The drug has been approved for use as an adjuvant therapy for 36 months in patients with KIT (CD117)-positive gastrointestinal stromal tumours (GIST).
Glivec is the only treatment available in the EU for the treatment of this life-threatening type of post-surgical tumour.
GIST are rare (affecting an estimated 5,000 new patients in the EU each year), but are difficult to diagnose and treat. Patients with KIT+ GIST are at risk of metastasis after surgery, and their survival prospects following tumour recurrence are poor.
An international phase III trial showed that three years’ treatment with Glivec significantly improved recurrence-free and overall survival rates in adults with post-surgical KIT+ GIST relative to one year’s treatment.
The recurrence-free and absolute survival rates for patients taking Glivec for three years were 66% and 92%; those for patients taking Glivec for one year were 48% and 82%.
The new label also states that treatment with Glivec beyond three years may improve progression-free survival but its effect on overall survival is not known.
Hervé Hoppenot, President, 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.
“Physicians now have a strong basis for recommending three years of treatment for these patients with KIT+ GIST after surgery.”