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Arzerra(TM) (ofatumumab) Demonstrates High Response Rates in Patients With Fludarabine Refractory Chronic Lymphocytic Leukemia (CLL)
Date:12/8/2008

sponding patients who did not have other recognized treatment options," said Lisa N. Drakeman, Chief Executive Officer of Genmab. "We are working together with GSK to bring this urgently needed new medicine to market as quickly as possible, and are currently collaborating on filing submissions."

Genmab and GSK now expect to file a Biologics License Application (BLA) filing with the US FDA in January 2009.

CLL is the most common form of leukemia in the Western world,(2) and the treatment of patients with refractory disease remains a significant challenge. Patients who have not responded to current standard therapies, specifically patients whose disease is refractory to fludarabine and alemtuzumab treatment or patients who are refractory to fludarabine but whose diseases make them inappropriate for treatment with alemtuzumab, experience poorer outcomes. Only about 20 percent of patients respond to available salvage therapies.(3) Currently there is no approved drug for the treatment of this patient population.

Ofatumumab is an investigational monoclonal antibody that targets a membrane-proximal (close to the cell surface), small loop epitope (a portion of a molecule to which an antibody binds) on the CD20 molecule on B cells.(4) This epitope is different from the binding sites targeted by other CD20 antibodies currently available or in development.(5) The CD20 molecule is a key target in CLL therapy because it is expressed in most B-cell malignancies.(6)

About the study(1)

The study includes patients with CLL refractory to both fludarabine and alemtuzumab, and patients who are refractory to fludarabine and considered inappropriate candidates for alemtuzumab due to bulky tumor masses in their lymph nodes. The study design calls for patients to receive eight weekly infusions of ofatumumab, followed by four monthly infusions. Patients receive 300 mg of ofatumumab at th
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SOURCE GlaxoSmithKline
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