ORLANDO, FLORIDA, December 11, 2001 -- According to studies presented at the 43rd annual meeting of the American Society of Hematology (ASH), Bexxar (tositumomab and iodine I 131 tositumomab), an investigational radioimmunotherapy being studied for the treatment of low-grade or transformed low-grade non-Hodgkin's lymphoma (NHL), provides durable, long-term responses when used either alone or following chemotherapy. Multiple presentations suggest that Bexxar, currently under review at the U.S. Food and Drug Administration (FDA), may offer an important new treatment option for relapsed or refractory NHL patients, and in particular for patients whose prognosis is usually very poor.

Reports of Durable, Objective Responses

Analysis of data on 582 patients with relapsed, refractory low-grade or transformed low-grade NHL who received Bexxar in clinical trials from 1990-2000, by John Leonard, M.D., clinical director, Center for Lymphoma and Myeloma, Weill Medical College of Cornell University, New York, and his colleagues, showed that Bexxar produced an overall response (defined as a reduction of at least 50 percent in overall tumor burden) in 57 percent of patients, half of whom remained in remission for 14.3 months or more [ASH Abstract #2527]. Furthermore, 28 percent of all patients showed a complete response (total elimination of disease confirmed by clinical or radiological evaluation) to Bexxar therapy, half of whom remained in remission for 4.8 years or longer. The average follow-up was 1.3 years with a maximum of 8.5 years.

"These results provide further evidence that Bexxar produces durable responses in patients with either low-grade or transformed low-grade NHL," said Dr. Leonard.

Novel First-Line Triple Modality Therapy

To evaluate a new approach to previously untreated NHL, investigators treated 35 patients in a clinical trial of "triple modality" therapy, the combination of chemotherapy (fludarabine), radiation (I
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Contact: Julie McQuain
Julie@jmpr.com
212-477-0472
JMPR Associates, Inc.
11-Dec-2001

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