Advice
Following a full submission
rituximab (MabThera) is accepted for restricted use within NHS Scotland for first-line treatment of patients with chronic lymphocytic leukaemia (CLL) in combination with fludarabine and cyclophosphamide.
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 practice. Evidence in patients over 70 years of age is limited.
Rituximab is restricted to use by specialists in haematology and haemato-oncology
Download detailed advice94KB (PDF)
Medicine details
- Medicine name:
- rituximab (MabThera)
- SMC ID:
- 540/09
- Indication:
- Chronic Lymphocytic Leukaemia (CLL)
- Pharmaceutical company
- Roche
- BNF chapter
- Malignant disease and immunosuppression
- Submission type
- Full
- Status
- Restricted
- Date advice published
- 08 June 2009