Observational Study of Taletrectinib for Advanced ROS1+ NSCLC With Brain Metastases

Summary: This is a multicenter, non-interventional, observational real-world study to evaluate the efficacy and safety of Taletrectinib in ROS1-positive non-small cell lung cancer (NSCLC) with brain metastases. Patients deemed eligible for Taletrectinib by their physicians were enrolled after providing informed consent. Taletrectinib will be administered according to clinical practice and data on treatment...

A Phase 3 Multicenter Open-label Study of Taletrectinib Versus a Standard of Care ROS1-Tyrosine Kinase Inhibitor (Crizotinib) in TKI-Naïve Patients With ROS1-Positive Locally Advanced or Metastatic Non-Small Cell Lung Cancer (TRUST-III)

Summary: This is a Phase 3, randomized, open-label, comparative, multicenter, international study for NSCLC patients whose tumor tissue exhibits ROS1 fusion positivity (i.e., ROS1+) and who have not previously received an ROS1-targeted TKI (i.e., ROS1-TKI-naïve). Approximately 138 ROS-1 TKI- naïve ROS1+NSCLC patients will be randomized in a 1:1 ration to one of 2 study arms: * Arm A: Taletrectinib monother...

Brand Information

IBTROZI (taletrectinib)
1INDICATIONS AND USAGE
IBTROZI
2DOSAGE FORMS AND STRENGTHS
Capsules: 200 mg, immediate release, white, opaque, size 0, hard capsules filled with white to light yellow powder, imprinted with “TAL” and “200” in blue ink on the body of the capsule. Each capsule contains 272 mg of taletrectinib adipate equivalent to 200 mg of taletrectinib.
3CONTRAINDICATIONS
None.
4ADVERSE REACTIONS
The following adverse reactions are discussed in greater detail in the WARNINGS AND PRECAUTIONS section:
  • Hepatotoxicity
  • Interstitial Lung Disease/Pneumonitis
  • QTc Interval Prolongation
  • Hyperuricemia
  • Myalgia with Creatine Phosphokinase Elevation
  • Skeletal fractures
4.1Clinical Trials Experience
Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.
The pooled safety population described in the WARNINGS AND PRECAUTIONS section and below reflects exposure to IBTROZI as a single agent at 600 mg orally once daily until disease progression or unacceptable toxicity in 352 patients with
5DESCRIPTION
IBTROZI (taletrectinib) capsules contain taletrectinib adipate, a kinase inhibitor for oral use. The molecular formula for taletrectinib adipate is C
Figure 1: Structure of Taletrectinib Adipate
Figure 1
(R) Indicates chiral center
Taletrectinib adipate is a white to yellowish powder and is practically insoluble or insoluble in water, anhydrous ethanol, isopropanol, acetonitrile, and n-hexane, sparingly soluble in methanol, and slightly soluble in N-methyl pyrrolidone. The aqueous solubility is pH dependent and decreases with increasing pH. The pKa1 is 5.39 and pKa2 is 8.65.
IBTROZI (taletrectinib) capsules for oral use are supplied as immediate-release hard capsules containing
The white opaque capsule shell contains hypromellose and titanium dioxide. The blue printing ink (SB-6008) contains butyl alcohol, dehydrated alcohol, FD&C Blue#1 Aluminum Lake, isopropyl alcohol, propylene glycol, shellac, strong ammonia solution, and titanium dioxide.
6HOW SUPPLIED/STORAGE AND HANDLING
IBTROZI is supplied as 200 mg, Size 0 white opaque hard capsules imprinted with “TAL” and “200” in blue ink in bottles of 30 capsules (NDC 84651-200-30) in a carton containing three bottles of 30 count for a total of 90 capsules per carton (NDC 84651-200-93).
Store IBTROZI at 20°C to 25°C (68°F to 77°F); excursions are permitted to 15°C to 30°C (59°F to 86°F) [
7PATIENT COUNSELING INFORMATION
Advise patients to read the FDA-approved patient labeling (Patient Information).