The UK's National Institute for Health and Clinical Excellence (NICE) has given its preliminary view that it is 'minded not to recommend' Swiss drug major's Glivec/Gleevec (imatinib) for the adjuvant (post surgery) treatment of adult patients with KIT (CD-117)-positive gastrointestinal stromal tumors (GISTs), who are at significant risk of disease recurrence.
However, the NICE has requested further analyses to be provided which evaluate imatinib's use in patients at high, moderate and significant risk of recurrence, and has invited the company and other formal consultees in the appraisal process, including patient/carer groups and health care professionals, to comment on the appraisal by April19. Novartis Oncology is working to provide this additional information and is hopeful that the review of such data will lead to a positive final decision.
Currently imatinib is the only licensed treatment approved as a post-surgery (adjuvant) therapy to delay the recurrence of this highly aggressive cancer. Without such an option, says Novartis, patients would be left with no other treatment to reduce the risk of relapse following surgery.
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