Tuesday said it has withdrawn its application for European Union approval for the lung cancer drug Iressa. The company acted because test results released last month showed that patients taking the drug had the same survival rates as patients taking a placebo.
AstraZeneca also said it continues to talk to the Food and Drug Administration about the future of a drug that was approved by the FDA in May 2003. The agency is considering whether to order the drug off the market.
The company's announcement Tuesday wasn't surprising given the results of data covering almost 1,700 patients that showed no statistically significant difference between Iressa patients and placebo patients. Iressa has been marketed in the U.S. for patients with non-small cell lung cancer who had failed at least two courses of chemotherapy.
Iressa had been
approved by the FDA under a special program called Subpart H, which allows drugs to reach the marketplace without having achieved traditional testing goals such as extended survival. Many of the drugs approved under this program are for advanced cancer and for HIV/AIDS.
Iressa was approved by the FDA because tests showed tumor shrinkage in 10% of the patients tested, and the agency said this result could serve as a proxy for improved survival. However, as a condition for Iressa staying on the market, AstraZeneca had to conduct a traditional survival-benefit test. This was the test that failed, although the company said the drug appeared to offer a survival benefit to Asians and non-smokers.
AstraZeneca said Tuesday that it withdrew its application from Europe because the survival-benefit test showed Iressa wouldn't meet regulators' standards. "The submission of a new
application will be considered for Iressa in the future," after the latest test results are reviewed, the company said. AstraZeneca added that it "remains convinced by the evidence that Iressa provides some benefit for patients with non-small cell lung cancer."
AstraZeneca's stock was off 8 cents to $36.14.