February 1, 2002
FDA approves Gleevec as oral treatment for Gastrointestinal Stromal Cancer
The U.S. Food and Drug Administration (FDA) today authorized the use of Gleevec to treat Gastrointestinal Stromal Tumor (GIST), a rare form of sarcoma that typically originates in the stomach or intestinal tract. Gleevec is one of the new generation of rationally designed cancer drugs that target abnormal enzymes in cancerous cells.
GIST affects an estimated 5,000 Americans each year. Surgery has been effective in treating some patients with malignant GIST, but there are few viable treatment options for those patients in which surgery failed. In these instances, the patients have generally died within a year or two of diagnosis.
George Demetri, MD, medical director of the Sarcoma Center at Dana-Farber Cancer Institute, is the lead investigator of the clinical study that looked at using Gleevec, an oral therapy, to treat GIST. The study also included researchers at the Oregon Health & Science University in Portland, Fox Chase Cancer Center in Philadelphia and the University of Helsinki in Finland. The research was conducted in collaboration with Novartis, the developer of Gleevec.
"Gleevec represents the most major advance to date for these patients who previously had no alternative other than surgery for treating this life-threatening and highly aggressive form of cancer," says Demetri. "The FDA's approval of Gleevec for the treatment of GIST further provides proof of the concept that expanding our molecular understanding of cancer can generate truly effective and well tolerated medications to treat human disease."
The FDA approved the use of Gleevec for the treatment of chronic myelogenous leukemia (CML) in May 2001.
Other Resources
FDA Approves Gleevec to Treat Gastrointestinal Stromal Cancer (FDA Talk Paper) read more
Treatment with Gleevec at Dana-Farber read more
