The FDA has granted Gleevec (imatinib) regular approval for use in adult patients following surgical removal of CD117-positive gastrointestinal stromal tumors (GIST).

Gleevec, developed by Novartis, was originally granted accelerated approval for the treatment of advanced or metastatic GIST in 2002. In 2008, Gleevec received a subsequent accelerated approval for adjuvant use for the treatment of patients with GIST who had had potentially curative resection (surgical removal) of GIST tumors, but who were at increased risk for a recurrence.

The Gleevec label is being updated to include clinical data from a large, randomized clinical study comparing patients receiving the pill for 12 months versus those receiving it for 36 months. Patients treated with Gleevec for 36 months had a significantly prolonged survival rate and non-recurrence rate, compared to those receiving it for 12 months. At 60 months, 92% of patients who had received 36 months of Gleevec were alive compared to 82% of patients who received 12 months of Gleevec.

“The development of Gleevec over the past decade highlights the need to further study drugs after approval to truly characterize their benefits,” said Richard Pazdur, M.D., director of the office of hematology and oncology products in the FDA's Center for Drug Evaluation and Research.