The marketing authorisation is 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 that the company is happy 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," Winkel added.
The EC authorisation for Arzerra is based on positive data from two clinical trials, including a Phase III trial and a Phase II trial.
The randomized, multicentre Phase III trial (OMB110911, COMPLEMENT 1) evaluated the combination of ofatumumab and chlorambucil versus chlorambucil alone in CLL patients.
The company said that results from the open-label, parallel-arm, pivotal trial showed that the combination statistically improved median progression-free survival compared to chlorambucil alone.
The Phase II trial (OMB115991) evaluated ofatumumab in combination with bendamustine in 44 patients with previously untreated CLL.