The Scottish Medicines Consortium (SMC) has accepted rituximab (MabThera®) for use within NHS Scotland for the treatment of patients with previously untreated and relapsed/refractory chronic lymphocytic leukaemia (CLL) in combination with chemotherapy. It is restricted to use by specialists in haematology and haemato-oncology.
According to the drug advice (see link below), rituximab in combination with fludarabine and cyclophosphamide resulted in significantly longer progression-free survival than fludarabine and cyclophosphamide alone. The patient population in the pivotal clinical study had an Eastern Cooperative Oncology Group Performance Status of 0 or 1 and was a younger population than that generally seen in clinical practice (evidence in patients over 70 years of age is limited).