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Briefing Note: rituximab (MabThera)

SMC has accepted rituximab for the treatment of patients with previously untreated and relapsed/refractory chronic lymphocytic leukaemia (CLL) in combination with chemotherapy. Rituximab is restricted for use by specialists in blood disorders and blood cancers.

  • CLL is the most common type of leukaemia (cancer of the white blood cells). Healthy white blood cells develop in the bone marrow and help to fight infection. In CLL, the white blood cells are not fully developed and multiply out of control crowding out healthy blood cells that can fight infection. CLL usually develops very slowly and many people with CLL do not need treatment for months or years.
  • CLL is treated by surgery, chemotherapy, radiation or a combination of these treatments. Rituximab is a type of anticancer drug called a monoclonal antibody. It binds to the abnormal cells and helps to destroy them while having no effect on healthy blood cells. Rituximab is given via a drip on day 0 of the first treatment cycle followed by day 1 of each subsequent cycle for 6 cycles in total. Chemotherapy should be given after the rituximab infusion.
  • Compared with fludarabine and cyclophosphamide alone, rituximab in combination with fludarabine and cyclophosphamide significantly lengthens progression-free survival by 10 months. However, the patients in the study were younger than those generally seen in practice, and evidence in patients over 70 years of age is limited.
  • There were no new safety concerns with rituximab in combination with chemotherapy for this indication. More patients in the rituximab in combination with chemotherapy group experienced severe neutropenia (abnormally low counts of white blood cells), febrile neutropenia (condition with fever) and granulocytopenia (abnormally low numbers of granular white blood cells) than in the chemotherapy group.
  • SMC accepted rituximab for restricted use because it was effective in combination with fludarabine and cyclophosphamide, and offers good value for money.