Crizotinib Receives Priority Review for Pediatric ALCL

The FDA has granted priority review to a supplemental new drug application for crizotinib to treat pediatric patients with relapsed/refractory systemic anaplastic large cell lymphoma (ALCL) that is ALK-positive.

“Despite high survival rates for children with ALK-positive ALCL, many will relapse, requiring novel treatment approaches,” said Chris Boshoff, MD, PhD, Chief Development Officer of Oncology at Pfizer. If approved, crizotinib would be the first biomarker-driven therapy for this indication.

In May 2018, crizotinib received breakthrough therapy designation from the FDA for systemic ALK-positive ALCL in pediatric patients. The E.U.’s European Medicines Agency also agreed to a pediatric investigational plan for crizotinib for this indication.

The FDA’s decision is based on results from the phase I/II ADVL0912 study and phase I A8081013 study. ADVL0912 tested the maximum safe dose of crizotinib in pediatric patients with relapsed or refractory solid tumors and ALCL. A8081013 evaluated crizotinib in adult and pediatric patients with ALK-positive cancers other than non-small cell lung cancer, including in patients with relapsed/refractory ALCL.

Sources: Pfizer press release, September 23, 2020;, “Crizotinib in Treating Younger Patients With Relapsed or Refractory Solid Tumors or Anaplastic Large Cell Lymphoma”;, “An Investigational Drug, Crizotinib (PF-02341066), Is Being Studied In Tumors, Except Non-Small Cell Lung Cancer, That Are Positive For Anaplastic Lymphoma Kinase (ALK).”