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Sutent FDA Approval History

FDA Approved: Yes (First approved January 26, 2006)
Brand name: Sutent
Generic name: sunitinib malate
Dosage form: Capsules
Company: Pfizer Inc.
Treatment for: Gastrointestinal Stromal Tumor, Renal Cell Carcinoma, Pancreatic Cancer

Sutent (sunitinib malate) is an oral multi-kinase inhibitor indicated for the treatment of gastrointestinal stromal tumors, advanced renal cell carcinoma (RCC), adjuvant treatment of patients at high risk of recurrent RCC following nephrectomy, and the treatment of pancreatic neuroendocrine tumors.

Development timeline for Sutent

Nov 16, 2017Approval FDA Approves Sutent (sunitinib malate) for Adjuvant Treatment of Adult Patients at High Risk of Recurrent Renal Cell Carcinoma
May 20, 2011Approval FDA Approves Sutent for Rare Type of Pancreatic Cancer
Jan 26, 2006Approval FDA Approves Sutent for Gastrointestinal Stromal Tumors and Advanced Renal Cell Carcinoma
Aug 10, 2005Pfizer Submits New Drug Application for Sutent to FDA

Further information

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