Genentech, Inc, a wholly-owned member of the Roche Group and Biogen Idec announced that the US 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 leukaemia (CLL).
The US 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.
Rituxan is a therapeutic antibody that binds to a specific protein called CD20 found on the surface of cancerous and normal B-cells. In non-Hodgkin’s lymphoma (NHL) and rheumatoid arthritis (RA), Rituxan works with the body’s own immune system to eliminate CD20-positive B-cells.
Biogen Idec creates new standards of care in therapeutic areas with high unmet medical needs.