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FDA Accepts Expanded Biologics License Application for Tositumomab and Iodine I 131 Tositumomab
Corixa has requested accelerated approval for the expanded use of BEXXAR in treatment of patients with relapsed or refractory low-grade, follicular or transformed CD20-positive non-Hodgkin's lymphoma (NHL) whose disease has relapsed following chemotherapy. The BEXXAR therapeutic regimen is currently indicated for the treatment of patients with CD20-positive, follicular NHL, with and without transformation, whose disease is refractory to the antibody treatment Rituximab and has relapsed following chemotherapy.
"The filing of the supplemental BLA demonstrates our continued commitment to the research and development of BEXXAR for the treatment of NHL," said Steven Gillis, Ph.D., chairman and chief executive officer of Corixa. "We look forward to working with the FDA to expeditiously complete the review process for BEXXAR in this expanded patient population."
About the BEXXAR Therapeutic Regimen
BEXXAR pairs the targeting ability of a monoclonal antibody (Tositumomab) and the therapeutic potential of radiation (Iodine-131). Combined, these agents form a radiolabeled monoclonal antibody regimen that is able to bind to the target antigen CD20 found on B cells, including normal cells and those that become cancerous in non-Hodgkin's lymphoma, thereby delivering the dose of radiation. BEXXAR, which is given in four visits over one to two weeks, is specifically dosed based on an individual's drug clearance rate, allowing the delivery of a predetermined amount of radiation to each patient.
The BEXXAR therapeutic regimen has been studied for over 13 years. In a multicenter, single-arm, clinical trial in 40 patients who had received an average of four prior chemotherapies and who had Rituximab-refractory disease (N=35), 63 percent (22 of 35) responded to BEXXAR. The median duration of response was 25 months. The results of this study were supported by demonstration of durable objective responses in four single-arm studies enrolling 190 patients evaluable for efficacy with Rituximab-naive, follicular non-Hodgkin's lymphoma, with or without transformation, who had relapsed following or were refractory to chemotherapy. Determination of clinical benefit of the BEXXAR therapeutic regimen was based on evidence of durable responses without evidence of an effect on survival.
The BEXXAR therapeutic regimen is not indicated for the initial treatment of patients with CD20-positive non-Hodgkin's lymphoma. The BEXXAR therapeutic regimen is intended as a single course of treatment. The safety of multiple courses of the BEXXAR therapeutic regimen, or combination of this regimen with other forms of irradiation or chemotherapy, has not been evaluated.
BEXXAR is not for everyone. Patients who are pregnant or allergic to any components of the regimen should not receive BEXXAR. Treatment with BEXXAR resulted in very low blood counts in the majority of patients, which could be serious, for an extended period of time (about a month). Infections occurred in almost half the patients, bleeding in one of eight patients, and treatment with supportive care in about one of four patients. Allergic reactions, including anaphylaxis, which may be severe, have occurred in patients receiving BEXXAR. Other less severe reactions during or following the infusion have included fever, chills, sweating, nausea, low blood pressure, shortness of breath and trouble breathing. Patients may also experience weakness, fever, nausea, increased cough, infection, pain, chills, rash or headache. There is a risk of hypothyroidism following the administration of BEXXAR. Administration of BEXXAR resulted in the development of antibodies to the mouse antibody (called HAMA). Certain cancer therapies including BEXXAR have been associated with the development of a second type of blood cancer and solid tumors. Thirty-two cases (3.2 percent) of myelodysplastic syndrome (a type of pre-leukemia) and/or leukemia and 52 cases of secondary tumors were reported in 995 patients enrolled in BEXXAR studies. After being treated with BEXXAR, less than five percent of patients suffered hair loss or developed severe nausea, vomiting or mucositis (sores in the mouth or gastrointestinal tract). Healthcare providers must be specifically trained to administer BEXXAR.
BEXXAR was developed by Corixa Corporation and is co-marketed in the United States by Corixa Corporation and GlaxoSmithKline. Additional information about the BEXXAR therapeutic regimen, including complete prescribing information, may be obtained by calling 877-423-9927 (4BEXXAR) or visiting http://www.bexxar.com.
Source: Corixa Corporation and GlaxoSmithKline