Rituxan got out of school early by completing the requirements of a Phase III trial during an early analysis. Follicular lymphoma patients who received the drug alone following its use with chemotherapy lived longer without disease progression than did those who stopped taking the drug after the chemo/drug therapy, say Genentech and Biogen Idec.
Of the more than half a million people suffering from non-Hodgkin lymphoma, about 25 percent have follicular lymphoma.
The positive results come from a multicenter, randomized, study of 1,200 patients with previously untreated advanced follicular lymphoma. Rituxan met its target of extending patient lives with their disease under control during a pre-planned interim analysis, prompting an independent monitoring board to recommend the early completion of the trial, according to a Genentech announcement. The drug's safety profile from the study was consistent with that previously reported.
The drug was approved for treating rheumatoid arthritis in 2006 and non-Hodgkin's lymphoma in 1997. The companies say they are now considering a potential new indication for Rituxan with the FDA and European regulators.
- here's the Genentech announcement