GlaxoSmithKline (GSK) and Genmab A/S (GEN) announced that the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion for Arzerra (ofatumumab), for the treatment of refractory chronic lymphocytic leukaemia (CLL).
The CHMP has recommended the conditional marketing authorisation of ofatumumab in the European Union for the treatment of patients with CLL who are refractory to fludarabine and alemtuzumab. Fludarabine and alemtuzumab are standard therapies currently used to treat CLL (Abbott 2006/Robak 2008).
Chronic lymphocytic leukaemia is a cancer of the blood and bone marrow. In patients with CLL who have not responded to treatment, or who have disease progression within six months to the latest treatment, the disease is termed refractory. Patients with refractory CLL have limited treatment options and poor outcomes with existing treatments (Keating 2002). Less than 25 per cent of these patients respond to existing treatments (Tam et al, 2007).
A conditional marketing authorisation is granted to a medicinal product with a positive benefit/risk assessment that fulfils an unmet medical need when the benefit to public health of immediate availability outweighs the risk inherent in the fact that additional data are still required. A conditional marketing authorisation is renewable annually. As part of the conditions of the conditional marketing authorisation for ofatumumab, GSK will be required to provide further data.
Ofatumumab is a novel human monoclonal antibody with a unique mode of action. It targets, a unique part of the CD20 molecule encompassing an epitope in the small loop (Teeling et al 2006). The CD20 molecule is a key target in CLL therapy, because it is expressed in most B cell malignancies (Cragg et al 2005).
Genmab A/S is a leading international biotechnology company focused on developing fully human antibody therapeutics for the potential treatment of cancer. Genmab's world class discovery and development teams are using cutting-edge technology to create and develop products to address unmet medical needs.