Therapeutic Response Statement (Sensitivity)

This therapeutic response statement Supports the relationship that BCR::ABL1 status confers therapeutic sensitivity to Imatinib in patients with Acute Lymphoblastic Leukemia.

The U.S. Food and Drug Administration granted approval to imatinib in combination with chemotherapy for the treatment of pediatric patients with newly diagnosed Philadelphia chromosome positive acute lymphoblastic leukemia (Ph+ ALL) in combination with chemotherapy.

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

Gleevec is a kinase inhibitor indicated for the treatment of pediatric patients with newly diagnosed Philadelphia chromosome positive acute lymphoblastic leukemia (Ph+ ALL) in combination with chemotherapy.

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/2013/021588s037lbl.pdf. Revised January 2013. Accessed October 6, 2026.

Contributions

Date	Contributor	Description
2025-06-26	Van Allen lab	Resolving statements mapped to incorrect propositions
2024-10-30	Van Allen lab	Initial access of FDA approvals
2013-01-25	Food and Drug Administration	Indication received traditional approval.