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NICE Recommends Breakthrough Anti-Cancer Drug Glivec (imatinib) for People with Gastrointestinal Stromal Tumours (GISTs).

FRIMLEY, Surrey, August 12 /PRNewswire/ -- The National Institute for Clinical Excellence (NICE) has today announced its final decision to fully approve the use of breakthrough drug Glivec (R) for the treatment of gastrointestinal stromal tumours (GISTs), a life-threatening cancer of the GI tract. Each year approximately 900 people in the UK are diagnosed with GISTs, and today's positive recommendation means around 250 of these people whose tumours have spread to other parts of their bodies, or are unsuitable for surgery, can now receive Glivec - the only effective treatment for GISTs - on the NHS.

Professor Ian Judson, consultant medical oncologist, Royal Marsden NHS Foundation Trust said: "It is excellent news that NICE is recommending the use of Glivec as first-line treatment for patients with advanced GIST. We know that Glivec is highly effective in controlling tumour growth and improving quality of life in this group of patients for whom there was hitherto no effective therapy. This decision should mean that all patients who need the drug will receive it and that it will be used appropriately."

UK patient support groups have welcomed the NICE decision. Dave Cook, GIST patient and founder of GIST Support UK said: "This decision is good news for patients who will have full access to the only effective treatment option available to them. This is particularly important for patients who are not suitable for surgery, as for them Glivec is potentially life-saving."

Glivec continues to improve the standard of care in GISTs, where it has altered the natural course of the disease and dramatically improved patients' lives. Studies show treatment with Glivec controls the disease in 85 per cent of patients[i].

GIST patient, Dan Wiseman from London said: "Glivec has already made a huge difference to my life, and now I know it will be available on the NHS, I can look ahead without worrying about how I receive my treatment in the future."

Conclusions from the final appraisal determination (FAD) will be presented to the NHS as clinical guidance by October 2004. Once this guidance is issued, it will be mandatory for all trusts and policyholders across England and Wales to provide Glivec for all suitable GIST patients. Glivec has been available on the NHS in Scotland for the treatment of GISTs since August 2002. Glivec is now fully approved for first-line management of people with inoperable and / or spreading GISTs and chronic myeloid leukaemia in all stages of the disease throughout the UK.

To see a copy of the final decision, please access the NICE website: www.nice.org.uk

NOTES TO EDITORS

About Glivec

On 24 May 2002, Glivec received a licence in the UK to treat patients with Kit (CD 117)-positive unresectable (inoperable) and/or metastatic malignant gastrointestinal stromal tumours (GISTs), a rare form of gastrointestinal cancer. On 9 August 2002, the SMC recommended that Glivec be made available to GIST patients through reimbursement by NHS Scotland.

About GISTs

GISTs are the most common malignant form of sarcoma that arise in the gastrointestinal tract, predominantly affecting people between 30 - 60 years of age. The UK incidence is approximately 15 cases per million or around 900 cases diagnosed each year. Historically, GISTs have been very difficult to treat due to their high levels of resistance to treatment with traditional chemotherapy and radiation therapy.

The UK incidence of spreading (metastatic) or inoperable (unresectable) disease is 250 cases. For these patients GISTs had represented an incurable malignancy, with an average survival rate of approximately one year. In cases where surgery was possible, it resulted essentially in treatment that relieved but did not cure the disease (palliative care).

About Novartis

Novartis AG (NYSE: NVS) is a world leader in pharmaceuticals and consumer health. In 2003, the Group's businesses achieved sales of USD 24.9 billion and a net income of USD 5.0 billion. The Group invested approximately USD 3.8 billion in R&D. Headquartered in Basel, Switzerland, Novartis Group companies employ about 80 000 people and operate in over 140 countries around the world. For further information please consult http://www.novartis.com. [i] Update of U.S.-Finnish Trial B2222; NEJM 2002. 347(7):472-480

For media enquiries, please contact: Fiona Turner Novartis Pharmaceuticals UK Ltd Tel: +44(0)1276-698-691 Fax: +44(0)1276-698-427, Darren Back Ruder Finn UK Ltd, Tel: +44(0)207-462 8900, Fax: +44(0207-462-8999, Email: dback@ruderfinn.co.uk
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