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When Other Drugs Fail: New Drug Approved for CML and ALL

The Food and Drug Administration has approved a new drug for the treatment of two types of leukemia to be used when other drugs have failed.

The drug, Sprycel (dasatinib), is approved for the treatment of chronic myeloid leukemia (CML) and patients with Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph+ ALL).

"Sprycel provides a new treatment option for patients with CML or Ph+ ALL who are resistant or intolerant to prior therapy," said Dr. Brian J. Druker, leukemia researcher from the Howard Hughes Medical Institute.

It is estimated that 4,500 people will be diagnosed with CML this year in the United States. Most will benefit from Gleevec treatment, but a small percentage will develop either resistance to the drug or serious side effects that will force them to try another treatment. Additionally, almost 4,000 people will be diagnosed with ALL this year, and those who have the Philadelphia chromosome-positive form of the disease will develop resistance sooner.

Leukemia is caused by the over-growth of blood cells and Sprycel, manufactured by Bristol-Myers Squibb Co., works by lowering the activity of the protein responsible for this uncontrolled growth.

In clinical trials, 45 percent of patients with early-stage CML who could no longer take Gleevec had a significant reduction of leukemia cells after taking Sprycel. Those with a more advanced stage of the disease or Ph+ ALL, had a somewhat lower level of response.

"Although the long term benefits of Sprycel are not yet known, early studies have suggested that Sprycel may offer a significant improvement for many patients whose disease is resistant to other therapies," said Dr. Steven Galson, director of the FDA's Center for Drug Evaluation and Research, in a press release, adding that more studies are needed to determine the true benefit of this drug for patients.

Significant side effects of Sprycel include fluid retention, infection, bleeding, anemia, low white blood cell counts and low platelet counts. It can also cause headache, fatigue and nausea. Also, the drug is not recommended for use by pregnant women, as it may harm the fetus.