Drugs
Gefitinib (marketed as Iressa) Information
FDA ALERT [6/2005]
FDA has approved new labeling for Iressa that states the medicine should be used only in cancer patients who have already taken the medicine and whose doctor believes it is helping them. New patients should not be given Iressa because in a large study Iressa did not make people live longer. There are other medicines for non-small cell lung cancer (NSCLC) that have shown an ability to make people live longer.
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.
Other Information
- FDA Public Health Advisory (6/17/2005)
- Questions and Answers on Iressa (6/17/2005)
- Iressa Label (6/17/2005)
- Regulatory History of Gefitinib from Drugs@FDA
Information on the June 2005 FDA Alert
On June 17, 2005, FDA announced approval of 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.
In May 2003, FDA approved Iressa (gefitinib). Iressa is an anticancer drug that inhibits an enzyme (tyrosine kinase) present in lung cancer cells, as well as other cancers and normal tissues, that appears to be important to the growth of cancer cells. Iressa has been used as a single agent for the treatment of non-small cell lung cancer (NSCLC) that has progressed after, or failed to respond to two other types of chemotherapy (drugs used to kill cancer cells).
In addition to the new labeling, FDA has agreed to AstraZeneca's proposal to limit distribution of this drug under a risk management plan called the Iressa Access Program.
Background Information
- Iressa Label (5/6/2004)
- Iressa Approval Letter
Adverse reactions or quality problems experienced with the use of this Product may be reported to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail or by fax, using the contact information at the bottom of this sheet.
