Novartis wins EU approval for gastro tumor drug

Novartis has reported that Glivec has 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 following surgery to remove gastrointestinal stromal tumors or GIST.

The European Commission decision applies in all 27 EU member states, plus Norway and Iceland. The approval represents the 10th indication for Glivec in the EU and follows recent approvals for similar indications in the US, Switzerland and several other countries.

The EU approval is based on Phase III data from a double-blind, randomized, multicenter study of 713 GIST patients throughout the US and Canada whose tumors had been surgically removed. The study, conducted by the American College of Surgeons Oncology Group, 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 placebo (P<0.0001). Therefore, the risk of recurrence was reduced by approximately 89% with Glivec as compared to placebo, said Novartis.

Alessandro Riva, executive vice president and global head of Novartis Oncology Development, said: 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.