Corixa and GSK begin Bexxar sales

Corixa Corp and GlaxoSmithKline have begun sales and marketing of Bexxar (Tositumomab and Iodine I 131 Tositumomab) to cancer treatment centres, oncologists and nuclear medicine professionals. The companies announced FDA approval of Bexxar on 30 June.

The BEXXAR therapeutic regimen, which is given in four office visits over one to two weeks, culminating in the administration of a patient-specific therapeutic dose, is indicated for the treatment of patients with CD20 positive, follicular, non-Hodgkin's lymphoma (NHL), with and without transformation, whose disease is refractory to Rituximab and has relapsed following chemotherapy.

'We are gratified by the enthusiastic reaction of the NHL treatment community to the approval of Bexxar and are pleased to be able to make it commercially available so soon after approval,' said Dr Steven Gillis, chairman and ceo of Corixa Corporation.

'The number of inquiries we've received at both companies and the Bexxar service center suggests to us that Bexxar addresses a genuine need in the fight against this deadly disease.'

'We have completed training of a large oncology-focused sales force that is now in the field, discussing the benefits of the Bexxar therapeutic regimen. We have also begun training numerous treatment sites and initiate operation of the Bexxar Service Center,' said Kevin Lokay, vice president of oncology at GlaxoSmithKline. 'Having this infrastructure in place allows us to quickly inform physicians and patients about Bexxar and helps ensure that each patient-specific dose of Bexxar can be ordered and rapidly delivered in a reliable and efficient manner.'

About 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 NHL cells, thereby initiating an immune response against the cancer and delivering a dose of radiation directly to tumor cells. The Bexxar therapeutic regimen has demonstrated independently confirmed, disease-free survival in heavily pre-treated patients with follicular NHL who had other poor prognostic factors. In a clinical trial in patients who had an average of 4 prior chemotherapies and who did not respond to or relapsed from Rituximab therapy, nearly a third (29%) had a complete response (no clinical signs of disease) to Bexxar. Furthermore, the median duration of these complete responses has not been reached after a median follow-up of 26 months. The principal dose limiting toxicity of Bexxar in clinical trials was generally reversible bone marrow suppression that could be prolonged and severe and required supportive care in approximately a quarter of the patients. Some patients also experienced weakness, nausea, fever, infection and cough, which were usually temporary and mild to moderate in severity. Like other cancer treatments, Bexxar may increase the long-term risk of other rare blood cancers.

About Non-Hodgkin's Lymphoma (NHL)

NHL 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 diagnosed with NHL in the United States alone. Of that total, 25 to 40 percent have follicular NHL, making it the second most common type. Transformed NHL is an aggressive and difficult to treat form of follicular NHL with a particularly poor