FDA Approves Pfizer's Xalkori To Treat Lung-cancer Patients With Gene Alteration

(RTTNews) - Pfizer Inc. (PFE) on Friday announced that FDA has approved a supplemental New Drug Application or sNDA for XALKORI® (crizotinib) to treat patients with metastatic non-small cell lung cancer (NSCLC) whose tumors are ROS1-positive.

In 2015, the FDA granted Breakthrough Therapy and Priority Review designations for this indication. XALKORI also is indicated for patients with metastatic NSCLC whose tumors are anaplastic lymphoma kinase (ALK)-positive as detected by an FDA-approved test

ROS-1 gene alterations have been identified in various cancers, including NSCLC. ROS-1 gene alterations are present in approximately 1 percent of patients with NSCLC.

Xalkori is an oral medication that blocks the activity of the ROS-1 protein in tumors that have ROS-1 gene alterations. This effect on ROS-1 may prevent NSCLC from growing and spreading.

FDA said the overall patient and disease characteristics of non-small cell lung cancer with ROS-1 gene alterations appear similar to those with the ALK gene alterations.

Xalkori was approved to treat certain patients with late-stage NSCLC that expresses an abnormal ALK gene in 2011.

On NYSE, the company shares closed at $30.28, up 2.3 percent on Friday.