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
Further information
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