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news.GlaxoSmithKline (GSK), a research-based pharmaceutical and healthcare company, has received marketing authorisation from European Medicines Agency (EMA) for Arzerra (ofatumumab).
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Arzerra is indicated for the treatment of chronic lymphocytic leukaemia (CLL) in patients who are refractory to fludarabine and alemtuzumab.
GSK claimed that Arzerra is a new monoclonal antibody that has a unique mode of action, which allows it to bind to the small loop of the CD20 molecule that is found on the surface of B-lymphocytes. This binding leads to the destruction of cancer cells by the body’s immune system.
GSK said that the EMA marketing authorisation for the drug is based the clinical trial evaluated 59 patients refractory to fludarabine and alemtuzumab therapy.
The result of the trial suggested that in the trial 58% overall response rate was observed in the study. Median progression free survival and overall survival were 5.7 and 13.7 months respectively. Complete resolution of lymphadenopathy (chronic abnormal enlargement of the lymph nodes) (nodes <1cm), splenomegaly (abnormal enlargement of the spleen), hepatomegaly (abnormal enlargement of the liver) and constitutional symptoms in patients were 16, 47, 50 and 48% respectively. Improvements in haemoglobin levels and platelet counts were also observed.