Ofatumumab, the first human anti-CD20 monoclonal antibody for the treatment of B cell hematologic malignancies.

Abstract

Ofatumumab is the first human anti-CD20 monoclonal antibody to be approved for patients in the United States and the European Union. Ofatumumab received accelerated approval from the U.S. Food and Drug Administration in October 2009 and was granted a conditional marketing authorization by the European Medicines Agency in April 2010 for the treatment of patients with chronic lymphocytic leukemia (CLL) refractory to fludarabine and alemtuzumab, based on interim results of a pivotal phase 2 trial. Preliminary positive results for ofatumumab in combination with chemotherapy in patients with CLL are currently being confirmed in larger randomized trials in both the frontline setting and the relapsed/refractory setting. Ofatumumab has also shown potential in treating B cell non-Hodgkin's lymphoma, such as follicular lymphoma (FL), diffuse large B cell lymphoma (DLBCL), and Waldenström's macroglobulinemia. Additional trials are ongoing to confirm activity of ofatumumab as monotherapy and in combination with chemotherapy in patients with FL or DLBCL.

• Authors: Ira V Gupta, Roxanne C Jewell
• Journal: Annals of the New York Academy of Sciences (Ann N Y Acad Sci) Vol. 1263 Pg. 43-56 (Aug 2012) ISSN: 1749-6632 [Electronic] United States
• PMID: 22830942 (Publication Type: Journal Article, Research Support, Non-U.S. Gov't, Review)
• Copyright: © 2012 New York Academy of Sciences.

Chemical References

• Antibodies, Monoclonal
• Antibodies, Monoclonal, Humanized
• Antigens, CD20
• ofatumumab

Topics

• Animals
• Antibodies, Monoclonal (immunology, therapeutic use)
• Antibodies, Monoclonal, Humanized
• Antigens, CD20 (immunology)
• Hematologic Neoplasms (drug therapy, immunology)
• Humans
• Lymphoma, B-Cell (drug therapy, immunology)
• Randomized Controlled Trials as Topic (methods)
• Treatment Outcome