Gleevec (imatinib) [package insert]. FDA.

Regulatory approval published by the Food and Drug Administration.

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.

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 newly diagnosed adult and pediatric patients with Philadelphia chromosome positive chronic myeloid leukemia (Ph+ CML) in chronic phase.	4
Gleevec is a kinase inhibitor indicated for the treatment of patients with Philadelphia chromosome positive chronic myeloid leukemia (Ph+ CML) in blast crisis (BC), accelerated phase (AP), or in chronic phase (CP) after failure of interferon-alpha therapy.
Gleevec is a kinase inhibitor indicated for the treatment of adult patients with relapsed or refractory Philadelphia chromosome positive acute lymphoblastic leukemia (Ph+ ALL).	2
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.
Gleevec is a kinase inhibitor indicated for the treatment of adult patients with myelodysplastic/myeloproliferative diseases (MDS/MPD) associated with platelet-derived growth factor receptor (PDGFR) gene re-arrangements.	2
Gleevec is a kinase inhibitor indicated for the treatment of adult patients with aggressive systemic mastocytosis (ASM) without the D816V c-Kit mutation or with c-Kit mutational status unknown.	1
Gleevec is a kinase inhibitor indicated for the treatment of adult patients with hypereosinophilic syndrome (HES) and/or chronic eosinophilic leukemia (CEL) who have the FIP1L1-PDGFRa fusion kinase (mutational analysis or fluorescence in situ hybridization [FISH] demonstration of CHIC2 allele deletion) and for patients with HES and/or CEL who are FIP1L1-PDGFRa fusion kinase negative or unknown.	1
Gleevec is a kinase inhibitor indicated for the treatment of patients with Kit (CD117) positive unresectable and/or metastatic malignant gastrointestinal stromal tumors (GIST).	1
Gleevec is a kinase inhibitor indicated for the adjuvant treatment of adult patients following 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	Chronic Myeloid Leukemia, BCR-ABL1+	Imatinib
Sensitivity (+)	BCR::ABL1	Chronic Myeloid Leukemia, BCR-ABL1+	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 (+)	KIT p.D816V	Aggressive Systemic Mastocytosis	Imatinib
Sensitivity (+)	FIP1L1::PDGFRA	Chronic Eosinophilic Leukemia, NOS	Imatinib
Sensitivity (+)	CD117 +	Gastrointestinal Stromal Tumor	Imatinib
Sensitivity (+)	FIP1L1::PDGFRA	Gastrointestinal Stromal Tumor	Imatinib