The FDA has approved the supplemental New Drug Application (sNDA) 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 (ALK)-positive. The safety and efficacy of XALKORI have not been established in older adults with relapsed or refractory, systemic ALK-positive ALCL. ALCL is a rare form of non-Hodgkin lymphoma (NHL) and accounts for approximately 30% of cases of NHL in young people. Approximately 90% of ALCL cases in young people are ALK-positive.
“We are proud to deliver the first biomarker-driven therapy for children and young adults with ALCL. XALKORI offers a meaningful new treatment option for young patients with relapsed or refractory ALK-positive ALCL,” said Chris Boshoff, M.D., Ph.D., Chief Development Officer, Oncology, Pfizer Global Product Development. “XALKORI transformed the treatment of ALK-positive non-small cell lung cancer as the first biomarker-driven therapy for that disease, and this approval is a notable milestone in our journey to continue to follow the science to address cancers with significant unmet need.”
Although the majority of people with ALK-positive ALCL respond well to chemotherapy and experience long-term remission, a number of patients will unfortunately relapse or require alternative treatment approaches.
“With increased attention being placed on the development of targeted agents and the importance of ALK in pediatric patients with ALCL, the approval of XALKORI is a significant victory in our ongoing fight against these cancers that provides an outpatient oral medication with the real possibility of robust and sustained responses,” said Yael Mossé, M.D., Associate Professor of Pediatrics at the University of Pennsylvania/ Children’s Hospital of Philadelphia and Principal Investigator for the pivotal study run through the Children’s Oncology Group. “ALK fusions play an important role in the pathology of ALCL, and it’s exciting that XALKORI is able to leverage this dependence to provide a treatment option for young people faced with ALCL disease progression.”