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

This page contains brief information about erlotinib hydrochloride 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):		Tarceva
FDA Approved:		Yes

Erlotinib hydrochloride is approved by the Food and Drug Administration (FDA) to treat non-small cell lung cancer (NSCLC) that has metastasized (spread) and that has not gotten better with chemotherapy.

Erlotinib hydrochloride is also approved to be used together with a drug called gemcitabine to treat pancreatic cancer that cannot be removed by surgery or has metastasized (spread).

Erlotinib hydrochloride is also being studied in the treatment of other types of cancer.

FDA Approval for Erlotinib Hydrochloride 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: Erlotinib Plus Chemotherapy Fails to Improve Overall Survival in Non-Small Cell Lung Cancer (NSCLC) (08/29/2005) ⁶ - Important clinical trial results for this drug, background information, and how the trial was done.

Clinical Trial Results: Erlotinib Plus Gemcitabine Boosts One-Year Survival in Pancreatic Cancer (05/14/2005) ⁷ - Important clinical trial results for this drug, background information, and how the trial was done.

Clinical Trial Results: Erlotinib Extends Survival in Advanced Lung Cancer (06/05/2004) ⁸ - Important clinical trial results for this drug, background information, and how the trial was done.

MedlinePlus Information on Erlotinib Hydrochloride 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 for Erlotinib Hydrochloride ¹⁰ - Check for trials from NCI's PDQ Cancer Clinical Trials Registry now accepting patients.

Glossary Terms

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.

Treatment with drugs that kill cancer cells.

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 that is used to treat pancreatic cancer that is advanced or has spread. It is also used together with other drugs to treat breast cancer that has spread, advanced ovarian cancer, and non-small cell lung cancer that is advanced or has spread. It is also being studied in the treatment of other types of cancer. Gemcitabine blocks the cell from making DNA and may kill cancer cells. It is a type of antimetabolite

Refers to the practices and procedures used for the prevention, treatment, or relief of symptoms of a diseases or abnormal conditions. This term may also refer to a legal drug used for the same purpose.

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.

A group of lung cancers that are named for the kinds of cells found in the cancer and how the cells look under a microscope. The three main types of non-small cell lung cancer are squamous cell carcinoma, large cell carcinoma, and adenocarcinoma. Non-small cell lung cancer is the most common kind of lung cancer.

A disease in which malignant (cancer) cells are found in the tissues of the pancreas. Also called exocrine cancer.