FDA Approves Genmab’s Arzerra in Conjunction with Fludarabine and Cyclophosphamide

Genmab has announced the FDA’s approval of Arzerra in combination with fludarabine and cyclophosphamide for the treatment of patients with relapsed chronic lymphocytic leukemia.

Approval of the drug was based on the results from a Phase III study that included 365 patients in 18 countries with relapsed chronic lymphocytic leukemia. The study evaluated the drug in patients who took the drug in combination with fludarabine and cyclophosphamide versus patients who took fludarabine and cyclophosphamide alone. The results were reported in April 2015.

The study met its primary endpoint, with patients receiving the Arzerra combination having a median progression-free survival of 28.9 months, compared with 18.8 months in patients receiving FC alone.