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Treats metastatic non-small cell lung cancer (NSCLC). NDA 217581, held by Pf Prism Cv. Crizotinib.
As of Nov 14, 2026, NDA 217581 (Xalkori), held by Pf Prism Cv, was first approved by FDA on Sep 7, 2023, with 0 approved supplements and 0 published complete response letters.
First approved: Sep 7, 2023
Review: Standard
Supplements approved: 0
Complete response letters: 0
What It's For
From the FDA-approved label (Indications and Usage)
XALKORI is a kinase inhibitor indicated for the treatment of
adult patients with metastatic non-small cell lung cancer (NSCLC) whose tumors are anaplastic lymphoma kinase (ALK) or ROS1-positive as detected by an FDA-approved test. ( 1.1, 2.1 )
pediatric patients 1 year of age and older and young adults with relapsed or refractory, systemic anaplastic large cell lymphoma (ALCL) that is ALK-positive. ( 1.2, 2.3 ) o Limitations of Use: The safety and efficacy of XALKORI have not been established in older adults with relapsed or refractory, systemic ALK-positive ALCL.
Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed daily; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters.Drugs@FDA and FDA complete response letters
