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| |  FDA Committee Recommends Approval Of Mylotarg (Gemtuzumab Ozogamicin) For AML MADISON, NJ -- March 20, 2000 -- The U.S. Food and Drug Administration's (FDA) Oncologic Drugs Advisory Committee voted that there was sufficient evidence of improved safety and acceptable efficacy to support accelerated approval for Mylotarg(TM) (gemtuzumab ozogamicin) for the treatment of patients aged 60 or older with CD33 positive relapsed acute myeloid leukaemia (AML). If approved by the FDA, Mylotarg(TM) would be the first chemotherapy agent targeted directly to cancerous cells using monoclonal antibody technology. The Committee's recommendation is provided to the FDA, but is not binding. However, the FDA regularly follows the recommendations of the Advisory Committee. Currently, there are no medications approved for the treatment of relapsed AML patients. Mylotarg(TM) is expected to expand the treatment options for these older patients with relapsed AML. Mylotarg(TM) is currently undergoing "priority review" by the FDA, an accelerated review process reserved for products that provide significant improvement compared to marketed products in the treatment, diagnosis, or prevention of a disease. If approved by the FDA, Mylotarg(TM) will be the first in a new class of anticancer therapy called antibody-targeted chemotherapy. This chemotherapy is based on a novel technology platform that uses a proprietary "linker" to combine a potent anti-tumor antibiotic with an anti-CD33 antibody. Mylotarg(TM) has been jointly developed by Wyeth-Ayerst and Celltech Group. Under the terms of the collaborative agreement, Mylotarg(TM) will be marketed by Wyeth-Ayerst Laboratories, the pharmaceutical division of American Home Products. AML is the most common type of leukaemia in adults. The American Cancer Society has estimated that 9,700 new cases of AML will occur in the United States in 2000. AML is characterised by a rapid accumulation of abnormal white blood cells in the blood and bone marrow, resulting in severe anaemia, and possibly infection, and haemorrhage during the course of the disease. If untreated, AML is rapidly fatal. Even with current treatment regimens, only about 20 percent of AML patients survive five or more years. "This positive decision from the FDA's Advisory Committee brings antibody-targeted chemotherapy one step closer to older Americans with CD33 positive relapsed AML," said L. Patrick Gage, President, Wyeth-Ayerst Research. "When the breakthrough technology platform is applied to other monoclonal antibodies it has the potential for treating other types of human cancers." Wyeth-Ayerst is working in the area of antibody-targeted chemotherapy. Mylotarg(TM) is a humanised recombinant antibody linked with a potent anti-tumour antibiotic called calicheamicin, isolated by Wyeth-Ayerst researchers from a bacterium in caliche clay, a soil found in Texas. The antibody portion of Mylotarg(TM) is specific for the CD33 antigen, a glyco- protein commonly expressed by myeloid leukaemic cells. The anti-CD33 antibody was humanised by Celltech. Wyeth-Ayerst Laboratories, a division of American Home Products Corporation, is a major research-oriented pharmaceutical company with leading products in the areas of women's health care, cardiovascular therapies, central nervous system drugs, anti-inflammatory agents, infectious disease, haemophilia, oncology, vaccines, and generic pharmaceuticals. American Home Products Corporation is one of the world's largest research-based pharmaceutical and health care products companies. It is a leader in the discovery, development, manufacturing and marketing of prescription drugs and over-the-counter medications. It is also a leader in vaccines, biotechnology, agricultural products and animal health care. Celltech Group plc is one of Europe's largest biopharmaceutical companies with a drug discovery capability of exceptional strength, including a leading position in antibody engineering. The merger with Medeva plc, in January 2000, combined Celltech's late stage development pipeline with a profitable and cash generating pharmaceutical business. Commenting, Dr. Peter Fellner, Chief Executive Officer of Celltech Group, said "The US approval recommendation for Mylotarg(TM) for the treatment of older patients by the FDA Oncologic Drugs Advisory Committee is a further key step in the regulatory process for this novel treatment for relapsed acute myeloid leukaemia". Related Links: Wyeth-Ayerst Laboratories and American Home Products Corporation.
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