Leaders at the U.S. Food and Drug Administration (FDA) recently granted approval of Xalkori to treat patients who have advanced (metastatic) non-small cell lung cancer (NSCLC) and tumors with an ROS-1 gene alteration.
Xalkori is the only treatment that the FDA has approved for people who have NSCLC and ROS-1.
In the U.S., lung cancer is the top cause of deaths related to cancer. In 2015 alone, there were approximately 221,200 new cases diagnosed -- and another 158,040 people who died from the disease.
The alterations in ROS-1 are believed to cause abnormal cells. These have been detected in several different cancers, like NSCLC. The gene changes are found in an estimated 1 percent of NSCLC patients.
The characteristics of the NSCLC and patients with NSCLC and ROS-1 gene alterations are similar to gene alterations found in anaplastic lymphoma kinase (ALK). Crizotinib has been approved to treat this illness.
“Lung cancer is difficult to treat, in part, because patients have different mutations, some of which are rare,” Richard Pazdur, director of the Office of Hematology and Oncology Products in the FDA’s Center for Drug Evaluation and Research, said. “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.”
