GSK, Genmab Get EC Marketing Authorization For New Indication For Use Of Arzerra

(RTTNews) - GlaxoSmithKline plc (GSK, GSK.L) and Denmark-based biotechnology company Genmab A/S (GMXAY.PK, GNMSF.PK) announced that the European Commission or EC has granted marketing authorization for a new indication for the use of Arzerra or ofatumumab, a human monoclonal antibody against CD20, in combination with chlorambucil or bendamustine for the treatment of patients with chronic lymphocytic leukemia or CLL who have not received prior therapy and who are not eligible for fludarabine-based therapy.

The approval is based on Phase III data from study with ofatumumab + chlorambucil & Phase II data from study with ofatumumab and bendamustine.

"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 Dr. Paolo Paoletti, President of Oncology, GSK.

"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. 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," said Jan van de Winkel, Chief Executive Officer of Genmab.

CLL, the most commonly diagnosed adult leukemia in Western countries, accounts for approximately one-third of all cases of leukemia. In Europe, the incidence rate for all subtypes of leukemia is 7.2 per 100,000 of which 34 per cent of cases are CLL, translating to approximately 12,500 new CLL cases each year. Each year, CLL is responsible for approximately 6,000 deaths across Europe. The average age of diagnosis is 72 years old, and approximately 90 per cent of patients with CLL are estimated to be over the age of 55. The majority of patients with CLL have at least one significant comorbidity such as hypertension, diabetes, cardiovascular disease, or chronic obstructive pulmonary disease.

Arzerra (ofatumumab) is a monoclonal antibody that is designed to target the CD20 molecule found on the surface of CLL cells and normal B lymphocytes.

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

Ofatumumab is being developed under a co-development and collaboration agreement between Genmab and GSK.

Arzerra is a trademark of the GSK group of companies.