Genmab Announces European Regulatory Submission for Ofatumumab in Combination with Fludarabine and Cyclophosphamide for Relapsed CLL

Genmab A/S (CPH:GEN) announced that a variation to the Marketing Authorization has been submitted to the European Medicines Agency (EMA) for the use of ofatumumab (Arzerra®) in combination with  fludarabine and cyclophosphamide (FC) for the treatment of patients with relapsed chronic lymphocytic leukemia (CLL).
According to the news:

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).

Jan van de Winkel, Ph.D., Chief Executive Officer of Genmab commented:

Today’s regulatory submission in Europe brings us another step closer to making ofatumumab available to a wider group of patients with relapsed CLL and we look forward to the EMA’s response.

Click here to view the full press release.