- 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.
at Zacks.com (Nov 18, 2014)