AstraZeneca’s non-small cell lung cancer drug, Iressa (gefitinib), should be pulled from the market because it does not improve survival rates and has been linked to deaths in Japan and the USA, influential consumer group, Public Citizen, said in a petition filed with the US Food and Drug Administration on Friday.
The group, which also testified to the FDA’s advisory panel that was assessing the drug after it failed to demonstrate a survival benefit in a recent clinical trial [[20/12/04b]], says that the product should be reclassified as an experimental drug. “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,” Dr Peter Lurie, deputy director of Public Citizen’s health research group, said in a statement. “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.”
Iressa won the coveted US green light back in May 2003, on the back of Phase II data and under the accelerate approval process, after results showed a 10% response rate, which was “reasonably likely to predict clinical benefit” [[06/05/03a]]. AstraZeneca was obliged to conduct follow-up studies to prove the drug actually prolonged survival. However, Public Citizen had urged the FDA not to approve the drug, saying it was “likely ineffective and dangerous” [[02/05/03a]]. Preliminary clinical trial results, released in December, showed that patients taking Iressa did not live any longer than those receiving placebo. The Anglo-Swedish company has since stopped marketing Iressa, but it is still available in the USA.
Furthermore, Public Citizen notes that Iressa has been linked to deaths from a condition known as interstitial lung disease. It claims that there have been 144 US reports of the condition in patients taking the drug between May 2003 and September 2004, including 87 deaths for which Iressa was suspected to be the cause.
The FDA is reviewing the drug’s safety, but is not expected to issue a final decision on whether it should remain on the market until it received the complete data from AstraZeneca.