FDA Approves Zykadia (Ceritinib) for Advanced Lung CancerMay 6, 2014
The US Food and Drug Administration (FDA) has approved Zykadia (ceritinib) for a type of late-stage non-small cell lung cancer. Zykadia is a kind of targeted drug that works by blocking proteins that help cancer cells grow. It specifically targets cells with mutations (changes) in the ALK gene.
Only a small percentage of non-small cell lung cancer patients test positive for the ALK gene mutation. Zykadia is intended for people with ALK-positive non-small cell lung cancer that spread (metastasized), after they were treated with Xalkori (crizotinib), the only other FDA-approved drug that targets cells with a mutated ALK gene.
Zykadia was approved under the FDA’s accelerated approval program for drugs that show promise against a serious disease. The FDA made its decision faster than usual. The company that makes the drug must submit additional clinical information after approval, to confirm its benefit.
The FDA based its decision on a clinical trial of 163 people with metastatic ALK-positive non-small cell lung cancer. All of them were treated with Zykadia. Tumors shrank in about half the patients, and the improvement lasted on average for about 7 months.
Common side effects of Zykadia include diarrhea, nausea, vomiting, abdominal pain, tiredness, loss of appetite, and constipation. Some patients’ lab tests indicated the drug was affecting their liver, kidneys, or pancreas, or showed increased glucose levels or lowered red blood cell counts (anemia).
Zykadia is marketed by Novartis.