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Imatinib approved to prevent GIST recurrence
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On Friday, the FDA announced the approval of imatinib as adjuvant treatment for patients with surgically removed gastrointestinal stromal tumors.
Imatinib (Gleevec, Novartis) is already approved to treat inoperable or metastasized GIST; it is the only drug approved as post-surgical treatment in this cancer type.
The approval was based on data from the randomized phase-3, double blind, study ACOSOG Z9001. The study included 700 patients who underwent surgical removal of their tumors. Patients were randomly assigned to receive 400 mg per day imatinib or placebo for one year. Median follow-up was 14 months.
Of patients assigned to imatinib, 8.4% had a cancer recurrence compared with 19.8% of patients assigned to placebo (HR=0.398; 95% CI, 0.259-0.610).
The most frequently reported adverse events were diarrhea, fatigue, nausea, edema, decreased hemoglobin, rash, vomiting and abdominal pain. – by Leah Lawrence
The FDA approval of imatinib in the adjuvant setting for fully resected GIST is consistent with studies that show the delay of recurrence in patients with intermediate- to high-risk GIST. The duration of this adjuvant therapy is unclear at this time.
– Alan Venook, MD
HemOnc Today Editorial Board member