FDA Approves Rituxan Plus Chemotherapy for Adult Leukemia Print E-mail
By Staff and Wire Reports   
Friday, 19 February 2010 09:14
Genentech, Inc., a wholly owned member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), and Biogen Idec (Nasdaq: BIIB) announced today the U.S. Food and Drug Administration (FDA) approved Rituxan® (rituximab) in combination with fludarabine and cyclophosphamide (FC) for people with previously untreated and previously treated CD20-positive chronic lymphocytic leukemia (CLL).

CLL is the most common form of adult leukemia and is a slow growing cancer that occurs when abnormal or malignant white blood cells are found in the blood and bone marrow. Because it is considered incurable, a primary goal of treatment is to increase the length of time patients live without the disease worsening (progression-free survival or PFS).

“Rituxan with chemotherapy can delay the need for additional treatment because it significantly extends the time people with CLL live without the disease worsening,” said Hal Barron, M.D., executive vice president, Global Development and chief medical officer, Roche and Genentech. “This approval provides an important option and new hope to the many people with this incurable cancer.”

“This approval in CLL reinforces the importance of Rituxan in hematologic cancers,” said Greg Reyes, M.D., Ph.D., senior vice president, Oncology Research and Development, Biogen Idec. “We are very pleased that Rituxan, either alone or in combination, has now achieved its fifth approval for the most common forms of non-Hodgkin’s lymphoma and adult leukemia.”

According to the American Cancer Society, there are nearly 90,000 people in the United States living with CLL, accounting for one-third of all leukemia cases. In 2009, more than 15,000 new CLL cases were expected to be diagnosed in the U.S.

Rituxan Efficacy in CLL

The approval is 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 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 CD20-positive CLL who had not previously received Rituxan (Rituxan-naïve). Both studies evaluated Rituxan plus FC compared with FC alone. The primary endpoint for both studies was PFS and secondary endpoints included overall survival, event-free survival, duration of response, response rate, complete response and toxicity.




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