Therapeutic Response Statement (Sensitivity) Deprecated

This therapeutic response statement Supports the relationship that BCR::ABL1 status confers therapeutic sensitivity to Imatinib in patients with Chronic Myeloid Leukemia, BCR-ABL1+.

The U.S. Food and Drug Administration granted approval to imatinib for the treatment of newly diagnosed adult and pediatric patients with Philadelphia chromosome positive chronic myeloid leukemia (Ph+ CML) in chronic phase.

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

Gleevec is a kinase inhibitor indicated for the treatment of newly diagnosed adult and pediatric patients with Philadelphia chromosome positive chronic myeloid leukemia (Ph+ CML) in chronic phase.

Citation

Novartis Pharmaceuticals Corporation. Gleevec (imatinib) [package insert]. U.S. Food and Drug Administration website. https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/021588s062lbl.pdf. Revised August 2022. Accessed October 30, 2024. Novartis Pharmaceuticals Corporation. Gleevec (imatinib) [package insert]. U.S. Food and Drug Administration website. https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021588s016lbl.pdf. Revised September 2006. Accessed October 6, 2026.

Contributions

Date	Contributor	Description
2026-09-28	Van Allen lab	Deprecated statements when consolidating CML and CML Ph+ disease codings.
2024-10-30	Van Allen lab	Initial access of FDA approvals
2006-09-27	Food and Drug Administration	Indication received traditional approval.