HealthDay News — The FDA has expanded indications for imatinib mesylate tablets (Gleevec, Novartis) to include treatment of adults who have undergone surgical removal of CD117-positive gastrointestinal stromal tumors (GIST), the agency said in a press release.
Imatinib mesylate tablets were first approved to treat Philadelphia chromosome positive chronic myeloid leukemia in 2001 and have subsequently been sanctioned for a number of forms of GIST, a rare cancer that forms in cells lining the gastrointestinal tract.
Labeling information for imatinib will be updated to include data from the randomized multicenter phase 3 clinical trial, upon which the new indication was based. Patients with CD117-positive GIST who were treated with 400 mg oral imatinib daily for 36 months had significantly increased recurrence-free survival compared to those assigned to the same imatinib dose for 12 months (hazard ratio=0.46; 95% CI:0.32-0.65; P=0.0001).
Overall survival at median 48-month follow up was also higher among the 36-month treatment group compared with the 12-month treatment group (HR=0.45; 95% CI:0.22-0.89; P=0.0187) with 25 deaths occurring in the 12 month treatment arm vs. 12 deaths in 36 month treatment arm (13% vs. 6%).
Common clinical side effects included swelling, nausea and vomiting, muscle cramps, bone or muscle pain, diarrhea, rash, fatigue and abdominal pain.