U.S. Group Asks FDA To Ban AstraZeneca Cancer Drug
10/19/2005 5:12:55 PM
A last-chance lung cancer drug that helped patients in preliminary trials didn't do well in a follow up, a failure that surprised manufacturer AstraZeneca. The company is trying to determine why things didn't go better. The drug, Iressa, was approved by the Food and Drug Administration (news - web sites) in 2003 for use in advanced lung cancer patients for whom standard therapy is no longer effective.
Studies showed Iressa shrank tumors in some terminally ill patients. But approval, based on preliminary studies, came with a requirement that the drug be further tested.
In a follow-up study it failed to produce an improvement that was statistically significant, prompting AstraZeneca to stop promoting it and to advise doctors that it had failed to live up to expectations.
On Friday the consumer group Public Citzen petitioned the FDA (news - web sites) to remove Iressa from the market because of its poor performance. The group had argued against the drug's approval, questioning its effectiveness and safety.
AstraZeneca told an FDA advisory committee, meeting this week to review several cancer drugs, that it is conducting a detailed analysis of the trial.