The drug’s use has been expanded to treat patients with advanced, or metastatic, NSCLC whose tumors have an ROS-1 gene alteration, which is believed to lead to abnormal cells.
Xalkori is the first and only FDA-approved treatment for patients with the ROS-1 gene alteration.
The drug was initially approved in 2011 to treat NSCLC patients who test positive for alterations in a gene known as ALK.
The FDA said the overall patient and disease characteristics of NSCLC with ROS-1 gene alterations appear same to those with the ALK gene alterations.
The approval was based on a study that included 50 patients with ROS1-positive metastatic NSCLC, treated with 250 mg of Xalkori two times a day orally.
About about two-thirds of participants (66%) experienced a complete or partial shrinkage of their NSCLC tumours, an effect that lasts an average of 18.3 months.
FDA Center for Drug Evaluation and Research director of the office of hematology and oncology products Richard Pazdur said: "Lung cancer is difficult to treat, in part, because patients have different mutations, some of which are rare.
"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 European Medicines Agency is also reviewing an application to extend the marketing authorization of Xalkori to include the treatment of adult patients with ROS1-positive advanced NSCLC.
In Europe, Xalkori is indicated for the first-line treatment of adults with ALK-positive advanced NSCLC and to treat adults with previously-treated ALK-positive advanced NSCLC.
Image: Pfizer world headquarters. Photo: courtesy of Norbert Nagel, Mörfelden-Walldorf, Germany.