Xalkori (crizotinib) [package insert]. FDA.

Regulatory approval published by the Food and Drug Administration.

Citation

Pfizer, Inc. Xalkori (crizotinib) [package insert]. U.S. Food and Drug Administration website. https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/202570s036lbl.pdf. Revised September 2023. Accessed October 30, 2024.

Regulatory approvals

Approved indications from this document for cancer drugs containing at least one biomarker.

Indication	Statements
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.	2
XALKORI is a kinase inhibitor indicated for the treatment of 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.	1
XALKORI is a kinase inhibitor indicated for the treatment of adult and pediatric patients 1 year of age and older with unresectable, recurrent, or refractory inflammatory myofibroblastic tumor (IMT) that is ALK-positive.	1

Therapeutic response

Precision oncology relationships for therapeutic response derived from this document.

Type	Biomarker(s)	Cancer type	Therapy(ies)
Sensitivity (+)	v::ALK	Non-Small Cell Lung Cancer	Crizotinib
Sensitivity (+)	v::ROS1	Non-Small Cell Lung Cancer	Crizotinib
Sensitivity (+)	v::ALK	Anaplastic Large Cell Lymphoma	Crizotinib
Sensitivity (+)	v::ALK	Inflammatory Myofibroblastic Tumor	Crizotinib