MabThera filed for aggressive NHL in EU

Roche's MabThera (rituximab) has been filed for approval in the newindication of aggressive non-Hodgkin's lymphoma in the European Union, The application is for MabThera to be used with the CHOP (cyclophosphamide, doxorubicin, vincristine and prednisone) combination regimen, and follows the results of a clinical trial showing that MabThera plus CHOP provides a significant benefit in survival compared to patients treated with CHOP alone.

"This is the first new drug combination in 20 years to show an improvement in overall survival in aggressive NHL," commented the lead investigator in the trial, Bertrand Coiffier of the Hospices Civiles de Lyon in France. The complete remission rate with the MabThera regimen was 71% at one year, compared to 59% with CHOP alone in patients stratified according to a good prognosis. Meanwhile, in those patients with a poor prognosis, median event-free survival was 18 months with MabThera plus CHOP and 10 months with CHOP alone, and this represents the first time that a regimen has been shown to be superior to CHOP in patients with a high risk of poor outcome.