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FDA Accepts Pfizer's sNDA for Xalkori in Rare ALK-Positive Pediatric Leukemia Indication

This article has been corrected to note that the FDA is expected to issue a decision on Pfizer's sNDA by January 2021, not 2020.

NEW YORK – Pfizer on Wednesday said that the US Food and Drug Administration has accepted its supplemental new drug application for crizotinib (Xalkori) for treating pediatric patients with relapsed or refractory systemic anaplastic large cell lymphoma (ALCL) characterized by ALK rearrangements.

ALCL is a rare form of non-Hodgkin lymphoma, and patients with ALK rearrangements tend to have a better prognosis and respond well to chemotherapy than those who don't. If approved, crizotinib would be the first biomarker-informed drug for this type of pediatric lymphoma, Pfizer highlighted in a statement.

The FDA has granted priority review to the application and is slated to issue a decision by January 2021. The agency has also granted breakthrough therapy designation to crizotinib in this indication.

Pfizer's sNDA contains data from two studies, ADVL0912and A8081013, which both showed that crizotinib had antitumor activity in ALK-positive ALCL. The first study, ADVL0912, was a Phase I/II evaluation of the maximum dose, safety, tolerability, and activity of crizotinib in pediatric patients with refractory solid tumors and ALCL. The second study, A8081013, investigated crizotinib in pediatric and adult patients with advanced, ALK-positive malignancies, including refractory ALCL, but not non-small cell lung cancer, since the drug is already approved in this tumor type.

In addition to seeking FDA approval in this indication, Pfizer also has an agreement with the European Medicines Agency on a pediatric investigational plan in this setting, which may eventually lead to a submission in the European Union.