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.