FDA severely limits access to cancer drug Iressa

Jun 20 2005

After Food and Drug Administration (FDA) officials agreed with studies showing lung cancer drug, Iressa, did not help patients live longer, drug company AstraZeneca said it would severely limit access to its drug.

The FDA who had been considering whether to withdraw the drug from the U.S. market, said they had found no survival benefit. They are no longer considering demanding Iressa's withdrawal, adding the drug's future would depend on further data.

The British drug maker has admitted that other therapies are more effective, but says it was still researching subgroups of patients who could benefit from Iressa.

The company says current patients who have improved with the drug can continue to take it, but new patients will have to enroll in clinical trials that consider Iressa experimental.

AstraZeneca says it is continuing to evaluate potential predictive biomarkers to better identify more readily those patients who are most likely to benefit from Iressa.

In a study released last year it was shown that Iressa patients with advanced lung cancer lived no longer than others who took a placebo. The company however has said that certain patients, including Asians and non-smokers, seemed to benefit.

Peter Lurie, deputy director of the consumer group Public Citizens Health Research Group, which has urged the FDA to ban the drug, said it was no longer commercially available for most patients, and other drugs, such as Tarceva, work better.

Tarceva is a competing drug developed by OSI Pharmaceuticals, Roche and Genentech.

The 4,000 Patients in the United States already on Iressa will still be able to receive the therapy as part of a special prescription refill program run by the company, says Judith Ochs, AstraZeneca's U.S. senior medical director.

After Sept. 15, no new patients will be allowed access to the drug unless they are enrolled in a trial.

The FDA says further analysis of the completed trials will determine the future role of the Iressa treatment.

Sales of Iressa reached $389 million in 2004, but are expected to fall this year following disclosure of the failed survival trial.