GlaxoSmithKline (GSK) And Genmab A/S (GEN.CO) Receive CHMP Positive Opinion For Arzerra™ In Combination With Chlorambucil Or Bendamustine As A First-Line Treatment For Patients With Chronic Lymphocytic Leukemia (CLL) Who Are Not Eligible For Fludarabine-Based Therapy
5/23/2014 10:04:58 AM
Copenhagen, Denmark; May 23, 2014 – 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 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.1
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