The US Food and Drug Administration (FDA) has approved Pfizer’s Xalkori (crizotinib) for the treatment of paediatric patients and young adults with relapsed or refractory, systemic anaplastic large cell lymphoma (ALCL).
This new approval will enable children and young adults with anaplastic lymphoma kinase (ALK)-positive ALCL to access the new treatment option in the US.
ALCL is a rare type of non-Hodgkin lymphoma (NHL) that accounts for around 30% of cases of NHL in young people – in addition, approximately 90% of ALCL cases in young people are ALK-positive.
The approval is based on results from Pfizer’s Study ADVL0912 which included 121 patients between the ages of one and 21. This included 21 patients with relapsed or refractory, systemic ALK-positive ALCL after at least one systemic treatment.
Patients treated with Xalkori demonstrated an objective response rate of 88% – among the 23 patients who achieved a response, 39% maintained their response for at least six months and 22% maintained their response for at least 12 months.
“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, 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,” he added.