Genentech and Biogen Idec's Phase III study of Rituxan in combination with fludarabine and cyclophosphamide chemotherapy met its primary endpoint of improving progression-free survival (PFS), as assessed by investigators, in patients with previously treated CD20-positive chronic lymphocytic leukemia (CLL), compared to chemotherapy alone. There were no new or unexpected safety signals reported in the study.  
   
An independent review of the primary endpoint is being conducted for U.S. regulatory purposes. Data from the study, REACH, will be submitted for presentation at a future medical meeting.  
   
"REACH, the largest relapsed CLL trial ever conducted, is the first Phase III study of this treatment combination to show an improvement in progression-free survival for patients," said Hal Barron, M.D., Genentech's senior vice president, development and chief medical officer. “We look forward to collaborating with Biogen Idec to discuss these data with the FDA in the future.”
   
"Patients with CLL currently have few approved treatment options after the disease progresses following initial chemotherapy," said Cecil Pickett, Ph.D., Biogen Idec's president of R&D. "The REACH results are promising, and pending confirmation of the results by independent review, we look forward to submitting an application to the FDA for Rituxan’s potential approval in this indication."