But approval, based on preliminary studies, came with a requirement that the drug be further tested.
In a follow-up trial, it failed to produce an improvement that was statistically significant, prompting the manufacturer, AstraZeneca to stop promoting it and to advise doctors that it had failed to live up to expectations for unknown reasons.
AstraZeneca told an FDA advisory committee, meeting this week to review several cancer drugs, that it is conducting a detailed analysis of the trial.
"The failure to reach statistical significance for survival in the overall population was completely unexpected," the company said in its report to the committee.
It went on to say that Iressa does produce responses in tumors and that some groups of patients did see benefits, notably people of Asian descent and nonsmokers.
So, NON smokers also get lung cancer? Aren't we constantly told that we will get lung cancer because we smoke? Sorry non-smokers. This one is for you.
Side effects after 7 days on this stuff 12/28/04 landed my mother in the hospital.She is still in a nursing home attemptng to regain her strength.
30 day supply $1,980.00 thanks for the old ATT health insurance,but it wont pay for the home at 90G's a year.