The FDA has approved a supplemental New Drug Application for crizotinib to treat pediatric patients and young adults with relapsed or refractory, systemic anaplastic large cell lymphoma (ALCL) that is anaplastic lymphoma kinase (ALK)-positive. 

A release from the manufacturer describes ALCL as “a rare form of non-Hodgkin lymphoma,” which accounts for approximately 30% of cases in young patients diagnosed with that form of lymphoma. Of patients diagnosed with the condition, the release noted that around 90% are ALK-positive. 

Chris Boshoff, MD, PhD, Chief Development Officer, oncology, Pfizer Global Product Development called crizotinib, “a meaningful new treatment option for these young patients. 

“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,” Boshoff added in the release. 

The approval was based on results from Study ADVL0912, which included more than 100 patients between the ages of 1 and 21. The release noted that 88% of patients treated with crizotinib experienced an objective response. Of the 23 patients who achieved a response, the release noted that 39% maintained their response for at least six months, with 22% maintaining the response for 12 months. 

The release noted that the safety profile of crizotinib in this patient population was consistent with what was seen in patients with ALK-positive and ROS1-positive metastatic NSCLC. The most common adverse reactions included diarrhea, vomiting, nausea, and vision disorder. The most common grade 3 or 4 laboratory abnormalities included neutropenia, lymphopenia, and thrombocytopenia. Grade 4 lab abnormalities included neutropenia, lymphopenia, and thrombocytopenia. 

Crizotinib received Breakthrough Therapy Designation as a treatment for ALK-positive ALCL in May 2018. The release noted that the safety and efficacy of crizotinib has not been established in older adults with relapsed or refractory, systemic ALK-positive ALCL.