Thursday, July 9, 2009

Arzerra (ofatumumab) appears promising for CLL

Arzerra (ofatumumab) appears promising for chronic lymphocytic leukemia (CLL). Ofatumumab (formerly known as HuMax-CD20) is a targeted therapy. It is actually a human monoclonal antibody that targets a distinct antibody binding site (the small loop epitope) of the CD20 molecule on the cell membrane of B cells. It is currently under development for the treatment of CLL and has also shown potential in treating follicular non-Hodgkin’s lymphoma, diffuse large B cell lymphoma, rheumatoid arthritis and relapsing remitting multiple sclerosis. Is it available yet? No. The FDA is currently still reviewing this biologic agent. Here's a snippet from the June GSK press release:
GlaxoSmithKline and Genmab A/S today announced that the United States Food and Drug Administration (FDA) informed the companies that the agency has extended the action date for the ofatumumab BLA application by three months.
The FDA has been slow recently, don't you think? Better safe than sorry? Or, is the FDA being overly-cautious? We don't want to see another Raptiva incident again, do we? Raptiva was voluntarily withdrawn in April by Genentech because of an increased risk of progressive multifocal leukoencephalopathy (PML), a rare and usually fatal disease of the central nervous system. It's difficult to find such rare adverse effects until the drug gets used by the public, so I don't think anyone is faulting either the FDA or Genentech.

Well, let's see what happens with ofatumumab.

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