FDA Approves Gleevec to Prevent Recurrence of Rare Gastrointestinal Cancer

[Guest guest]

FDA Home Page | Search FDA Site | FDA A-Z Index | Contact FDA

FDA News

FOR IMMEDIATE RELEASE

December 19, 2008

Media Inquiries:

Riley, 301-796-4674

Consumer Inquiries:

888-INFO-FDA

FDA Approves Gleevec to Prevent Recurrence of Rare Gastrointestinal Cancer

The U.S. Food and Drug Administration today approved Gleevec (imatinib mesylate)

for a new indication – keeping cancer from growing in patients following

surgical removal of a gastrointestinal stromal tumor or GIST.

GIST is a fairly rare form of cancer that originates in cells found in the wall

of the GI tract. These cells, known as interstitial cells of Cajal, are part of

the autonomic nervous system, which helps to control the movement of food and

liquid through the stomach and intestines.

Gleevec, first approved by the FDA in 2001, is one of the first drugs in a class

of agents that block cellular communications that result in tumor growth

" Approval of Gleevec offers health care professionals and patients an important

new therapeutic option for patients with this uncommon gastrointestinal

disease, " said Pazdur, M.D., director, Office of Oncology Drug Products,

Center for Drug Evaluation and Research, FDA. " 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 new patients are diagnosed with GIST each year in the

United States. Because symptoms of GIST are no different than other GI

complaints such as nausea and vomiting, the cancer is difficult to detect early.

Patients initially undergo surgery to remove the tumor but GIST commonly recurs.

Gleevec is intended to be given to patients following surgery to help prevent

tumor recurrence.

The efficacy of Gleevec was established in a clinical trial in which patients

received either Gleevec or a placebo for one year after surgical removal of the

tumor. The optimal treatment duration is not known.

There were significantly fewer recurrences of GIST in patients receiving Gleevec

than in patients who did not. The most frequently reported adverse reactions

were diarrhea, fatigue, nausea, swelling of the feet, decreased red blood cell

counts, rash, vomiting and abdominal pain.

Gleevec is manufactured by Novartis AG, Basel, Switzerland.

#

4-H Leader extraordinaire!

All-Star Advisor to the most awesome

 kids of Amador County!

California Collegiate Shooting Sports