GlaxoSmithKline (GSK) and Genmab have received European Commission marketing authorisation for Arzerra as first-line treatment for chronic lymphocytic leukaemia in combination with chlorambucil or bendamustine for patients ineligible for fludarabine-based therapy.
The EC has granted marketing authorisation for a new indication for the use of Arzerra (ofatumumab) in combination with chlorambucil or bendamustine to treat patients with chronic lymphocytic leukaemia (CLL) who have not received prior therapy and who are not eligible for fludarabine-based therapy.
Genmab CEO Jan van de Winkel said: "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."
The EC authorisation of the first-line indication for Arzerra is based on positive data from two clinical trials, including a Phase III study and a Phase II study.
The randomised, multicentre Phase III study (OMB110911, COMPLEMENT 1) assessed the combination of ofatumumab and chlorambucil versus chlorambucil alone in CLL patients.
Results from the open-label, parallel-arm, pivotal study showed that the combination demonstrated a statistically significant improvement in median progression-free survival compared to chlorambucil alone.
The Phase II study (OMB115991) evaluated ofatumumab in combination with bendamustine in 44 patients with previously untreated CLL.
Results from the single-arm, multicentre study showed that ofatumumab in combination with bendamustine demonstrated an overall response rate of 95% and a complete response rate of 43%.
Arzerra is a monoclonal antibody that is designed to target the CD20 molecule found on the surface of CLL cells and normal B lymphocytes. The drug is being developed under a co-development and collaboration agreement between Genmab and GSK.
Image: Peripheral blood smear showing chronic lymphocytic leukaemia cells. Photo: courtesy of Mary Ann Thompson.