Roche’s therapeutic antibody MabThera/Rituxan (rituximab) has delayed disease progression in patients with a form of leukaemia, the drug giant says.
Results from a pivotal Phase III trial, which investigated MabThera in combination with chemotherapy (fludarabine and cyclophosphamide), showed a significant improvement in progression free survival in patients with relapsed or refractory Chronic Lymphocytic Leukaemia.
“The positive results of the REACH study are very encouraging news for patients suffering from a disease that remains life-threatening and incurable,” said William Burns, Chief Executive of the Pharmaceuticals Division of Roche.
“The outcome of this trial, together with the positive findings of the pivotal CLL8 trial in first-line CLL patients, clearly demonstrate the important role MabThera will have in the treatment of this devastating disease.”
Preliminary analysis of the safety data is in line with previous trials.
MabThera, marketed in the US by Genentech and Biogen Idec, is already used to treat patients with stage III-IV follicular lymphoma, CD20 positive diffuse large B cell non-Hodgkin’s lymphoma and severe active rheumatoid arthritis. In the first half of 2008, the drug brought 2.9 billion Swiss francs worth of sales.
The data from the REACH study will be used in applying for approval of the drug in the treatment of relapsed or refractory CLL.
