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Feb 27, 2012

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

  • 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. 

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Scientifically Studying Ecstasy

MDMA (commonly known as the empathogen “ecstasy”) is classified as a Schedule 1 drug, which is reserved for compounds with no accepted medical use and a high abuse potential. Two researchers from Stanford, however, call for a rigorous scientific exploration of MDMA's effects to identify precisely how the drug works, the data from which could be used to develop therapeutic compounds.

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