NICE Approves MabThera(R) (Rituximab) As Maintenance Therapy For Patients With Follicular Non-Hodgkin Lymphoma

Main Category: Lymphoma / Leukemia
Also Included In: Regulatory Affairs / Drug Approvals
Article Date: 28 Feb 2008 - 1:00 PDT

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The National Institute for Health and Clinical Excellence (NICE) issued final guidance recommending the use of MabThera(R) (rituximab), as a maintenance therapy for patients with relapsed/refractory follicular non-Hodgkin lymphoma (NHL) responding to induction therapy with chemotherapy with or without rituximab. 1 This is an important breakthrough as it represents a new treatment approach that can allow patients with this potentially fatal disease to manage it as a chronic condition and live for an average of over four years before the disease returns.

Maintenance treatment with rituximab is a new approach to managing NHL, which allows patients who have responded to initial treatment to receive maintenance therapy every three months for up to two years. Data have shown that when treated with rituximab maintenance therapy, patients' risk of death was reduced by 48%. In addition, their average time of living disease-free was significantly extended to over four years (51.5 months) compared to just 14.9 months when left untreated with maintenance during this remission period (p<0.0001).2

Dr Premini Mahendra, Consultant Haematologist at the Queen Elizabeth Hospital, Birmingham, commented "Rituximab is continuing to revolutionise the management of NHL. The positive NICE guidance for rituximab in the maintenance setting represents a significant step forward in the management of one of the most common forms of NHL. By reducing the risk of death and trebling progression free survival in patients living with this disease, the maintenance approach to treatment is moving this cancer to a chronic disease status."

Rituximab, the world's first monoclonal antibody licensed for cancer treatment in the UK, has received consistent positive NICE guidance during the 10 years since its launch, with today's announcement being the fourth positive NICE guidance that the treatment has received across its various NHL indications since 2002. It remains the only therapy that increases overall patient survival when used in combination with chemotherapy to treat aggressive NHL.

Rituximab has many characteristics essential for a maintenance therapy: it is both effective and well tolerated, and can maintain active concentrations in the blood with intervals of several months between administrations. This enables most patients to continue with everyday life whilst on maintenance therapy without having to undergo repeated courses of chemotherapy to treat their disease.

Follicular NHL is the most common type of indolent NHL.3 It is a slow-developing but ultimately often fatal cancer of the lymphatic system, with patients suffering from multiple relapses after treatment, with periods of stable or undetectable disease (a 'partial' or 'complete' remission) in between. NHL is the sixth most common cancer in the UK.4 Each year there are over 5,200 new cases in men and 4,700 cases in women.5

In the maintenance phase no new safety concerns were reported that were not already known from the use of rituximab as induction therapy. Neutropenia was the most common adverse event with an incidence of 11% in the rituximab group compared with 5.4% in the observation group (p=0.07). This most likely accounted for the significant increase in the grade 3-4 infection rate in the rituximab group compared with observation (9% vs 2.4%, p=0.009). There were no deaths related to rituximab maintenance treatment. Other common side effects can be experienced during the drug's infusion - mainly fever, chills and rigors.2

With the publication of this final guidance, Primary Care Trusts (PCTs) and NHS Trusts, which manage the implementation of NICE approved therapies, have a maximum of three months in which to fully implement this use of rituximab, ensuring all eligible patients have access to this NICE-recommended option.

About MabThera (rituximab)

Rituximab is currently approved for first-line use for patients with later stages of follicular NHL in combination with the chemotherapy in those resistant to chemotherapy or in second or subsequent relapse, and as a monotherapy for later stages of follicular NHL. It is also approved for use as maintenance treatment in patients with relapsed or refractory follicular lymphoma and in combination with CHOP (cyclophosphamide, doxorubicin, vincristine and prednisolone) chemotherapy for patients with diffuse large B-cell (aggressive) NHL.6

It 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 defense to attack and kill the marked B-cells. Stem cells in bone marrow lack the CD20 antigen, allowing healthy B-cells to regenerate after treatment and return to normal levels within several months.6

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 healthcare groups, Roche in the UK employs nearly 2,000 people in pharmaceuticals and diagnostics. 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. Find out more at http://www.rocheuk.com.

References:

1. NICE STA Rituximab for the treatment of relapsed or refractory stage III or IV follicular non-Hodgkin lymphoma. 27th February 2008

2. Van Oers MH et al. Rituximab maintenance improves clinical outcome of relapsed/resistant follicular non- Hodgkin's lymphoma, both in patients with and without rituximab during induction: results of a prospective randomized phase II intergroup trial. Blood 2006; pre-published online (http://www.bloodjournal.org) July 27, 2006.

3. Lymphoma Association UK publication, "Lymphomas", accessed from Lymphoma Association website, http://www.lymphoma.org.uk/support/ (taken from website on 18.12.07).

4. NHL is the sixth most common cancer in the UK (taken from website on 21.2.08).

5. Each year there are over 5,200 new cases in men and 4,700 cases in women

6. Rituximab summary of product characteristics.

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