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Lorbrena

lorlatinib
ALK/ROS1 TKI (3rd Gen) FDA Approved 2018 Pfizer
Route
Oral
Half-Life
24 hrs
FDA Approved
2018
Manufacturer
Pfizer
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1. Indications and Usage

NSCLC: ALK-positive metastatic NSCLC.

2. Dosage and Administration

100 mg orally once daily.

3. Dosage Forms and Strengths

Tablets: 25 mg, 100 mg

4. Contraindications

Strong CYP3A inducers contraindicated.

5. Warnings and Precautions
  • Hyperlipidemia: Cholesterol 84%, triglycerides 67%.
  • CNS Effects: Cognitive (21%), mood (16%), psychotic effects.
  • AV Block: Monitor ECG.
  • ILD/Pneumonitis: Permanently discontinue.
  • Embryo-Fetal Toxicity: Can cause fetal harm.
6. Adverse Reactions
Most Common Adverse Reactions

Hypercholesterolemia (84%), Hypertriglyceridemia (67%), Edema (55%), Peripheral Neuropathy (48%), Fatigue (31%), Weight Gain (31%), Cognitive Effects (21%), Diarrhea (22%)

Hypercholesterolemia
84%
Hypertriglyceridemia
67%
Edema
55%
Peripheral Neuropathy
48%
Fatigue
31%
Weight Gain
31%
Cognitive Effects
21%
Diarrhea
22%

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

7. Drug Interactions

Strong CYP3A Inducers: Contraindicated.
CYP3A Substrates: Moderate CYP3A inducer.

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

Third-generation ALK/ROS1 TKI designed for CNS penetration, inhibiting wild-type ALK and resistance mutations including G1202R.

Pharmacokinetics

Bioavailability: 81%. Protein binding: 66%. t½: 24h. Urine 48%, feces 41%.

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 Lorbrena Trials on ClinicalTrials.gov ↗ 📚 PubMed: Lorbrena Clinical Trials ↗
FDA-Approved Tumor Types

Lorbrena 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 Lorbrena. 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 Lorbrena (lorlatinib) approved for?

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

How is Lorbrena (lorlatinib) administered?

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

How does Lorbrena (lorlatinib) work?

Third-generation ALK/ROS1 TKI designed for CNS penetration, inhibiting wild-type ALK and resistance mutations including G1202R.

What are the most common side effects?

Hypercholesterolemia (84%), Hypertriglyceridemia (67%), Edema (55%), Peripheral Neuropathy (48%), Fatigue (31%), Weight Gain (31%), Cognitive Effects (21%), Diarrhea (22%) Hypercholesterolemia 84% Hypertriglyceridemia 67% Edema 55% Peripheral Neuropathy 48% Fatigue 31% Weight Gain 31% Cognitive Effe

← All Therapies Full Prescribing Information ↗