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Cancer Drug Information

  • Reviewed: 01/18/2011

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FDA Approval for Gefitinib

Brand name(s): Iressa®

  • Approved for non-small cell lung cancer

Full prescribing information is available, including clinical trial information, safety, dosing, drug-drug interactions and contraindications.

On June 17, 2005, the U.S. Food and Drug Administration approved new labeling for gefitinib (Iressa®, a trademark of AstraZeneca) that limits the indication to cancer patients who, in the opinion of their treating physician, are currently benefiting, or have previously benefited, from gefitinib treatment. The FDA has agreed to AstraZeneca's proposal to limit distribution of this drug under a risk management plan called the Iressa Access Program to the following patient populations:
  • patients currently receiving and benefiting from gefitinib
  • patients who have previously received and benefited from gefitinib
  • 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 gefitinib if AstraZeneca decides to make it available under the IND and the patients meet the criteria for enrollment under the IND.

Gefitinib, 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 gefitinib the surrogate end-point was tumor response rate. The response rate in patients taking the drug was approximately 10 percent.

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 gefitinib, erlotinib (Tarceva™) has been approved for treatment of this same group. Erlotinib was approved based on improved overall survival.

The FDA has carefully reviewed data from two failed clinical studies of gefitinib, 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 given either 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 erlotinib.

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

The FDA is not considering market withdrawal of gefitinib 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 gefitinib treatment.

This summary was provided by Richard Pazdur, M.D., director of the FDA's Division of Oncology Drug Products.

The FDA is the division of the U.S. Department of Health and Human Services charged with ensuring the safety and effectiveness of new drugs and other products. (See "Learn How Drugs and Devices Get Approved.") The FDA's mission is to promote and protect the public health by helping safe and effective products to reach the market in a timely way, and monitoring products for continued safety after they are in use.