Genmab Announces U.S. FDA Approval of Arzerra® (ofatumumab) in Combination with Fludarabine and Cyclophosphamide for Relapsed CLL

The U.S. Food and Drug Administration has approved ofatumumab (Arzerra®) in combination with fludarabine (F) and cyclophosphamide (C) for the treatment of patients with in relapsed chronic lymphocytic leukemia (CLL). This latest approval is based on data from Phase III COMPLEMENT 2 study which evaluated ofatumumab in combination with FC versus FC alone in patients with relapsed CLL. The approval was based on an improvement in progression-free survival (PFS). The median PFS was 28.9 months with the addition of ofatumumab to FC compared with 18.8 months with FC alone (P = .0032). The overall response rate (ORR) with the triplet was 84% versus 68% in the control arm (P = .0003), with complete response rates of 27% versus 7%, respectively.

The application, which received Priority Review in May 2016, was submitted to the FDA by Novartis under the ofatumumab collaboration between Novartis and Genmab.

This is the fourth CLL indication approved in the U.S. for Arzerra. The previous approvals include:

• 2009 – Previously treated patients with CLL that is no longer responding to chemotherapy, specifically fludarabine and alemtuzumab.
• 2014 – Ofatumumab plus chlorambucil for previously untreated patients with CLL who were considered inappropriate for treatment with fludarabine.
• 2016 – Maintenance therapy with ofatumumab for patients in complete or partial response following at least two lines of therapy with recurrent or progressive CLL.

Read more here:

http://ir.genmab.com/releasedetail.cfm?ReleaseID=987180

http://www.onclive.com/web-exclusives/ofatumumab-combination-approved-for-relapsed-cll

https://globenewswire.com/news-release/2016/08/31/868285/0/en/Genmab-Announces-U-S-FDA-Approval-of-Arzerra-ofatumumab-in-Combination-with-Fludarabine-and-Cyclophosphamide-for-Relapsed-CLL.html