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Home Industry News Novartis receives CHMP backing for Glivec label update

Novartis receives CHMP backing for Glivec label update

24th January 2012

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.ADNFCR-8000103-ID-801272758-ADNFCR

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