The FDA has approved Pfizer’s supplemental New Drug Application for Xalkori (crizotinib) for the treatment of pediatric patients 1 year of age and older and young adults with relapsed or refractory, systemic anaplastic large cell lymphoma (ALCL) that is anaplastic lymphoma kinase positive.
ALCL, a rare form of non-Hodgkin lymphoma (NHL), makes up approximately 30% of cases of NHL in the younger patient population. It is the first biomarker-driven therapy for children and young adults with ALCL.
Approval was based on results from study ADVL0912, which is a multicenter, single arm, open-label study in 121 patients between the ages of 1 and 21 that included 26 patients with relapsed or refractory, systemic ALK-positive ALCL after at least one systemic treatment. The safety profile was consistent with what has been observed in patients with ALK-positive and ROS-1 positive metastatic non-small cell lung cancer (NSCLC). The most common side effects, which occurred in more than 35% of patients, included, but were not limited to: diarrhea, vomiting, nausea, headache, fatigue, decreased appetite, abdominal pain and cough.
Xalkori is a tyrosine kinase inhibitor (TKI) indicated for the treatment of patients with metastatic NSCLC whose tumors are ALK- or ROS1-positive as detected by an FDA-approved test. In addition to the United States, it has received approval for patients with ALK-positive NSCLC in more than 90 countries including Australia, Canada, China, Japan, South Korea and the European Union. Xalkori is also approved for ROS1-positive NSCLC in more than 70 countries. Xalkori is indicated for the treatment of pediatric patients 1 year of age and older and young adults with relapsed or refractory, systemic anaplastic large cell lymphoma (ALCL) that is ALK-positive. The safety and efficacy of Xalkori have not been established in older adults with relapsed or refractory, systemic ALK-positive ALCL.