Regulatory approval

Published by the Health Canada.

Health Canada approved ceritinib as monotherapy for the first-line treatment of adult patients with anaplastic lymphoma kinase (ALK)-positive locally advanced (not amenable to curative therapy) or metastatic non-small cell lung cancer (NSCLC).

This is written in the approval document as:

ZYKADIA (ceritinib) as monotherapy is indicated for the first-line treatment of adult patients with anaplastic lymphoma kinase (ALK)-positive locally advanced (not amenable to curative therapy) or metastatic non-small cell lung cancer (NSCLC).

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.

Organization(s)	Biomarker(s)	Cancer type	Therapy(ies)
HC (1)	v::ALK	Non-Small Cell Lung Cancer	Ceritinib