Gleevec (imatinib) [package insert]. FDA.

Regulatory approval published by the Food and Drug Administration. Deprecated

Citation

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.

Regulatory approvals

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

Indication	Statements
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.	1

Therapeutic response

Precision oncology relationships for therapeutic response derived from this document.

Organizations	Biomarkers	Cancer types	Therapies
FDA (1)	BCR::ABL1	Acute Lymphoblastic Leukemia	Imatinib