Xalkori Granted New Lymphoma Indication

January 14, 2021 – The U.S. FDA has approved a new indication for Xalkori® (crizotinib), manufactured by Pfizer. The drug is now indicated to treat relapsed or refractory, systemic anaplastic large cell lymphoma (ALCL) that is anaplastic lymphoma kinase (ALK)-positive in young adults and in pediatric patients who are least one year of age.

ALCL is a form of non-Hodgkin lymphoma (NHL) that makes up approximately 30% of all NHL diagnoses in children and young adults. About 90% of these patients have ALK-positive disease. Initial treatment with chemotherapy is often successful in putting ALK-positive ALCL into long-term remission. However, patients may need an alternative treatment if their disease relapses or does not respond to the usual standard of care.

In a clinical study, Xalkori delivered an 88% objective response rate. Of the patients who responded to treatment, 39% maintained their response for at least six months, while 22% maintained their response for 12 months or more. Recommended dosing under the new indication is 280mg/m 2 of the patient’s body surface area, taken by mouth twice daily until disease progression or unacceptable toxicity occur.

Xalkori first received FDA approval in 2011. It is also indicated to treat ALK-positive or ROS1-positive metastatic non-small cell lung cancer (NSCLC).