Glivec 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 (GISTs).
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 postsurgery, or adjuvant, Glivec the risk of recurrence was reduced by 89%.
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 postsurgery 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, MD, Executive Vice President, Global Head, Novartis Oncology Development.
The EU approval is based on phase III data from a double-blind, randomised, multicentre study of 713 GIST patients throughout the US 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 Glivec 400mg daily or placebo for one year immediately following surgery.
The results showed that 98% of the patients receiving Glivec remained recurrence-free after one year, compared with approximately 82% of those receiving placebos.
Therefore, the risk of recurrence was reduced by approximately 89% with Glivec as compared with placebo.
The investigators reported that Glivec therapy was well tolerated by most patients, with side-effects similar to those observed in previous clinical trials. These side-effects include nausea, diarrhoea and swelling.
Copyright Press Association 2009