FDA Approves Crizotinib for Treatment of Rare Lymphoma in Children

 

We are delighted to see the drug approval news out of the Food and Drug Administration (FDA) this week, which expands treatment options for a rare type of lymphoma in children. The FDA has approved crizotinib (Pfizer’s XALKORI®) for the treatment of children and young adults with relapsed or refractory ALK-positive Anaplastic Large Cell Lymphoma (ALCL).

FDA approval of XALKORI for children with this rare form of lymphoma is an exciting advance in pediatric precision oncology treatments. Xalkori is a successful therapy for adults with ALK positive tumors, and careful study through NCI’s Children’s Oncology Group has shown that this drug is successful for children whose lymphoma has recurred after being treated with standard agents.

ALCL is a rare form of non-Hodgkin lymphoma, and approximately 90% of ALCL cases in young people are ALK-positive. For children with ALK-positive ALCL who do not respond well to traditional treatments or who suffer a relapse, XALKORI offers new hope in the form of the first biomarker-driven treatment option for this disease.

Notably, ALK inhibitors were the topic of the ACCELERATE Platform’s first Pediatric Strategy Forum, held in January 2017. The report out of that meeting clearly identified “an unmet need in relapsed ALCL where ALK inhibitors could play an important role.”

Our founder Susan Weiner serves as a Patient Advocate in ACCELERATE, working to increase collaboration between U.S. and European Union regulators and researchers.

“ACCELERATE’s Pediatric Strategy Forum meeting prioritized crizotinib four years ago as a treatment for refractory ALK positive pediatric anaplastic large cell lymphoma. Its recent approval is an example of how successful treatments for children can result from thoughtful deliberation and partnerships among industry, academia and patient advocates,” said Dr. Weiner.

 
ResearchJessica KeanFDA, drug development, XALKORI, lymphoma