GlaxoSmithKline (GSK) and Genmab have taken another step towards expanding the target population for chronic lymphocytic leukaemia (CLL) drug Arzerra, after filing for first-line use in the US.
The two partners submitted an application to the FDA seeking approval for Arzerra (ofatumumab) in CLL patients who have not received prior treatment for the cancer and cannot receive fludarabine-based therapy. Arzerra was awarded breakthrough status for this indication by the FDA last month.
In trials, first-line treatment with Arzerra plus chlorambucil improved progression-free survival (PFS) in CLL patients, and approval in the first-line setting is considered to be critical for the drug’s commercial success.
GSK and Genmab said late last week that patients taking Arzerra and chlorambucil experienced a 9-month improvement in progression free survival (PFS) compared to patients taking chlorambucil alone (22.4 months versus 13.1 months, respectively).
The full study results are scheduled to be presented at the American Society of Hematology (ASH) annual meeting in December.
Arzerra is a monoclonal antibody that helps mobilise the body’s immune response against cancerous B-cells expressing a molecule called CD20.
The product was first approved by the FDA in 2009 treatment for CLL patients who have not responded to Genzyme’s Campath (alemtuzumab) or the chemotherapy fludarabine, but has brought in relatively modest sales in that setting thanks to robust competition from Roche’s Rituxan/ MabThera (rituximab), which has the same molecular target.
Sales were £60m ($97m) last year but are continuing to pick up, rising 41 per cent to £38m in the first six months of 2013 with the help of approval in Japan in March, and GSK has described it as a “potential market leader” in CLL.
Arzerra was also filed for approval as a first-line CLL therapy in the EU earlier this month and it remains in phase III testing as a non-Hodgkin’s lymphoma (NHL) treatment and in earlier testing for other indications such as follicular lymphoma (FL), diffuse large B-cell lymphoma (DLBCL), Waldenstrom’s macroglobulinemia (WM) and relapsing-remitting multiple sclerosis (RRMS).