On Jan. 31, 2012, the U.S. Food and Drug Administration (FDA) granted Gleevec (imatinib) regular approval for use in adult patients following surgical removal of CD117-positive gastrointestinal stromal tumors (GIST). This action also highlighted an increase in overall patient survival when the drug is taken for 36 months rather than the standard 12 months of treatment.

Gleevec 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 that is 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 accelerated approval program provides earlier patient access to promising new drugs while the confirmatory clinical trials are being conducted. Regular approval for the metastatic GIST indication was also granted in 2008.