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Europe Issues Positive Opinion for MabThera (Rituxmab), Treatment for Indolent Non-Hodgkin's Lymphoma BASEL, SWITZERLAND -- July 12, 2004 -- Roche announced that the European Union's Committee for Human Medicinal Products (CHMP) has issued a positive opinion for the first line use of MabThera (rituximab)® as a treatment for indolent non-Hodgkin's lymphoma (NHL) in combination with conventional chemotherapy. The decision was based on phase III study results which showed MabThera in combination with CVP (cyclophosphamide, vincristine and prednisolone) chemotherapy to be significantly superior to CVP chemotherapy alone: · Time to treatment failure was significantly prolonged by more than 1 ½ years: 26 months versus 7 months; · Freedom from disease progression was nearly doubled: 27 months versus 15 months; · More patients responded to the combination treatment: overall response rate was 81 per cent versus 57 %, and complete response rate quadrupled to 41% from 10%. "This is an important step for patients suffering from indolent NHL," said Stefan Manth, Head of Roche's Oncology Division. "The European approval of MabThera for this indication will mean that double the number of patients will benefit from this innovative and highly effective treatment. It is our hope that MabThera will eventually alter the natural history of indolent non-Hodgkin's lymphoma, breaking the cycle of relapse and remission, and allowing many patients to enter a state of durable remission." The CHMP's positive opinion will now be proposed for approval by the European Commission. The approval will allow for earlier use of MabThera in combination with chemotherapy for patients with indolent NHL. MabThera was approved for the treatment of relapsed or refractory indolent NHL in June 1998 and in combination with CHOP (cyclophosphamide, doxorubicin, vincristine, prednisone) chemotherapy for treatment of aggressive NHL in March 2002. Non-Hodgkin's lymphoma affects 1.5 million people worldwide. Indolent NHL, representing about 45% of NHL patients, is a slow developing but serious cancer of the lymphatic system. About the study The filing for approval of MabThera in indolent NHL is based on final results from the multi-centre, phase III randomised study, which involved 321 patients from 11 countries [1] and compared a treatment regimen of MabThera plus CVP chemotherapy with CVP chemotherapy alone. Patients were previously untreated and were diagnosed with advanced stage, indolent (follicular) NHL. Of the 321 patients involved, 159 were randomised into the CVP chemotherapy group and 162 into the MabThera plus CVP chemotherapy treatment group. Reference: [1] Australia, Belgium, Brazil, Canada, France, Israel, Poland, Portugal, Spain, Switzerland, U.K. SOURCE: Ketchum E-mail this page to a friend or colleague! To print, use this version