Corixa Corporation, a developer of immunotherapeutics, and GlaxoSmithKline announced that the US FDA has accepted Corixa's supplemental Biologics License Application (sBLA) for expanded use of the Bexxar therapeutic regimen (Tositumomab and Iodine I 131 Tositumomab). The FDA also has granted priority review status to the Bexxar BLA. As a result, the Companies expect the FDA to complete its review of the Bexxar sBLA by January 2005.
Bexxar was developed by Corixa Corporation and is co-marketed in the United States by Corixa Corporation and GlaxoSmithKline.
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 have 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, release from Corixa said.
"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, 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," he added.
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 radio-labelled 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.
Corixa is a biopharmaceutical company developing oncology and immunology products that manage human diseases. On June 30, 2003, Corixa had announced that the FDA approved Bexxar for the treatment of patients with CD20-positive, follicular NHL.