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Medicare will cover treatment with Bexxar, a life-saving cancer drug invented at U-M

Ann Arbor -A cancer therapy originally invented at the University of Michigan Comprehensive Cancer Center will now be available to Medicare patients under a new ruling announced today by the Centers for Medicare & Medicaid Services.

The announcement marks the final leg in the journey of the treatment called Bexxar from the concept and laboratory stage to widespread clinical use as a targeted weapon against the deadly cancer non-Hodgkins lymphoma. NHL, which affects the blood, bone marrow and lymphatic tissues, is the nation's sixth-leading cause of cancer death.

Bexxar was approved on June 30 by the U.S. Food and Drug Administration for use against cases of NHL that are resistant to other treatments. But today's issuing of coding instructions by CMS means that hospitals can receive payment from Medicare for treating patients with Bexxar. A CMS coding instruction usually paves the way for other insurers to cover a treatment's costs for their members.

"It's incredibly gratifying to see Bexxar make it this far, and be available to patients who need new options to survive," says co-inventor Mark Kaminski, M.D. (pictured at right), co-director of the Mark Kaminski, M.D., co-director of the Leukemia/Lymphoma/Bone Marrow Transplant Program Leukemia/Lymphoma/Bone Marrow Transplant Program at the U-M Comprehensive Cancer Center. "This caps an effort that began years ago with basic research, and it has reached this point through dedication and tireless effort by all involved - including the many patients who took part in years of clinical trials."

Kaminski developed Bexxar with U-M nuclear medicine pioneer Richard Wahl, M.D., now chair of nuclear medicine at Johns Hopkins University Medical Center. Further development was conducted in collaboration with scientists at Coulter Corporation, which was subsequently acquired by Corixa Corp., in December 2000. Bexxar will be co-marketed in the United States by Corixa and GlaxoSmithKline.

Kaminski says he expects to begin treating patients with Bexxar within days, though he is still interested in conducting clinical trials to further evaluate the potential of this therapy for various forms of NHL.

The CMS codes are retroactive to July 1, 2003, and include reimbursement for all the procedures necessary to administer Bexxar, including scans and calculations related to the drug's cancer-killing radioactive component.

Bexxar, whose chemical name is tositumomab and iodine I 131 tositumomab, combines an antibody that seeks out cancer cells, and a radioactive form of the element iodine. It attaches to a protein found only on the surface of the blood's B-cells, including those turned malignant in non-Hodgkin's lymphoma patients.

The compound is believed to work through a combination of immune system activity involving the antibody, and effects from the radiation released by the iodine 131. Through this targeted approach, the tumor cells receive a greater concentration of therapeutic radiation while minimizing radiation exposure to normal tissues.

In independent clinical trials, Bexxar treatment has led to disease-free survival in heavily pre-treated patients with follicular NHL (thought to be an incurable form of the disease) who had other poor prognostic factors. In a clinical trial in patients who had an average of four prior chemotherapies and who did not respond to or relapsed from other antibody therapy, nearly a third (29 percent) of patients on Bexxar had a complete response, with no clinical signs of their disease remaining. Five years later, most were still disease-free.

Bexxar is given as a single, short course of treatment over a period of one to two weeks. In contrast, NHL patients' standard chemotherapy regimens are often repeated over six to eight months, and each cycle of treatment may last as long as three to four weeks with a recovery period in between each course.

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. For more information on Bexxar from its manufacturer, visit www.bexxar.com or call 1-877-4BEXXAR.

Written by: Kara Gavin

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