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Drug Safety Evaluation

Ofatumumab for treating chronic lymphocytic leukemia: a safety profile

, &
 

Abstract

Introduction: Ofatumumab, the first fully human IgG1κ, belongs to the second generation of the first class of anti-CD20 monoclonal antibodies. The drug used alone and in combination with drugs having different mechanisms of action has shown a favorable toxicity profile and significant benefit especially in relapsed/refractory chronic lymphocytic leukemia (CLL) patients in doses up to 2000 mg.

Areas covered: This article reviews pharmacokinetic, clinical application for CLL treatment, and safety profile of ofatumumab as well as differences and similarity between ofatumumab and rituximab. Publications in English from 2010 through October 2015 were surveyed on the MEDLINE database for articles. Proceedings of the American Society of Hematology held during the last 5 years were also included.

Expert opinion: Ofatumumab more effectively than rituximab enhanced complement-dependent cytotoxicity playing the crucial role for its therapeutic activity. The drug is highly effective in the first-line and salvage treatment of CLL, essentially as a part of immunochemotherapy, and probably also as maintenance therapy. Its safety profile is very advantageous, since adverse events are usually limited to grade 1 and 2 infusion-related reactions, which tend to decrease throughout the treatment. Its advantage over the other anti-CD20 monoclonal antibodies in the treatment of CLL remains to be determined in the direct head-to-head trials.

Declaration of interest

This work was supported in part by the grant from the Medical University of Lodz (No 503/1-093-01/503-01) and by the Foundation for the Development of Diagnostics and Therapy, Warsaw, Poland. T Robak received research grants from Hoffmann-La Roche and GlaxoSmithKline and travel grants from Hoffmann-La Roche. D Wolowiec was a member of Advisory Board of Roche, Poland, and has received a travel grant from Roche, Poland. The authors have no other relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript apart from those disclosed.

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