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Published on 23 January 2012

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EMA backs Glivec® for 3-year gastro treatment

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The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion to update the Glivec® (imatinib) label to include 36 months of treatment after surgery for adult patients with KIT (CD117)-positive gastrointestinal stromal tumours (GIST).

This extended treatment regimen has been shown to improve recurrence-free survival and overall survival for KIT+ GIST patients.

The CHMP opinion was based on data from a multicentre, open-label, Phase III clinical trial.

Results of the study, which were first presented in June 2011 at the American Society of Clinical Oncology plenary session, showed that at five years, 66% of patients taking Glivec for three years after surgery for KIT+ GIST remained free of cancer recurrence (primary endpoint), compared to 48% who had received Glivec for only one year after surgery (p<0.0001).

In addition, at five years, 92% of patients taking Glivec for three years after surgery were alive (secondary endpoint) compared to 82% who had received Glivec for only one year after surgery (p=0.019).

“This CHMP positive opinion marks another major milestone in the evolution of GIST treatment, which began almost a decade ago with the introduction of Glivec in the metastatic setting,” said Hervé Hoppenot, President, Novartis Oncology.

European Medicines Agency



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