On May 23, 2014 GlaxoSmithKline and Genmab reported 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 authorization for Arzerra for a new indication in combination with chlorambucil or bendamustine for the treatment of patients with chronic lymphocytic leukemia (CLL) who have not received prior therapy and who are not eligible for fludarabine-based therapy (Press release Genmab, MAY 23, 2014, View Source [SID:1234500533]).
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 authorization. A final decision by the EC is anticipated during the third quarter of 2014.