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GlaxoSmithKline, Genmab Get Positive Opinion From EMA Committee on Arzerra Treatment for Chronic Lymphocytic Leukemia

GlaxoSmithKline, Genmab Get Positive Opinion From EMA Committee on Arzerra Treatment for Chronic Lymphocytic Leukemia

Health-care giant GlaxoSmithKline (GSK) and biotechnology company Genmab said the European Medicines Agency's Committee for Medicinal Products for Human Use 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 to treat patients with chronic lymphocytic leukemia who haven't received prior therapy and aren't eligible for fludarabine-based therapy. A CHMP positive opinion is one of the final steps before marketing authorization is granted by the European Commission, but doesn't always result in marketing authorization. A final decision by the EC is anticipated during Q3. GSK was down 0.3% at $54.96 in recent trading shortly after the U.S. market open. The American depositary shares trade in a 52-week range of $48.30 to $56.73.

GlaxoSmithKline, Genmab Get Positive Opinion From EMA Committee on Arzerra Treatment for Chronic Lymphocytic Leukemia