Dec. 21, 2004 - A lung cancer drug recently approved under the FDA's accelerated approval process has failed to provide any benefits for those taking it in a major clinical trial.
FDA officials say lung cancer patients currently taking Iressa should consult with their doctors as soon as possible but should not change their treatment without first talking to their doctor.
Other chemotherapy drugs for lung cancer include Taxotere and Tarceva, which have been shown to extend the life of people with non-small-cell lung cancer whose cancer has progressed while being treated with other drugs.
Iressa was approved in May 2003 to treat people with non-small-cell lung cancer who had failed two or more courses of chemotherapy. Non-small-cell lung cancer is the most common form of lung cancer and accounts for about 80% of all cases.
The FDA's accelerated approval process allows the agency to approve a drug for marketing if it's deemed reasonably likely to benefit people taking the drug.
FDA officials say Iressa was approved because data from initial clinical trials showed that it caused tumors to shrink in 10% of lung cancer patients, which was thought to predict a survival benefit.
Another provision of the accelerated approval program is that the drug's manufacturer must further study the drug to verify the expected benefit.
In this case, a clinical trial started after the approval of Iressa looked at 1,700 lung cancer patients. The study showed that the drug did not prolong survival. Iressa's maker, AstraZeneca, is a WebMD sponsor.
Under the program, the FDA may remove from the market a drug that fails to show a benefit. Officials say a decision will be made regarding Iressa after they have evaluated the recent study results.