Novartis secures label expansion for Zykadia

30 June 2017

Novartis (NOVN: VX) has successfully extended the marketable use of Zykadia (ceritinib) in Europe, to include the first-line treatment of patients with ALK-positive advanced non-small cell lung cancer (NSCLC).

The decision was based on the results of the pivotal ASCEND-4 trial, which showed a 45% reduction in the risk of disease progression in the Zykadia arm. The company gained approval for a similar label expansion in the USA a month ago.

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 NSCLC.

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