Imatinib Granted Expanded Use in Patients with Rare Gastrointestinal Tumors
The Food and Drug Administration (FDA) granted imatinib (Gleevec) regular approval for use in adult patients following surgical removal of CD117-positive gastrointestinal stromal tumors (GIST). CD117, or Kit, is a molecular marker found on most GISTs. The approval highlights an increase in overall survival when the drug is taken for 36 months rather than the standard 12 months.In a large randomized clinical study, GIST patients who took imatinib for 36 months had significantly longer overall survival, and lived longer without the disease recurring, than those who took imatinib for 12 months. At 60 months, 92 percent of patients who took imatinib for 36 months were alive, compared with 82 percent of patients who took it for 12 months.
Imatinib was originally granted accelerated approval for the treatment of metastatic GIST in 2002. In 2008, imatinib received a subsequent accelerated approval for adjuvant use to treat GIST patients who had had their tumors removed but who were at increased risk for a recurrence. Accelerated approval provides earlier patient access to promising new drugs while confirmatory clinical trials are conducted. Regular approval for the metastatic GIST indication was also granted in 2008.
"The development of [imatinib] over the past decade highlights the need to further study drugs after approval to truly characterize their benefits," said Dr. Richard Pazdur, director of the Office of Hematology and Oncology Products in the FDA Center for Drug Evaluation and Research. "Although originally approved in the metastatic disease setting, this subsequent trial has demonstrated that longer use of [imatinib] can prolong patient's lives in earlier disease settings."
The most common side effects observed in patients receiving imatinib include swelling (edema), nausea, vomiting, muscle cramps, bone or muscle pain, diarrhea, rash, fatigue, and abdominal pain.
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