Gleevec (imatinib) [product monograph]. HC.

Regulatory approval published by the Health Canada.

Citation

Novartis Pharmaceuticals Canada Inc. Gleevec (imatinib) [product monograph]. Health Canada website. https://pdf.hres.ca/dpd_pm/00067276.PDF. Revised August 2021. Accessed June 2025.

Regulatory approvals

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

Indication	Statements
GLEEVEC (imatinib mesylate) is indicated for the treatment of adult patients with newly diagnosed, Philadelphia chromosome-positive, chronic myeloid leukemia (CML) in chronic phase.	1
GLEEVEC (imatinib mesylate) is indicated for the treatment of adult patients with Philadelphia chromosome-positive chronic myeloid leukemia (CML) in blast crisis or accelerated phase, or in chronic phase after failure of interferon-alpha therapy.	1
GLEEVEC (imatinib mesylate) is indicated for use as a single agent for induction phase therapy in adult patients with newly diagnosed Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph+ALL).	1
GLEEVEC (imatinib mesylate) is indicated for the treatment of adult patients with relapsed or refractory Ph+ALL as monotherapy.	1
GLEEVEC (imatinib mesylate) is indicated for the treatment of adult patients with myelodysplastic/myeloproliferative diseases (MDS/MPD) associated with platelet-derived growth factor receptor (PDGFR) gene re-arrangements.	4
GLEEVEC (imatinib mesylate) is indicated for the treatment of adult patients with aggressive sub-types of systemic mastocytosis (ASM and SMAHNMD) without the D816V c-Kit mutation.	1
GLEEVEC (imatinib mesylate) is indicated for the treatment of adult patients with advanced hypereosinophilic syndrome (HES) and/or chronic eosinophilic leukemia (CEL) with FIP1L1-PDGFRα rearrangement.	1
GLEEVEC (imatinib mesylate) is indicated for the treatment of adult patients with Kit (CD117) positive unresectable and/or metastatic malignant gastrointestinal stromal tumors (GIST).	1
GLEEVEC (imatinib mesylate) is indicated for the adjuvant treatment of adult patients who are at intermediate to high risk of relapse following complete resection of Kit (CD117) positive GIST.	1

Therapeutic response

Precision oncology relationships for therapeutic response derived from this document.

Type	Biomarker(s)	Cancer type	Therapy(ies)
Sensitivity (+)	BCR::ABL1	Chronic Myelogenous Leukemia	Imatinib
Sensitivity (+)	BCR::ABL1	Chronic Myelogenous Leukemia	Imatinib
Sensitivity (+)	BCR::ABL1	Acute Lymphoid Leukemia	Imatinib
Sensitivity (+)	BCR::ABL1	Acute Lymphoid Leukemia	Imatinib
Sensitivity (+)	PDGFRA rearrangements	Myelodysplastic Syndromes	Imatinib
Sensitivity (+)	PDGFRB rearrangements	Myelodysplastic Syndromes	Imatinib
Sensitivity (+)	PDGFRA rearrangements	Myeloproliferative Neoplasm	Imatinib
Sensitivity (+)	PDGFRB rearrangements	Myeloproliferative Neoplasm	Imatinib
Sensitivity (+)	KIT p.D816V	Aggressive Systemic Mastocytosis	Imatinib
Sensitivity (+)	FIP1L1::PDGFRA	Chronic Eosinophilic Leukemia, NOS	Imatinib
Sensitivity (+)	CD117 +	Gastrointestinal Stromal Tumor	Imatinib
Sensitivity (+)	CD117 +	Gastrointestinal Stromal Tumor	Imatinib