The US Food and Drug Administration has approved ofatumumab in combination with fludarabine and cyclophosphamide for the treatment of relapsed chronic lymphocytic leukemia (CLL).1
“This is the fourth CLL indication approved in the [United States] for Arzerra, and we are pleased to see the availability of this treatment expand to a wider number of patients,” Jan van de Winkel, PhD, Chief Executive Officer of Genmab, stated in a press release.
The approval of this supplemental biologics license application was based on data from the open-label, phase 3 COMPLEMENT 2 trial (Ofatumumab Added to Fludarabine-Cyclophosphamide vs Fludarabine-Cyclophosphamide Combination in Relapsed Subjects With Chronic Lymphocytic Leukemia; ClinicalTrials.gov Identifier: NCT00824265), which compared the efficacy and safety of fludarabine plus cyclophosphamide with or without ofatumumab for up to 6 cycles in 365 patients with relapsed CLL.
The study demonstrated that median progression-free survival was 28.9 months with ofatumumab compared with 18.8 months for patients receiving fludarabine and cyclophosphamide alone (hazard ratio [HR], 0.67; P =.0032).
The safety profile of ofatumumab in this setting was consistent with previous reports. The most common adverse reactions were infusion reactions, neutropenia, leukopenia, and febrile neutropenia.
The dose and schedule of ofatumumab for this indication is 300 mg on day 1 followed by 1000 mg on day 8 of cycle 1, then 1000 mg on day 1 of subsequent 28-day cycles for a maximum of 6 cycles.
Ofatumumab is also indicated for the treatment of previously untreated CLL in combination with chlorambucil, CLL refractory to fludarabine and alemtuzumab, and patients who are in complete or partial response after at least 2 lines of therapy for recurrent or progressive CLL.
1. Genmab announces U.S. FDA approval of Arzerra (ofatumumab) in combination with fludarabine and cyclophosphamide for relapsed CLL [news release]. Copenhagen, Denmark; August 31, 2016. http://ir.genmab.com/releasedetail.cfm?ReleaseID=987180. Accessed September 27, 2016.