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Home Industry News Novartis’ Glivec receives approval

Novartis’ Glivec receives approval

22nd December 2008

Novartis’ Glivec has received approval as a first treatment to reduce the risk of cancer returning in patients with gastrointestinal stromal tumours (GIST).

The endorsement followed phase III tests on patients, which found 91.6 per cent taking the drug remained cancer-free on a 14-month median follow-up – compared to 80.2 per cent of those taking placebo.

As a result of the approval, Glivec is now the only post-surgery treatment indicated to delay the return of the tumours.

David Epstein, president and chief executive officer of Novartis Oncology, said: “When Glivec was first approved for the treatment of ? Kit-positive GIST six years ago, it revolutionised the treatment of this life-threatening cancer.

“This ? approval means patients can benefit from Glivec earlier in the course of their disease.”

Belonging to a group of cancers known as soft tissue sarcomas, GIST can most often be found in the stomach and small intestine.

The incidence of the condition is estimated to be 4,500 to 6,000 new cases per year in the US.

Last week, Novartis announced plans to initiate a phase III trial of Afinitor.

Set to be undertaken in HER-2-positive metastatic breast cancer patients, the company said its decision was as a result of positive results in two other tests.

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