Bexxar aids non-Hodgkin's patients

According to several studies presented at the 45th annual meeting of the American Society of Hematology (ASH), Bexxar (Tositumomab and Iodine I 131 Tositumomab) is active in a variety of patients with difficult-to-treat lymphomas, including patients with heavily pre-treated follicular non-Hodgkin's lymphoma who have had multiple relapses, patients who initially responded to but subsequently relapsed following the Bexxar therapeutic regimen, and patients with previously untreated mantle cell lymphoma who received Bexxar as a component of sequential therapy.

The Bexxar therapeutic regimen, which is administered in four visits over one to two weeks, is approved by the FDA for use in a single course for the treatment of patients with CD20 positive, follicular, non-Hodgkin's lymphoma, with and without transformation, whose disease is refractory to the antibody treatment Rituximab and has relapsed following chemotherapy. Bexxar is not approved for front-line use as a single agent or in combination with chemotherapy for non-Hodgkin's lymphoma or mantle cell lymphoma. It is also not indicated for re-treatment of non-Hodgkin's lymphoma.

'These data confirm that 20-25% of patients with follicular non-Hodgkin's lymphoma treated with Bexxar achieved a complete response lasting a minimum of 12 months, the majority remained in complete response with a median follow-up of nearly five years,' said Dr Morton Coleman, director, Center for Lymphoma and Myeloma, Weill Medical College of Cornell University and the New York Presbyterian Hospital, who presented the analysis. 'For these patients, who have experienced multiple relapses and endured several courses of re-treatment, getting five or more disease-free and treatment-free years from a single, short course of therapy is very encouraging.'

About the Bexxar therapeutic regimen

Bexxar is a dual-action therapy that pairs the tumor-targeting ability of an antineoplastic (cancer killing) monoclonal antibody (Tositumomab) and the therapeutic potential of radiation (Iodine-131) with patient-specific dosing. Combined, these agents form a radiolabeled monoclonal antibody (Iodine I 131 Tositumomab) that is able to bind to the target antigen CD20 found on non-Hodgkin's lymphoma cells, thereby initiating an immune response against the cancer and delivering a dose of radiation directly to tumor cells. Bexxar is the only non-Hodgkin's lymphoma therapy that is specifically dosed based on an individual's drug clearance rate, allowing the delivery of a pre-determined amount of radiation to each patient. The Bexxar therapeutic regimen, which has been studied for over 10 years, has demonstrated independently confirmed durable responses (responses with a time to progression of at least 12 months) in heavily pre-treated patients with follicular non-Hodgkin's lymphoma. In a clinical trial in patients who had a median of 4 prior chemotherapies and who had Rituximab-refractory disease, 63% responded to Bexxar. Half of these patients had a response that lasted 25 months or longer. Determination of clinical benefit of the therapeutic regimen was based on evidence of durable responses without evidence of an effect on survival.

About Non-Hodgkin's Lymphoma

Non-Hodgkin's lymphoma is a form of cancer that affects the blood, bone marrow and lymphatic tissues. Non-Hodgkin's lymphoma currently is the sixth-leading cause of cancer-related deaths in the United States, is expected to claim the lives of 23,400 Americans this year, and has the second-fastest-growing mortality rate. According to statistics from the National Cancer Institute (NCI), approximately 300,000 people are afflicted with non-Hodgkin's lymphoma in the United States alone. Of that total, 25-40% have follicular non-Hodgkin's lymphoma, making it the second most common type. Transformed non-Hodgkin's lymphoma is an aggressive and difficult to treat form of follicular non-Hodgkin's lymphoma with a particularly poor prognosis.