Review proposal, October 2007
Review of NICE Technology Appraisal Guidance No 86, on the use of imatinib for the treatment of unresectable and/or metastatic gastro-intestinal stromal tumours
Review Proposal - October 2007
Following consultation in February 2007, the majority of comments received by the Institute agreed with the proposal put forward; to plan an update to the guidance into the appraisal work programme. The Institute's Guidance Executive decided to proceed with the proposal.
The manufacturer of imatinib has since advised the Institute that there may be changes to the licence in relation to dosing. These changes are dependent on new analyses which are due to be available at the end of this year. Regulatory updates will be submitted on the basis of these data, where appropriate, with expected approval mid-2008.
Therefore the Institute is proposing to update the guidance to include the regulatory updates, subject to agreement from the Department of Health.
In order to be completely confident that this is appropriate, we are asking all relevant consultees and commentators with an interest in this topic, to inform us of any evidence which would suggest that an earlier review would be beneficial. Please see appendix A for a full list of the organisations we have contacted.
Please note all comments received will be published on the Institute's website when a decision has been taken.
16 October 2007
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