Roche's MabThera approved in Europe for CLL

Roche has been given the thumbs-up by regulators in Europe to sell its cancer blockbuster MabThera as a treatment for chronic lymphocytic leukaemia.

The European Commission has approved MabThera (rituximab) in combination with chemotherapy for use in patients with previously-untreated CLL, the most common type of leukaemia to affect adults. The decision was expected after the European Medicines Agency’s Committee for Medicinal Products for Human Use recommended approval in January.

The approval is on a Phase III study which showed that patients receiving MabThera in combination with chemotherapy as first-line treatment lived an average of 40 months without their cancer progressing compared to 32 months for patients on chemotherapy alone. That data suggests that the combo “has the potential to become the standard of care for the treatment of CLL”, said Michael Hallek of the University of Cologne.

William Burns, head of Roche’s pharmaceutical division, said “we have seen MabThera transform the lives of more than 1.5 million patients with non-Hodgkin’s lymphoma and we hope this approval will bring about a similar change for people suffering from this condition. CLL accounts for approximately 30-40% of all forms of leukaemia in Western countries and is 30% more common in men than women.

Earlier this year, Roche submitted a marketing authorisation application to the EMEA for the use of MabThera, which is sold in the USA as Rituxan by Biogen Idec and Genentech, in patients who have previously been treated for CLL but whose cancer has returned.