AstraZeneca announces U.S. labeling change to Iressa (gefitinib tablets)

AstraZeneca has announced that after discussions with the U.S. Food and Drug Administration (FDA), the company is making a labeling change to Iressa (gefitinib tablets).

Based on the FDA's assessment of currently available data, including the lack of survival benefit in the Phase III Trial 709 (ISEL) comparing Iressa to placebo in advanced recurrent non-small-cell lung cancer (NSCLC), and the availability of other treatment options in the United States that do prolong life, the revised label indicates that Iressa is only to be used in patients who have previously taken Iressa and are benefiting or have benefited from Iressa. In addition, Iressa will continue to be available for use in clinical trials approved by an Institutional Review Board (IRB) prior to June 17, 2005. Clinical trials approved by an IRB after June 17, 2005, must be conducted under an investigational new drug application (IND).

To implement the new label, as of September 15, 2005, AstraZeneca will initiate the Iressa Access Program to fill renewal prescriptions for Iressa through a single mail order pharmacy for patients meeting the criteria set forth by the label. Iressa will remain available in the United States, through the Iressa Access Program, for patients who are currently benefiting or who have benefited, pending availability of new data that would support an additional revision to the label, or possible future withdrawal. Approximately 4,000 patients currently are taking Iressa in the United States.

"AstraZeneca and the FDA have worked diligently to ensure uninterrupted access for existing patients in the United States who are benefiting from Iressa. Current patients should be assured that their access to Iressa will continue with this program," said Dr. Judith Ochs, oncologist and Senior Medical Director for Iressa in the United States. "The label change now clarifies which patients the FDA believes should receive this drug and the Iressa Access Program ensures that only those patients will be able to get the medication."

Patients taking Iressa as of September 15, 2005 may continue to receive Iressa and will fill prescription refills through the Iressa Access Program after required patient and physician forms are filed. After September 15, 2005, no new patients will be allowed access to Iressa unless they are part of a clinical study approved by an IRB prior to June 17, 2005 or they are part of a clinical study approved by an IRB after June 17, 2005 that is conducted under an IND. The updated label and information on the Iressa Access Program, including enrollment forms, are available by calling AstraZeneca at 1-800-601-8933 or via the web at http://www.iressa-access.com/

Iressa is approved in the United States under accelerated approval by the FDA (sub-part H) that enabled the drug to be approved on the basis of adequate and well-controlled clinical trials establishing that the drug product had an effect on a surrogate end point likely to predict clinical benefit in a serious or life threatening illness for which there is an unmet medical need. The Phase III study called ISEL, or trial 709, released in December showed that Iressa did not produce a statistically significant survival advantage over placebo in patients with advanced NSCLC.

AstraZeneca is continuing to evaluate potential predictive biomarkers to better identify more readily those patients who are most likely to benefit from Iressa. AstraZeneca is committed to continuing Iressa research and to validating the emerging science in controlled clinical trials.