Drug updated on 4/16/2024
| Dosage Form | Tablet (oral:150 mg) |
| Drug Class | Kinase 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.
Summary
- 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 Title | Year | Source |
|---|---|---|
| Zykadia (ceritinib) prescribing information. | 2021 | Novartis Pharmaceuticals Corporation, East Hanover, NJ |
Systematic Reviews / Meta-Analyses
Clinical Practice Guidelines
| Document Title | Year | Source |
|---|---|---|
| Guidelines for clinical practice of ALK fusion detection in non-small-cell lung cancer: A proposal from the Chinese RATICAL study group. | 2021 | Journal of the National Cancer Center |
| Metastatic non-small cell lung cancer: ESMO clinical practice guidelines for diagnosis, treatment and follow-up. | 2020 | Annals of Oncology |