FDA approves Gleevec for expanded use in patients with rare gastrointestinal cancer

            The U.S. Food and Drug Administration recently granted Gleevec (imatinib) regular approval for use in adult patients following surgical removal of CD117-positive gastrointestinal stromal tumors (GIST). Today’s action also highlights 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.

            GIST is a rare form of cancer that originates in cells found in the wall of the GI tract. These cells, known as interstitial cells of Cajal, are part of the autonomic nervous system, which regulates body processes such as food digestion. More than half of GISTs start in the stomach.

            The most common side effects observed in patients receiving Gleevec include swelling (edema), nausea, vomiting, muscle cramps, bone or muscle pain, diarrhea, rash, fatigue, and abdominal pain.

            Gleevec was first approved by FDA in May 2001 to treat patients with advanced Philadelphia chromosome positive chronic myeloid leukemia, a blood and bone marrow disease linked to a genetic abnormality.