Variation to MAA submitted to EMA for Arzerra (ofatumumab) combination treatment for relapsed chronic lymphocytic leukemia- Novartis

Genmab has announced that a variation to the Marketing Authorization has been submitted to the European Medicines Agency (EMA) for the use of Arzerra (ofatumumab) 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 the 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 (HR =0.67, p=0.0032).