Novartis says FDA gives Gleevec priority review

Gleevec, already approved to treat other cancers, is Novartis' second best-selling drug. The FDA ruling concerns the drug's use in preventing gastrointestinal stromal tumors, which affect connective tissue, from recurring after they have been removed surgically.

Priority review means the FDA intends to approve or deny the application, or ask for more information, in six months instead of 10.

The Swiss company said the FDA's ruling was based on a late-stage clinical trial in which patients treated with Gleevec lived longer without a recurrence than patients treated with a placebo. Patients who were given Gleevec tablets were also 89 percent less likely to have their tumors return.

The trial involved patients with kit-positive gastrointestinal cancer, meaning they had a mutation in a particular protein that is one of the major causes of gastrointestinal cancer. Novartis said that mutation is present in more than 90 percent of cases in the U.S.

Gleevec, or imatinib mesylate, is marketed as Glivec in most worldwide markets. Novartis is also seeking regulatory approval in the European Union and Switzerland, and it plans to file similar applications in other countries soon.