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."