Glivec (imatinib) received approval from the European Commission (EC) 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 following surgery to remove gastrointestinal stromal tumours (GIST).
A rare, life-threatening cancer of the gastrointestinal tract, GIST 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 per cent.
The EC decision applies in all 27 European Union (EU) member states, plus Norway and Iceland. The approval represents the tenth indication for Glivec in the EU and follows recent approvals for similar indications in the US, Switzerland and several other countries.
"The approval of Glivec for post-surgery GIST means that for the first time, patients in Europe with this life-threatening disease will have a treatment option that can significantly reduce their risk of GIST coming back after surgery," said Alessandro Riva, executive vice president, global head, Novartis Oncology Development.
Glivec is approved in more than 90 countries including the US, EU and Japan, for the treatment of all phases of Ph+ chronic myeloid leukaemia (CML).