The FDA today granted regular approval for Gleevec (imatinib) for use in adult patients following surgical removal of CD117-positive gastrointestinal stromal tumors (GIST); highlighting an increase in overall patient survival when the drug is taken for 36 months rather than the standard 12 months of treatment.
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. It 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 in 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 label is being updated to include clinical data from a large randomized clinical study comparing 12 to 36 months of Gleevec. Use of Gleevec for 36 months significantly prolonged overall survival and the time a patient lived without the disease recurring, compared to those receiving 12 months of Gleevec. At 60 months, 92% of patients who received 36 months of Gleevec were alive compared to 82% of patients who received 12 months of Gleevec.
Gleevec is a pill that should be taken with a meal and a glass of water.
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 is marketed by Novartis Pharmaceuticals Corp. based in East Hanover, N.J.