FDA approves Novartis’ cancer-blocking drug Gleevec

12/22/2008

ROCKVILLE, Md. The Food and Drug Administration has approved a Novartis drug for use in preventing cancer from growing in patients after surgical removal of gastrointestinal stromal tumors, also known as GIST.

Gleevec (imatinib mesylate) originally received FDA approval in 2001 and is one of the first drugs in a class that blocks cellular communications that result in tumor growth.

“Approval of Gleevec offers healthcare professionals and patients an important new therapeutic option for patients with this uncommon gastrointestinal disease,” director of the FDA Center for Drug Evaluation and Research’s Office of Oncology Drug Products Richard Pazdur said in a statement. “It illustrates how the continued study of a once novel drug throughout its product lifecycle can yield new and important uses.”

About 5,000 to 6,000 patients in the United States receive GIST diagnoses every year. The cancer can be difficult to detect early because its symptoms are no different than other GI complaints such as nausea and vomiting.

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