Therapeutic Response Statement (Sensitivity)

This therapeutic response statement Supports the relationship that v::ALK status confers therapeutic sensitivity to Ceritinib in patients with Non-Small Cell Lung Cancer.

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 statement is based on a regulatory approval from the European Medicines Agency:

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.

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.