FDA Approves Zykadia for Lung Cancer

The United States Food and Drug Administration (FDA) has recently approved the targeted therapy Zykadia (ceritinib) for patients with late-stage lung cancer.
Specifically, Zykadia has been approved for patients with non-small cell lung cancer (NSCLC) that has spread to distant sites in the body, and is considered to be anaplastic lymphoma kinase (ALK)-positive. Patients must have already received treatment with crizonitinb.

Lung cancer is categorized by the type of cell the cancer originated within the lung. Non-small cell lung cancer is by far the most common type of lung cancer in the world, accounting for approximately 85% of all lung cancers.

As science and technology becomes more sophisticated, scientists are able to create further categories based upon specific mutations or protein arrangements on cancer cells.

Anaplastic lymphoma kinase (ALK) is a type of protein complex that spans the inside and outside of a cell. Although it is a normal part of cells, if it becomes mutated, ALK can increase the rate of growth and spread of cancer cells. Cancer that has a mutated ALK is referred to as ALK-positive. Approximately 2-7% of NSCLC is ALK-positive. The FDA has already approved a laboratory test to determine whether cancer is ALK-positive.

Zykadia is an ALK tyrosine kinase inhibitor, meaning it blocks the effects of a mutated ALK.

The FDA granted Zykadia approval based on results from a clinical trial that included 163 patients with advanced ALK-positive NSCLC.

Approximately half of the patients demonstrated a reduction in size of their cancer tumors.
The anti-cancer effects of Zykadia lasted approximately 7 months.
The most common side effects included diarrhea, nausea, vomiting and abdominal pain.
Reference: United States Food and Drug Administration. FDA News Release. FDA approves Zykadia for late-stage lung cancer. Accessed April 30, 2014. Available at: