May 02, 2014 9:00 AM

Author: Office of Public Affairs


The US Food and Drug Administration (FDA) fast-tracked approval of a new treatment for non-small-cell lung cancer, based on its potential to fill an unmet clinical need. The drug, ceritinib, will be marketed as Zykadia by the pharmaceutical company Novartis.

The leading cause of death among cancer patients is lung cancer, 90% of which are non-small-cell lung cancers. Of patients with this cancer subtype – many of whom are nonsmokers - 5% carry a mutation in the anaplastic lymphoma kinase (ALK) gene, a defect that causes uncontrolled cell growth leading to cancer. Treatment options are limited for these patients, who typically develop resistance to the most commonly prescribed drug, crizotinib, and experience a relapse within twelve months.

The FDA green-lighted Zykadia for this group, for whom there are no other treatment options. Their hastened decision was largely based on a worldwide collaboration among clinical investigators, who found that the drug was safe and effective.

“Very early on, we could see that the drug was benefitting patients with advanced disease,” said Dr. Sunil Sharma, professor of internal medicine at the University of Utah School of Medicine and director of clinical research at the Huntsman Cancer Institute. His research team enrolled one of the largest patient cohorts for the study.

Patients who were in advanced stages of cancer, and who had already developed resistance to existing drugs, took part in the multicenter clinical trial. Zykadia was effective in over half of the patients, whose cancer responded to the drug for an average of seven months.

“These patients usually have no other options and the remarkable activity of this drug is demonstrated by its early approval by the FDA after a phase I trial,” said Sharma.

A process that often takes decades, Zykadia moved from bench to bedside in a swift three and a half years. Investigators credit the accomplishment on a highly focused approach toward drug development and testing, and strong collaboration between clinical investigators, patients, Novartis and the FDA. 

Results from the clinical trial were published in March, 2014 in the New England Journal of Medicine.

Listen to an interview with Dr. Sharma about the new treatment on The Scope Radio.

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