EU approve Arzerra combination treatment for CLL-GSK/Genmab
The European Commission (EC) has granted marketing authorisation for a new indication for the use of Arzerra (ofatumumab), from Glaxo Smith Kline and Genmab, 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.
Approval is based on data from two trials: A Phase III study which demonstrated a statistically significant, 71 per cent improvement in median progression-free survival compared to chlorambucil alone (22.4 months versus 13.1 months, respectively) and a Phase II study which demonstrated that ofatumumab in combination with bendamustine provided an overall response rate of 95 per cent and a complete response rate of 43 per cent.
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