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New use of cancer therapy can halve risk of death

New use of cancer therapy can halve risk of death

News release
10 November 2006
For immediate release

MedSafe registration approval has been given for a new use of a cancer treatment for patients diagnosed with indolent non-Hodgkin’s lymphoma (NHL).

MabThera® (rituximab), a monoclonal antibody, has been approved for maintenance treatment of indolent NHL. Maintenance therapy is administered to patients after the completion of the primary therapy (commonly chemotherapy) to prevent relapse or recurrence once their cancer has gone into remission.

The submission to Medsafe by Roche Products (New Zealand) Limited incorporated Phase III clinical trial data on 465 patients worldwide, including 11 New Zealand patients. The data showed that maintenance therapy with MabThera can reduce the risk of death for relapsed indolent NHL patients by up to 48 percent1, and can extend the progression free survival time (the probability a patient will remain alive without the disease progressing or getting worse) by 60 percent (p<0.0001), which is regarded as very significant statistically in the final analysis .

Dr Peter Browett, Medical Director of the Leukaemia and Blood Foundation, says the announcement is excellent news for NHL sufferers as this is the first time the benefit of maintenance therapy in lymphoma has been clearly demonstrated.

“Maintenance treatment with MabThera offers patients the chance to gain several years of life free from disease and has been shown to prolong survival”.

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“Indolent NHL is currently viewed as an incurable and recurring disease but the introduction of maintenance treatment could change it to a more manageable chronic disease, which will have huge benefits to patients.”

Dr Browett says approximately 700 New Zealanders are diagnosed with non-Hodgkin’s lymphoma each year2 and almost half of these (45 per cent)3 will be diagnosed with an indolent, slower growing form of the disease.

It is estimated that more than 150 patients with indolent non-Hodgkin’s lymphoma will relapse every year in New Zealand3, many requiring periods of hospitalisation and potentially unpleasant and life disrupting treatment with chemotherapy or radiotherapy.

Registration approval in New Zealand comes soon after European approval.

MabThera belongs to a class of pharmaceutical treatments called biological therapies. Unlike traditional chemotherapies, which are often derived from chemicals that attack growing cells directly, biological therapies work with the body’s immune system to assist it in identifying, combating and ‘killing’ cancer cells and tumours.

The treatment works with the body’s immune system to remove B cells, a type of white blood cell that can cause non-Hodgkin’s lymphoma. The body then generates new, healthy B cells to replace the ones that have been lost.

Maintenance treatment with MabThera will initially be made available as an unfunded medicine to indolent NHL patients in the private setting, although Stuart Knight, Sales and Marketing Director at Roche Products (New Zealand) Limited says an application for PHARMAC funding will be made during 2007.

He says MabThera will be beneficial as a maintenance therapy because it does not need to be used in combination with chemotherapy and is well tolerated by patients.


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