FDA approves Novartis' Gleevec for GIST

The US Food and Drug Administration has extended the indication of Swiss drug major Novartis' Gleevec (imatinib mesylate) to include the  prevention of cancer growth following surgical removal of a  gastrointestinal stromal tumor.

About 5,000 to 6,000 new patients are diagnosed with GIST each year in  the USA. Because symptoms are no different than other gastrointestinal  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. In clinical trials, there were significantly-fewer  recurrences of GIST in patients receiving Gleevec than in those given  placebo.

"Approval of Gleevec offers health care professionals and patients an  important new therapeutic option for patients with this uncommon  gastrointestinal disease," said Richard Pazdur, director of the FDA's  Oncology Drug Center for Drug Evaluation and Research Products' Office.  "It illustrates how the continued study of a once novel drug throughout  its product lifecycle can yield new and important uses," he added.