The US Food and Drug Administration has approved Sutent (sunitinib malate) for the adjuvant treatment of adult patients at high risk of recurrent renal cell carcinoma (RCC) following nephrectomy.
The approval was based on a multi-center, clinical trial in which 615 patients with high risk RCC were treated with surgical nephrectomy and then received additional treatment either Sutent once daily, 4 weeks on treatment followed by 2 weeks off, or no additional therapy and directly compared. The average duration of survival without cancer for patients taking Sutent was 6.8 years compared with 5.6 years years for those receiving no additional treatment.
The most common adverse reactions (≥25%) to Sutent were fatigue/asthenia, diarrhea, mucositis/stomatitis, nausea, decreased appetite/anorexia, vomiting, abdominal pain, hand-foot syndrome, hypertension, bleeding events, dysgeusia/altered taste, dyspepsia, and thrombocytopenia. The labeling contains a boxed warning to alert healthcare professionals and patients about the risk of hepatoxicity which may result in liver failure or death.
This is the first medication approved for use following surgery in high risk renal cell cancer.