FDA Expands Sunitinib Indication To Include Adjuvant Therapy for Renal Cell Carcinoma

The US Food and Drug Administration (FDA) approved expanding the indication of sunitinib to include adjuvant therapy for adult patients with renal cell carcinoma (RCC) who are at high risk of relapse after nephrectomy, according to a press release.¹

The approval was based on data from the S-TRAC phase 3 study (ClinicalTrials.gov Identifier: NCT00375674), for which researchers randomly assigned 615 patients with RCC to receive post-nephrectomy adjuvant oral sunitinib or placebo for 1 year. Eligible patients had locoregional disease, tumor stage III or greater, and/or regional lymph-node metastases. No patients previously received systemic therapy.

After a median follow-up of 5.4 years, the median disease-free survival was 6.8 years (95% CI, 5.8-not evaluable) in the sunitinib arm vs 5.6 years (95% CI, 3.8-6.6) in the placebo arm (hazard ratio, 0.76; 95% CI, 0.59-0.98; P = .03).

After 5 years, 8% more patients in the sunitinib arm were alive without progressive disease than patients in the placebo arm (59.3% vs 51.3%, respectively).

Severe adverse events include hepatotoxicity, heart failure, myocardial ischemia/infarction, QT prolongation/Torsade de Pointes, hypertension, hemorrhage, tumor lysis syndrome, thrombotic microangiopathy, and proteinuria.

Thirty to 40% of patients with RCC relapse a median of 2 years after nephrectomy. The majority of relapses occur within 5 years.

Reference

1. FDA expands approval of Sutent to reduce the risk of kidney cancer returning. Silver Spring, MD: US Food and Drug Administration; November 16, 2017. https://www.fda.gov/NewsEvents/Newsroom/ PressAnnouncements/ucm585657.htm. Accessed November 17, 2017.