Sutent Approved for Patients at High Risk of Recurrent RCC

Sutent was first approved in 2006 for the treatment of certain patients with gastrointestinal stromal tumors and advanced renal cell carcinoma.

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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