Questions and Answers on Iressa's (gefitinib) New Labeling

1. What is the new labeling for Iressa?

The Food and Drug Administration (FDA) has approved new labeling for gefitinib (Iressa) that limits its use to patients with cancer who in the opinion of their treating physician, are currently benefiting, or have previously benefited, from Iressa treatment. In addition, AstraZeneca will distribute the drug under restrictions as part of the Iressa Access Program 2. Why is the FDA limiting the use of Iressa? The FDA is limiting the use of Iressa because recent clinical trials have not shown Iressa to benefit patients with cancer.

2. When was Iressa first approved?

Iressa was approved for marketing in May 2003 under FDA's accelerated approval regulations (21 CFR part 314, subpart H).

3. What are the accelerated approval regulations?

These regulations allow FDA to approve products that provide a meaningful therapeutic benefit over existing therapies for serious or life threatening illnesses on the basis of an effect on a surrogate endpoint that FDA has determined is reasonably likely to predict clinical benefit. Accelerated approval is granted on the condition that the manufacturer must continue testing the drug in clinical trials to demonstrate that the drug indeed provides clinical benefit to the patient. If the studies fail to demonstrate clinical benefit of the drug, or if the sponsor does not pursue the confirmatory studies with due diligence, the FDA may withdraw the product from the market more quickly than usual.