FDA Approves Gleevec to Prevent Recurrence of Rare Gastrointestinal Cancer

January 15, 2009

The US Food and Drug Administration has approved Gleevec (imatinib mesylate) for a new indication?keeping cancer from growing in patients following surgical removal of a gastrointestinal stromal tumor (GIST).

The US Food and Drug Administration has approved Gleevec (imatinib mesylate) for a new indication—keeping cancer from growing in patients following surgical removal of a gastrointestinal stromal tumor (GIST).

Gleevec, manufactured by Novartis AG (Basel, Switzerland), was first approved by the FDA in 2001 and is one of the first drugs in a class of agents that block cellular communications that result in tumor growth. It is intended to be given to patients following surgery to help prevent tumor recurrence.

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

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.