Regulatory approval

Published by the European Medicines Agency.

The European Medicines Agency (EMA) has authorized ceritinib for the treatment of adult patients with anaplastic lymphoma kinase (ALK)-positive advanced non-small cell lung cancer (NSCLC) previously treated with crizotinib.

This is written in the approval document as:

Zykadia as monotherapy is indicated for the treatment of adult patients with anaplastic lymphoma kinase (ALK)-positive advanced non-small cell lung cancer (NSCLC) previously treated with crizotinib.

Citation

Novartis Europharm Limited. Zykadia (ceritinib) [product information]. European Medicines Agency website. https://www.ema.europa.eu/en/documents/product-information/zykadia-epar-product-information_en.pdf. Revised December 2023. Accessed March 26, 2024.

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