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Clinical Trials

Gleevec (imatinib mesylate)

The following drug information is obtained from various newswires, published medical journal articles, and medical conference presentations.


Approval Status:

Approved May 2001

Specific Treatments:

chronic myeloid leukemia

Therapeutic Areas

General Information

Gleevec has been approved for treatment of patients with chronic myeloid leukemia (CML) in myeloid blast crisis, accelerated phase, or chronic phase, for whom interferon-alpha therapy has failed. It is available in oral capsule formulation. Gleevec is the first anti-cancer drug developed with rational drug design, based on the understanding of how cancer cells work.

CML is caused by a reciprocal translocation between chromosomes nine and 22 that results in the "Philadelphia chromosome", a known marker for the disease. There are an estimated 4,500 new cases of CML each year in the United States and 2,400 Americans die from the disease annually.

Clinical Results

The response to Gleevec was evaluated in three international, open-label, single-arm, phase II studies in 1,027 patients diagnosed with Philadelphia chromosome positive CML. Effectiveness was rated primarily by hematologic response, but cytogenetic response was also measured.

Patients in chronic phase showed a hematologic response of 88% and a cytygenetic response of 49%. The response rates for these two measures were 63% and 21% for those in accelerated phase and 26% and 13.5% in blast crisis.

Side Effects

Adverse events associated with the use of imatinib mesylate may include (but are not limited to) the following:

  • nausea
  • fluid retention
  • muscle cramps
  • diarrhea
  • vomiting
  • hemorrhage
  • musculoskeletal pain
  • skin rash
  • headache
  • fatigue

Mechanism of Action

Gleevec (imatinib mesylate) is a protein-tyrosine kinase inhibitor that blocks the constitutive abnormal tyrosine kinase, Bcr-Abl tyrosine kinase, that is created by the Philadelphia chromosome abnormality found in CML. The drug inhibits proliferation and induces apoptosis in Bcr-Abl positive cells and in fresh leukemic cells. The preciseness with which Gleevec targets the cancer cells is more advanced than most other oncology products. (from Gleevec Prescribing Information)

Additional Information

For additional information on Gleevec, please visit Gleevec.

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