title: Ceritinib: first global approval.
abstract: 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.
authors: Adis, Level 1, 5 The Warehouse Way, Northcote, 0627, Auckland, New Zealand, dru@adis.com.
authors: Sohita
authors: S
authors: Dhillon
authors: Madeleine
authors: M
authors: Clark
mesh_terms: D000818:Animals; D000970:Antineoplastic Agents / Q000494:pharmacology / Q000627:therapeutic use*; D002289:Carcinoma, Non-Small-Cell Lung / Q000175:diagnosis / Q000188:drug therapy*; D002986:Clinical Trials as Topic / Q000379:methods; D017277:Drug Approval; D006801:Humans; D008175:Lung Neoplasms / Q000175:diagnosis / Q000188:drug therapy*; D011743:Pyrimidines / Q000494:pharmacology / Q000627:therapeutic use*; D020794:Receptor Protein-Tyrosine Kinases / Q000037:antagonists & inhibitors*; D013450:Sulfones / Q000494:pharmacology / Q000627:therapeutic use*
chemical_list: D000970:Antineoplastic Agents; D011743:Pyrimidines; D013450:Sulfones; D020794:Receptor Protein-Tyrosine Kinases; C586847:ceritinib