AstraZeneca Says It Is Shocked By The Non-Performance Of Lung Cancer Drug Iressa; a stunned AstraZeneca told an FDA advisory committee, which is reviewing cancer medications, that it was going to conduct a detailed analysis to find out precisely why Iressa turned out to be a dud in follow-up studies.
Promoted by the company as a last-chance drug in the treatment of lung cancer, Iressa showed promising results in preliminary trials but failed to live upto the expectations in the follow-ups. Iressa was granted approval by the Food and Drug Administration in 2003 and was meant for use in advanced lung cancer patients for whom standard therapy has failed to produce any results.
Iressa shrank tumors in some terminally ill patients, but was approved on the basis that further testing was required. However, there was no significant improvement in the follow-up studies. This prompted AstraZeneca to advise doctors not to promote the drug.
"The failure to reach statistical significance for survival in the overall population was completely unexpected," the company said. It went on to add that people of Asian descent and nonsmokers benefited from the drug. Doctors at the University of Texas Southwestern Medical Center, found that this group had a gene mutation that caused an increased sensitivity to Iressa.
AstraZeneca has requested the FDA advisory committee not to make a decision on the commercial availability of the drug till it completes its analysis. The analysis is expected to be complete in May/June 2005. Meanwhile, Public Citizen, a US based citizens action group has asked the FDA to take Iressa off the shelves.
