Drug intelligence / Profile preview

ofatumumab + fludarabine + cyclophosphamide

Development stage
Unknown
Lead developer
Novartis
Modality
Monoclonal Antibodies → Antibody-Based Therapeutics, Small Molecules
Administration
Intravenous
01

Overview

Ofatumumab + fludarabine + cyclophosphamide is a combination chemotherapy and immunotherapy regimen approved for the treatment of relapsed chronic lymphocytic leukemia (CLL). Ofatumumab is a human monoclonal antibody that targets the CD20 antigen on B-lymphocytes, leading to cell lysis through antibody-dependent and complement-dependent cytotoxicity. Fludarabine and cyclophosphamide are both cytotoxic small molecules; fludarabine is a purine analog that interferes with DNA synthesis and disrupts cell division, while cyclophosphamide acts as an alkylating agent, cross-linking DNA and preventing cell replication. The combination is more effective than fludarabine and cyclophosphamide alone in improving progression-free survival in CLL patients, as demonstrated in phase III trials. This regimen is administered intravenously and is associated with risks typical for chemotherapy and CD20-targeted monoclonal antibodies, such as neutropenia, infection, reactivation of hepatitis B, and rare risk of progressive multifocal leukoencephalopathy[1][3][5][7].

Brand names
ArzerraFludaraCytoxan
Other names
OFC regimenOfatumumab-based chemoimmunotherapyb-National Heart, Lung, and Blood Institute (NHLBI)-chronic lymphocytic leukemia-small lymphocytic lymphoma
02

Targets

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