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.

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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. 2
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. 2
Gleevec is a kinase inhibitor indicated for the treatment of adult patients with relapsed or refractory Philadelphia chromosome positive acute lymphoblastic leukemia (Ph+ ALL). 1
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
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.

Organizations Biomarkers Cancer types Therapies
FDA (2) BCR::ABL1 Chronic Myelogenous Leukemia Imatinib
FDA (2) BCR::ABL1 Chronic Myeloid Leukemia, BCR-ABL1+ Imatinib
FDA (2) BCR::ABL1 Acute Lymphoid Leukemia Imatinib
FDA (1) PDGFRA rearrangements Myelodysplastic Syndromes Imatinib
FDA (1) PDGFRB rearrangements Myelodysplastic Syndromes Imatinib
FDA (1) not KIT p.D816V Aggressive Systemic Mastocytosis Imatinib
FDA (1) FIP1L1::PDGFRA Chronic Eosinophilic Leukemia, NOS Imatinib
FDA (1) CD117 + Gastrointestinal Stromal Tumor Imatinib
FDA (1) FIP1L1::PDGFRA Gastrointestinal Stromal Tumor Imatinib