Genentech and Biogen Idec Receive a Complete Response from the FDA for Rituxan for Chronic Lymphocytic Leukemia
South San Francisco, Calif. and Cambridge, Mass. -- November 18, 2009 -- Genentech, Inc., a wholly-owned member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), and Biogen Idec (Nasdaq: BIIB) announced today that the U.S. Food and Drug Administration (FDA) issued a complete response on the companies applications for Rituxan® (rituximab) plus fludarabine and cyclophosphamide (FC) for the treatment of people with previously untreated and previously treated chronic lymphocytic leukemia (CLL).
The FDA has not requested any new data to complete its review of these applications. Genentech and Biogen Idec will continue final label discussions with the FDA and are committed to making Rituxan in combination with FC an FDA-approved option for people with CLL.
About Chronic Lymphocytic Leukemia
According to the American Cancer Society, 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. It 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.
Rituxan in Chronic Lymphocytic Leukemia
These applications are based on data from two Phase III studies, CLL8 and REACH. Sponsored by Roche and conducted by the German CLL Study Group, CLL8 was a global, multi-center, randomized, open-label, Phase III study that enrolled 817 patients with previously untreated (first-line) CD20-positive CLL. REACH was a global, multi-center, randomized, open-label, Phase III study sponsored by Genentech, Biogen Idec and Roche that enrolled 552 patients with previously treated (relapsed or refractory) CD20-positive CLL who had not previously received Rituxan (Rituxan-naïve). Both studies evaluated Rituxan plus FC chemotherapy compared with FC chemotherapy alone. The primary endpoint for both studies was progression-free survival and secondary endpoints were overall survival, event-free survival, duration of response, response rate, complete response and toxicity.