FDA Approves Ofatumumab With Chemo for Relapsed CLL
The FDA approved ofatumumab (Arzerra) for the treatment relapsed chronic lymphocytic leukemia.
The U.S. Food and Drug Administration (FDA) approved ofatumumab (Arzerra), in combination with fludarabine and cyclophosphamide, for the treatment relapsed chronic lymphocytic leukemia (CLL).1
Approval for this indication is based on clinical data from the phase 3 COMPLEMENT-2 trial, which evaluated 6 cycles of ofatumumab plus fludarabine, and cyclophosphamide versus fludarabine and cyclophosphamide alone, among 365 patients with relapsed CLL.
Median progression-free survival was 28.9 months with ofatumumab and chemotherapy, in contrast with 18.8 months in patients treated with chemotherapy alone (hazard ratio, 0.67; P = .0032).
The safety profile of ofatumumab in this patient population was consistent with previously reported findings; no new safety signals were observed.
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Ofatumumab, a CD20-directed cytolytic monoclonal antibody, is also indicated for the treatment of: previously untreated patients with CLL, in combination with chlorambucil, for whom fludarabine-based therapy is considered inappropriate, recurrent or progressive CLL for patients who are in complete or partial response after at least 2 lines of therapy, and patients with CLL refractory to fludarabine and alemtuzumab.
- Genmab announces U.S. FDA approval of Arzerra® (ofatumumab) in combination with fludarabine and cyclophosphamide for relapsed CLL [press release]. Genmab website. http://ir.genmab.com/releasedetail.cfm?ReleaseID=987180. Updated August 31, 2016. Accessed August 31, 2016.