Genentech and Biogen Idec reported receiving an FDA go-ahead for Rituxan® in combination with fludarabine and cyclophosphamide (FC) as a treatment for CD20-positive chronic lymphocytic leukemia. Approval covers the combination therapy in people with either previously treated or untreated disease.
Today’s green light is the fifth for Rituxan in hematologic cancers. The companies claim CD20-positive CLL is the most common form of adult leukemia and accounts for some 30–40% of all forms of leukemia in Western countries.
Approval was based on data from two Phase III studies: in patients with previously untreated CD20-positive CLL and in previously treated but rituxan-naive patients. Data from the former trial showed that in comparison with FC therapy alone, addition of Rituxan to FC improved progression-free survival by 79%. Results from the second trial showed adding Rituxan to FC therapy improved progression-free survival by 32%.