Following results of a large study that showed Iressa did not help people with the disease live longer, the FDA says only lung cancer patients already using Iressa whose doctors believe it is helping them should continue to use the drug.
New lung cancer patients will only be able to use Iressa as part of strictly controlled clinical trials.
Iressa was approved for treating lung cancer in May 2003 under a special FDA program that allows drugs that appear promising to be approved despite absolute proof that they increase survival. Astra Zeneca, Iressa's manufacturer, is a WebMD sponsor.
Drug Didn't Meet Expectations
Initial studies of Iressa showed that 10% of people with lung cancer responded to the drug in terms of slower tumor growth after other available treatments failed.
But two studies that were published after Iressa's approval have shown that the drug didn't live up to its expectations, and
The FDA says it is not considering taking Iressa off the market, and the results of new and ongoing studies of the drug will determine its role in lung cancer treatment.