General Information | Phase III trial results | Article about Sutent Drug Interactions

The United States Food and Drug Administration (FDA) announced Jan. 26 2006, that it has approved Sutent (sunitinib) for patients with GISTs that had stopped responding to Gleevec or that were unable to tolerate Gleevec. It is also approved for advanced kidney cancer.

Sutent is known to be a potent inhibitor of wild-type KIT and has shown activity in adult patients with wild-type GIST. Combining this knowledge, along with the knowledge that KIT was activated in Pediatric GIST, Dr. Katherine Janeway and her clinical colleagues at Dana Farber Cancer Institute have treated six Pediatric GIST patients with advanced tumors that are resistant to imatinib with Sutent. Five of the six patients have had disease stabilization or a partial response. In four of the five patients the duration of response was longer than was seen with the previous Gleevec treatment. This finding appears to suggest a possible role for Sutent in Pediatric GIST. See the results as reported at the 2006 ASCO meeting. Also see the Dana Farber press release June 5, 2006 New targeted therapy shows promise in children with metastatic GIST

Sutent is also approved in a number of countries outside of the United States.

Sutent® is known by several different names:

• Sutent®, the brand name
• Sunitinib malate, the generic name
• SU11248 (sometimes written as SU011248) in clinical trials

Sutent is a pill that is taken once daily. The usual dosage is 50 mg per day. It is given daily for four weeks, before a two week rest period. This cycle is then repeated as long as the patient continues to show benefit. Sutent has also been given at 37.5 mg every day in a phase II clinical trial with results comparable to the 4 week on/2 week off schedule.

Sutent is a tyrosine kinase inhibitor that is similar to Gleevec in some ways. Both drugs inhibit the KIT protein (mutated in 80-85% of GISTs) and the PDGFRa protein (mutated in 5-7% of GISTs). Inhibition of these proteins provides a direct anti-tumor effect when the target protein (KIT or PDGFRa) is mutated. In addition, some tumors that don't have KIT or PDGFRa mutations (called "wild-type" GISTs) might still provide a growth/survival signal through KIT activation and might still benefit from KIT inhibition (either by Gleevec or by Sutent).

Both Sutent and Gleevec also provide an antiangiogenic effect through inhibition of PDGFRß. PDGFRß is involved in the recruitment of pericytes, which are needed to form new blood vessels to feed the tumors.

In addition to inhibiting these three proteins, Sutent provides an additional antiangiogenic effect that Gleevec does not; Sutent inhibits the "VEGF" receptors. VEGF is one of the most promising of the antiangiogenesis targets. For detailed information about angiogenesis visit the website of The Angiogenesis Foundation.

Target Proteins Inhibited
Gleevec Sutent
abl (including bcr/abl) VEGFR1

View a presentation about Sutent for GIST (loads slowly)
(A Broadband Internet (Cable, DSL) connection is preferred)
Includes information on: Sutent approval, safety information, reported side effects,
dosing and pharmacokinetics and other information.

Sutent for GIST (10 MB)

Sutent Capsules


Side Effect Guide

Being able to properly manage the side effects of Sutent, or any drug, is one of the key steps required to allow patients to take their medication as prescribed by their doctor. It is also one of the keys to feeling better and being able to do the things that are important to you. has a interactive guide to help patients create a list of symptoms and side effects to share with your doctor.

Note: These links take you to the website

Also see the full text article, Evolving Strategies for the Management of Hand–Foot Skin Reaction Associated with the Multitargeted Kinase Inhibitors Sorafenib and Sunitinib

Sutent Side Effect Guide

Sutent-Tips for living well

Financial Assistance

Patients and physicians can visit or phone FirstRESOURCE at (877) 744-5675 for information about patient assistance for those who don’t have drug coverage and for information about reimbursement issues or appeals assistance.

View a presentation about accessing Sutent; financial assistance, etc

Additional Links (some may be more relevant to adult GIST)

• 2005 ASCO presentation by Dr. Robert Maki:
• Fact sheet (Phase 1/2 trial summary)
• (Results) Phase 3, Multicenter, Randomized, Double-blind, Placebo-controlled Trial of SU11248 in Patients Following Failure of Imatinib for Metastatic GIST
• 2005 ASCO presentation by Dr. George Demetri
• SU11248, a multi-targeted tyrosine kinase inhibitor, can overcome imatinib (IM) resistance caused by diverse genomic mechanisms in patients (pts) with metastatic gastrointestinal stromal tumor (GIST)
• Managing the side effects of Sutent - a practical guide
• Safety and efficacy of second-line sunitinib in GIST

For more information about Sutent, call your doctor, visit or see the full Prescribing Information.

Also see Sutent Dose Card and GIST Patient Brochure: