Pfizer’s Xalkori? (crizotinib) has received Breakthrough Therapy designation from the U.S. Food and Drug Administration (FDA) for the potential treatment of patients with ROS1-positive non-small cell lung cancer (NSCLC).
Occurring in approximately one percent of NSCLC cases, ROS1-positive NSCLC represents a particular molecular subgroup of NSCLC. Xalkoricurrently is approved in the U.S. for the treatment of patients with metastatic NSCLC whose tumours are anaplastic lymphoma kinase (ALK)-positive as detected by an FDA-approved test.
Enacted as part of the 2012 FDA Safety and Innovation Act (FDASIA), Breakthrough Therapy designation is intended to expedite the development and review of a potential new medicine if it is intended to treat a serious or life-threatening disease and preliminary clinical evidence indicates that the drug may demonstrate substantial improvement over existing therapies.
Xalkori exhibited marked anti-tumour activity in patients with ROS1-positive advanced NSCLC
“We are excited that the FDA has granted Breakthrough Therapy designation for Xalkori as a potential treatment for patients with ROS1-positive NSCLC,” said Dr. Mace Rothenberg, senior vice president of Clinical Development and Medical Affairs and chief medical officer for Pfizer Oncology. “Xalkori pioneered precision medicine for ALK-positive metastatic NSCLC, and ROS1 represents a second molecular subgroup of NSCLC in which Xalkori has demonstrated a level of anti-tumour activity that can potentially make a real difference for patients.”
The Breakthrough Therapy designation was based on a data analysis from an expansion cohort of a global Phase 1 study (Study 1001), which evaluated Xalkori in 50 patients with ROS1-positive advanced NSCLC. These data published in the November 20, 2014 issue of the New England Journal of Medicine demonstrated that Xalkori exhibited marked anti-tumour activity in patients with ROS1-positive advanced NSCLC. The safety profile of Xalkori in ROS1-rearranged advanced NSCLC was similar to that observed in patients with ALK-positive advanced NSCLC.
