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BRIEF-EU grants Genmab marketing approval for Arzerra combination
December 13, 2016 / 6:07 AM / a year ago

BRIEF-EU grants Genmab marketing approval for Arzerra combination

Dec 13 (Reuters) - Danish pharmaceutical company Genmab :

* European Commission grants marketing authorisation for Arzerra (Ofatumumab) in combination with Fludarabine and Cyclophosphamide for treatment of adult patients with relapsed chronic lymphocytic leukemia (CLL)

* Approval follows Nov. 10 recommendation, where the Committee for Medicinal Products for Human Use (CHMP) issued a positive opinion recommending that Arzerra be approved in this indication

* Approval based on data from Phase III COMPLEMENT 2 study Source text for Eikon: Further company coverage: (Reporting by Annabella Pultz Nielsen)

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