NO NEW PATIENTS TO RECEIVE ASTRAZENECA'S CANCER DRUG IRESSA

AstraZeneca's lung-cancer treatment Iressa will no longer be available to new patients beginning in September under a new labeling plan that will keep the embattled drug on the market.

The revised label, which was crafted by AstraZeneca after discussions with the FDA, indicates that Iressa (gefitinib) is only to be used in patients who have previously taken Iressa and are benefiting or have benefited from the drug, the company announced recently. To implement the new label, AstraZeneca will initiate the Iressa Access Program Sept. 15 to fill renewal prescriptions for the drug through a single mail-order pharmacy. Only patients taking the drug as of Sept. 15 will be eligible for the program.

"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," said AstraZeneca's senior medical director Judith Ochs.

The drastic labeling revision comes amid concerns about Iressa's efficacy, which was called into question after the release of data from AstraZeneca's "Iressa Survival Evaluation in Lung Cancer" (ISEL) trial. Released in December 2004, the Phase III study failed to show that Iressa significantly prolonged survival in lung-cancer patients compared to a placebo.

AstraZeneca, meanwhile, said it is committed to keeping the drug available to current users, of which there are approximately 4,000 in the U.S. The company said the labeling revision would remain in place pending availability of new data that would support an additional revision to the label, or possible future withdrawal.