Therapeutic Response Statement (Sensitivity)

This therapeutic response statement Supports the relationship that v::ALK status confers therapeutic sensitivity to Crizotinib in patients with Anaplastic Large Cell Lymphoma.

The U.S. Food and Drug Administration granted approval to crizotinib 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.

This statement is based on a regulatory approval from the Food and Drug Administration:

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.

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. Pfizer, Inc. Xalkori (crizotinib) [package insert]. U.S. Food and Drug Administration website. https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/202570s030lbl.pdf. Revised January 2021. Accessed October 6, 2026.

Contributions

Date	Contributor	Description
2024-10-30	Van Allen lab	Initial access of FDA approvals
2021-01-14	Food and Drug Administration	Indication received traditional approval.