FDA label
What is imatinib used for?
The FDA-approved uses of imatinib, quoted from the Indications and Usage section of its DailyMed label.
Source: DailyMed SPL label file dated 2026-10-23. Publisher page
The FDA label for imatinib lists 10 uses: Newly Diagnosed Philadelphia Positive Chronic Myeloid Leukemia (Ph+ CML); Ph+ CML in Blast Crisis (BC), Accelerated Phase (AP) or Chronic Phase (CP) After Interferon-alpha (IFN) Therapy; Adult Patients with Ph+ Acute Lymphoblastic Leukemia (ALL); Pediatric Patients with Ph+ Acute Lymphoblastic Leukemia (ALL); and 6 more.
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Imatinib Mesylate, tablet, film coated
Indications and Usage, quoted from the label by Teva Pharmaceuticals USA, Inc. (ANDA204285). Cross-references to other label sections are left out.
Newly Diagnosed Philadelphia Positive Chronic Myeloid Leukemia (Ph+ CML)
Newly diagnosed adult and pediatric patients with Philadelphia chromosome positive chronic myeloid leukemia (Ph+ CML) in chronic phase.
Ph+ CML in Blast Crisis (BC), Accelerated Phase (AP) or Chronic Phase (CP) After Interferon-alpha (IFN) Therapy
Patients with Philadelphia chromosome positive chronic myeloid leukemia in blast crisis, accelerated phase, or in chronic phase after failure of interferon-alpha therapy.
Adult Patients with Ph+ Acute Lymphoblastic Leukemia (ALL)
Adult patients with relapsed or refractory Philadelphia chromosome positive acute lymphoblastic leukemia (Ph+ ALL).
Pediatric Patients with Ph+ Acute Lymphoblastic Leukemia (ALL)
Pediatric patients with newly diagnosed Philadelphia chromosome positive acute lymphoblastic leukemia (Ph+ ALL) in combination with chemotherapy.
Myelodysplastic/Myeloproliferative Diseases (MDS/MPD)
Adult patients with myelodysplastic/myeloproliferative diseases associated with platelet-derived growth factor receptor (PDGFR) gene re-arrangements.
Aggressive Systemic Mastocytosis (ASM)
Adult patients with aggressive systemic mastocytosis without the D816V c-Kit mutation or with c-Kit mutational status unknown.
Hypereosinophilic Syndrome (HES) and/or Chronic Eosinophilic Leukemia (CEL)
Adult patients with hypereosinophilic syndrome and/or chronic eosinophilic leukemia who have the FIP1L1-PDGFRα 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-PDGFRα fusion kinase negative or unknown.
Dermatofibrosarcoma Protuberans (DFSP)
Adult patients with unresectable, recurrent and/or metastatic dermatofibrosarcoma protuberans.
Kit+ Gastrointestinal Stromal Tumors (GIST)
Patients with Kit (CD117) positive unresectable and/or metastatic malignant gastrointestinal stromal tumors.
Adjuvant Treatment of GIST
Adjuvant treatment of adult patients following complete gross resection of Kit (CD117) positive GIST.
Source: DailyMed label, set id a9cfc301-3c7f-4910-8813-41dcb0b4ca69, version 16, effective September 15, 2026. NDC 0093-7629, one of 35 listings for this product.
Questions
What is imatinib used for?
The FDA label for imatinib lists 10 uses: Newly Diagnosed Philadelphia Positive Chronic Myeloid Leukemia (Ph+ CML); Ph+ CML in Blast Crisis (BC), Accelerated Phase (AP) or Chronic Phase (CP) After Interferon-alpha (IFN) Therapy; Adult Patients with Ph+ Acute Lymphoblastic Leukemia (ALL); Pediatric Patients with Ph+ Acute Lymphoblastic Leukemia (ALL); and 6 more.
What drug class is imatinib?
FDA lists imatinib in the Kinase Inhibitor established pharmacologic class.
Does this page cover off-label uses or dosing?
No. This page shows only the Indications and Usage section of the FDA label. Ask a pharmacist or prescriber about dosing.