EMA Recommends Novartis’ Lung Cancer Drug Zykadia
Novartis reports that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency adopted a positive opinion for Zykadia (ceritinib) to treat adult patients with anaplastic lymphoma kinase (ALK)-positive advanced non-small cell lung cancer (NSCLC) previously treated with crizotinib[. If approved in the European Union (EU), Zykadia will be the first treatment option to address an unmet medical need for patients with ALK+ NSCLC previously treated with crizotinib.
In the EU, the European Commission generally follows the recommendations of the CHMP and delivers its final decision within three months of the CHMP recommendation. The decision will be applicable to all 28 European Union member states plus Iceland, Norway, and Liechtenstein. Zykadia is currently approved in the United States, Mexico, Chile, South Korea, Guatemala, and Ecuador. Additional regulatory reviews are underway in North America, South America, Central America and Asia.
Zykadia is an oral, selective inhibitor of anaplastic lymphoma kinase (ALK), a gene that can fuse with others to form an abnormal “fusion protein” that promotes the development and growth of certain tumors in cancers including non-small cell lung cancer (NSCLC).