Iressa (gefitinib) was approved by the FDA on May 5, 2003 “as a single agent treatment for patients with advanced non-small cell lung cancer (NSCLC), the most common form of lung cancer in the U.S. Iressa was reviewed and approved under the FDA’s accelerated approval program, which is intended to allow patients suffering from serious or life threatening diseases earlier access to promising new drugs.”

Unfortunately, as has been the case with several “fast track” approvals in recent years, the lack of large-scale longitudinal tests prior to marketing has once more come back to haunt a drug manufacturer and the FDA itself.
On December 17, 2004, the FDA released a statement “regarding the failure of a clinical trial of Iressa (gefitinib) to show overall survival advantage in treating patients with lung cancer.”

This confirmed a notification from AstraZeneca on December 16, that “a large clinical trial comparing Iressa (gefitinib) with placebo in patients with non-small cell lung cancer who had failed other courses of cancer therapy showed no survival benefit from taking Iressa.”

On June 17, the FDA announced a new label for Iressa that “limits the indication to cancer patients who, in the opinion of their treating physician, are currently benefiting, or have previously benefited, from gefitinib treatment.” The FDA made it clear that Iressa should not be given to new patients because “in a large study Iressa did not make people life longer.”

Now, the Wall Street Journal has reported that complaints have been brought before two prosecutors by the families of cancer patients who died after taking Iressa against AstraZeneca. The company states that, while it has not received word of the criminal complaints, it has received notice of four civil lawsuits related to Iressa.
The drug, that was once believed to be the next multibillion-dollar blockbuster, was first reduced to little more than an expensive placebo when long-term testing showed the drug did not help lung cancer patients life longer. As of September 15, it will only be available in the U.S. to patients enrolled in continuing studies.
In Japan, some 22,000 patients have taken the drug since 2002. Significantly, doctors have reported that 600 of those patients died from interstitial pneumonia, a lung disease.
The criminal complaints allege AstraZeneca exaggerated claims as to the drugs effectiveness and ran advertising before the drug was approved. Japanese health officials had endorsed the drug in March by recommending that doctors continue prescribing it while AstraZeneca kept studying the drug to better understand how it actually works; something even the FDA never admitted understanding either.

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