Novartis' Glivec approved in Europe to cut GIST recurrence

Swiss drug major Novartis' Glivec (imatinib) received approval from the European Commission to become the first and only treatment available in  Europe to reduce the risk of recurrence in adult patients who are at  significant risk of relapse after surgery to remove gastrointestinal  stromal tumors.

A rare, life-threatening cancer of the gastrointestinal tract, GISTs are  known to be aggressive, returning in as many as half of all patients  within a median of two years after initial surgery. However, data from a  pivotal Phase III study recently found that when patients with GIST were  treated with post-surgery, or adjuvant, Glivec, the risk of recurrence  was reduced by 89%.

The approval represents the tenth indication for Glivec in Europe and  follows recent approvals for similar indications in the USA,  Switzerland and several other countries.