Lung Cancer Drug Earns Early FDA Approval

United States federal regulators have approved a new treatment for advanced lung cancer about four months earlier than expected, according to a recent public announcement.

The U.S. Food and Drug Administration (FDA) announced the accelerated approval of Zykadia for treatment a specific type of late-stage non-small cell lung cancer in patients with a dangerous genetic mutation that encourages the production of anaplastic lymphoma kinase (ALK) protiens. These protens normally encourage the formation of cancerous cells, putting patients with the ALK-positive NSCLC genetic mutation at significantly higher risk of developing an aggressive lung cancer.

Zykadia, produced by Novartis, has ceritinib as its active ingredient. Ceritinib is a ALK tyrosine kinase inhibitor, blocking the production of the dangerous cancer-promoting proteins.

According to the FDA release, this condition was already treated with crizotinib. However, ceritinib reportedly works more directly and effectively, displaying "a greater understanding of the underplaying molecular pathways of a disease," Richard Pazdur, director of products in the FDA's Center of Drug Evaluation and Research explained in an FDA release.

Prior to approval, Zykadia had been promoted to the FDA's "new breakthrough" designation, which is designed to speed up the approval process for dugs seen as an advance over existing therapies, if any exist. Zykadia is the fourth drug ever to receive this rare approval designation, according to the FDA release.

The approval, which came four months earlier than Novartis expected, occurred after the cancer treatment's safety and effectiveness was shown in the results of Phase III clinical trials that involved nearly 200 participants with metastatic ALK-positive NSCLC.

According to the FDA, lung cancer is the leading cause of cancer-related deaths among men and women in the United States and will kill and estimated 159,260 people this year, according to data from the Nation Cancer Institute.

Zykadia's approval was announced in a FDA release on April 29.