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FDA green light for 'magic bullet' radioimmunotherapy in NHL patients

FDA green light for 'magic bullet' radioimmunotherapy in NHL patients

01 July 2003 - News Editor

Corixa & GSK to market BEXXAR® dual action therapy for non-Hodgkins lymphoma in US.

"Vision of a new direction in cancer therapy"as 63% of patients show responses for up to 2-years

The US Food and Drug Administration (FDA) has approved BEXXAR® (Tositumomab and Iodine I- 131 Tositumomab) 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.

Corixa and GlaxoSmithKline will co-market BEXXAR in the United States. The companies expect to begin supplies of BEXXAR in the US by the end of July 2003.

BEXXAR is a dual-action therapy, combining the tumour-targeting ability of a cancer-killing monoclonal antibody (Tositumomab) with the therapeutic potential of a radioactive isotope (Iodine-131). This combination ’magic bullet’ forms a radiotagged monoclonal antibody (Iodine I-131 Tositumomab) that can bind to the target antigen, CD20, found on NHL cells. Treating patients with NHL using BEXXAR starts an immune response against the cancer at the same time as delivering a dose of radiation directly to tumour cells.

Approval of BEXXAR represents the culmination of a decade of collaboration between Corixa’s scientists and outside investigators. Steven Gillis, Ph.D., Corixa’s Chairman and CEO of Corixa Corp. sees this as a "victory for patients with NHL who have been waiting for new options."

In trials of patients with NHL disease defined as refractory to Rituximab, 63% had a response to BEXXAR, with 29% of patients showing a complete response (no clinical signs of disease) for median times greater than two years.

Commenting on the "impressive rate of complete and durable remissions with BEXXAR in patients who had relapsed following or failed to respond to both chemotherapy and Rituximab therapy," Professor Mark S. Kaminski, M.D., co-director of the Leukemia / Lymphoma / Bone Marrow Transplant Program at the University of Michigan Cancer Center said the new treatment "gives us the opportunity to offer real hope to the follicular NHL patients including those who have exhausted other treatment options."

The targeted treatment BEXXAR "represents our vision of a new direction in cancer therapy.,"declared Kevin Lokay, Vice President of Oncology at GlaxoSmithKline.

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 US. NHL is expected to claim the lives of 23,400 Americans this year, and it has the second-fastest growing mortality rate.

National Cancer Institute (NCI), data suggest that 300,000 people suffer with NHL in the US alone and  25 to 40% have follicular NHL. This makes it the second most common type. Transformed NHL is an aggressive form of follicular NHL that is difficult to treat and has a particularly poor prognosis.

Related article - Ontario firm manufactures BEXXAR


Keywords : Corixa US GlaxoSmithKline (GSK) UK BEXXAR® (Tositumomab and Iodine I-131 Tositumomab) Cancer Non-Hodgkins lymphoma (NHL) Follicular NHL Transformed NHL Refractory Rituximab treatment Dual action Clinical trials Response rate



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04/12/2008 21:15:16