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T00-23                                           Print Media:         301-827-6242
May 18, 2000                                     
                                                 Consumer Inquiries:  888-INFO-FDA

FDA APPROVES NEW CANCER DRUG

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 conditions.

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 disease.

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.

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