FDA Approves AstraZeneca's Iressa

IRESSA is indicated as monotherapy for the continued treatment of patients with locally advanced or metastatic non-small cell lung cancer after failure of both platinum-based and docetaxel chemotherapies who are benefiting or have benefited from IRESSA.

In light of positive survival data with other agents including another oral EGFR inhibitor, physicians should use other treatment options in advanced non-small cell lung cancer patient populations who have received one or two prior chemotherapy regimens and are refractory or intolerant to their most recent regimen.

The effectiveness of IRESSA was initially based on objective response rates. Subsequent studies intended to demonstrate an increase in survival have been unsuccessful. Specifically, results from a large placebo-controlled randomized trial in patients with advanced NSCLC who progressed while receiving or within 90 days of the last dose of chemotherapy or were intolerant to the most recent prior chemotherapy regimen, did not show an improvement in survival.

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.

Iressa belongs to a group of medications known as epidermal growth factor receptor (EGFR) tyrosine kinase inhibitors and is used in the treatment of non-small cell lung cancer. Iressa is intended to block an enzyme in the body needed for some cancer cells to reproduce and survive.

Iressa is a cancer chemotherapy medication. Gefitinib interferes with the growth of cancer cells and slows their growth and spread in the body.

Iressa is used in the treatment of non-small cell lung.