Xalkori Receives Approval for Expanded Use

The FDA has expanded the use of crizotinib, making it the first and only FDA-approved treatment for individuals with advanced non-small cell lung cancer whose tumors have an ROS-1 gene alteration.

The FDA has expanded the use of crizotinib (Xalkori), making it the first and only FDA-approved treatment for individuals with advanced non-small cell lung cancer whose tumors have an ROS-1 gene alteration.

“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 non-small cell lung cancer,” said Richard Pazdur, director of the Office of Hematology and Oncology Products in the FDA’s Center for Drug Evaluation and Research, in a press release.

Xalkori works by blocking the activity of the ROS-1 protein in tumors that have ROS-1 gene alterations, thereby potentially preventing the cancer from growing and spreading.

The safety and efficacy of this oral drug was tested in 50 patients with ROS-1 positive tumors. The patients received Xalkori twice daily, and researchers studied the effects on the shrinkage of their tumors.

Around 66% of the patients experienced complete or partial shrinkage of their tumor. This effect lasted a median of 18.3 months.

The most common adverse effects associated with Xalkori are nausea, vision disorders, diarrhea, vomiting, and swelling. However, it may also potentially cause liver problems, abnormal heartbeats, and inflammation in the lungs.