CHMP recommends ofatumumab (Arzerra) in combination with fludarabine and cyclophosphamide (FC) for the treatment of relapsed chronic lymphocytic leukemia- Novartis + Genmab A/S

Genmab A/S has announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has issued a positive opinion recommending the use, in the European Union, of ofatumumab (Arzerra) in combination with fludarabine and cyclophosphamide (FC) for the treatment of adult patients with relapsed chronic lymphocytic leukemia (CLL). The variation to the Marketing Authorization for this indication was submitted to the EMA in March by Novartis under the ofatumumab collaboration between Novartis and Genmab.

The CHMP's positive opinion was based on results from the Phase III COMPLEMENT 2 study that evaluated ofatumumab in combination with FC versus FC alone in patients with relapsed CLL. Top-line results from COMPLEMENT 2 were reported in April 2015.

Comment: The addition of Arzerra to fludarabine and cyclophosphamide improved progression-free survival by 54% over the two drugs on their own, according to Phase III data from COMPLEMENT-2 study. Patients receiving Arzerra as part of their combination went a median 28.9 months without their disease worsening, compared with 18.8 months for patients who got just the fludarabine-cyclophosphamide combination.