rituximab (MabThera)

following a full submission:

rituximab (MabThera) is accepted for restricted use within NHS Scotland.

Licensed indication under review: for the treatment of patients with previously untreated and relapsed/refractory chronic lymphocytic leukaemia (CLL) in combination with chemotherapy.

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.

SMC restriction: Rituximab is restricted to use by specialists in haematology and haematooncology.