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Pfizer Says FDA Accepts SNDA For XALKORI, Grants Priority Review - Quick Facts

Pharma major Pfizer Inc. (PFE) announced Wednesday that the U.S. Food and Drug Administration (FDA) has accepted and granted priority review to its 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.

XALKORI received Breakthrough Therapy designation (BTD) for the ALK-positive ALCL indication in May 2018 and if approved, would be the first biomarker-driven therapy for this type of pediatric lymphoma. The Prescription Drug User Fee Act (PDUFA) goal date for a decision by the FDA is January 2021.

The FDA submission is supported by the results from Study ADVL0912 (NCT00939770) and Study A8081013 (NCT01121588). Study ADVL0912 is a Phase 1/2 study conducted in collaboration with the Children's Oncology Group (COG).

Anaplastic large cell lymphoma is a rare type of non-Hodgkin lymphoma (NHL), divided into ALK-positive or ALK-negative disease.

XALKORI is a tyrosine kinase inhibitor (TKI) indicated for the treatment of patients with metastatic NSCLC whose tumors are ALK-positive or ROS1-positive as detected by an FDA-approved test.

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