Regulatory approval

Published by the Health Canada.

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/00064867.PDF. Revised February 2022. Accessed June 2025.

Therapeutic response

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

Type Biomarker(s) Cancer type Therapy(ies)
Sensitivity (+) v::ALK Non-Small Cell Lung Cancer Ceritinib