Genmab A/S announced that a supplemental Biologics License Application (sBLA) has been submitted to the U.S. Food and Drug Administration (FDA) for the use of ofatumumab (Arzerra®) in combination with fludarabine and cyclophosphamide (FC) for the treatment of patients with relapsed chronic lymphocytic leukemia (CLL).
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The application was submitted by Novartis under the ofatumumab collaboration between Novartis and Genmab.
The application is based on results from a Phase III study, COMPLEMENT 2 which evaluated ofatumumab in combination with FC versus FC alone in patients with relapsed CLL.
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Top-line results from this trial were reported in April 2015. The study met the primary endpoint with a median progression free survival in patients receiving ofatumumab in combination with FC of 28.9 months, compared to 18.8 months in patients receiving FC alone.
