Mabthera(R) (Rituximab) Approved In UK For Relapsed And Difficult-To-Treat Patients With Most Common Leukaemia

Main Category: Lymphoma / Leukemia / Myeloma
Also Included In: Blood / Hematology;  Cancer / Oncology;  Regulatory Affairs / Drug Approvals
Article Date: 01 Oct 2009 - 0:00 PDT

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MabThera® (rituximab) is now available in the UK for relapsed and difficult-to-treat (refractory) patients with chronic lymphocytic leukaemia (CLL),1 the most common form of leukaemia.2,3,4 Rituximab in combination with chemotherapy halts the progression of the disease by 10 months longer than chemotherapy alone in patients who have been treated previously but have either not responded adequately or whose cancer has returned.5 In addition, the new combination almost doubles the number of CLL patients achieving complete remission, compared to chemotherapy alone.4 More than 20,000 people in the UK are living with CLL6 and approximately two thirds of people with the disease will relapse.

Professor Andrew Pettitt, Consultant Haematologist at Royal Liverpool University Hospital and an investigator in the pivotal REACH trial, commented; "The partnering of rituximab with chemotherapy is one of the most significant advances we have seen in this type of leukaemia - it has improved patient outcomes considerably. For patients who have relapsed after previous treatment - a common scenario in this disease - the combination of rituximab with further chemotherapy offers a vital lifeline. The ultimate goal for these patients is to get them back into the best remission possible, and rituximab with chemotherapy achieves this for twice as many patients compared with chemotherapy alone."

Rituximab was granted a licence in March 2009 for previously untreated patients and has received positive recommendations from the National Institute for Health and Clinical Excellence (NICE) and Scottish Medicines Consortium (SMC) for first-line use in combination with fludarabine and cyclophosphamide (FC) chemotherapy. The new licence indication in relapsed and refractory CLL patients ensures that all people with CLL can now be considered for treatment with rituximab. Jane Barnard, Chair of the CLL Support Association, commented; "We welcome the news that people who have relapsed or simply not responded to their first treatment now have another option available to them. Any new treatment that enables patients to experience longer periods without their disease will help give back precious quality of life free from debilitating symptoms."

The REACH trial which supported the licence indication compared rituximab in combination with fludarabine and cyclophosphamide (known as R-FC) with FC alone, in people with CLL who had had one course of chemotherapy previously and who required further treatment. Those in the R-FC arm had progression-free survival extended by 10 months compared to those given FC (30.6 months versus 20.6 months respectively).5 This constituted a 50 per cent improvement for R-FC over FC. Complete remission rates were also nearly doubled in the R-FC arm: 24 per cent versus 13 per cent of those given FC alone.5

Tony Gavin, Director of Campaigning and Advocacy, Leukaemia CARE, said; "Chronic Lymphocytic Leukaemia (CLL) is the most common form of leukaemia in the UK, yet has historically suffered from limited treatment options. We are delighted with this announcement because finding new ways to target and treat CLL, particularly in patients who have been treated and relapsed or failed to respond to initial treatment, is essential to successfully managing this condition."

The most frequent reported or observed serious adverse drug reactions in patients receiving rituximab were infusion-related reactions, infections and cardiovascular events.1

Please refer to the rituximab Summary of Product Characteristics for full details, available at: http://www.emc.medicines.org.uk.

About Roche in the UK

Roche aims to improve people's health and quality of life with innovative products and services for the early detection, prevention, diagnosis and treatment of disease. Part of one of the world's leading Roche Products healthcare groups, Roche in the UK employs nearly 2,000 people in pharmaceuticals and diagnostics.

Globally Roche is the leader in diagnostics, and a major supplier of medicines for the treatment of cancer, transplantation, virology, bone and rheumatology, obesity and renal anaemia. Further information at: http://www.rocheuk.com.

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.

About the REACH trial

REACH was an open-label, multi-centre, multinational randomised phase III study of 552 patients with relapsed/ refractory CLL. The trial was designed to evaluate the efficacy and tolerability of R-FC versus FC. The primary end-point was progression-free survival. The lead investigator was Professor Tadeusz Robak, Medical University, Lodz, Poland.

Date of preparation: September 2009

References:

1. MabThera Summary of Product Characteristics

2. CLL Support Association: http://www.cllsupport.org.uk/aboutcll.htm Accessed September 2009

3. Cancer Research UK: http://www.cancerhelp.org.uk/help/default.asp?page=17964 Accessed September 2009

4. 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

5.'Rituximab, Fludarabine and Cyclophosphamide (R-FC) prolongs progression free survival in relapsed or refactory chronic lymphocytic leukaemia (CLL) compared with FC alone: Final results from the International Randomized Phase III REACH Trial', Tadeusz Robak et al, abstract presented at the 50th ASH Annual Meeting and Exposition, December 6-9, 2008, San Francisco CA

6. 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 2009

Source
Roche