US FDA expands use of Pfizer's Xalkori

The US Food and Drug Administration on Friday approved pharma giant Pfizer’s (NYSE: PFE) Xalkori (crizotinib) to treat people with advanced (metastatic) non-small cell lung cancer (NSCLC) whose tumors have an ROS-1 gene alteration.

Xalkori is the first and only FDA approved treatment for patients with ROS-1 positive NSCLC. 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. The news lifted Pfizer’s share price 3.08% to $30.50 by close of trading on Friday.

“Today’s approval of Xalkori for ROS1-positive metastatic NSCLC represents an important milestone for patients who previously had limited treatment options,” said Mace Rothenberg, senior vice president of clinical development and medical affairs and chief medical officer for Pfizer Oncology.