publication date: Nov. 17, 2017

FDA approves adjuvant indication for Sutent in renal cell carcinoma

FDA approved Sutent (sunitinib malate) for the adjuvant treatment of adult patients who are at a high risk of renal cell carcinoma returning after nephrectomy.

Sutent is sponsored by Pfizer Inc.

The application went to the FDA Oncologic Drugs Advisory Committee on Sept. 19 (The Cancer Letter, Sept. 22).

“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, director of the FDA’s Oncology Center of Excellence and acting director of the Office of Hematology and Oncology Products in the FDA’s 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.”

Sutent, a kinase inhibitor, was first approved in 2006 for the treatment of certain patients with gastrointestinal stromal tumors and advanced renal cell carcinoma. It is also approved for patients with a certain type of pancreatic cancer.

The approval of Sutent for the adjuvant treatment of renal cell carcinoma was based on a randomized trial of 615 patients with high risk of recurrent renal cell carcinoma following nephrectomy. The … Continue reading FDA approves adjuvant indication for Sutent in renal cell carcinoma

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