The U.S. Food and Drug Administration has approved Zykadia (ceritinib) for patients with anaplastic lymphoma kinase-positive non-small cell lung cancer four months ahead of schedule.
Zykadia, marketed by Novartis, is an ALK tyrosine kinase inhibitor that blocks proteins that help cancerous cells develop. Before now, there was only one other drug — crizotinib — approved as an ALK tyrosine kinase inhibitor. Zykadia is intended for patients with metastatic ALK-positive NSCLC who previously were treated with crizotinib.
Only 2 to 7 percent of patients with NSCLS are ALK-positive, according to the FDA.
Zykadia was granted breakthrough therapy designation, priority review and orphan product designation. The FDA approved Zykadia through the accelerated approval program, which allows the FDA to approve drugs intended to treat serious or life-threatening diseases based on clinical data demonstrating the drug is likely to have clinical benefit for patients.
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