GSK And Genmab Get EU Approval For Arzerra In CLL

GlaxoSmithKline and Genmab reported that the European Commission has given its approval to the companies’ marketing authorization application for Arzerra (ofatumumab) for the treatment of patients with chronic lymphocytic leukemia (CLL). The EC approved Arzerra in combination with chlorambucil or bendamustine for the treatment of CLL patients who are treatment-naïve and unable to be treated with fludarabine-based therapy.

The approval was based on positive results from two clinical trials showing that ofatumumab in combination with bendamustine rendered an overall response rate (ORR) of 95 per cent and a complete response rate (CR) of 43 percent in patients with previously treatment-naïve CLL and who were incompatible with fludarabine-based treatment.

Arzerra is a monoclonal antibody designed to target the CD20 molecule expressed on the surface of CLL cells and normal B lymphocytes. The drug is approved in the EU to treat patients with CLL refractory to fludarabine and alemtuzumab.

Dr. Paolo Paoletti, President of Oncology at GSK, 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 - chlorambucil or bendamustine.”

Dr. Jan van de Winkel, CEO of Genmab, said, “We are very pleased to receive this decision that Arzerra is approved in the EU in the front-line setting in combination with two different alkylating chemotherapies… We hope to receive additional approvals in frontline across the globe in the future.”

Chronic lymphocytic leukemia is responsible for around one-third of all leukemia cases around the world. It is the most diagnosed of all adult leukemia cases in Western countries. In the EU, there are 12,500 new CLL cases every year with approximately 6,000 deaths per year. A majority of CLL patients have at least one comorbidity such as chronic obstructive pulmonary disease (COPD), hypertension, or diabetes.

The U.S. Food and Drug Administration (FDA) approved the use of Arzerra in combination with chlorambucil as a treatment for CLL.

GSK also recently announced its decision to sell a drug portfolio, which includes Arzerra, to Novartis for up to $16 billion.