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Home Industry News Novartis: Glivec first therapy to reduce recurrence of GIST

Novartis: Glivec first therapy to reduce recurrence of GIST

28th August 2008

Novartis has hailed Glivec (imatinib) as the first therapy to reduce the recurrence of gastrointestinal stromal tumours (GIST) after surgery.

The firm noted clinical data shows an 89 per cent reduction in the risk of GIST relapse in patients administered with Glivec after surgery, which it describes as “unprecedented”.

It said these results are the basis for regulatory filings with the European Medicines Agency, Swissmedic and US Food and Drug Administration (FDA).

Novartis claimed these regulatory submissions underline its ongoing dedication to bringing new therapeutic approaches to patients suffering from rare diseases.

The FDA has this week given the compound priority review status for this indication.

Herve Hoppenot, executive vice-president and chief commercial officer of Novartis Oncology, said: “FDA priority review status acknowledges the potential for Glivec to become the first post-surgery treatment available to GIST patients.”

He added its availability may create a fundamental transformation in the treatment of this condition.

Around one in two patients experience a recurrence of GIST following surgery.

In June 2008, Novartis announced the results of an international clinical trial showing the administration of a higher initial dose of Glivec in chronic myeloid leukaemia patients resulted in better early responses.

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