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GEN News Highlights : Feb 27, 2012

EC Approves Three-Year Treatment Label Update for Novartis’ Glivec

Phase III study showed extending therapy by two years increased recurrence-free and overall survival.

Novartis confirmed that the European Commission approved an update to the Glivec® (imatinib) label to include 36 months of treatment with the drug following surgery for adults with KIT (CD117-positive) gastrointestinal stromal tumors (GIST). FDA approved a similar label update at the start of February in the U.S. where the drug is called Gleevec.

Regulatory clearance in the EU for the three-year treatment recommendation was based on data from a 397-patient Phase III trial, which showed that recurrence free-survival was 66% for relevant KIT-positive GIST patients receiving Glivec for three years post surgery compared with 48% for patients who received Glivec for just one year. Overall survival rates at five years were 92% and 82%, respectively.

“This approval marks a key milestone in advancing the postsurgical treatment of GIST for certain patients in Europe, where Glivec is the only available therapy in this setting,” comments Hervé Hoppenot, president of Novartis oncology.