Sutent

Treats gastrointestinal stromal tumor (GIST) after disease progression on or intolerance. NDA 21938, held by Cppi Cv. Sunitinib Malate.

As of Nov 14, 2026, NDA 21938 (Sutent), held by Cppi Cv, was first approved by FDA on Jan 26, 2006, with 35 approved supplements and 0 published complete response letters.

First approved: Jan 26, 2006
Review: Priority
Supplements approved: 35
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

SUTENT is a kinase inhibitor indicated for:

treatment of adult patients with gastrointestinal stromal tumor (GIST) after disease progression on or intolerance to imatinib mesylate.
treatment of adult patients with advanced renal cell carcinoma (RCC).
adjuvant treatment of adult patients at high risk of recurrent RCC following nephrectomy.
treatment of progressive, well-differentiated pancreatic neuroendocrine tumors (pNET) in adult patients with unresectable locally advanced or metastatic disease. 1.

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 36 submissions below


Aug 30, 2021	Supplement 39Efficacy (new indication or use) · Standard review	Approved	Letter Label Medication Guide
May 7, 2019	Supplement 36Efficacy (new indication or use) · Priority review	Approved	Letter Label Pediatric Medical Review
Nov 16, 2017	Supplement 33Efficacy (new indication or use) · Standard review	Approved	Letter Label
May 20, 2011	Supplement 13Efficacy (new indication or use) · Priority review	Approved	Letter Label
Jul 1, 2010	Supplement 10Efficacy (new indication or use) · Standard review	Approved	Letter Label
Feb 2, 2007	Supplement 5Efficacy (new indication or use) · Priority review	Approved	Letter Label Review
Feb 2, 2007	Supplement 4Efficacy (new indication or use) · Priority review	Approved	Letter Label Review
Feb 2, 2007	Supplement 3Efficacy (new indication or use)	Approved	Letter Review Label
Jan 26, 2006	Original applicationNew molecular entity · Priority review	Approved	Review Letter Label Pediatric Amendment 1

Products

4 strengths and forms


SutentEQ 12.5MG BASE · capsule;oral	Sunitinib Malate	RxReference drug
SutentEQ 25MG BASE · capsule;oral	Sunitinib Malate	RxReference drug
SutentEQ 50MG BASE · capsule;oral	Sunitinib Malate	RxReference drug
SutentEQ 37.5MG BASE · capsule;oral	Sunitinib Malate	RxReference drug

All 36 submissions, including labeling and manufacturing supplements


Aug 30, 2021	Supplement 39Efficacy (new indication or use) · Standard review	Approved	Letter Label Medication Guide
Aug 14, 2020	Supplement 37Labeling · Standard review	Approved	Label Letter
Jul 10, 2020	Supplement 38Labeling · Standard review	Approved	Letter Label
May 7, 2019	Supplement 36Efficacy (new indication or use) · Priority review	Approved	Letter Label Pediatric Medical Review
Dec 13, 2018	Supplement 35Labeling · Standard review	Approved	Label Letter
Nov 16, 2017	Supplement 33Efficacy (new indication or use) · Standard review	Approved	Letter Label
Nov 16, 2015	Supplement 31Labeling · Standard review	Approved	Label Letter
Oct 8, 2015	Supplement 30Manufacturing · Priority review	Approved	None posted
Apr 24, 2015	Supplement 29Labeling · Standard review	Approved	Label Letter
Apr 24, 2015	Supplement 28Labeling · Standard review	Approved	Label Letter
Dec 19, 2014	Supplement 27Labeling · Standard review	Approved	Letter Label
Jun 11, 2014	Supplement 26Labeling · Standard review	Approved	Letter
Aug 30, 2013	Supplement 25Labeling · Standard review	Approved	Label Letter
Aug 30, 2013	Supplement 24Labeling · Standard review	Approved	Label Letter
Nov 16, 2012	Supplement 23Labeling · Standard review	Approved	Letter Label
Nov 16, 2012	Supplement 22Labeling · Standard review	Approved	Letter Label
Nov 16, 2012	Supplement 21Labeling · Standard review	Approved	Letter Label
Apr 20, 2012	Supplement 20Labeling	Approved	Letter Label
Apr 20, 2012	Supplement 19Labeling	Approved	Letter Label
May 20, 2011	Supplement 18Labeling	Approved	Letter Label
May 20, 2011	Supplement 17Labeling · Standard review	Approved	Letter Label
May 20, 2011	Supplement 13Efficacy (new indication or use) · Priority review	Approved	Letter Label
Jul 1, 2010	Supplement 15Labeling	Approved	Letter Label
Jul 1, 2010	Supplement 14Labeling	Approved	Label Letter
Jul 1, 2010	Supplement 11Labeling	Approved	Label Letter
Jul 1, 2010	Supplement 10Efficacy (new indication or use) · Standard review	Approved	Letter Label
Mar 31, 2009	Supplement 9Manufacturing	Approved	Label Letter
Nov 7, 2008	Supplement 8Labeling · Standard review	Approved	Letter Label
Nov 7, 2008	Supplement 7Labeling · Standard review	Approved	Label Letter
Nov 7, 2008	Supplement 6Labeling · Standard review	Approved	Letter Label
Feb 2, 2007	Supplement 5Efficacy (new indication or use) · Priority review	Approved	Letter Label Review
Feb 2, 2007	Supplement 4Efficacy (new indication or use) · Priority review	Approved	Letter Label Review
Feb 2, 2007	Supplement 3Efficacy (new indication or use)	Approved	Letter Review Label
Feb 2, 2007	Supplement 2Labeling · Standard review	Approved	Letter Label Review
May 10, 2006	Supplement 1Manufacturing	Approved	None posted
Jan 26, 2006	Original applicationNew molecular entity · Priority review	Approved	Review Letter Label Pediatric Amendment 1

Identifiers

Application: NDA 21938
Drugs@FDA: Overview at FDA
Company: CPPI CV

Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed daily; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters