Tasigna Approved for Initial Treatment of Chronic Myeloid Leukemia

Posted on June 22nd, 2010 by

The U.S. Food and Drug Administration has expanded the approval of Tasigna® (nilotinib) to include the initial treatment of patients with Philadelphia chromosome-positive chronic myeloid leukemia in chronic phase.

Each year in the United States, approximately 5,000 people are diagnosed with chronic myeloid leukemia (CML). Most cases of CML are characterized by a chromosomal abnormality—the Philadelphia chromosome—in which genetic material is exchanged between chromosome 9 and chromosome 22. This exchange brings together two genes: BCR and ABL. The combination of these two genes into the single BCR-ABL gene results in the production of a protein that contributes to uncontrolled cell growth.

Recognition of the pivotal role of the BCR-ABL protein in CML led to the development of Gleevec® (imatinib), which blocks the activity of this protein. Gleevec produces high rates of remission among patients with chronic-phase CML, often with few side effects, and has dramatically changed the treatment of this disease.

Tasigna also targets the BRC-ABL protein, and was previously approved for CML patients who were resistant or intolerant to Gleevec.

To compare Tasigna with Gleevec in the initial treatment of CML, researchers conducted a study among 846 patients with newly diagnosed, Philadelphia chromosome-positive, chronic-phase CML. Patients were treated with either Gleevec or Tasigna.

The study was designed to measure a significant reduction in the number of CML cancer cells in the blood stream (i.e., major molecular response) at 12 months. About 44 percent of patients who received Tasigna experienced a major molecular response compared with 22 percent of patients who received Gleevec.

These results suggest that Tasigna may be more effective than Gleevec for the initial treatment of CML.

Reference: FDA news release. FDA Approves New Indication for Tasigna.
Approval expands use in treatment of rare type of leukemia. June 17, 2010.

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