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Genmab Announces European Regulatory Submission for Ofatumumab in Combination with Fludarabine and Cyclophosphamide for Relapsed CLL
Mar. 09, 2016 09:51AM PST
Biotech InvestingGenmab 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).
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.