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

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

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

Cetuximab is approved by the Food and Drug Administration (FDA) to treat the following types of cancer:

• Squamous cell carcinoma of the head and neck (SCCHN). Cetuximab is used by itself to treat SCCHN that has metastasized (spread to other parts of the body) or recurred (come back) after other chemotherapy. It is also used with radiation therapy, as a first-time treatment for advanced SCCHN.
• Colorectal cancer. Cetuximab is used to treat colorectal cancer that has metastasized or has recurred after other chemotherapy. It is sometimes used with another drug called irinotecan.

Cetuximab is being studied in the treatment of other types of cancer.

Patient Information Sheet on Cetuximab ⁴ - A lay language summary of important information about this drug that may include the following:

• FDA warnings or alerts 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 FDA patient information sheet applies only to approved uses of the medicine. However, much of the information may also apply to unapproved uses that are being studied.

FDA Approval for Cetuximab ⁵ - 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 ⁶ - Detailed scientific definition and other names for this drug.

Clinical Trial Results: Combining Targeted Drugs Is Worse in Colorectal Cancer (02/24/2009) ⁷ - Important clinical trial results for this drug, background information, and how the trial was done.

Clinical Trial Results: Colorectal Cancer Trials Support Gene Testing for Two Drugs (11/12/2008) ⁸ - Important clinical trial results for this drug, background information, and how the trial was done.

Clinical Trial Results: Cetuximab Plus Chemotherapy Extends Survival for Advanced Lung Cancer (06/19/2008) ⁹ - Important clinical trial results for this drug, background information, and how the trial was done.

Clinical Trial Results: Colorectal Cancer Drugs Require Careful Patient Selection (06/18/2008) ¹⁰ - Important clinical trial results for this drug, background information, and how the trial was done.

Clinical Trial Results: Cetuximab Plus Chemotherapy Extends Survival in Advanced Head and Neck Cancer (06/26/2007) ¹¹ - Important clinical trial results for this drug, background information, and how the trial was done.

Clinical Trial Results: Cetuximab Plus Radiation Beneficial for Patients with Head and Neck Cancer (06/05/2004) ¹² - Important clinical trial results for this drug, background information, and how the trial was done.

Clinical Trial Results: Cetuximab Combination More Effective Than Cetuximab Alone in Colorectal Cancer (06/01/2003) ¹³ - Important clinical trial results for this drug, background information, and how the trial was done.

MedlinePlus Information on Cetuximab ¹⁴ - 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 for Cetuximab ¹⁵ - 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 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 cancer that begins in the skin or in tissues that line or cover internal organs. Sarcoma is cancer that begins in bone, cartilage, fat, muscle, blood vessels, or other connective or supportive tissue. Leukemia is 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.

Treatment with drugs that kill cancer cells.

Cancer that develops in the colon (the longest part of the large intestine) and/or the rectum (the last several inches of the large intestine before the anus).

Any substance, other than food, that is used to prevent, diagnose, treat or relieve symptoms of a disease or abnormal condition. Also refers to a substance that alters mood or body function, or that can be habit-forming or addictive, especially a narcotic.

Initial treatment used to reduce a cancer. First-line therapy is followed by other treatments, such as chemotherapy, radiation therapy, and hormone therapy to get rid of cancer that remains. Also called induction therapy, primary therapy, and primary treatment.

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 active ingredient in a drug used alone or in combination with other drugs to treat colon cancer or rectal cancer that has spread to other parts of the body or has come back after treatment with fluorouracil. It is also being studied in the treatment of other types of cancer. Irinotecan blocks certain enzymes needed for cell division and DNA repair, and it may kill cancer cells. It is a type of topoisomerase inhibitor and a type of camptothecin analog.

To spread from one part of the body to another. When cancer cells metastasize and form secondary tumors, the cells in the metastatic tumor are like those in the original (primary) tumor.

The use of high-energy radiation from x-rays, gamma rays, neutrons, protons, and other sources to kill cancer cells and shrink tumors. Radiation may come from a machine outside the body (external-beam radiation therapy), or it may come from radioactive material placed in the body near cancer cells (internal radiation therapy). Systemic radiation therapy uses a radioactive substance, such as a radiolabeled monoclonal antibody, that travels in the blood to tissues throughout the body. Also called irradiation and radiotherapy.

Cancer that has recurred (come back), usually after a period of time during which the cancer could not be detected. The cancer may come back to the same place as the original (primary) tumor or to another place in the body. Also called recurrence.

Cancer of the head and neck that begins in squamous cells (thin, flat cells that form the surface of the skin, eyes, various internal organs, and the lining of hollow organs and ducts of some glands). Squamous cell carcinoma of the head and neck includes cancers of the nasal cavity, sinuses, lips, mouth, salivary glands, throat, and larynx (voice box). Most head and neck cancers are squamous cell carcinomas.