Roche: EU Approves MabThera In Chronic Lymphocytic Leukemia

Swiss pharmaceutical company Roche Holding AG (ROG.VX) Friday said that the European Commission has approved MabThera, or rituximab, in combination with chemotherapy for use in patients with previously-untreated chronic lymphocytic leukemia, or CLL, the most common type of leukemia to affect adults.

The approval is based on results from the pivotal phase III study CLL8. "Data from the CLL8 trial suggest that MabThera used in combination with chemotherapy has the potential to become the standard of care for the treatment of CLL," said Professor Michael Hallek, University of Cologne, Germany, who led the German CLL Study Group in conducting the CLL8 trial.

The results 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 an average of 32 months for patients receiving chemotherapy alone.

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. The results of CLL8 demonstrate that patients treated with MabThera lived longer without their disease progressing, reducing the number of frequent hospital visits.

CLL is the most common type of leukemia in adults, accounting for approximately 30%-40% of all forms of leukemia in Western countries.It mainly affects the elderly with 70-80% of patients diagnosed after the age of 55 and it is most commonly diagnosed between 65 and 70 years of age.

While CLL is generally considered a disease that is slow to progress, a significant proportion of patients have rapidly progressing forms of the disease.

Earlier this year Roche submitted a Marketing Authorisation Application to the European Medicines Agency, or EMEA, for the use of MabThera in patients who have previously been treated for their CLL but whose cancer has returned.

Company Web site: http://www.roche.com

-Zurich Bureau, Dow Jones Newswires; [phone]; [e-mail]