A newly approved chemotherapy drug offers hope for leukemia patients. The drug, called Mylotarg, is being offered at the University of Maryland Greenebaum Cancer Center where researchers are also conducting a study to assess the drug's effectiveness in combination with other chemotherapy drugs and its impact when it is given earlier in the course of treatment.
Mylotarg -- the first targeted chemotherapy agent using monoclonal antibody technology -- was the first drug approved by the U.S. Food and Drug Administration to treat relapsed acute myeloid leukemia (AML), a cancer of the blood and bone marrow that results in uncontrolled proliferation of white blood cells.
AML is the most common type of acute leukemia in adults and, if untreated, is a rapidly fatal disease. The American Cancer Society estimates that 9,700 new cases of AML will occur in the United States this year; more than three-fourths of patients with AML are over the age of 60. Even with treatment, only about 20 percent of AML patients survive five or more years.
Mylotarg was approved by the U.S. Food and Drug Administration last month for patients age 60 or older who have relapsed for the first time and are poor candidates for conventional treatment.
In three earlier Phase II trials involving 142 patients -- including patients at the University of Maryland Greenebaum Cancer Center -- Mylotarg alone produced a 26 percent overall remission rate in patients age 60 and older in their first relapse. Hair loss, a common side effect of chemotherapy, was not associated with Mylotarg treatment. The drug's safety in patients whose condition has debilitated to a more severe stage has not been established and there have been no controlled trials demonstrating a clinical benefit of the drug compared with other treatments.
"We're always concerned with balancing the risks and benefits to patients," says Stanley Frankel, M.D., director of clinical studies at the University of Maryland Greenebaum Cancer Center and associate professor of medicine at the University of Maryland School of Medicine. "Because it offers a chance of being as effective, if not more effective, than other chemotherapy drugs, and with less toxicity, the introduction of Mylotarg as a new treatment option may benefit our AML patients."
Mylotarg was approved as an "orphan" drug, intended for the treatment of rare diseases. The "orphan" designation provides special tax benefits designed to encourage research and testing of drugs that may be clinically useful but aren't likely to attract the interest of pharmaceutical companies because costs of development and distribution may exceed anticipated sales revenues due to its limited market appeal.
Myeloid leukemia is characterized by a rapid accumulation of abnormal white blood cells in the blood and bone marrow, resulting in severe anemia, infection and hemorrhage. Mylotarg is given to patients on two occasions, two weeks apart, as a two-hour intravenous infusion. Standard chemotherapy is given in the hospital for seven days and requires patients to be hospitalized for an extended period of time.
"We anticipate Mylotarg will be an important treatment option for older patients with relapsed AML who frequently cannot tolerate conventional combination chemotherapy," said L. Patrick Gage, Ph.D., president, Wyeth-Ayerst Research. "Mylotarg can be administered in outpatient settings and this may be desirable to many patients."
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