Posted by Michael Wonder on 23 Sep 2020
FDA accepts supplemental new drug application for Pfizer’s Xalkori (crizotinib) for the treatment of paediatric ALK positive anaplastic large cell lymphoma
23 September 2020 - If approved, Xalkori would be the first biomarker driven therapy for paediatric ALK positive anaplastic large cell lymphoma.
Pfizer today announced that the U.S. FDA has accepted and granted priority review to the Company’s supplemental new drug application for Xalkori (crizotinib) for the treatment of paediatric patients with relapsed or refractory systemic anaplastic large cell lymphoma that is anaplastic lymphoma kinase (ALK) positive.
Xalkori received breakthrough therapy designation for the ALK positive anaplastic large cell lymphoma indication in May 2018 and if approved, would be the first biomarker driven therapy for this type of paediatric lymphoma. The Prescription Drug User Fee Act goal date for a decision by the FDA is January 2020.
