GlaxoSmithKline and Genmab seek European Marketing Authorisation of Arzerra (Ofatumab) in Advanced Stage Blood Cancer

10-Feb-2009 - Denmark

GlaxoSmithKline (GSK) and Genmab A/S announced the submission of a Marketing Authorisation Application (MAA) to the European Medicines Agency (EMEA) for Arzerra(TM) (ofatumumab) for the treatment of chronic lymphocytic leukaemia (CLL). If approved, ofatumumab would be indicated for the treatment of patients with CLL who have previously failed, or are inappropriate for, standard therapies. Ofatumumab targets a distinct binding site on the CD20 molecule of B-cells and it could become the first monoclonal antibody targeted to CD20 available for these patients.

Ofatumumab is an investigational, fully human monoclonal antibody that targets a membrane-proximal small loop epitope on the CD20 molecule of B-cells. This epitope is different from the binding sites targeted by other CD20 antibodies currently available. The CD20 molecule is a key target in CLL therapy because it is highly expressed in most B-cell malignancies. Ofatumumab is being developed under a co-development and commercialisation agreement between Genmab and GlaxoSmithKline. It is not yet approved in any country.

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Topic world Antibodies

Antibodies are specialized molecules of our immune system that can specifically recognize and neutralize pathogens or foreign substances. Antibody research in biotech and pharma has recognized this natural defense potential and is working intensively to make it therapeutically useful. From monoclonal antibodies used against cancer or autoimmune diseases to antibody-drug conjugates that specifically transport drugs to disease cells - the possibilities are enormous

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Topic world Antibodies

Topic world Antibodies

Antibodies are specialized molecules of our immune system that can specifically recognize and neutralize pathogens or foreign substances. Antibody research in biotech and pharma has recognized this natural defense potential and is working intensively to make it therapeutically useful. From monoclonal antibodies used against cancer or autoimmune diseases to antibody-drug conjugates that specifically transport drugs to disease cells - the possibilities are enormous