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FDA panel supports cancer treatment developed at UMHS
- The University of Michigan Health System welcomes the strong support by an advisory panel to the U.S. Food and Drug Administration for a cancer treatment developed and tested at UMHS.
Although final approval by the FDA for marketing in the United States is not guaranteed based on the panel's recommendation, the determination announced Wednesday night is a strong step in the direction of approval, says Mark Kaminski, M.D., co-director of the Leukemia/Lymphoma/Bone Marrow Transplant Program at the U-M Comprehensive Cancer Center.
The treatment, called Bexxar (tositumomab and iodine I 131 tositumomab) therapy, was originally conceived and developed by Kaminski and U-M nuclear medicine pioneer Richard Wahl, M.D., in collaboration with scientists at Coulter Corp., which was acquired by Corixa Corp. in December 2000. Kaminski has led several clinical trials of Bexxar that provided clinical evidence of its efficacy. Wahl is now chair of nuclear medicine at Johns Hopkins University Medical Center.
Designed to precisely target certain cancerous cells with radiation while sparing non-cancerous areas, it has shown great promise in the treatment of non-Hodgkins lymphoma, including after chemotherapy failure
Bexxar combines a mouse monoclonal antibody to which radioactive iodine 131 is attached. This radioactive antibody locks on to a protein called CD20 found only on the surface of the blood's B-cells, including those that have turned malignant in non-Hodgkin's lymphoma patients.
The treatment works through a combination of immune system activity involving the monoclonal antibody, and effects from the radiation released by the iodine 131. Through this targeted approach, the cancer cells receive a greater concentration of therapeutic radiation while minimizing radiation exposure to normal tissues.
Non-Hodgkin's lymphoma is a form of cancer that affects the blood and lymphatic tissues. The sixth leading cause of cancer death in the U.S., NHL also has the second fastest-growing incidence rate of all cancers.
According to the National Cancer Institute, nearly 300,000 Americans have NHL, among them 140,000 with the low-grade or transformed low-grade forms of the disease. In more than 30 years, the survival rates of low-grade NHL patients have not changed, and patients continue to die from the disease or complications associated with current treatments.
For more on cancer treatment and studies at UMHS, call 800-865-1125.