NEW YORK -- May 7, 2009 -- The European Commission (EC) has approved imatinib (Glivec) to reduce the risk of recurrence in adult patients who are at significant risk of relapse following surgery to remove gastrointestinal stromal tumours (GIST).
The approval was based on a double-blind, randomised, multicentre, phase 3 study of 713 patients with GIST from the United States and Canada whose tumours had been surgically removed.
The study, conducted by the American College of Surgeons Oncology Group (ACOSOG), compared the recurrence-free survival of patients taking either imatinib 400 mg daily or placebo for 1 year immediately following surgery.
Results showed that 98% of the patients receiving imatinib remained recurrence-free after 1 year compared with approximately 82% of those receiving placebo (P < .0001). Thus, the risk of recurrence was reduced by approximately 89% with imatinib as compared with placebo.
Imatinib was well tolerated by most patients, and side effects included nausea, diarrhoea, and edema.
SOURCE: Novartis
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