FDA Approves Rituxan for Chronic Lymphocytic Leukemia Treatment

Genentech and Biogen Idec have been working together to bring Rituxan, a therapeutic antibody, to the market as a treatment for chronic lymphocytic leukemia (CLL). The U.S. Food and Drug Administration (FDA) has issued a complete response on the companies' applications for Rituxan plus fludarabine and cyclophosphamide (FC) for treating previously untreated and previously treated CLL. The FDA has not requested any new data, and Genentech and Biogen Idec will continue final label discussions with the FDA to make Rituxan an FDA-approved option for people with CLL. CLL is a slow-growing disease that occurs when too many abnormal white blood cells are found in the blood and bone marrow, making it difficult for the body to fight infection.

Key Takeaways:

• The FDA has not requested any new data to complete its review of the applications for Rituxan plus FC for CLL treatment.
• Genentech and Biogen Idec will continue final label discussions with the FDA to make Rituxan an FDA-approved option for CLL treatment.
• CLL is the most common adult leukemia, accounting for one-third of all leukemia in the United States.
• Nearly 90,000 Americans are living with CLL and more than 15,000 new cases will be diagnosed this year.
• Rituxan works by binding to a specific protein called CD20 found on the surface of cancerous and normal B-cells.
• The primary endpoint for the studies was progression-free survival, and secondary endpoints were overall survival, event-free survival, duration of response, response rate, complete response, and toxicity.
• The studies, CLL8 and REACH, enrolled 817 and 552 patients with previously untreated and previously treated CLL, respectively.

Statistics:

• CLL is the most common adult leukemia.
• Nearly 90,000 Americans are living with CLL.
• Over 15,000 new CLL cases will be diagnosed in the United States this year.
• CLL8 study enrolled 817 patients with previously untreated CLL.
• REACH study enrolled 552 patients with previously treated CLL.

Sources:

• Genentech, Inc.
• Biogen Idec (Nasdaq: BIIB)
• U.S. Food and Drug Administration (FDA)
• American Cancer Society