Drug Approved for Leukemia Treatment

The U.S. Food and Drug Administration has approved Mylotarg (gemtuzumab ozogamicin for injection) byWyeth-Ayerst Laboratories, a division of American Home Products Corp., for patients 60 years and older in first relapse with CD33-positive acute myeloid leukemia (AML) who are not considered candidates for cytotoxic chemotherapy.Mylotarg is the first targeted chemotherapy agent using monoclonal antibody technology, according to a company news release. Mylotarg, which was designated an orphan drug in November 1999, is the first drug specifically approved to treat relapsed AML patients.AML is the most common type of acute leukemia in adults. An estimated 9,700 new cases of AML will occur in the United States in 2000. More than 75% of patients with AML are older than 60.Mylotarg is the first drug in the class of anticancer drugs called "antibody-targeted" chemotherapy. The drug combines a potent anti-tumor antibiotic with an antibody that binds to a protein commonly found on leukemic cells.