GlaxoSmithKline and Genmab receive EU approval for leukaemia therapy

GlaxoSmithKline and Genmab have announced that their drug Arzerra has been approved in Europe for a new chronic lymphocytic leukaemia (CLL) indication.

The human monoclonal antibody has been ratified for use in combination with chlorambucil or bendamustine for the treatment of patients with CLL who have not received prior therapy and are not eligible for fludarabine-based treatment.

Data from a pair of phase III trials has demonstrated the strong response rates and survival benefits associated with the drug among patients in this category. Arzerra will be launched in this new indication in Europe in the coming months.

It is also authorised in the EU for the treatment of patients with CLL refractory to fludarabine and alemtuzumab.

Dr Paolo Paoletti, president of oncology at GlaxoSmithKline, said: "Today's decision by the European Commission for the first-line use of Arzerra offers a new treatment option for appropriate CLL patients and enables physicians flexibility in their choice of adjunct chemotherapy."

CLL is the most common form of leukaemia in adults, with approximately 11,019 new cases being recorded in Europe each year.