FDA approves Novartis breakthrough therapy cancer drug

The FDA gives a thumbs up to Novartis' (NVS +1.2%) Zykadia (ceritinib) as a treatment for patients with a certain type of late-stage (metastatic) non-small cell lung cancer months ahead of schedule.

Zykadia is an anaplastic lymphoma kinase (ALK) tyrosine kinase inhibitor that blocks cancer cell-promoter proteins.

The agency granted Zykadia breakthrough therapy designation, priority review and orphan drug designation. Its clearance comes four months ahead of the August 24 PDUFA date.

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