US regulators have expanded the approved uses of Novartis/Genmab's Arzerra so that the biologic can now be used alongside fludarabine and cyclophosphamide (FC) for the treatment of patients with relapsed chronic lymphocytic leukaemia (CLL).
The approval rides on the back of data from the Phase III COMPLEMENT 2 trial evaluating Arzerra (ofatumumab) in combination with FC versus FC alone in patients with relapsed CLL, which showed that the drug improved median progression free survival (28.9 months versus 18.8 months, respectively).
In the US, Arzerra is already cleared for use in combination with chlorambucil for previously untreated CLL patients for whom fludarabine-based therapy is considered inappropriate, as well as extended treatment of patients who are in complete or partial response after at least two lines of therapy for recurrent or progressive CLL.
"This is the fourth CLL indication approved in the US for Arzerra, and we are pleased to see the availability of this treatment expand to a wider number of patients," said Jan van de Winkel, Genmab's chief executive.
CLL is the most commonly diagnosed adult leukaemia in Western countries, accounting for around one in four cases of the disease. Most CLL patients experience disease progression despite initial response to therapy, highlighting the need for new treatment options.