Novartis's Glivec gets new EU leukaemia approvals

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Tue Sep 19, 2006 1:47am ET253

Novartis's Glivec gets new EU leukaemia approvals

ZURICH, Sept 19 (Reuters) - Novartis (NOVN.VX:

<http://today.reuters.com/stocks/overview.aspx?symbol=NOVN.VX & WTmodLoc=I

nvArt-C1-ArticlePage1> Quote,

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dLoc=InvArt-C1-ArticlePage1> Profile,

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odLoc=InvArt-C1-ArticlePage1> Research) said on Tuesday that its Glivec

treatment had received additional EU approvals to help patients with a

rapidly progressive form of leukemia as well as a hard-to-treat solid

cancer tumour.

Glivec has now received European Union approval for use in adult

patients with newly diagnosed Ph+ acute lymphoblastic leukaemia (ALL) in

combination with chemotherapy.

It also has approval as a single agent for patients with relapsed or

refractory Ph+ ALL, Novartis said in a statement.

The EU also approved Glivec for treatment of adult patients with

unresectable, recurrent and/or metastatic dermatofibrosarcoma

protuberans (DFSB) who are not eligible for surgery.

DFSB begins as a hard lump found in the skin of the chest, abdomen or

leg and progresses to invade nearby tissues.

The approval was expected, as the European Medicines Agency had already

given the drug a positive opinion as a treatment for the rare tumours.

Glivec, or Gleevec as it is known in the United States, was was approved

five years ago for patients with chronic myeloid leukaemia (CML) and has

grown to be Novartis's second-biggest selling product, with sales last

year of $2.2 billion.

The drug has transformed life expectancy for people with CML and a type

of stomach cancer called GIST. Five years of use shows patients taking

Glivec have a 90 percent survival rate.