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GlaxoSmithKline Plc and Genmab A/S receive FDA approval for Arzerra(r) (ofatumumab) as first-line treatment in combination with Chlorambucil for Patients with Chronic Lymphocytic Leukemia

Thursday, 17 Apr 2014 03:52pm EDT 

GlaxoSmithKline Plc and Genmab A/S:U.S. Food and Drug Administration (FDA) has approved Supplemental Biologic License Application (sBLA) for use of Arzerra(r) (ofatumumab), a CD20-directed monoclonal antibody, in combination with chlorambucil for treatment of previously untreated patients with chronic lymphocytic leukemia (CLL).For whom fludarabine-based therapy is considered inappropriate.FDA approval of first-line indication is based on results from Phase III study (COMPLEMENT 1).Says which demonstrated statistically significant improvement in median progression-free survival (PFS) in patients who received combination of ofatumumab and chlorambucil compared to patients who received chlorambucil alone.Ofatumumab is being developed under a co-development and collaboration agreement between Genmab and GSK.Arzerra is a registered trademark of the GSK group of companies.