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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.

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

Drug Details

Drug Name: rituximab (MabThera)
SMC Drug ID: 591/09
Manufacturer: Roche
Indication: Relapsed/refractory CLL
BNF Category:
Submission Type: Full submission
Status: Restricted
Date Advice Published: 18 January 2010