FDA approves leukemia drug for gastrointestinal cancer
Monday, February 4th 2002, 12:00 am
By: News On 6
WASHINGTON (AP) _ The Food and Drug Administration announced Friday it had approved use of the drug Gleevec for patients with a rare gastrointestinal cancer.
The approval allows Novartis Pharmaceuticals to market Gleevec for treatment of gastrointestinal stromal tumor, which affects about 5,000 people in the United States.
In a study of 147 patients with inoperable tumors, 56 had a reduction in tumor size of 50 percent or more when treated with the drug, FDA said. The patients have not been followed long enough to determine the duration of the effect, the agency said.
Side effects, which were generally mild to moderate, included fluid retention, nausea, vomiting, diarrhea, skin rash, muscle cramps, liver toxicity and lower blood cell counts.
Gleevec was first approved in May for treatment of another rare cancer, chronic myeloid leukemia.