The Food and Drug Administration (FDA) has granted an expedited review to Basel-based Novartis AG’s cancer drug Glivec/Gleevec, meaning the agency will complete its appraisal in 6 months rather than 10 months, after tests showed the pill lowers the risk of certain stomach and intestinal tumors returning after the malignancy has been surgically removed.

The Novartis drug was originally approved in 2001 for chronic myeloid leukemia, and doctors use it currently to treat gastrointestinal tumors.

Glivec/Gleevec generated $ 1.8 billion dollars in the first half of the year.

The Glivec/Gleevec study data on which the FDA based its decision was from a Phase III, double-blind, randomized, multicenter, international study with over 700 patients who had surgery to remove their tumors.

At the beginning of 2007, the trial met its main goal, and results showed a high 89 percent reduction in risk of tumors returning after surgery in patients treated with Glivec/Gleevec versus placebo. These results were so positive that the patients on placebo were offered to go onto the medication.