The Food and Drug Administration (FDA) has approved an expanded indication for Sutent (sunitinib malate; Pfizer) for use as adjuvant treatment in adults who are at high risk of renal cell carcinoma (RCC) returning after a nephrectomy, making it the first treatment for this indication. 

The expanded approval was based on data from the S-TRAC trial, a multicenter, international, randomized, double-blind, placebo-controlled Phase 3 trial of Sutent versus placebo in 615 patients with clear cell histology and high risk of recurrent RCC following nephrectomy. The primary endpoint of the study was improvement in disease-free survival (DFS) defined as the interval between randomization and tumor recurrence, or secondary primary cancer death from any cause.

The data showed after 5 years, 59.3% of patients treated with Sutent had not experienced cancer recurrence or death vs. 51.3% of patients receiving placebo. The median DFS was 6.8 years (95% CI: 5.8, not reached [NR]) in the Sutent arm compared with 5.6 years (95% CI: 3.8, 6.6) in the placebo arm.  

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No new safety signals were identified in the S-TRAC trial. The labeling for Sutent contains a boxed warning to alert about the risk of hepatoxicity, which may result in liver failure or death.

Sutent, a kinase inhibitor, is already indicated to treat advanced RCC, gastrointestinal stromal tumors after disease progression on or intolerance to imatinib mesylate; and progressive, well-differentiated pancreatic neuroendocrine tumors (pNET) in patients with unresectable locally advanced or metastatic disease.

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