MabThera receives positive opinion in Europe for first-line treatment for chronic lymphocytic leukaemia

Important step towards licence extension for MabThera in combination with chemotherapy as initial treatment

Roche announced today that the European Union’s Committee on Human Medicinal Products (CHMP) has issued a positive recommendation for the use of MabThera (rituximab) with any chemotherapy combination as a first-line treatment for chronic lymphocytic leukaemia (CLL), the most common form of adult leukaemia.

The label extension is based on the impressive, highly significant results of the international CLL8 study which showed that the median time until patients progressed with their disease, experienced a relapse or died was 40 months if patients were given MabThera plus chemotherapy compared to just 32 months for those that received chemotherapy alone. MabThera is already licensed for the treatment of non-Hodgkin’s lymphoma (NHL). Pending the final approval by the EU authorities, physicians will soon be able to prescribe MabThera to CLL patients in combination with their preferred chemotherapy regimen.

“Treatment with MabThera achieved significantly better outcomes for the patients than chemotherapy alone. This provides hope for the future treatment of a disease that remains life-threatening and incurable,” said William M. Burns, CEO Roche Pharma.

CLL is the most common type of leukaemia in adults, accounting for approximately 25-30% of all forms of leukaemia. Overall incidence of CLL is around three per 100,000 and is twice as common in men compared to women. It mainly affects the elderly with 70-80% of patients diagnosed after the age of 55 and the median age for diagnosis believed to be approximately 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.
About CLL8

The CLL8 study is an international study conducted by the German CLL Study Group and Professor Michael Hallek (Cologne, Germany) in collaboration with Roche. It included 817 patients with CLL receiving first-line treatment. The study was conducted at 191 study sites across 11 countries. In this randomised study, patients received either MabThera in combination with chemotherapy (fludarabine and cyclophosphamide) or chemotherapy alone. The primary endpoint of the study was progression-free survival. No new or unexpected safety signals were observed.
About MabThera

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 defences 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.

In oncology, MabThera is indicated

* For the treatment of previously untreated patients with stage III-IV follicular lymphoma in combination with chemotherapy;
* As maintenance therapy for patients with relapsed/refractory follicular lymphoma responding to induction therapy with chemotherapy with or without MabThera
* for the treatment of patients with CD20 positive diffuse large B cell non-Hodgkin’s lymphoma in combination with CHOP (cyclophosphamide, doxorubicin, vincristine, prednisolone) chemotherapy.
* As monotherapy for treatment of patients with stage III-IV follicular lymphoma who are chemoresistant or are in their second or subsequent relapse after chemotherapy.

In addition, in rheumatology, MabThera in combination with methotrexate is indicated for the treatment of adult patients with severe active rheumatoid arthritis who have had an inadequate response or intolerance to other disease-modifying anti-rheumatic drugs (DMARD) including one or more tumour necrosis factor (TNF) inhibitor therapies.

MabThera is known as Rituxan in the United States, Japan and Canada. To date, more than 1.5 million patients have been treated with MabThera worldwide.

Genentech and Biogen Idec co-market MabThera in the United States, and Roche markets MabThera in the rest of the world, except Japan, where MabThera is co-marketed by Chugai and Zenyaku Kogyo Co. Ltd.
About Roche

Headquartered in Basel, Switzerland, Roche is one of the world’s leading research-focused healthcare groups in the fields of pharmaceuticals and diagnostics. As the world’s biggest biotech company and an innovator of products and services for the early detection, prevention, diagnosis and treatment of diseases, the Group contributes on a broad range of fronts to improving people’s health and quality of life. Roche is the world leader in in-vitro diagnostics and drugs for cancer and transplantation, and is a market leader in virology. It is also active in other major therapeutic areas such as autoimmune diseases, inflammatory and metabolic disorders and diseases of the central nervous system. In 2007, sales by the Pharmaceuticals Division totaled 36.8 billion Swiss francs, and the Diagnostics Division posted sales of 9.3 billion francs. Roche has R&D agreements and strategic alliances with numerous partners, including majority ownership interests in Genentech and Chugai, and invested over 8 billion Swiss francs in R&D in 2007. Worldwide, the Group employs about 80,000 people. Additional information is available on the Internet at www.roche.com.

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