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).
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.
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.
