Xalkori (crizotinib) filed with FDA for ROS-1 positive non-small cell lung cancer- Pfizer

The FDA has accepted and granted Priority Review for a supplemental New Drug Application (sNDA) for Xalkori (crizotinib), from Pfizer, for the treatment of patients with metastatic non-small cell lung cancer (NSCLC) whose tumors are ROS1-positive. In April 2015, Xalkori received Breakthrough Therapy designation by the FDA for this potential indication. If approved, Xalkori would be the first FDA-approved biomarker-driven therapy for the treatment of ROS1-positive metastatic NSCLC. The projected FDA action date is April 2016.

The submission to the FDA is based on data from a multicenter, single-arm Phase I study (Study 1001) that evaluated Xalkori in 53 patients with ROS1-positive metastatic NSCLC. Data from 50 of these patients were published in the November 20, 2014 issue of The New England Journal of Medicine and showed that Xalkori exhibited marked anti-tumor activity in patients with ROS1-positive metastatic NSCLC. Additionally, the safety profile of Xalkori in ROS1-positive metastatic NSCLC was consistent with that observed in patients with ALK-positive metastatic NSCLC.

Comment: Epidemiology data suggest that ROS1 rearrangements occur in approximately one percent of NSCLC cases. Of the estimated 1.5 million new cases of NSCLC worldwide each year, roughly 15,000 may be driven by oncogenic ROS1 fusions.