EU approval for GSK and Genmab's Arzerra as first-line CLL therapy

The European Commission has granted marketing authorization for a new indication for the use of UK pharma giant GlaxoSmithKline (LSE: GSK) and Danish partner Genmab’s (OMX: GEN) Arzerra(ofatumumab), a human monoclonal antibody against CD20, in combination with chlorambucil or bendamustine for the treatment of patients with chronic lymphocytic leukemia (CLL) who have not received prior therapy and who are not eligible for fludarabine-based therapy.

“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 - chlorambucil or bendamustine,” said Paolo Paoletti, president of oncology, GSK.

“This is another important milestone and we look forward to a successful launch under this new indication of the drug in Europe in the coming months. We hope to receive additional approvals in frontline across the globe in the future,” added Jan van de Winkel, chief executive of Genmab.