Roche announced that the European Commission has approved MabThera (rituximab) for first line use in treatment of indolent non-Hodgkin's lymphoma (NHL) in combination with conventional chemotherapy.

The European Commission's 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.

The results revealed that -time to treatment failure was significantly prolonged by more than 1½ 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 per cent, and complete response rate quadrupled to 41per cent from 10 per cent, a release from Roche said.

"This approval is excellent news for the many indolent NHL patients suffering from this potentially fatal disease," William M Burns, head of Roche's Pharmaceuticals division adding, "MabThera in combination with chemotherapy is a vital treatment option, and making it available to patients across Europe underlines its position as the standard of care in indolent NHL."

MabThera monotherapy 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 per cent of NHL patients, is a slow developing but serious cancer of the lymphatic system, and patients are prone to relapse after treatment.

"This approval for MabThera marks a major advance in the treatment of indolent NHL," said Kapil Dhingra, vice president Roche Oncology. "By every criterion of effectiveness, whether time to progression, disease-free survival or duration of response, patients who received MabThera in addition to chemotherapy had a superior outcome as compared to those receiving conventional chemotherapy only. This is the first time that the addition of a well tolerated biologic agent to chemotherapy has led to such a significant clinical benefit in this condition," he added.

The filing for approval of MabThera in indolent NHL was based on final results from the multi-centre, phase III randomised study, which involved 321 patients from 11 countries 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.

MabThera is a therapeutic antibody that binds to a particular protein - the CD20 antigen - on the surface of normal and malignant B-cells. It then recruits the body's natural defence to attack and kill the marked B-cells. Stem cells (B-cell progenitors) in bone marrow lack the CD20 antigen, allowing healthy B-cells to regenerate after treatment and return to normal levels within several months.