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.
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- Medicine name:
- rituximab (MabThera)
- SMC ID:
- Relapsed/refractory CLL
- Pharmaceutical company
- BNF chapter
- Malignant disease and immunosuppression
- Submission type
- Date advice published
- 18 January 2010