New Labeling for Iressa (gefitinib)

FDA Public Health Advisory New Labeling and Distribution Program for Gefitinib (Iressa)

The Food and Drug Administration (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 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 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.

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 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%. 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.