Adis Drug Profile
First Online: 19 September 2012 DOI:
10.2165/11203850-000000000-00000 Cite this article as: Sanford, M. & McCormack, P.L. Drugs (2010) 70: 1013. doi:10.2165/11203850-000000000-00000 Abstract
Ofatumumab is a fully human anti-CD20 monoclonal antibody that induces antibody-dependent cell-mediated cytotoxicity and complement-dependent cytotoxicity in CD20-expressing B lymphocytes. Ofatumumab is highly potent in lysing B cells, and this appears to stem from its binding site on the short extracellular loop of the target CD20 protein and its slow release from the target molecule.
In a pivotal, noncomparative study in patients with fludarabine- and alemtuzumab-refractory chronic lymphocytic leukaemia (CLL), ofatumumab induced objective responses in 58% (99% CI 40, 74) of patients, which met a prespecified superiority criterion. The median duration of response was 7.1 months.
The median progression-free survival was 5.7 months and the median overall survival was 13.7 months.
In patients with fludarabine- and alemtuzumab-refractory CLL, infections and neutropenia were the most frequent treatment-related adverse events (all grades) that occurred during ofatumumab treatment; infections that commenced during treatment led to death in five patients (8%).
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