FDA Approves Gleevec For GIST Treatment

02/01/02    Portland, Ore.

OHSU researcher led trials for deadly intestinal cancer

The Food and Drug Administration today approved the drug Gleevec, formerly known as STI571, for the treatment of gastrointestinal stromal tumors, or GIST. The tumors are among the most deadly of intestinal cancers, as there is no other effective treatment besides early surgical removal.

"Not only have we seen shrinkage in size and quantity of tumors, but patients are feeling better than they have in many months," said Charles Blanke, M.D., director of gastrointestinal oncology at the Oregon Health & Science University Cancer Institute. Blanke is one of three principal investigators of the initial clinical trials using Gleevec on GIST. Blanke and Michael Heinrich, M.D., began studying the possibility that Gleevec could target the protein that drives GISTs after consulting with colleague Brian Druker, M.D., the OHSU researcher who helped develop the drug to fight a form of leukemia.

GIST affects about 5,000 - 10,000 Americans a year, striking any of the organs in the entire length of the gastrointestinal tract or its lining. These tumors are prone to spread to other organs and, once spread, they often are unresponsive to chemotherapy or irradiation, and invariably fatal. Clinical trials for GIST using Gleevec began in July 2000 at OHSU, Dana-Farber Cancer Institute and Fox Chase Cancer Center.

In clinical trials, more than half of patients with GIST have gone into remission on Gleevec, and more than 90 percent of patients reported major signs of clinical improvement in their conditions. "This is exciting news, not just because these results validate the theory of targeted therapy, but because these patients have no other options," said Blanke.

Gleevec, manufactured by Novartis, was approved by the FDA for chronic- and acute-phase CML treatment in May 2001. Patients seeking more information about the GIST or CML clinical trials can call 503 494-1080 or visit www.ohsu.edu.