The FDA today granted “breakthrough therapy” designation to ofatumumab for treatment of patients with chronic lymphocytic leukemia.
The designation applies to use of ofatumumab (Arzerra, GlaxoSmithKline) in combination with chlorambucil in patients with untreated CLL who unsuitable for fludarabine-based therapy.
Ofatumumab is a human monoclonal antibody that targets an epitope on the CD20 molecule encompassing parts of the small and large extracellular loops.
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also read my post on newdrugapprovals
https://newdrugapprovals.wordpress.com/2013/07/08/gsk-tests-ofatumumab-in-rare-skin-disorder/
Ofatumumab (trade name Arzerra, also known as HuMax-CD20) is a human monoclonal antibody (for the CD20 protein) which appears to inhibit early-stage B lymphocyte activation. It is FDA approved for treating chronic lymphocytic leukemia that is refractory to fludarabine and alemtuzumab (Campath) and has also shown potential in treating Follicular non-Hodgkin’s lymphoma, Diffuse large B cell lymphoma, rheumatoid arthritis and relapsing remitting multiple sclerosis. Ofatumumab has also received conditional approval in Europe for the treatment of refractory chronic lymphocytic leukemia. This makes ofatumumab the first marketing application for an antibody produced by Genmab, as well as the first human monoclonal antibody which targets the CD20 molecule that will be available for patients with refractory CLL.Designated an orphan drug by FDA for the treatment of B-CLL
DRUG APPROVALS BY DR ANTHONY MELVIN CRASTO
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