Roche cancer drug gets NICE thumbs up
pharmafile | March 5, 2010 | News story | Sales and Marketing | MabThera, Roche
NICE has recommended Roche’s MabThera to treat patients with the most common form of leukaemia, relapsed or refractory chronic lymphocytic leukaemia.
Cancer Research UK welcomed the decision, saying the drug has already had a big impact on the chances of survival for patients with lymphoma.
The charity’s policy manager Hilary Tovey said: “NICE’s decision to recommend this drug is further good news for patients with chronic lymphocytic leukaemia. Our scientists were involved in the development of rituximab and this is an excellent example of how quality scientific research continues to help find new ways to treat cancer.”
Ken Campbell, clinical information officer at Leukaemia and Lymphoma Research, added: “Leukaemia & Lymphoma Research welcome the announcement that NICE has recommended that Rituximab used with fludarabine and cyclophosphamide should be available for treatment of patients with chronic lymphocytic leukaemia.
“Chronic lymphocytic leukaemia is the commonest form of leukaemia in the Western world; fortunately many patients do not need treatment initially and some will never need treatment. It is important that, when treatment is necessary, as many options as possible are available.
“The new approval will extend the options available to patients for whom initial treatment has failed or who had an initial response but their illness has become resistant. Rituximab used with fludarabine and cyclophosphamide was known to be clinically effective for this group; NICE have now confirmed that it is also cost-effective.”
CLL is the most common form of adult leukaemia and accounts for around 30-40% of leukaemia cases in Western countries and is currently deemed incurable. The treatment aim is to control the disease and extend patient life expectancy with progression-free survival.
The blockbuster cancer treatment is also indicated for Non Hodgkin’s Lymphoma and last year earned Roche $5.6 billion in revenues.
Research recommendations
NICE’s final draft guidance recommends the drug, in combination with fludarabine and cyclophosphamide, to treat CLL – except where the condition has not previously responded to fludarabine or has relapsed within six months of treatment, or has previously been treated with MabThera.
The guidance also recommends Roche conduct further research on how the drug performs in two areas where there is currently a lack of evidence.
These are when patients have previously received MabThera and the chemotherapy combination, or when chemotherapy agents other than fludarabine and cyclophosphamide are used.
NICE was more emphatic this week about data requirements for another Roche drug, directly asking the manufacturer for more information on the cost-effectiveness of its rheumatoid arthritis treatment RoActemra.
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