Related pages Drug Information Summaries 1 Approval Process for New Cancer Treatments 2 Access to Investigational Drugs 3

This page contains brief information about everolimus 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):		Afinitor
FDA Approved:		Yes

Everolimus is approved by the Food and Drug Administration (FDA) to treat patients with advanced renal cell carcinoma who have already been treated with sunitinib or sorafenib and have not gotten better.

Everolimus is also approved to be used in a medical device called a stent to treat coronary (heart) artery disease. The drug is released over time, from the stent into the wall of the coronary artery. This helps to keep the artery open. This use comes under the brand name Xience V.

Everolimus is being studied in the treatment of other types of cancer and other conditions.

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

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

Clinical Trial Results: Everolimus Extends Progression-Free Survival in Advanced Kidney Cancer (07/30/2008) ⁶ - Important clinical trial results for this drug, background information, and how the trial was done.

Rapamycin Agent Improves Response to Low-Dose Cisplatin (04/05/2005) ⁷ - Information about the use of this drug to treat cancer.

Clinical Trials for Everolimus ⁸ - Check for trials from NCI's PDQ Cancer Clinical Trials Registry now accepting patients.

Glossary Terms

Cancer that has spread to other places in the body and usually cannot be cured or controlled with treatment.

A blood vessel that carries blood from the heart to tissues and organs in the body.

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.

A disease in which there is a narrowing or blockage of the coronary arteries (blood vessels that carry blood and oxygen to the heart). Coronary artery disease is usually caused by atherosclerosis (a build up of fatty material and plaque inside the coronary arteries). The disease may cause chest pain, shortness of breath during exercise, and heart attacks. The risk of coronary artery disease is increased by having a family history of coronary artery disease before age 50, older age, smoking tobacco, high blood pressure, high cholesterol, diabetes, lack of exercise, and obesity. Also called CAD and coronary heart disease.

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.

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.

A drug used to treat advanced kidney cancer and a type of liver cancer that cannot be removed by surgery. It is also being studied in the treatment of other types of cancer. Sorafenib stops cells from dividing and may prevent the growth of new blood vessels that tumors need to grow. It is a type of kinase inhibitor and a type of antiangiogenesis agent. Also called BAY 43-9006, Nexavar, and sorafenib tosylate.

A device placed in a body structure (such as a blood vessel or the gastrointestinal tract) to keep the structure open.

A drug used to treat gastrointestinal stromal tumors (GIST) that have not responded to treatment with imatinib mesylate (Gleevec). Sunitinib is also used to treat advanced kidney cancer and is being studied in the treatment of other types of cancer. It is a type of tyrosine kinase inhibitor, a type of vascular endothelial growth factor (VEGF) receptor inhibitor, and a type of angiogenesis inhibitor. Also called SU011248, SU11248, sunitinib malate, and Sutent.