Rituximab (MabThera) approved in Europe

Swiss pharmaceutical giant F. Hoffman-La Roche (CH-4070 Basel, Switzerland) today announced that the European Commission (European Agency for the Evaluation of Medicinal Products/EMEA) has approved rituximab (MabThera, known as Rituxan in the United States, Japan and Canada) for use in patients with relapsed or refractory chronic lymphocytic leukemia.

Relapsed or refractory chronic lymphocytic leukemia or CLL is is a blood and bone marrow disease that usually se slowly worsens. It is the second most common type of leukemia in adults and often occurs during or after middle age, accounting for approximately 30-40% of all forms of leukemia in Western countries. Overall incidence of CLL is around three per 100,000 and is 30% more common in men than women. The incidence of CLL is markedly increased in patients older than 65 with a median age at diagnosis of 72 years. While CLL is generally considered a disease that is slow to progress, a significant proportion of patients have rapidly progressing forms of the disease. The disease rarely occurs in children.The approval of rituximab, a therapeutic antibody that binds to the CD20 antigen on the surface of normal and malignant B-cells, is supported by the impressive results from REACH, the largest randomized clinical trial ever reported in previously-treated CLL. The study, conducted at 88 sites across 17 countries, included 552 patients with relapsed or refractory CLL. The primary endpoint of the study was progression-free survival.Physicians can now prescribe rituximab in combination with chemotherapy (fludarabine and cyclophosphamide) to patients who have been treated for the disease but whose cancer has returned or who have not responded appropriately to therapy. Rituximab is already the standard of care for initial treatment of CLL.?This approval will make MabThera plus chemotherapy the gold-standard therapy for people living with relapsed or refractory CLL?, said Professor Tadeusz Robak, Medical University of Lodz, Poland and principal investigator for the REACH trial. ?Although all patients with CLL will unfortunately eventually relapse, treatment with MabThera significantly prolongs remission. This will help ease the burden of the cancer and enable patients to enjoy the relative freedom that comes with this relief from symptoms.?The results of REACH showed that patients with relapsed or refractory CLL who were treated with rituximab in combination with chemotherapy lived an average ten months longer without their disease progressing, compared to those receiving chemotherapy alone (30.6 months vs. 20.6 months ? based on SmPC REACH data submitted by Roche to EMEA). At present, CLL is considered incurable and the aim of treatment is to control the disease by managing symptoms and extending the time patients live without their disease worsening.?Today?s approval of MabThera in CLL throws a life line to patients suffering from this terrible disease?, said William M. Burns, CEO, Roche Pharmaceuticals Division. ?After the approval for use in patients with previously untreated CLL earlier this year, this latest license extension means that MabThera can now offer real hope to all patients with CLL.?Earlier this year, Roche received marketing approval for rituximab in combination with chemotherapy in previously-untreated patients with advanced CLL.

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