Ceritinib is an oral anaplastic lymphoma kinase (ALK) inhibitor developed by 
Novartis for the treatment of tumours characterised by genetic abnormalities in 
ALK. ALK is a member of the insulin receptor family of tyrosine kinases that can 
become oncogenic when fused to other proteins. Ceritinib has been approved in 
the US under 'Breakthrough Therapy' designation for the second-line treatment of 
ALK-positive non-small cell lung cancer (NSCLC). Regulatory submissions have 
also been made in the EU and other countries. Phase III development is ongoing 
worldwide to evaluate ceritinib both as a first- and second-line therapy for 
ALK-positive NSCLC. This article summarizes the milestones in the development of 
ceritinib leading to this first approval for the treatment of patients with 
ALK-positive metastatic NSCLC who have progressed on or are intolerant to 
crizotinib.