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IROs Help Decide Medically on Approved Uses of Off-Label Drugs for Cancer
Date:3/24/2009

LANSDALE, Pa., March 24 /PRNewswire/ --- As the Food and Drug Administration (FDA) approves new cancer fighting drugs for the market, researchers often study their use for non-approved, or off-label, treatments. When the studies show promise for combating other forms of cancer, physicians may prescribe these drugs to patients. By some estimates, nearly 20 percent of all drugs prescribed in the United States are for off-label use. Oncologists prescribe cancer drugs off-label about 60 percent of the time.

"Researchers continually explore the effectiveness of off-label drugs on cancer, which changes the boundaries of the standard of care," said Joyce Muller, president of NAIRO, a national trade organization of independent review organizations (IROs). "Because cancer drugs are often expensive, off-label use requires that health plans look closely at whether these drugs meet plan language for patient reimbursement or are investigational or experimental."

What is Off-label Use?

The FDA approves a drug for a specific treatment and considers any other use "off-label." Because applying for FDA approval is expensive, it often doesn't make financial sense for the drug manufacturer to pursue multiple uses. Although the use of many drugs off-label has been thoroughly researched and often considered the standard of care, this doesn't mean the FDA approves their off-label use.

A few promising cancer drugs are approved by the FDA for multiple use, including Avastin, Revlimid, Imatinib and Erbitux. For example, the agency initially approved Avastin for metastatic colorectal cancer. Then later it approved the drug for non-small cell lung cancer (2006) and breast cancer (2008). Used off-label, however, some doctors see Avastin as a "miracle drug" and may prescribe it for treating other cancers, including prostate, renal cell, head and neck, pancreatic, ovarian and hepatocellular.

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SOURCE NAIRO
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