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Information for Healthcare Professionals: Gefitinib (marketed as Iressa)

[For additional information about this drug, see Gefitinib Information.]

FDA ALERT [6/2005]:

FDA has approved new labeling for gefitinib (Iressa) that limits the indication to cancer patients who, in the opinion of their treating physician, are currently benefiting, or have previously benefited, from Iressa treatment. AstraZeneca plans to limit distribution of this drug under a risk management plan called the Iressa Access Program.

This information reflects FDA’s preliminary analysis of data concerning this drug. FDA is considering, but has not reached a final conclusion about, this information. FDA intends to update this sheet when additional information or analyses become available.

To report any unexpected adverse or serious events associated with the use of Iressa, please contact the FDA MedWatch program either online, by regular mail or by fax, using the contact information at the bottom of this page.


Under the Iressa Access Program prescriptions for Iressa will be limited to the following patient populations:

  • patients currently receiving and benefiting from Iressa;

  • patients who have previously received and benefited from Iressa; and

  • previously enrolled patients or new patients in non-Investigational New Drug (IND) clinical trials approved by an IRB prior to June 17, 2005.

New patients may also be able to obtain Iressa if AstraZeneca decides to make it available under IND and the patients meet the criteria for enrollment under the IND.

Data Summary

Iressa, an orally administered epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor, was approved for marketing in May 2003 for patients with non-small cell lung cancer (NSCLC) under Subpart H accelerated approval regulations that allow products to be approved on the basis of a surrogate endpoint for clinical efficacy. For Iressa the surrogate end-point was tumor response rate. The response rate in patients taking the drug was approximately 10%. The approved indication was for the treatment of patients who were refractory to established cancer treatments (both a platinum drug and docetaxel). However, since the initial approval of Iressa, Tarceva (erlotinib) has been approved for treatment of this same group. Tarceva was approved based on improved overall survival.

FDA has carefully reviewed data from two failed clinical studies of Iressa, one of which was required by the agency as part of the drug’s accelerated approval. This trial enrolled patients with regionally advanced or metastatic NSCLC who had failed one or two prior treatment regimens. In this large study, 1,692 patients were randomized to gefitinib or placebo. There was no significant survival benefit in the overall study population nor in patients who had high levels of a surface marker called “EGFR”. In contrast, the presence of EGFR at high levels appears to predict a good response to Tarceva.

In the second trial in patients with stage III NSCLC, after completion of induction and consolidation chemotherapy and radiation therapy, patients were randomized to Iressa or placebo maintenance therapy. No Iressa survival benefit could be demonstrated.

The Food and Drug Administration is not considering market withdrawal of Iressa at this time. New clinical trials are being developed, other ongoing trials are being completed, and there will be further analysis of the completed trials described above. These will determine the future role of Iressa treatment.

Questions? Call Drug Information, 1-888-INFO-FDA (automated) or 301-827-4570


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