Adjuvant Renal Cell Carcinoma Drug Receives FDA Greenlight


Sunitinib malate (Sutent) may improve disease-free survival among patients with renal cell carcinoma.

The FDA recently issued regulatory approval to sunitinib malate (Sutent) as an adjuvant therapy for adults at risk of recurrent renal cell carcinoma (RCC) following nephrectomy, according to a press release.

Sutent is an oral multi-kinase inhibitor that first received FDA approval in 2006 for the treatment of advanced RCC, which accounts for


90% of all kidney cancers.

The new approval was based on positive findings from the S-TRAC clinical trial, which included 615 patients who were at a high risk of recurrent RCC.

In the study, patients were randomized 1:1 to receive sunitinib malate 50-mg once daily for 4 weeks


followed by 2 weeks off, or placebo.

The investigators found that the median disease-free survival for patients treated with sunitinib malate was 6.8 years compared with 5.6 years for the placebo cohort, according to the FDA.

At 5 years, 59.3% of patients administered sunitinib malate did not experience recurrence or death compared with 51.3% of patients administered placebo, according to the release.

However, at the time of the analysis, the overall survival benefit for to sunitinib malate could not be determined, according to the release.

The most common adverse reactions included 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 FDA advises that sunitinib malate comes with a boxed warning regarding the risk of hepatoxicity, which can result in liver failure or death, according to the release.

Sunitinib malate is indicated as a 50-mg dose once daily for 4 weeks, followed by 2 weeks off for nine 6-week cycles, according to the FDA. The drug can be taken with or without food.

“This is the first adjuvant treatment approved for patients with renal cell carcinoma, which is significant because patients with this disease who have a nephrectomy are often at high risk of the cancer returning,” said Richard Pazdur, MD, director of the FDA Oncology Center of Excellence and acting director of the Office of Hematology and Oncology Products in the FDA Center for Drug Evaluation and Research. “There is now an approved therapy for patients who previously did not have options to potentially reduce cancer recurrence.”

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