Eric Sabo, 06/22/2005

A drug that has been used by thousands of lung cancer patients should be tightly restricted because it fails to improve survival, the Food and Drug Administration (FDA) announced last week. The FDA will allow the relatively new therapy, Iressa, to stay on from the market for now, but doctors can only prescribe the drug to patients with non-small cell lung cancer (NSCLC) who have already shown some type of improvement from the treatment.

The ruling is the latest setback for what had seemed like a highly promising cancer drug. Approved by the FDA in 2003, Iressa belongs to a new wave of therapies that attack the disease with greater precision than chemotherapy or radiation. Iressa quickly gained favor after a small study showed it could shrink tumors in patients with advanced, hard-to-treat lung cancer. This past December, however, the FDA revealed that Iressa's cancer fighting effects did not translate into longer lives, based on results of a larger trial involving 1,700 patients.

As part of the agreement with the FDA, Astra Zeneca, the company that manufactures Iressa, plans to make the treatment available until at least September 15, 2005. "Iressa will remain available in the United States, through the Iressa Access Program, for patients who are currently benefiting or who have benefited," according to a statement. Some 4,000 Americans are currently taking Iressa, the company said.

The Options
The FDA and other experts said that lung cancer patients have several effective alternatives from which to choose. The chemotherapy standby, Taxotere, has been shown to increase survival, and the FDA recently approved a newer agent, Alimta, which is equally effective. Tarceva is yet another targeted drug for NSCLC that works similar to Iressa. In contrast to Iressa, however, the drug has been shown to extend survival by up to two months if chemotherapy fails to work.

 

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