GlaxoSmithKline and partner Genmab have won approval from regulators in the USA for their leukaemia drug Arzerra.

Specifically, the US Food and Drug Administration has given the green light to Arzerra ((ofatumumab) for chronic lymphocytic leukaemia as a treatment for patients who have not responded to Genzyme Corp’s Campath (alemtuzumab) or the chemotherapy fludarabine.

Arzerra is a monoclonal antibody that causes the body’s immune response to fight against normal and cancerous B-cells. It attaches to the small and large loop epitopes – on a molecule called CD20, which is found on the surface of B-cells, the type of cell which becomes cancerous in CLL.

Genmab’s chief executive Lisa Drakeman said the approval from the FDA, which follows a recommendation issued in May by the agency’s Oncology Drugs Advisory Committee, said the thumbs-up “marks a key milestone” for the Danish firm “as it is our first antibody to reach the market”. The approval has triggered a milestone payment of 116 million Danish kroner, approximately $23 million.

GSK and Genmab have high hopes for Arzerra but suffered a setback in August after disappointing data was presented from a trial looking at its effects in patients suffering from non-Hodgkin's lymphoma. The drug is also being evaluated for rheumatoid arthritis.

SuperGen cancer deal
Meantime, GSK has entered into a collaboration with the USA’s SuperGen to discover and develop cancer therapeutics based on epigenetic targets.

Under the terms of the deal, GSK is buying $3 million of SuperGen shares “priced at a premium to market” and making a $2 million upfront fee. It could also fork out milestone payments of over $375 million, plus royalties.

Epigenetics refers to the regulation of genes with mechanisms other than changes to the underlying DNA sequence.