Regulatory approval

Published by the European Medicines Agency. Approved

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.

This is written in the approval document.

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.

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

Contributions

Date	Contributor	Description
2024-10-20	Van Allen lab	Adding EMA approvals for use to database
2015-05-06	European Medicines Agency	Indication received approval from the European Commission.