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Lung Cancer Drug Iressa Should Be Removed From Market

March 4, 2005

Lung Cancer Drug Iressa Should Be Removed From Market

Drug Approved Through Fast Track, But Failed to Reduce Death Rate

WASHINGTON, D.C. – Iressa, a drug approved to treat non-small cell lung cancer, should be pulled from the market because it does not improve survival rates and has been linked to deaths in Japan and the United States, Public Citizen told the U.S. Food and Drug Administration (FDA) today.

In a petition filed today to have the drug pulled from the market, and in testimony delivered to the FDA’s Advisory Committee on Oncologic Drugs, Public Citizen said that Iressa should be reclassified as an experimental drug.

Iressa was approved in May 2003 under an accelerated approval program.  Because it had been demonstrated only to reduce tumor size, its approval was conditioned on the manufacturer, AstraZeneca, studying the drug further to determine whether it prolonged survival. That study has been done; patients taking Iressa didn’t live any longer than patients taking a placebo.

Rather than pull the drug, however, as the FDA has the authority to do under the accelerated approval process, the agency merely advised patients to consider taking one of two other drugs that – unlike Iressa – have been proven effective in prolonging survival.

Further, Iressa has been linked to deaths. In January, Japanese scientists linked Iressa to a total of 1,473 adverse events and 588 deaths in that country. In addition, according to a Public Citizen analysis of the FDA’s adverse event reactions database, there have been 144 reports of acute interstitial pneumonia in patients taking the drug between May 2003 and September 2004, including 87 deaths for which Iressa was suspected to be the cause.

The continued use of Iressa “puts all patients at risk for a serious and potentially fatal lung disease that is occurring with a relatively high incidence,” said Dr. Peter Lurie, deputy director of Public Citizen’s Health Research Group. “Leaving Iressa on the market increases the likelihood that patients will be diverted from an effective therapy to an ineffective therapy, endangering their lives. Keeping a drug on the market while effectively telling people to avoid taking it is not an adequate public health response.”

To read the petition, click here.