Lorlatinib

(Lorbrena®)

Lorlatinib

Drug updated on 5/17/2024

Dosage FormTablet (oral; 25 mg, 100 mg)
Drug ClassKinase inhibitors
Ongoing and
Completed Studies
ClinicalTrials.gov

Indication

  • Indicated for the treatment of adult patients with metastatic non-small cell lung cancer (NSCLC) whose tumors are anaplastic lymphoma kinase (ALK)-positive as detected by an FDA-approved test.

Latest News

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Summary
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  • Lorlatinib (Lorbrena) is indicated for the treatment of adult patients with metastatic non-small cell lung cancer (NSCLC) whose tumors are anaplastic lymphoma kinase (ALK)-positive as detected by an FDA-approved test.
  • Nine studies were reviewed to compare the safety and efficacy of lorlatinib to other ALK inhibitors in treating NSCLC.
  • In terms of progression-free survival, lorlatinib shows superior results compared to crizotinib and closely follows alectinib and brigatinib; it also demonstrates remarkable benefits in controlling CNS progression among populations with baseline brain metastases.
  • While comparisons involving overall survival improvements remain less conclusive for lorlatinib, alectinib has been shown to significantly improve OS compared to other ALK inhibitors like crizotinib.
  • Adverse events associated with lorlatinib are noted as being among the highest when compared to other ALK inhibitors, including changes in lipid levels, weight gain, cognitive effects, and mood effects; however, its high efficacy, particularly in managing CNS involvement, distinguishes it from others.
  • Alectinib emerges frequently as a preferred option due its balance between efficacy and safety, especially within the first-line or second-line settings, while brigatinib exhibits significant improvement in patient-reported outcomes.

Product Monograph / Prescribing Information

Document TitleYearSource
Lorbrena (lorlatinib) Prescribing Information.2023Pfizer Inc., New York, NY

Systematic Reviews / Meta-Analyses

Document TitleYearSource
Identifying optimal ALK inhibitors in first- and second-line treatment of patients with advanced ALK-positive non-small-cell lung cancer: a systematic review and network meta-analysis2024BMC Cancer
Comparing efficacy and safety of upfront treatment strategies for anaplastic lymphoma kinase-positive non-small cell lung cancer: a network meta-analysis2023Exploration of Targeted Anti-Tumor Therapy
Comparative safety of anaplastic lymphoma kinase tyrosine kinase inhibitors in advanced anaplastic lymphoma kinase-mutated non-small cell lung cancer: Systematic review and network meta-analysis2023Lung Cancer
A Bayesian network meta-analysis of ALK inhibitor treatments in patients with ALK-positive non-small cell lung cancer.2023Cancer Medicine
Efficacy and safety of first-line treatments for patients with advanced anaplastic lymphoma kinase mutated, non–small cell cancer: a systematic review and network meta-analysis.2023Cancer
Toxicity profile of anaplastic lymphoma kinase tyrosine kinase inhibitors for patients with non‑small cell lung cancer: a systematic review and meta‑analysis.2022Investigational New Drugs
ALK inhibitors in ALK-rearranged non-small cell lung cancer with and without brain metastases: Systematic review and network meta-analysis.2022BMJ Open
Targeted therapy for advanced anaplastic lymphoma kinase (ALK)‐rearranged non‐small cell lung cancer.2022The Cochrane Database of Systematic Reviews
Comparative efficacy and safety of lorlatinib and alectinib for ALK-rearrangement positive advanced non-small cell lung cancer in Asian and non-Asian patients: a systematic review and network meta-analysis.2021Cancers

Clinical Practice Guidelines