Novartis cancer drug given Swiss approval

Novartis says it expects EU approval for the drug by the middle of the year Keystone Archive

The Swiss pharmaceuticals giant, Novartis, has won regulatory approval in Switzerland for a new treatment against a rare form of intestinal cancer.

The new drug, Glivec, has already been cleared for use in the United States against gastro-intestinal stromal tumours (GISTs).

Swissmedic, the Swiss health authority, said on Monday Novartis could market the drug for use against GISTs, making it the first country in Europe to do so.

A decision is however currently pending from European Union regulators.

Novartis announced in February that an EU advisory panel had recommended the use of Glivec and the company is expecting formal approval of the drug by the middle of the year.

Marie-Françoise Rutimeyer, a spokeswoman for Novartis, told swissinfo that there are different drug registration procedures in different countries and for that reason drug approval varies from country to country.

“We follow in general the registration process for the US, for Switzerland, Europe and Japan,” she said.

In the case of Glivec, the US and Switzerland are ahead of Europe.

Leukaemia treatment

The US Food and Drug Administration initially approved the drug last year for the treatment of a specific form of leukaemia – chronic meloid leukaemia (CML), a rare blood disease.

“The clinical trials were very advanced on the first indication against CML,” Rutimeyer said, “but when we continued our clinical trials it became visible that it also worked in this second indication against GISTs.”

Novartis says Glivec will offer patients suffering from GISTs an alternative to surgery.

The cancer affects around 12,000 people each year – most of them middle-aged.

swissinfo with agencies