(1888PressRelease)
May 10, 2009 - A rare, life-threatening cancer of the gastrointestinal tract, GIST are known to be aggressive[2],[3], returning in as many as half of all patients[4] within a median of two years after initial surgery[2]. 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 countries[5].
"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, Executive Vice President, Global Head, Novartis Oncology Development.
About Novartis
Novartis AG provides healthcare solutions that address the evolving needs of patients and societies. Focused solely on healthcare, Novartis offers a diversified portfolio to best meet these needs: innovative medicines, cost-saving generic pharmaceuticals, preventive vaccines, diagnostic tools and consumer health products. Novartis is the only company with leading positions in these areas. In 2008, the Group's continuing operations achieved net sales of USD 41.5 billion and net income of USD 8.2 billion. Approximately USD 7.2 billion was invested in R&D activities throughout the Group. Headquartered in Basel, Switzerland, Novartis Group companies employ approximately 98,000 full-time-equivalent associates and operate in more than 140 countries around the world. For more information, please visit http://www.novartis.com.
Eric Althoff
Novartis Global Media Relations
+41 61 324 7999 (direct)
+41 79 593 4202 (mobile)
eric.althoff ( @ ) novartis dot com
Sabrina Oei
Novartis Oncology
+1 862 778 6387 (direct)
sabrina.oei ( @ ) novartis dot com
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