Priority review has been granted by the U.S. Food and Drug Administration (FDA) for Xalkori (crizotinib), which is indicated for the treatment of patients with metastatic non-small cell lung cancer (NSCLC).
Xalkori is a product of Pfizer Inc. The therapy was designated by the FDA earlier this year as a breakthrough therapy. Currently, there are no biomarker-driven treatments like Xalkori on the market.
FDA action is expected to take place by April 2016.
“The development of Xalkori in a subgroup of patients is an example of the capability of precision medicine to identify treatments for patients whose tumors contain rare genetic mutations, such as ROS1-positive metastatic NSCLC," Dr. Mace Rothenberg, chief medical officer at Pfizer Oncology, said.
For more information, log on to www.xalkori.com.