Posted by Michael Wonder on 01 Sep 2016
Genmab announces U.S. FDA approval of Arzerra (ofatumumab) in combination with fludarabine and cyclophosphamide for relapsed CLL
31 August 2016 - Arzerra now approved by U.S. FDA for use in combination with fludarabine and cyclophosphamide in relapsed CLL
Approval based on data from phase III COMPLEMENT 2 study.
Genmab announced today that the U.S. FDA has approved a supplemental biologics license application for the use of ofatumumab (Arzerra) in combination with fludarabine and cyclophosphamide for the treatment of patients with relapsed chronic lymphocytic leukemia (CLL). The application, which received priority review in May 2016, was submitted to the FDA by Novartis under the ofatumumab collaboration between Novartis and Genmab.
Approval for this indication by the FDA is 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.
"This is the fourth CLL indication approved in the U.S. for Arzerra, and we are pleased to see the availability of this treatment expand to a wider number of patients," said Jan van de Winkel, Ph.D., Chief Executive Officer of Genmab.
