NICE rejects Novartis' Glivec for GIST

The National Institute for Health and Clinical Excellence (NICE) has issued final guidance ruling against the use of Novartis' Glivec (imatinib) as an adjuvant treatment for patients who have had a gastrointestinal stromal tumour (GIST) removed and are at risk of the cancer recurring.

NICE say that although there is evidence that giving imatinib as adjuvant post-surgery therapy can delay the recurrence of GIST, there is a lack of evidence relating to the clinical effectiveness of imatinib, in particular whether adjuvant imatinib extends life expectancy, how long treatment should be continued and whether resistance to imatinib develops.

The NICE Appraisal Committee has recommended that appraisal is considered for review in 2011, when more mature evidence is expected to be available.

Andrew Dillon, chief executive of NICE said: "Although there is some evidence that imatinib may delay cancer recurring in certain people who have had surgery to remove their tumours, it is not clear that it increases survival or that it improves patients' quality of life. At around £19,500 per patient per year, this is an expensive drug, and we need to be more confident about how well it works and what its side-effects are before we consider recommending it for use in the NHS.

"The Appraisal Committee did, however, recommend that an early review date should be set for this appraisal so that evidence on the impact of adjuvant imatinib treatment on overall survival can be considered as soon as results from ongoing trials become available."

Imatinib is already approved by NICE for patients with chronic myeloid leukaemia and for those with GIST that cannot be removed by surgery.