Sutent® Approved for Kidney Cancer

Sutent® Approved for Kidney Cancer

The United States Food and Drugs Administration (FDA) has approved the new targeted agent Sutent (sunitinib malate) for treatment of advanced renal cell carcinoma (the most common type of kidney cancer). Sutent® will be available for use on February 3, 2006.

The kidneys are each filled with tiny tubules that clean and filter the blood-the process that removes waste and makes urine. Renal cell cancer (RCC) is a malignancy involving these tubules of the kidney.

Advanced renal cell carcinoma refers to cancer that has spread beyond the kidney to different places in the body. Treatment for advanced RCC includes four basic treatment options: surgery, radiation, chemotherapy, and biologic therapy. (Biologic therapy uses substances made by the body or made in a laboratory that are used to boost, or direct, the patient’s own immune system to fight the cancer.)

Stem cell transplantation is also being evaluated for renal cell cancer. As well, Nexavar®, also a newly approved agent for advanced RCC, is a therapeutic approach that targets enzymes involved in cancer growth and formation of blood vessels that supply nutrients to cancer cells. Once a patient’s disease stops responding to standard therapy, treatment options for advanced RCC are limited.

Sutent is an oral targeted agent that works by inhibiting multiple biologic pathways involved in the growth, replication, and spread of cancer cells. Sutent deprives cancer cells of blood and nutrients needed for growth.

Results from two clinical trials prompted the FDA approval of Sutent. The first clinical trial included 106 patients, and the second trial included 63 patients. All patients had metastatic RCC (cancer spread to distant sites in the body) and had cancer progression following prior cytokine therapy (therapy to stimulate the immune system to fight the cancer). The majority of patients had also undergone the surgical removal of their kidney (nephrectomy).

  • Overall anticancer response rates were 25.5% in the first trial, and 36.5% in the second trial.
  • Anticancer responses lasted 27 weeks in the first trial and 54 weeks in the second trial.
  • The most common side effects included diarrhea, skin discoloration, mouth irritation, weakness, and altered taste.

Patients with advanced RCC may wish to speak with their physician regarding their individual risks and benefits of treatment with Sutent. Patients and physicians can call 1-877-744-5675 for information regarding patient assistance for those who don’t have prescription drug coverage and information about reimbursement issues or appeals assistance.


  1. United States Food and Drug Administration (FDA). FDA Approves New Treatment for Gastrointestinal and Kidney Cancer. Available at: Accessed January 2006.

  2. Pfizer. Sutent Prescribing Information. Available at: Accessed January 2006.

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