The U.S. Food and Drug Administration (FDA) has approved a Supplemental Biologic License Application (sBLA) for the use of Arzerra® (ofatumumab) in combination with chlorambucil in previously untreated patients with chronic lymphocytic leukemia (CLL) for whom fludarabine-based therapy is considered inappropriate.
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 and 4,580 will die from 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 to 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. The disease tends to get worse slowly.
Arzerra is monoclonal antibody that targets a molecule known as CD20, which is found on the surface of B-cells.
This most recent approval was based on the results from a phase II study known as COMPLEMENT 1. The multi-center, randomized, open-label trial included 447 patients for whom fludarabine-based therapy was considered to be inappropriate (because of advanced age or presence of co-morbidities). Patients were randomized to receive Arzerra plus chlorambucil or chlorambuicl alone. The results indicated a statistically significant improvement in median progression-free survival (PFS) in patients who received Arzerra/chlorambucil compared to those who received chlorambucil alone (22.4 months versus 13.1 months).
The majority of adverse reactions were Grade 2 or lower in both treatment arms.
The most common adverse reactions (greater than or equal to 5%) with Arzerra in combination with chlorambucil (greater than or equal to 2% more than in the control arm) were infusion reactions, neutropenia, asthenia, headache, leukopenia, herpes simplex, lower respiratory tract infection, arthralgia and upper abdominal pain. Overall, 67 percent of patients who received Arzerra experienced one or more symptoms of infusion reaction. Ten percent of patients experienced a grade 3 or greater infusion reaction.
The results of this randomized trial were considered adequate to verify the clinical benefit, which resulted in Arzerra being converted from accelerated approval to regular approval.
Genmab and GSK press release: GSK and Genmab receive FDA approval for Arzerra® (ofatumumab) as first-line treatment in combination with chlorambucil for patients with Chronic Lymphocytic Leukaemia (CLL) for whom fludarabine-based therapy is considered inappropriate
Available at: http://www.gsk.com/media/press-releases/2014/gsk-and-genmab-receive-fda-approval-for-arzerra-ofatumumab.html Accessed April 25, 2014.
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