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GlaxoSmithKline and Genmab Submit Arzerra(TM) (Ofatumumab) Application to FDA for the Treatment of Advanced Stage Blood Cancer
Date:1/30/2009

slow-growing NHL.(8) Finally, a Phase II study is evaluating ofatumumab plus ICE or DHAP chemotherapy regimen in relapsed/refractory diffuse large B-cell lymphoma (DLBCL).

About ofatumumab

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.(9) This epitope is different from the binding sites targeted by other CD20 antibodies currently available.(10) The CD20 molecule is a key target in CLL therapy because it is highly expressed in most B-cell malignancies.(11)

Ofatumumab is being developed to treat chronic lymphocytic leukemia, non-Hodgkin's lymphoma, diffuse large B-cell lymphoma, rheumatoid arthritis, and relapsing-remitting multiple sclerosis under a co-development and commercialization agreement between Genmab and GlaxoSmithKline. It is not yet approved in any country.

The companies intend to submit an application for marketing approval in Europe shortly.

About CLL

CLL is the most common adult leukemia(1,2) and one of the most common malignant lymphoid diseases.(12) Based on 2007 worldwide estimates, leukemia accounted for more than 330,000 new cases and more than 245,000 deaths.(13)

CLL cells are malignant B-cells(14) that have low surface expression levels of CD20 molecules.(9) B-cells normally protect the body from invading pathogens by developing into plasma cells, which make antibodies. These antibodies directly inactivate pathogens or attach to pathogens to prepare them for destruction by other white blood cells.(14,15)

GlaxoSmithKline (GSK)

GlaxoSmithKline - one of the world's leading research-based pharmaceutical and healthcare companies - is committed to improving the quality of human life by enabling people to do more, feel better, an
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