FDA Approves Rituximab (Rituxan) Plus Chemotherapy for CLL 
On Thursday February 18, 2010, the U.S. Food and Drug Administration (FDA) approved rituximab (Rituxan) in combination with fludarabine and cyclophosphamide for patients with untreated or previously treated CD20-positive chronic lymphocytic leukemia. This treatment combination is referred to as FCR (fludarabine-cyclophosphamide-rituximab).
The drug combination was approved based on evidence from two Phase III clinical trials, the CLL8 study and the REACH study. Both trials compared rituximab (Rituxan) plus fludarabine and cyclophosphamide to fludarabine and cyclophosphamide alone. The progression-free survival results, which indicate how long patients lived in the study without their disease getting worse, were statistically favorable for the patients receiving rituximab (Rituxan) as part of the combination therapy.
Chronic lymphocytic leukemia (CLL) accounts for approximately 6 percent of all non-Hodgkin lymphomas (NHL). According to the American Cancer Society, approximately 15,000 new cases of CLL are diagnosed annually in the United States. Chronic lymphocytic leukemia is considered a slow-growing cancer. However, over time, it can progress to a more aggressive type of lymphoma. The disease occurs when malignant white blood cells are located in the bloodstream and bone marrow.
Rituximab (Rituxan) is a monoclonal antibody that targets a protein called CD20, which is found on the surface of cancerous and normal B-cells. The drug has already received approval (as a single agent or in combination with specific chemotherapies) for certain people with follicular lymphoma, diffuse large B-cell lymphoma or slow-growing B-cell NHL. Rituximab (Rituxan) has already been approved in Europe for the frontline treatment of CLL.
To read the press release issued by Genentech, Inc., please click here.
To learn more about CLL, you can view available webcasts or view/download LRF's publication entitled Understanding CLL/SLL: A Guide for Patients Survivors and Loved Ones.
2/19/10 | 
