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Drug Information
    Posted: 10/05/2006    Updated: 04/21/2009
Related pages
Drug Information Summaries 1

Approval Process for New Cancer Treatments 2

Access to Investigational Drugs 3
Sunitinib Malate

This page contains brief information about sunitinib malate and a collection of links to more information about the use of this drug, related news and research results, and ongoing clinical trials.

US Brand Name(s):Sutent
FDA Approved:Yes

Sunitinib malate is approved by the Food and Drug Administration (FDA) to treat a type of stomach cancer called gastrointestinal stromal tumor (GIST). It is used in patients whose condition has become worse while taking another drug called imatinib mesylate or who are not able to take imatinib mesylate.

Sunitinib malate is also approved to treat metastatic renal cell carcinoma (kidney cancer).

Sunitinib malate is also being studied in the treatment of other types of cancer.

Information from the FDA

FDA Approval for Sunitinib Malate 4 - Information from the FDA about the approval of this drug and the clinical trials that led to the approval.

Information from the NCI

Definition from the NCI Drug Dictionary 5 - Detailed scientific definition and other names for this drug.

Sunitinib Linked to Heart Failure and Hypertension (01/08/2008) 6 - Information about the use of this drug to treat cancer.

Clinical Trial Results: Sunitinib Effective Against GIST After Imatinib Fails (08/05/2006) 7 - Important clinical trial results for this drug, background information, and how the trial was done.

Clinical Trial Results: Sunitinib and Temsirolimus - Two New Targeted Drugs for Advanced Kidney Cancer (06/05/2006) 8 - Important clinical trial results for this drug, background information, and how the trial was done.

Information from the National Library of Medicine (NLM)

MedlinePlus Information on Sunitinib Malate 9 - A lay language summary of important information about this drug that may include the following:

  • warnings about this drug,
  • what this drug is used for and how it is used,
  • what you should tell your doctor before using this drug,
  • what you should know about this drug before using it,
  • other drugs that may interact with this drug, and
  • possible side effects.

Drugs are often studied to find out if they can help treat or prevent conditions other than the ones they are approved for. This NLM patient information sheet applies only to approved uses of the drug. However, much of the information may also apply to unapproved uses that are being studied.

Clinical Trials

Clinical Trials for Sunitinib Malate 10 - Check for trials from NCI's PDQ Cancer Clinical Trials Registry now accepting patients.

Important: The drug information on this Web page is meant to be educational. It is not a substitute for medical advice. The information may not cover all possible uses, actions, interactions, or side effects of this drug, or precautions to be taken while using it. Please see your health care professional for more information about your specific medical condition and the use of this drug.




Glossary Terms

cancer (KAN-ser)
A term for diseases in which abnormal cells divide without control and can invade nearby tissues. Cancer cells can also spread to other parts of the body through the blood and lymph systems. There are several main types of cancer. Carcinoma is a cancer that begins in the skin or in tissues that line or cover internal organs. Sarcoma is a cancer that begins in bone, cartilage, fat, muscle, blood vessels, or other connective or supportive tissue. Leukemia is a cancer that starts in blood-forming tissue such as the bone marrow, and causes large numbers of abnormal blood cells to be produced and enter the blood. Lymphoma and multiple myeloma are cancers that begin in the cells of the immune system. Central nervous system cancers are cancers that begin in the tissues of the brain and spinal cord. Also called malignancy.
Food and Drug Administration
An agency in the U.S. federal government whose mission is to protect public health by making sure that food, cosmetics, and nutritional supplements are safe to use and truthfully labeled. The Food and Drug Administration also makes sure that drugs, medical devices, and equipment are safe and effective, and that blood for transfusions and transplant tissue are safe. Also called FDA.
gastrointestinal stromal tumor (GAS-troh-in-TES-tih-nul STROH-mul TOO-mer)
A type of tumor that usually begins in cells in the wall of the gastrointestinal tract. It can be benign or malignant. Also called GIST.
imatinib mesylate (ih-MAH-tih-nib MEH-zih-layt)
A drug used to treat different types of leukemia and other cancers of the blood, gastrointestinal stromal tumors, skin tumors called dermatofibrosarcoma protuberans, and a rare condition called systemic mastocytosis. It is also being studied in the treatment of other types of cancer. Imatinib mesylate blocks the protein made by the bcr/abl oncogene. It is a type of tyrosine kinase inhibitor. Also called Gleevec and STI571.
metastatic (meh-tuh-STA-tik)
Having to do with metastasis, which is the spread of cancer from the primary site (place where it started) to other places in the body.
renal cell cancer
The most common type of kidney cancer. It begins in the lining of the renal tubules in the kidney. The renal tubules filter the blood and produce urine. Also called hypernephroma.
stomach cancer (STUH-muk KAN-ser)
Cancer that forms in tissues lining the stomach. Also called gastric cancer.


Table of Links

1http://www.cancer.gov/cancertopics/druginfo/alphalist
2http://www.cancer.gov/clinicaltrials/learning/approval-process-for-cancer-drugs
3http://www.cancer.gov/cancertopics/factsheet/Therapy/investigational-drug-access
4http://www.cancer.gov/cancertopics/druginfo/fda-sunitinib-malate
5http://www.cancer.gov/Templates/drugdictionary.aspx?CdrID=299061
6http://www.cancer.gov/ncicancerbulletin/NCI_Cancer_Bulletin_010808/page3
7http://www.cancer.gov/clinicaltrials/results/sunitinib-and-GIST0806
8http://www.cancer.gov/clinicaltrials/results/sunitinib-and-temsirolimus0606
9http://www.nlm.nih.gov/medlineplus/druginfo/meds/a607052.html
10http://www.cancer.gov/Search/ClinicalTrialsLink.aspx?id=299061&idtype=1