FDA Update

May 2014, Vol 4, No 3 - FDA News

Zykadia Approved for Metastatic, ALK-Positive Lung Cancer

On April 29, 2014, the US Food and Drug Administration (FDA) approved ceritinib (Zykadia; Novartis) for the treatment of patients with metastatic, anaplastic lymphoma kinase (ALK)-positive non–small-cell lung cancer (NSCLC). Ceritinib is an ALK tyrosine kinase inhibitor that blocks proteins that promote cancer cell growth. The drug is approved for the treatment of patients with late-stage NSCLC who were previously treated with crizotinib, the first and only other ALK tyrosine kinase inhibitor ap­­proved by the FDA.

The FDA approved ceritinib under the FDA’s accelerated approval process, 4 months ahead of its scheduled final review date, to expedite access to this drug for a patient population with a life-threatening condition and very few treatment options available.

The safety and efficacy of ceritinib was established in a clinical trial with 163 patients with metastatic, ALK-positive NSCLC. All patients received ceritinib: approximately 50% of the patients had their tumor shrink with this therapy, and this result lasted an average of approximately 7 months.

Reported side effects were mainly gastrointestinal, such as diarrhea, nausea, vomiting, and abdominal pain. Laboratory abnormalities included increased liver enzymes and pancreatic enzymes, as well as in­­creased glucose levels.