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Treats gastrointestinal stromal tumor (GIST) after disease progression on or intolerance. Sold as Sutent. Every FDA application for this active ingredient: 2 branded and 8 generic.
As of Nov 15, 2026, FDA lists 10 applications for Sunitinib Malate (sold as Sutent), first approved Jan 26, 2006, with 12 new uses approved and 0 published complete response letters.
First approved: Jan 26, 2006
Applications: 10
New uses approved: 12
Complete response letters: 0
Medicare spending, 2025: $39.6M
First approved in the EU: Jul 19, 2006
First approved in Japan: Apr 16, 2008
Medicare Spending
CMS Part D and Part B, 2025, before manufacturer rebates; matched by generic name
First approved in Japan 27 months after the US. PMDA's English list since 2008, matched by ingredient; see all Japanese approvals
SutentA drug with a new additional indication and a new dosage for pancreatic neuroendocrine tumour. · Pfizer Japan Inc. · Aug 10, 2012
Sutent, new ingredientA drug containing a new active ingredient indicated for the treatment of imatinib-resistant gastrointestinal stromal tumors, and unresectable or metastatic… · Pfizer Japan Inc. · Apr 16, 2008
Clinical Trials
54 open or ongoing studies name this ingredient as an intervention, including as a comparator; newest first. See all
Applications, approvals and products come from FDA's Drugs@FDA data files, refreshed weekly, grouped by active ingredient as FDA spells it. Complete response letters are FDA's published letters. Medicare spending is CMS's Part D and Part B dashboard, matched to this ingredient by generic name; shortages are FDA's shortage list, matched by application number; clinical trials are ClinicalTrials.gov studies naming the ingredient as an intervention, refreshed daily; safety programs are FDA's REMS list, matched by application number or, for shared programs, by ingredient.Drugs@FDA
Mylan
Eugia Pharma