Gleevec Approval Widened to Include Rare Cancer
WEDNESDAY, Feb. 1 -- U.S. Food and Drug Administration approval for the Novartis drug Gleevec has been expanded to include adults who have had surgical removal of CD117-positive gastrointestinal stromal tumors (GIST), the agency said in a news release.
GIST is a rare cancer that forms in cells that line the walls of the GI tract, including the stomach. Such cells play a role in food digestion and other bodily processes, the FDA said.
Gleevec, first approved in 2001 to treat a genetic disease called Philadelphia chromosome positive chronic myeloid leukemia, has been sanctioned subsequently for a number of forms of GIST.
Gleevec's label will be updated to include clinical study results about CD117-positive GIST. The drug significantly increased patient survival when taken for 36 months, compared to the standard 12 months, the FDA said.
Common clinical side effects of Gleevec included swelling, nausea and vomiting, muscle cramps, bone or muscle pain, diarrhea, rash, fatigue and abdominal pain.
Novartis is based in East Hanover, N.J.
The U.S. National Institutes of Health has more about GIST.
Posted: February 2012