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Xalkori FDA Approval History

Last updated by Judith Stewart, BPharm on Sep 15, 2023.

FDA Approved: Yes (First approved August 26, 2011)
Brand name: Xalkori
Generic name: crizotinib
Dosage form: Capsules and Oral Pellets
Company: Pfizer Inc.
Treatment for: Non-Small Cell Lung Cancer, Anaplastic Large Cell Lymphoma - ALK-Positive, Inflammatory Myofibroblastic Tumor

Xalkori (crizotinib) is an oral anaplastic lymphoma kinase (ALK) inhibitor for the treatment of ALK or ROS1-positive non-small cell lung cancer, ALK-positive anaplastic large cell lymphoma, and ALK-positive inflammatory myofibroblastic tumors.

  • Xalkori is 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.
    - 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.
    Limitations of Use: The safety and efficacy of Xalkori have not been established in older adults with relapsed or refractory, systemic ALK-positive ALCL.
    - adult and pediatric patients 1 year of age and older with unresectable, recurrent, or refractory inflammatory myofibroblastic tumor (IMT) that is ALK-positive.

Development timeline for Xalkori

Jul 14, 2022Approval FDA Approves Xalkori (crizotinib) for ALK-Positive Inflammatory Myofibroblastic Tumors
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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