U.S. Food and Drug Administration Approves Crizotinib (Xalkori) for Pediatric ALCL

On January 14, 2021, the U.S. Food and Drug Administration (FDA) approved crizotinib (Xalkori, Pfizer Inc.) for the treatment of pediatric patients 1 year of age and older and young adults with ALK-positive relapsed or refractory, systemic anaplastic large cell lymphoma (ALCL).  This is the first biomarker-driven therapy approved for pediatric ALCL.

“Crizotinib represents an exciting new development in the treatment of this disease,” said Meghan Gutierrez, chief executive officer at the Lymphoma Research Foundation. “Researchers have made significant progress in our understanding of ALCL, which we hope will continue to improve treatment strategies and the options for children with ALCL. Today’s news builds upon this progress and provides hope to pediatric patients with ALCL and their loved ones.”

The safety and efficacy of crizotinib have not been established in older adults with relapsed or refractory, systemic ALK-positive ALCL.

For more information on the FDA approval of crizotinib (Xalkori) and other approvals, visit the FDA’s website or lymphoma.org/ALCLFDAUpdates.

LRF Helpline

The LRF Helpline is available to help patients and their loved ones better understand their lymphoma diagnosis so that they can feel empowered to make the most informed decisions about their treatment and long-term care.  The Helpline can also connect patients to financial assistance resources, legal, and insurance help.

Feel free to contact the LRF Helpline with any of your lymphoma-related questions, Monday through Friday from 9:30am – 7:30pm Eastern Standard Time (ET). Call (800) 500-9976 or email at helpline@lymphoma.org.