Zykadia for Metastatic, ALK-Positive Lung Cancer

August 2014 Vol 7, Special Issue ASCO 2014 Payers' Perspectives in Oncology - FDA Approvals

On April 29, 2014, the 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 its 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.

The safety and efficacy of ceritinib were 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.

The 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.

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Last modified: August 21, 2014
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