FDA accepts sNDa for Xalkori for the treatment of pediatric patients with relapsed or refractory systemic anaplastic large cell lymphoma. - Pfizer

Pfizer Inc. announced that the FDA has accepted and granted priority review to the Company’s supplemental New Drug Application (sNDA)for Xalkori (crizotinib) for the treatment of pediatric patients with relapsed or refractory systemic anaplastic large cell lymphoma (ALCL) that is anaplastic lymphoma kinase (ALK)-positive. The Prescription Drug User Fee Act (PDUFA) goal date for a decision by the FDA is January 2021. Anaplastic large cell lymphoma is a rare type of non-Hodgkin lymphoma (NHL), divided into ALK-positive or ALK-negative disease. Though the five-year survival rate for children with cancer in the U.S. is now the highest it’s ever been at 80%, children with cancer continue to face challenges in treating their disease, including rare tumor types, variations in medicine response and prolonged risk of side effects. The FDA submission is supported by the results from Study ADVL0912 (NCT00939770) and Study A8081013 (NCT01121588). Study ADVL0912 is a Phase 1/II study conducted in collaboration with the Children’s Oncology Group (COG), evaluating the maximum dose that is safe and tolerable, and assessing clinical activity in pediatric patients with relapsed or refractory solid tumors and ALCL. Pfizer provided funding and support to COG for this trial. Study A8081013 evaluated Xalkori in pediatric and adult patients with advanced malignancies known to be ALK-positive other than non-small cell lung cancer (NSCLC) and included patients with relapsed or refractory ALCL. These two studies showed compelling antitumor activity in pediatric and adult patients who received Xalkori.