FDA approved Gleevec (imatinib) for Multiple Kinase-Driven CancersFDA approved Gleevec for several types of cancer and blood disorders.

FDA From the archive Source published April 18, 2003 Summary added July 15, 2026 DOI ↗ Editorial oversight: Dr. Julia Lee, PhD · Oncology, Genomics & Drug Development

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Key Takeaway

Consider Gleevec for multiple

The FDA has approved Gleevec (imatinib), a kinase inhibitor, for a broad range of indications including Philadelphia chromosome positive chronic myeloid leukemia (Ph+ CML) in chronic phase, blast crisis, accelerated phase, and after interferon-alpha failure; Philadelphia chromosome positive acute lymphoblastic leukemia (Ph+ ALL); myelodysplastic/myeloproliferative diseases (MDS/MPD) with PDGFR gene rearrangements; aggressive systemic mastocytosis (ASM) without D816V c-Kit mutation; hypereosinophilic syndrome (HES) and chronic eosinophilic leukemia (CEL) with FIP1L1-PDGFRα fusion; dermatofibrosarcoma protuberans (DFSP); and Kit (CD117) positive gastrointestinal stromal tumors (GIST) in both metastatic and adjuvant settings. This approval provides a targeted therapy option for these malignancies, many of which have limited treatment alternatives. Clinicians should note that dosing varies by indication and hepatic function, and that treatment should continue as long as there is no evidence of progressive disease or unacceptable toxicity.

＋ Clinical Details (Mechanism · Dosing · Trial Data · Warnings)

Mechanism of Action

Gleevec is a kinase inhibitor that inhibits the Bcr-Abl tyrosine kinase, the constitutive abnormal tyrosine kinase created by the Philadelphia chromosome abnormality in CML and Ph+ ALL. It also inhibits the receptor tyrosine kinases for platelet-derived growth factor (PDGF) and stem cell factor (SCF), c-Kit, and inhibits PDGF- and SCF-mediated cellular events.

Indication & Patient Population

Gleevec is indicated for: - Newly diagnosed adult and pediatric patients with Philadelphia chromosome positive chronic myeloid leukemia (Ph+ CML) in chronic phase. - Patients with Ph+ CML in blast crisis (BC), accelerated phase (AP), or in chronic phase (CP) after failure of interferon-alpha therapy. - Adult patients with relapsed or refractory Ph+ acute lymphoblastic leukemia (ALL). - Pediatric patients with newly diagnosed Ph+ ALL in combination with chemotherapy. - Adult patients with myelodysplastic/myeloproliferative diseases (MDS/MPD) associated with platelet-derived growth factor receptor (PDGFR) gene re-arrangements. - Adult patients with aggressive systemic mastocytosis (ASM) without the D816V c-Kit mutation or with c-Kit mutational status unknown. - Adult patients with hypereosinophilic syndrome (HES) and/or chronic eosinophilic leukemia (CEL) who have the FIP1L1-PDGFRα fusion kinase (mutational analysis or FISH demonstration of CHIC2 allele deletion) and for patients with HES and/or CEL who are FIP1L1-PDGFRα fusion kinase negative or unknown. - Adult patients with unresectable, recurrent and/or metastatic dermatofibrosarcoma protuberans (DFSP). - Patients with Kit (CD117) positive unresectable and/or metastatic malignant gastrointestinal stromal tumors (GIST). - Adjuvant treatment of adult patients following complete gross resection of Kit (CD117) positive GIST.

Dosing & Administration

Dosing varies by indication: - Adults with Ph+ CML CP: 400 mg/day - Adults with Ph+ CML AP or BC: 600 mg/day - Pediatrics with Ph+ CML CP: 340 mg/m²/day - Adults with Ph+ ALL: 600 mg/day - Pediatrics with Ph+ ALL: 340 mg/m²/day - Adults with MDS/MPD: 400 mg/day - Adults with ASM: 100 mg/day or 400 mg/day - Adults with HES/CEL: 100 mg/day or 400 mg/day - Adults with DFSP: 800 mg/day - Adults with metastatic and/or unresectable GIST: 400 mg/day - Adjuvant treatment of adults with GIST: 400 mg/day - Patients with mild to moderate hepatic impairment: 400 mg/day - Patients with severe hepatic impairment: 300 mg/day All doses should be taken with a meal and a large glass of water. Doses of 400 mg or 600 mg should be administered once daily, whereas a dose of 800 mg should be administered as 400 mg twice a day. For patients unable to swallow tablets, tablets may be dispersed in water or apple juice. For daily dosing of 800 mg and above, use the 400-mg tablet to reduce exposure to iron. Treatment may be continued as long as there is no evidence of progressive disease or unacceptable toxicity.

Key Clinical Trial Data

Trial data not available in label.

Warnings & Contraindications

Not reported in label.

Place in Therapy

Gleevec is a first-line treatment for newly diagnosed Ph+ CML in chronic phase and for Ph+ ALL in combination with chemotherapy in pediatric patients. It is also indicated for various other kinase-driven malignancies, often after failure of prior therapies or as targeted therapy for specific genetic abnormalities. Its use is guided by molecular markers such as Bcr-Abl, PDGFR rearrangements, c-Kit mutations, and FIP1L1-PDGFRα fusion.

The FDA has approved a new drug called Gleevec (imatinib) for a wide range of cancers and blood disorders. Gleevec is a type of targeted therapy called a kinase inhibitor. It works by blocking signals that tell cancer cells to grow. The drug is approved for several conditions including Philadelphia chromosome positive chronic myeloid leukemia (CML), a type of blood cancer. It also treats acute lymphoblastic leukemia (ALL) with the same genetic change, certain bone marrow disorders, aggressive systemic mastocytosis, hypereosinophilic syndrome, chronic eosinophilic leukemia, dermatofibrosarcoma protuberans (a rare skin cancer), and gastrointestinal stromal tumors (GIST).

Gleevec is for patients whose cancers have specific genetic markers. For example, it treats CML in different phases and GIST that cannot be removed by surgery or has spread. The approval covers both initial treatment and cases where other treatments have failed. This is important because many of these conditions have few other options.

The approval means doctors now have a new tool to treat these diseases. However, Gleevec is not a cure for everyone. It works best in patients with the right genetic changes. Dosing depends on the condition and liver function. Treatment should continue as long as it is working and side effects are manageable.

If you or a loved one has one of these conditions, talk to your doctor about whether Gleevec might be right for you. Your doctor can check for the specific genetic markers and discuss benefits and risks. This is a promising option, but it is not for everyone.

What this means for you:

Gleevec is a new targeted drug for several cancers; ask your doctor if it fits your specific diagnosis.

Study Details

Study typeFda approval

PublishedApr 2003

View Original Abstract ↓

1 INDICATIONS AND USAGE 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. ( 1.1 ) 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. ( 1.2 ) Adult patients with relapsed or refractory Philadelphia chromosome positive acute lymphoblastic leukemia (Ph+ ALL). ( 1.3 ) Pediatric patients with newly diagnosed Philadelphia chromosome positive acute lymphoblastic leukemia (Ph+ ALL) in combination with chemotherapy. ( 1.4 ) Adult patients with myelodysplastic/myeloproliferative diseases (MDS/MPD) associated with platelet-derived growth factor receptor (PDGFR) gene re-arrangements. ( 1.5 ) Adult patients with aggressive systemic mastocytosis (ASM) without the D816V c-Kit mutation or with c-Kit mutational status unknown. ( 1.6 ) Adult patients with hypereosinophilic syndrome (HES) and/or chronic eosinophilic leukemia (CEL) 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. ( 1.7 ) Adult patients with unresectable, recurrent and/or metastatic dermatofibrosarcoma protuberans (DFSP). ( 1.8 ) Patients with Kit (CD117) positive unresectable and/or metastatic malignant gastrointestinal stromal tumors (GIST). ( 1.9 ) Adjuvant treatment of adult patients following resection of Kit (CD117) positive GIST. ( 1.10 ) 1.1 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. 1.2 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. 1.3 Adult Patients With Ph+ Acute Lymphoblastic Leukemia (ALL) Adult patients with relapsed or refractory Philadelphia chromosome positive acute lymphoblastic leukemia (Ph+ ALL). 1.4 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. 1.5 Myelodysplastic/Myeloproliferative Diseases (MDS/MPD) Adult patients with myelodysplastic/myeloproliferative diseases associated with platelet-derived growth factor receptor (PDGFR) gene re-arrangements. 1.6 Aggressive Systemic Mastocytosis (ASM) Adult patients with aggressive systemic mastocytosis without the D816V c-Kit mutation or with c-Kit mutational status unknown. 1.7 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. 1.8 Dermatofibrosarcoma Protuberans (DFSP) Adult patients with unresectable, recurrent and/or metastatic dermatofibrosarcoma protuberans. 1.9 Kit+ Gastrointestinal Stromal Tumors (GIST) Patients with Kit (CD117) positive unresectable and/or metastatic malignant gastrointestinal stromal tumors. 1.10 Adjuvant Treatment of GIST Adjuvant treatment of adult patients following complete gross resection of Kit (CD117) positive GIST.

FDA approved Gleevec (imatinib) for Multiple Kinase-Driven CancersFDA approved Gleevec for several types of cancer and blood disorders.

Study Details

Combination of Local Treatment and Systemic Therapy Improves Outcomes in Patients with Hepatocellular Carcinoma

Combining local and systemic treatments improves survival in liver cancer

Clinical research that matters. Delivered to your inbox.

FDA approved Gleevec (imatinib) for Multiple Kinase-Driven CancersFDA approved Gleevec for several types of cancer and blood disorders.

Study Details

Combination of Local Treatment and Systemic Therapy Improves Outcomes in Patients with Hepatocellular Carcinoma

Combining local and systemic treatments improves survival in liver cancer

Clinical research that matters. Delivered to your inbox.

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