On November 16, 2017, the U.S. Food and Drug Administration approved the Pfizer Inc. drug Sutent (sunitinib malate) as the first approved adjuvant treatment for adult patients who are at a high risk of kidney cancer (renal cell carcinoma) returning after a kidney has been removed (nephrectomy). An adjuvant treatment is a form of therapy that is taken by patients following the initial surgical removal of a diseased kidney to lower the risk of cancer coming back. In a statement, Richard Pazdur, M.D., 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 remarked on the approval of Sutent. In that statement, he said with the approval of Sutent, adjuvant treatment for those at a high risk of kidney cancer returning following the removal of a kidney, that “there is now an approved therapy for patients who previously did not have options to potentially reduce cancer recurrence.” The approval of Sutent also comes with a warning related to both common and severe side effects, including a boxed warning that advises both healthcare professionals and patients about the risk of severe liver damage (hepatoxicity), which may result in liver failure or death. For more information about the approval of Sutent, and to read the full FDA NEWS RELEASE, click here to go directly to the FDA site
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