FDA Approves Pfizer’s Xalkori for ALK-Positive Inflammatory Myofibroblastic Tumors

The FDA has approved Pfizer’s oral drug Xalkori (crizotinib) for treatment of adult and pediatric patients one year and older with unresectable, recurrent or refractory inflammatory anaplastic lymphoma kinase (ALK)-positive myofibroblastic tumors.

In addition to this most recent approval, Xalkori is approved for patients with metastatic nonsmall-cell lung cancer whose tumors are ALK- or ROS1-positive.

The kinase inhibitor, which first received FDA approval in 2011, is also indicated for pediatric patients and young adults with relapsed or refractory, systemic anaplastic large cell lymphoma (ALCL) that is ALK-positive.