FDA Grants Priority Review for New Use for Pfizer’s Xalkori
The US Food and Drug Administration has accepted and granted priority review for a supplemental new drug application (sNDA) for Xalkori (crizotinib) 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, according to Pfizer. Xalkori is currently indicated for patients with metastatic NSCLC whose tumors are anaplastic lymphoma kinase (ALK)-positive as detected by an FDA-approved test. The projected FDA action date is April 2016.
Priority review status accelerates FDA review time from 10 months to a goal of six months from the day of acceptance of filing and is given to drugs that may offer major advances in treatment or may provide a treatment for which no adequate therapy existing therapies.
ROS1 rearrangement occurs when the ROS1 gene attaches to another gene and changes the way each gene normally functions, which can contribute to cancer-cell growth. 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 fusion, according to information from the company.