Roche today announced it has submitted a Marketing Authorisation Application (MAA) to the European Medicines Agency (EMEA) for the use of MabThera (rituximab) in patients with relapsed or refractory chronic lymphocytic leukaemia (CLL).
The submission in relapsed or refractory CLL follows news on 23 January of a positive recommendation by the European Union’s Committee on Human Medicinal Products (CHMP) for the use of MabThera in previously untreated CLL patients.
This filing means that physicians may soon be able to prescribe MabThera to CLL patients who have been treated for the disease but whose cancer has returned. The submission is based on impressive results from REACH, one of the largest randomised clinical trials ever reported in the treatment of CLL. This study showed that patients with relapsed or refractory CLL who were treated with MabThera in combination with standard chemotherapy lived an average ten months longer without their disease progressing compared to those receiving chemotherapy alone (30.6 months vs 20.6 months).
“CLL is an extremely difficult disease to treat and physicians are constantly searching for better ways to manage their patients,” said Professor Tadeusz Robak, Medical University of Lodz, Poland and principal investigator for the REACH trial. “The availability of effective treatment options, such as MabThera, will provide new hope for patients with what currently is a life-threatening and incurable disease.”
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.
MabThera is already licensed for the treatment of non-Hodgkin’s lymphoma (NHL) and was approved in Switzerland in December 2008 in previously untreated CLL patients.
About REACH
The REACH study is a randomised international study that included 552 patients with relapsed or refractory CLL. It was conducted at 88 study sites across 17 countries. The study was set up to investigate whether treatment of patients with relapsed or refractory CLL with MabThera in combination with chemotherapy (fludarabine and cyclophosphamide) was more beneficial than treatment with chemotherapy alone. The primary endpoint of the study was to show an increase in terms of median progression-free survival.
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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