GSK and Genmab receive CHMP positive opinion for Arzerra (ofatumumab) in combination with chlorambucil or bendamustine as a first-line treatment for patients with chronic lymphocytic leukaemia (CLL) who are not eligible for fludarabine-based therapy

GlaxoSmithKline plc (LSE: GSK) and Genmab A/S (OMX: GEN) announced today 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.
Source: GSK news - Category: Pharmaceuticals Source Type: news