Arzerra™ Approved for Refractory Chronic Lymphocytic Leukemia

The targeted therapy Arzerra™ (ofatumumab) has been granted accelerated approval by the U.S. Food and Drug Administration for treatment of patients with chronic lymphocytic leukemia (CLL) that is refractory to Fludara® (fludarabine) and Campath® (alemtuzumab).

Chronic lymphocytic leukemia (CLL) is the most common form of adult leukemia. The American Cancer Society estimates that approximately 15,000 people will be diagnosed with CLL this year. Currently, there are approximately 95,000 people in the United States living with CLL.

CLL is characterized by the production of atypical lymphocytes. Lymphocytes are specialized immune cells that exist in two forms: B- and T-cells. These cells are produced in the bone marrow and each serves a specific function in aiding the body fight infection.

The large majority of CLL cases involve mature B-lymphocytes that tend to live much longer than normal. B-lymphocytes accumulate in the blood, bone marrow, lymph nodes, and spleen. This results in overcrowding of these areas and suppression of the formation and function of blood and immune cells. Additionally, the cancerous lymphocytes themselves do not function normally, leading to a further reduction in the body’s ability to fight infection.

Arzerra is monoclonal antibody that targets a molecule known as CD20, which is found on the surface of B-cells.

The approval of Arzerra was based on a study among patients with CLL that was refractory (not responsive) to Fludara and Campath. Forty-two percent of patients responded to treatment with Arzerra. Treatment responses lasted a median of 6.5 months. The most common serious side effects of Arzerra were infections, neutropenia, and fever.

Reference: Genmab and GSK press release. GSK and Genmab receive accelerated approval for ARZERRA™. Available at: Accessed October 28, 2009.

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