Novartis has been granted a recommendation from Europe's Committee for Medicinal Products for Human Use (CHMP) for a new label update for the drug Glivec.
The European Medicines Agency committee has given a positive opinion on Novartis' plans to make the treatment available to adult patients with KIT -positive gastrointestinal stromal tumours (GIST) for three years after undergoing surgery.
It follows positive phase III clinical trial data that has shown the treatment's efficacy in improving recurrence-free survival and overall survival rates.
Applications are also underway for similar Glivec label updates in the US and internationally, thus helping to further improve the availability of the widely-used chronic myeloid leukaemia therapy.
Herve Hoppenot, president for Novartis Oncology, said: "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."
This comes after the CHMP recommended Novartis' drug Signifor for the treatment of Cushing's disease earlier this week.
The European Medicines Agency committee has given a positive opinion on Novartis' plans to make the treatment available to adult patients with KIT -positive gastrointestinal stromal tumours (GIST) for three years after undergoing surgery.
It follows positive phase III clinical trial data that has shown the treatment's efficacy in improving recurrence-free survival and overall survival rates.
Applications are also underway for similar Glivec label updates in the US and internationally, thus helping to further improve the availability of the widely-used chronic myeloid leukaemia therapy.
Herve Hoppenot, president for Novartis Oncology, said: "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."
This comes after the CHMP recommended Novartis' drug Signifor for the treatment of Cushing's disease earlier this week.