Novartis
has been granted European regulatory approval to extend the use of its drug
Glivec to new patient populations.
The European Commission has approved an update to the treatment's labelling to include 36 months of treatment after surgery for adults with KIT-positive gastrointestinal stromal tumours (GIST).
Data from pivotal phase III trials has shown that the extended treatment regimen can improve recurrence-free and overall survival rates after 12 months.
The new decision follows on from a positive recommendation from the European Medicines Agency's Committee for Medicinal Products for Human Use and applies to all 27 EU member states, plus Norway and Iceland.
Herve Hoppenot, president for Novartis Oncology, said: "This approval marks a key milestone in advancing the post-surgical treatment of GIST for certain patients in Europe, where Glivec is the only available therapy in this setting."
Earlier this month, Novartis and Enanta Pharmaceuticals announced a new collaboration with Enanta Pharmaceuticals that will see the companies developing a new treatment for hepatitis C.
The European Commission has approved an update to the treatment's labelling to include 36 months of treatment after surgery for adults with KIT-positive gastrointestinal stromal tumours (GIST).
Data from pivotal phase III trials has shown that the extended treatment regimen can improve recurrence-free and overall survival rates after 12 months.
The new decision follows on from a positive recommendation from the European Medicines Agency's Committee for Medicinal Products for Human Use and applies to all 27 EU member states, plus Norway and Iceland.
Herve Hoppenot, president for Novartis Oncology, said: "This approval marks a key milestone in advancing the post-surgical treatment of GIST for certain patients in Europe, where Glivec is the only available therapy in this setting."
Earlier this month, Novartis and Enanta Pharmaceuticals announced a new collaboration with Enanta Pharmaceuticals that will see the companies developing a new treatment for hepatitis C.