The FDA’s Oncologic Drug Advisory Committee today voted 6-6 on whether the risk-benefit profile of sunitinib malate is acceptable for the adjuvant treatment of patients with a high-risk for recurrent renal cell carcinoma following nephrectomy.

The committee considered data from the S-TRAC trial, which randomly assigned patients at high risk for recurrent renal cell carcinoma following nephrectomy to 1 year of sunitinib (Sutent, Pfizer Oncology; n = 309) or placebo (n = 306). Patients assigned sunitinib received 50-mg doses for 4 weeks following by 2 weeks off, and the dose could be reduced to 37.5 mg.