GlaxoSmithKline plc and Genmab A/S announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has issued a positive opinion recommending a variation to the terms of the marketing authorisation for Arzerra (ofatumumab) for a new indication in combination with chlorambucil or bendamustine for the treatment of patients with chronic lymphocytic leukaemia (CLL) who have not received prior therapy and who are not eligible for fludarabine-based therapy.

“This CHMP opinion for Arzerra in the first-line setting brings GSK one step closer to offering a new treatment option for patients with previously untreated CLL in Europe.” said Dr Rafael Amado, Head of Oncology R&D at GSK.  

“We are pleased to receive the positive opinion from the CHMP for Arzerra in combination with chlorambucil or bendamustine for first line CLL and look forward to a final decision from the European Commission in the next few months,” said Jan van de Winkel, chief executive officer of Genmab.

The CHMP recommendation of the first-line indication is based on results from two trials in patients with previously untreated CLL considered inappropriate for a fludarabine-based treatment:

Phase III OMB110911 study (COMPLEMENT 1), a randomised, open-label, parallel-arm, multicentre, pivotal Phase III study evaluating the combination of ofatumumab and chlorambucil (N=221) versus chlorambucil alone (N=226) phase II OMB115991, a single-arm, multicentre study that evaluated the efficacy of ofatumumab in combination with bendamustine (N= 44)

A CHMP positive opinion is one of the final steps before marketing authorisation is granted by the European Commission (EC), but does not always result in marketing authorisation. A final decision by the EC is anticipated during the third quarter of 2014.