Iressa, FDA Approves Drug for Lung Cancer

On June 17, 2005 the The Food and Drug Administration (FDA) has approved new labeling for gefitinib (Iressa) that limits 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 the Iressa Access Program. For more, please read the "Questions and Answers on Iressa's (gefitinib) New Labeling" article.


Iressa (gefitinib) is a groundbreaking new type of anti-cancer drug for people with the most common type of lung cancer. It is different from all prior chemotherapy. That is, Iressa works by uniquely blocking cellular enzymes that stimulate cell growth. So, in the future, look for the emergence of other (hopefully more effective) anti-cancer drugs that work at specific cellular or molecular sites.

With this approval by the Food and Drug Administration (FDA), patients having advanced lung cancer that is unresponsive to standard treatment now will have at least some treatment available to them. Credit the FDA for the relatively rapid availability of this drug. You see, Iressa was approved under the FDA's accelerated approval program. This program provides patients with serious disease earlier access to promising new drugs.

Leslie J. Schoenfield, M.D., Ph.D.
Medical Editor, MedicineNet.com


The Food and Drug Administration (FDA) on May 5th, 2003 announced the approval of Iressa (gefitinib) tablets as a single agent treatment for patients with advanced non-small cell lung cancer (NSCLC), the most common form of lung cancer in the US. Iressa is being approved as a treatment for patients whose cancer has continued to progress despite treatment with platinum-based and docetaxel chemotherapy, two drugs that are currently the standard of care in this disease.