Posted by Michael Wonder on 13 Dec 2016
European Commission grants marketing authorization for Arzerra (ofatumumab) in combination with fludarabine and cyclophosphamide in relapsed CLL
12 December 2016 - Approval based on data from Phase III COMPLEMENT 2 trial.
Genmab announced today that the European Commission has granted a marketing authorisation for the use of ofatumumab (Arzerra) in combination with fludarabine and cyclophosphamide for the treatment of adult patients with relapsed chronic lymphocytic leukaemia in the European Union.
The variation to the marketing authorisation for this indication was submitted to the EMA in March 2016 by Novartis under the ofatumumab collaboration between Novartis and Genmab. Subsequently, on November 10, the CHMP issued a positive opinion recommending that Arzerra be approved in this indication.
