CH-4002 Basel

• Main Authors: Media Release, Communique Aux, Medias Medienmitteilung
• Other Authors: The Pennsylvania State University CiteSeerX Archives
• Format: Text
• Language: English
• Subjects: Executive Vice President; Global Head; Novartis Oncology Development. Study details; Gist; Norway; Riva; Iceland
• Online Access: http://citeseerx.ist.psu.edu/viewdoc/summary?doi=10.1.1.599.3769; http://hugin.info/134323/R/1311895/303983.pdf

Glivec ® approved in EU as first post-surgery therapy to reduce risk of cancer returning in patients with aggressive gastrointestinal tumors • Post-surgery use of Glivec shown to reduce the risk of gastrointestinal stromal tumors (GIST) returning by 89%1 • GIST are a rare, aggressive and potentially deadly type of cancer2,3 Basel, May 7, 2009 – 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 tumors (GIST). A rare, life-threatening cancer of the gastrointestinal tract, GIST are known to be aggressive2,3, returning in as many as half of all patients4 within a median of two years after initial surgery2. 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%1. 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 countries5. “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, MD