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THE Food and Drug Administration (FDA) is considering the product license application for a monoclonal antibody—toxin conjugate for use in preventing and treating graft-vs-host disease (GvHD) in bone marrow transplant patients.
This and other new agents for treating T cell mediated diseases recently were discussed at the Hoag Cancer Center's Biotherapy of Cancer Symposium in Newport Beach, Calif, and at an American Cancer Society seminar in Phoenix, Ariz.
If the FDA approves the antibody— toxin conjugate (called Orthozyme CD5plus by its developer, XOMA Corp, Berkeley, Calif), it would be the first immunotoxin to be licensed for the treatment of any disease.
Although the license application proposes its use for treating bone marrow transplant patients with steroid-resistant GvHD, the antibody—toxin conjugate also shows promise for treating autoimmune diseases such as rheumatoid arthritis and type I diabetes, as well as certain hematologic malignancies, says Vera S. Byers, MD, PhD, who is director
Skolnick A. Application Considered for Immunotoxin in Treatment of Graft-vs-Host Disease. JAMA. 1991;265(16):2041–2042. doi:10.1001/jama.1991.03460160015002
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