Regulatory approval

Published by the Health Canada. Approved

Health Canada approved ceritinib for the treatment of adult patients with ALK-positive locally advanced (not amenable to curative therapy) or metastatic NSCLC who have progressed on or who were intolerant to crizotinib.

This is written in the approval document as:

ZYKADIA (ceritinib) as monotherapy is indicated for the treatment of adult patients with ALK-positive locally advanced (not amenable to curative therapy) or metastatic NSCLC who have progressed on or who were intolerant to crizotinib.

Citation

Novartis Pharmaceuticals Canada Inc. Zykadia (ceritinib) [product monograph]. Health Canada website. https://pdf.hres.ca/dpd_pm/00082721.PDF. Revised December 2025. Accessed April 2026.

Therapeutic response

Precision oncology relationships for therapeutic response derived from this regulatory approval.

Organizations	Biomarkers	Cancer types	Therapies
HC (1)	v::ALK	Non-Small Cell Lung Cancer	Ceritinib

Contributions

Date	Contributor	Description
2024-10-30	Van Allen lab	Initial access of FDA approvals