GlaxoSmithKline files for approval of first-line CLL therapy

GlaxoSmithKline and partner Genmab have filed for European regulatory approval of their drug Arzerra (ofatumumab) in a new chronic lymphocytic leukaemia indication.

A marketing authorisation variation application has been submitted to the European Medicines Agency for approval of ofatumumab in combination with alkylator for CLL patients who have not received prior treatment and are inappropriate for fludarabine-based therapy.

Arzerra has not been approved as a first-line therapy for CLL anywhere in the world, but phase III clinical trial data suggests that the drug could offer benefits for these patients.

CLL is the most common form of leukaemia in adults, with approximately 11,019 new cases being recorded in Europe each year. To date, no curative chemotherapy options have been developed, making the availability of new treatments for the disease essential.

This comes after the company's drug Revolade received approval in a new hepatitis C indication from the European Commission last month.