Ceritinib

(Zykadia®)

Ceritinib

Drug updated on 4/16/2024

Dosage FormTablet (oral:150 mg)
Drug ClassKinase inhibitors
Ongoing and
Completed Studies
ClinicalTrials.gov

Indication

  • Indicated for the treatment of adults 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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  • Ceritinib (Zykadia) is indicated for the treatment of adults with metastatic non-small cell lung cancer (NSCLC) whose tumors are anaplastic lymphoma kinase (ALK)-positive.
  • The information was derived from 17 studies concerning ceritinib's role in treating ALK-positive NSCLC, focusing on clinical outcomes like progression-free survival, overall survival, objective response rate, and treatment-related adverse events across various populations and subgroups.
  • While ceritinib has shown effectiveness in improving progression-free survival and objective response rate compared to chemotherapy and crizotinib, it is often outperformed by other medications such as lorlatinib and alectinib, which demonstrate superior progression-free survival rates along with better safety profiles or objective response rates.
  • In patients with brain metastases specifically, lorlatinib showcases the most favorable outcomes, making it a preferred option over ceritinib.
  • Ensartinib showed the best progression-free survival results among Asian populations, suggesting differences in drug efficacy based on demographic factors, thus emphasizing a personalized medicine approach when treating ALK-positive NSCLC.
  • Although all ALK inhibitors, including ceritinib, improve progression-free survival relative to chemotherapy, its high incidence of severe adverse events makes its safety profile less desirable than others, especially alectinib, which is repeatedly highlighted for having a superior safety profile.
  • Ceritinib's common side effects include diarrhea, hepatotoxicity, increased serum creatinine, while lorlatinib is noted for lipid changes, weight gain, cognitive effects, and mood effects. Despite these higher toxicity levels, lorlatinib could be beneficial, particularly for those patients who have brain metastases.
  • Treatment-related deaths were rare across all ALK inhibitors, indicating a generally acceptable safety profile compared to ceritinib's counterparts.

Product Monograph / Prescribing Information

Document TitleYearSource
Zykadia (ceritinib) prescribing information.2021Novartis Pharmaceuticals Corporation, East Hanover, NJ

Systematic Reviews / Meta-Analyses

Document TitleYearSource
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
Comparative efficacy of ALK inhibitors for treatment-naïve ALK-positive advanced non-small cell lung cancer with central nervous system metastasis: A network meta-analysis. 2023International Journal of Molecular Sciences
A Bayesian network meta-analysis of ALK inhibitor treatments in patients with ALK-positive non-small cell lung cancer.2023Cancer Medicine
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-analysis.2023Lung Cancer
Efficacy and safety of anaplastic lymphoma kinase inhibitors for non-small cell lung cancer: A systematic review and network meta-analysis. 2023Thoracic Cancer
Comparing efficacy and safety of upfront treatment strategies for anaplastic lymphoma kinase-positive non-small cell lung cancer: A network meta-analysis.2023Exploration of Targeted Anti-tumor Therapy
Targeted therapy for advanced anaplastic lymphoma kinase (ALK)‐rearranged non‐small cell lung cancer. 2022Cochrane Database of Systematic Reviews
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
Therapy for stage IV non–small-cell lung cancer with driver alterations: ASCO living guideline.2022Journal of Clinical Oncology
Comparative efficacy and safety of first-line treatments for advanced non-small cell lung cancer with ALK-rearranged: A meta-analysis of clinical trials. 2021BMC Cancer
Efficacy and safety of first-line treatment strategies for anaplastic lymphoma kinase-positive non-small cell lung cancer: A Bayesian network meta-analysis.2021Frontiers in Oncology
Efficacy and safety of ceritinib in anaplastic lymphoma kinase-rearranged non-small cell lung cancer: A systematic review and meta-analysis2020Journal of Clinical Pharmacy and Therapeutics
ALK inhibitors for non-small cell lung cancer: A systematic review and network meta-analysis.2020PLOS ONE
The incidence of ALK inhibitor-related pneumonitis in advanced non-small cell lung cancer patients: A systematic review and meta-analysis.2019Lung Cancer
Safety issues with the ALK inhibitors in the treatment of NSCLC: A systematic review.2019Critical Reviews in Oncology/Hematology
Meta-analysis of overall incidence and risk of ALK inhibitors-induced liver toxicities in advanced non-small-cell lung cancer.2019Medicine

Clinical Practice Guidelines