FDA approves Arzerra combination therapy for CLL - GSK/Genmab
The FDA has approved a Supplemental Biologic License Application (sBLA) for the use of Arzerra (ofatumumab), from Glaxo Smith Kline/Genmab, in combination with chlorambucil for the treatment of previously untreated patients with Chronic Lymphocytic Leukaemia (CLL) for whom fludarabine-based therapy is considered inappropriate.
Approval is based on results from a Phase III study (COMPLEMENT 1) which demonstrated statistically significant improvement in median progression-free survival (PFS) in patients who received the combination of ofatumumab and chlorambucil compared to patients who received chlorambucil alone.
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