DiagnosticsMabthera(R) (Rituximab) Available On NHS For UK's Most Common Leukaemia
The National Institute for Health and Clinical Excellence (NICE) today issued its recommendation for the use of MabThera® (rituximab) in the UK"s most common form of leukaemia, chronic lymphocytic leukaemia (CLL).1,2,3 NICE"s final guidance recommends rituximab in combination with fludarabine and cyclophosphamide (FC) chemotherapy as an option for previously untreated patients with CLL.4 The addition of rituximab to FC chemotherapy has been proven to halt progression of the disease by 10.5 months longer than chemotherapy alone, and more than doubles the number of CLL patients achieving complete remission, compared to chemotherapy.5,6 More than 20,000 people in the UK are living with CLL and there are an estimated 3,700 new cases every year.7,8 Professor John Gribben, Consultant Haematologist and Medical Oncologist, Barts and The London NHS Trust, commented:
"The ability to add rituximab to chemotherapy is a major advance in the way we can treat chronic lymphocytic leukaemia. Where previously our goal was just to improve symptoms, for the first time we now have a treatment combination that is capable of producing much higher remission rates and more durable responses. This is great news for patients and clinicians, who have been waiting many years for an advance that provides significant benefits compared to chemotherapy alone."
In the pivotal clinical trial, the addition of rituximab to FC chemotherapy extended the period of time after treatment in which the disease progression is halted ("progression-free survival") by 10.5 months
when compared to chemotherapy alone (3.5 years vs. 2.7 years).6 In addition, the number of patients achieving complete remission was more than twice that of chemotherapy alone (36 per cent vs. 17 per
cent).5
Tony Gavin, Director of Campaigning and Advocacy, Leukaemia CARE, said: "This NICE recommendation means many more people with the most common form of leukaemia should be able to Roche Products Limited
access rituximab on the NHS. Now Final Guidance is granted, rituximab should be made available immediately to all patients eligible for this treatment."
Jane Barnard, Chair of the CLL Support Association, said: "This is great news for CLL patients, many more of whom will now have the potential to gain additional time in remission and relief from debilitating symptoms such as extreme fatigue and the pain and discomfort of swollen glands."
CLL is a blood cancer caused when abnormal white blood cells (B-cells) grow out of control. They then outnumber healthy cells in the bone marrow and prevent the immune system from working normally. CLL accounts for approximately one third of leukaemias.2
"Roche welcomes this NICE recommendation for MabThera. CLL is a devastating disease that has no cure. Longer, deeper remissions allow people to return to work and family life with reduced or eliminated symptoms," said John Melville, General Manager, Roche Products Ltd.
Adding rituximab to chemotherapy in CLL results in an overall manageable tolerability profile, which helps maintain patients" quality of life. In the pivotal trial, adding rituximab to FC led to a higher incidence of haematological toxicity (where the bone marrow is suppressed, making it harder for the body to produce blood cells). Specifically, the increased incidence of neutropenia (a reduction in a specific type of white blood cell) was statistically significant, but this did not lead to a significant difference in infections between the two types of treatment.5
Please refer to the rituximab Summary of Product Characteristics for full details, available at:
http://www.emc.medicines.org.uk.
About CLL
Chronic lymphocytic leukaemia (CLL) is a blood cancer caused by a type of abnormal white blood cell (B-cells). Healthy B-cells are involved in fighting infection by producing antibodies. CLL leads to the suppression of the immune system, failure of the bone marrow and infiltration of malignant cells into organs. CLL can spread to the lymph nodes, spleen, liver, central nervous system and other organs. It does not usually form a solid mass or tumour.2 Further information in the CLL backgrounder
(COMM00333a).
About Rituximab (MabThera)
Rituximab is a monoclonal antibody (sometimes shortened to "MAB"), a type of man-made molecule that targets specific cells, or parts of cells, for destruction. Rituximab binds to a particular protein, the CD20 antigen, which is expressed on the surface of normal and malignant mature B-cells, a type of white blood cell vital to the body"s immune system. Disruption to the normal function of B-cells is a hallmark of many diseases, including non-Hodgkin lymphoma, rheumatoid arthritis and CLL. The way in which rituximab targets B-cells means it is capable of tackling more than one disease. Rituximab is licensed in chronic lymphocytic leukaemia, certain types of non-Hodgkin lymphoma and rheumatoid arthritis.
CLL8 Trial
CLL8, the pivotal trial on which rituximab"s first-line CLL licence is based, was an international, multicentre study. It included 817 patients with CLL who needed treatment for the first time. The study was conducted at 191 study sites across 11 countries. The trial was designed to evaluate the efficacy and tolerability of rituximab plus chemotherapy versus chemotherapy alone for initial treatment. The primary endpoint of the study was progression-free survival.
References
1. CLL Support Association: http://www.cllsupport.org.uk/aboutcll.htm Accessed 1 July 2009
2. Cancer Research UK: http://www.cancerhelp.org.uk/help/default.asp?page=17964Accessed 1 July 2009
3. Byrd JC et al. "Randomized phase 2 study of fludarabine with concurrent versus sequential treatment with rituximab in symptomatic,
untreated patients with B-cell chronic lymphocytic leukemia: results from Cancer and Leukemia Group B 9712 (CALGB 9712)", Blood 2003;
101: 6-14
4. National Institute for Health and Clinical Excellence. Single Technology Appraisal TA174, July 2009: Rituximab for the first-line treatment of
chronic lymphocytic leukaemia. http://www.nice.org.uk/TA174.
5. Rituximab (MabThera®) Summary of Product Characteristics, March 2009
6. Hallek H. ASH presentation, December 2008. Data on file. MAB015
7. The estimated 20-year prevalence of CLL in the UK is 20,185. Figure has been calculated by applying the 2005 Scottish prevalence rates
(http://www.isdscotland.org/isd/183.html) per 100,000 to the 2005 UK population. Accessed 1 July
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