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The FDA has granted regular approval of Gleevec (imatinib) for use in adult patients after surgical removal of CD117-positive gastrointestinal stromal tumors (GIST). The label is also being updated to increase the standard length of treatment from 12 months to 36 months.


The drug was granted accelerated approval in 2008 for adjuvant use in GIST patients whose tumors had been surgically removed and who were at increased risk of recurrence. And, the drug had been originally granted accelerated approval for the treatment of advanced or metastatic GIST in 2002, and then regular approval in 2008.


"The development of Gleevec over the past decade highlights the need to further study drugs after approval to truly characterize their benefits," Richard Pazdur, MD, Director of the FDA's Office of Hematology and Oncology Products in the Center for Drug Evaluation and Research, said in a statement. "This subsequent trial has demonstrated that longer use of Gleevec can prolong patient's lives in earlier disease settings."


The approvals come after clinical trials showed significantly prolonged overall survival rates and the time a patient lived without disease recurrence when patients received 36 months vs 12 months of Gleevec (OT 8/10/11). After 60 months, 92 percent of patients who had taken the drug for 36 months were alive compared with 82 percent of the patients who had taken the drug for 12 months. The patients on the drug longer had a 54 percent reduction in risk of recurrence and a 55 percent reduction in risk of death.


The most commonly reported side effects for the drug, a pill that should be taken with a meal and a glass of water, are edema, nausea, vomiting, muscle cramps, bone or muscle pain, diarrhea, rash, fatigue, and abdominal pain.


The first approved use for Gleevec, which is marketed by Novartis, was in 2001, for patients with advanced Philadelphia chromosome positive chronic myeloid leukemia.