FDA issues complete response for Rituxan, a drug for treating chronic lymphocytic leukemia

Nov 19 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.