FDA approved a new drug, Mylotarg, for the treatment of CD33
positive acute myeloid leukemia. The drug is approved for patients 60
years or older who have relapsed for the first time and are poor
candidates for cytotoxic therapy. Mylotarg was approved as an orphan
drug, a drug intended for the treatment of rare diseases or
This new treatment is given in IV form as a 2-hour infusion in two
doses given fourteen days apart. Standard chemotherapy is given in the
hospital for 7 days and requires patients to be hospitalized for an
extended period of time.
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 during the course of the
Three clinical studies with Mylotarg involved 142 patients with
surrogate markers based on rates of complete remission. A total of 80
patients were age 60 or older. Side effects included liver toxicity.
During the clinical trials 14 to 24 percent of patients showed elevations
in liver enzymes leading to clinical liver disease and jaundice.
Mylotarg (Gemtuzumab Ozogomicin for injection) is manufactured by
Wyeth Ayerst of Philadelphia, Pa. The company's Web site can be reached at http://www.ahp.com/wyeth.htm.