ROZLYTREK® (entrectinib) by Genentech, Inc.


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Indications & Usage

ROZLYTREK is a kinase inhibitor indicated for the treatment of:

• Adult patients with ROS1-positive metastatic non-small cell lung cancer (NSCLC), as detected by an FDA-approved test.

• Adult and pediatric patients 12 years of age and older with solid tumors that:

    • have a neurotrophic tyrosine receptor kinase (NTRK) gene fusion, as detected by an FDA-approved test without a known acquired resistance mutation, 
    • are metastatic or where surgical resection is likely to result in severe morbidity, and
    • have progressed following treatment or have no satisfactory alternative therapy.

This indication is approved under accelerated approval based on tumor response rate and durability of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trials.

 

Please see Important Safety Information in the full Prescribing Information.

Dosage & Administration
  • Select patients for treatment based on the presence of ROS1 rearrangement(s) or NTRK gene fusion.
Information on FDA-approved tests for the detection of ROS1 rearrangement(s) in NSCLC and NTRK gene fusion(s) in solid tumors is available at www.fda.gov/CompanionDiagnostics.
 
  • Recommended Dosage for ROS1-Positive Non-Small Cell Lung Cancer:
    • 600 mg orally once daily with or without food until disease progression or unacceptable toxicity
  • Recommended Dosage for NTRK Gene Fusion-Positive Solid Tumors:
    • Adults: 600 mg orally once daily with or without food until disease progression or unacceptable toxicity

    • Pediatric Patients 12 Years and Older: Recommended dosage is based on body surface area (BSA) as shown below
      • BSA greater than 1.50 m2: 600 mg orally once daily

      • BSA 1.11 to 1.50 m2: 500 mg orally once daily

      • BSA 0.91 to 1.10 m2: 400 mg orally once daily
  • For more information on ROZLYTREK dosing and dose modifications due to adverse reactions, see the full Prescribing Information

Dosage Forms and Strengths 
 
Capsules: 100 mg and 200 mg

Please see Important Safety Information in the full Prescribing Information.

ROZLYTREK® and its logo are registered trademarks of Genentech, Inc. 

 

© 2022 Genentech USA, Inc. All rights reserved. This site is intended for U.S. residents only.

M-US-00012574(v2.0).

Please see Important Safety Information below and in the full Prescribing Information.

 

INDICATIONS AND IMPORTANT SAFETY INFORMATION

INDICATIONS 

ROS1-Positive Non-Small Cell Lung Cancer

ROZLYTREK is indicated for the treatment of adult patients with ROS1-positive metastatic non-small cell lung cancer (NSCLC), as detected by an FDA-approved test.

NTRK Gene Fusion-Positive Solid Tumors

ROZLYTREK is indicated for the treatment of adult and pediatric patients 12 years of age and older with solid tumors that:

  • have a neurotrophic tyrosine receptor kinase (NTRK) gene fusion, as detected by an FDA-approved test without a known acquired resistance mutation,
  • are metastatic or where surgical resection is likely to result in severe morbidity, and
  • have either progressed following treatment or have no satisfactory alternative therapy.

This indication is approved under accelerated approval based on tumor response rate and durability of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trials.

SELECT IMPORTANT SAFETY INFORMATION

Congestive Heart Failure (CHF): Assess left ventricular ejection fraction (LVEF) prior to initiation of ROZLYTREK in patients with symptoms or known risk factors for CHF. Monitor patients for clinical signs and symptoms of CHF. For patients with myocarditis with or without a decreased ejection fraction, MRI or cardiac biopsy may be required to make the diagnosis. For new onset or worsening CHF, withhold ROZLYTREK, reassess LVEF, and institute appropriate medical management. Reduce dose or permanently discontinue ROZLYTREK based on severity of CHF or worsening LVEF.

Central Nervous System (CNS) Effects: CNS adverse reactions, including cognitive impairment, mood disorders, dizziness, and sleep disturbances, can occur with ROZLYTREK. Withhold and then resume at same or reduced dose upon improvement, or permanently discontinue ROZLYTREK based on severity.

Skeletal Fractures: ROZLYTREK increases the risk of fractures. Promptly evaluate patients with signs or symptoms of fractures.

Hepatotoxicity: Monitor liver tests, including ALT and AST, every 2 weeks during the first month of treatment, then monthly thereafter and as clinically indicated. Withhold or permanently discontinue ROZLYTREK based on severity. If withheld, resume ROZLYTREK at same or reduced dose based on severity.

Hyperuricemia: Assess serum uric acid levels prior to initiation and periodically during treatment with ROZLYTREK. Monitor patients for signs and symptoms of hyperuricemia. Initiate treatment with urate-lowering medications as clinically indicated and withhold ROZLYTREK for signs and symptoms of hyperuricemia. Resume at same or reduced dose upon improvement based on severity.

QT Interval Prolongation: Monitor patients who have or who are at risk for QTc interval prolongation. Assess QT interval and electrolytes at baseline and periodically during treatment. Withhold and then resume at same or reduced dose, or permanently discontinue ROZLYTREK based on severity.

Vision Disorders: Withhold for new visual changes or changes that interfere with activities of daily living until improvement or stabilization. Conduct an ophthalmological evaluation as appropriate. Resume at same or reduced dose upon improvement or stabilization.

Embryo-Fetal Toxicity: ROZLYTREK can cause fetal harm. Advise females of reproductive potential of the potential risk to a fetus and use of effective contraception.

Most Common Adverse Reactions: The most common adverse reactions (≥20%) were fatigue (48%), constipation (46%), dysgeusia (44%), edema (40%), dizziness (38%), diarrhea (35%), nausea (34%), dysesthesia (34%), dyspnea (30%), myalgia (28%), cognitive impairment (27%), increased weight (25%), cough (24%), vomiting (24%), pyrexia (21%), arthralgia (21%), and vision disorders (21%).

Drug Interactions:

Moderate and Strong CYP3A Inhibitors:

  • For adult and pediatric patients 12 years and older with a BSA >1.50 m2, reduce the dose of ROZLYTREK if coadministration of moderate or strong CYP3A inhibitors cannot be avoided
  • For pediatric patients 12 years and older with a BSA ≤1.50 m2, avoid coadministration with ROZLYTREK

Moderate and Strong CYP3A Inducers: Avoid coadministration with ROZLYTREK.

Use in Specific Populations:

  • Lactation: Advise not to breastfeed

You may report side effects to the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. You may also report side effects to Genentech at 1-888-835-2555.

 

Please see additional Important Safety Information in the full Prescribing Information.