Xalkori Approved by FDA to Treat Certain Forms of Lung Cancer
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Xalkori Approved by FDA to Treat Certain Forms of Lung Cancer

March 15, 2016

The Food and Drug Administration (FDA) has issued an approval for new drug to treat patients suffering from advanced (metastatic) non-small cell lung cancer (NSCLC).

The approval was granted to Xalkori, a drug marketed by Pfizer. The treatment is designed for patients whose tumors have an ROS-1 gene alteration. It is the first and only FDA-approved treatment for patients with ROS-1 positive NSCLC.

Xalkori is an oral medication that blocks the activity of the ROS-1 protein in tumors that have ROS-1 gene alterations. This effect on ROS-1 may prevent NSCLC from growing and spreading.

"Lung cancer is difficult to treat, in part, because patients have different mutations, some of which are rare," Richard Pazdur said in a written statement. Pazdur is the director of the Office of Hematology and Oncology Products in the FDA's Center for Drug Evaluation and Research. "The expanded use of Xalkori will provide a valuable treatment option for patients with the rare and difficult to treat ROS-1 gene mutation by giving health care practitioners a more personalized way of targeting ROS-1 positive NSCLC."

The safety and effectiveness of Xalkori was assessed in a 50-person study. Results showed that 66 percent of participants experienced a complete or partial shrinkage of their NSCLC tumors, an effect that lasted a median of 18.3 months.

The FDA granted the Xalkori expanded use application breakthrough therapy designation and priority review status. These are programs intended to encourage the development of certain new drugs due to their potential to benefit patients with serious or life-threatening conditions. Xalkori also received orphan drug designation, which provides incentives such as tax credits, user fee waivers and eligibility for exclusivity to assist and encourage the development of drugs for rare diseases.