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NICE extends MabThera recommendation

Extension for Roche's chronic lymphocytic leukaemia drug recommended for people with relapsed and difficult-to-treat versions of the disease

Roche's blood cancer therapy, MabThera (rituximab), for chronic lymphocytic leukaemia (CLL), has received a favourable opinion from the National Institute for Health and Clinical Excellence (NICE) and is now recommended to include people with relapsed and difficult-to-treat versions of the disease in England and Wales.

However, the NICE extension does not include patients who have received the full therapeutic dose of MabThera in the first line setting or who are refractory to fludarabine.

The decision was based on evidence demonstrating that, when given in combination with fludarabine and cyclophosphamide (FC) chemotherapy, the targeted antibody, rituximab, extends the length of remission by 10 months and almost doubles the likelihood of achieving complete response compared to chemotherapy alone.

Dr Claire Dearden, consultant haematologist at the Royal Marsden Hospital, commented: "When added to chemotherapy, rituximab consistently delivers superior outcomes to chemotherapy alone, putting more patients into longer remissions, the key goal of treatment for chronic leukaemia. NICE's decision to widen its recommendation to include relapsed and refractory CLL patients is very encouraging and will mean that many more people will now be able to benefit from this potent treatment combination."

Findings from the phase III REACH trial, covering 552 patients with relapsed/refractory CLL, which provided evidence for NICE's recommendation, compared rituximab in combination with fludarabine and cyclophosphamide chemotherapy (known as R-FC) with FC alone, in people who had previously received one prior therapy for CLL and required further treatment.

NICE will review its guidance in December 2010 to consider rituximab in combination with other suitable chemotherapy drugs for the treatment of CLL.

Rituximab was granted a licence by the European Medicines Agency (EMA) in March 2009 for use in previously untreated patients with CLL in combination with any suitable chemotherapy. This was extended in September 2009 to include people with relapsed and refractory CLL. The Scottish Medicines Consortium issued updated guidance in January 2010 recommending rituximab in combination with any suitable chemotherapy for CLL patients in Scotland on the NHS.

28th July 2010

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