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Xalkori FDA Approval History

Last updated by Judith Stewart, BPharm on Jan 28, 2021.

FDA Approved: Yes (First approved August 26, 2011)
Brand name: Xalkori
Generic name: crizotinib
Dosage form: Capsules
Company: Pfizer Inc.
Treatment for: Non-Small Cell Lung Cancer; Anaplastic Large Cell Lymphoma

Xalkori (crizotinib) is an oral anaplastic lymphoma kinase (ALK) inhibitor indicated for the treatment of patients with advanced non-small cell lung cancer (NSCLC) whose tumors are ALK-positive or ROS1-positive, and for the the treatment of pediatric patients and young adults 1 year of age and older with relapsed or refractory systemic anaplastic large cell lymphoma (ALCL) that is ALK-positive.

Development Timeline for Xalkori

DateArticle
Jan 14, 2021Approval  Pfizer’s Xalkori (crizotinib) Approved by FDA for ALK-positive Anaplastic Large Cell Lymphoma in Children and Young Adults
Mar 11, 2016Approval  FDA Expands Use of Xalkori (crizotinib) to Treat ROS-1 Positive Non-Small Cell Lung Cancer
Aug 26, 2011Approval  FDA Approves Xalkori with Companion Diagnostic for a Type of Late-Stage Lung Cancer
May 17, 2011Pfizer Announces Simultaneous Filing Of New Drug Applications For Crizotinib With U.S. Food And Drug Administration And Japanese Ministry Of Health, Labour And Welfare
Jan 12, 2011Pfizer Initiates Rolling Submission For A New Drug Application In The U.S. For Its Fast-Tracked Investigational Compound Crizotinib (PF-02341066) For Patients With ALK-Positive Advanced Non-Small Cell Lung Cancer

Further information

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