Lung Cancer Alliance News

July 25, 2005

The Lung Cancer Alliance joined today in sending a legal document to the Food and Drug Administration (FDA) urging wider access to Iressa (gefitinib).

"Iressa is not a cure for all non-small cell lung cancers and it doesn't even work in most patients. But it does work well in those with a certain genetic mutation, and consequently FDA should not prohibit new patients and their doctors from trying the drug," said Laurie Fenton, president of the Lung Cancer Alliance.

The FDA approved Iressa in 2003. One of the first of the so-called targeted therapies, Iressa has been controversial since its approval for non-small cell lung cancer (NSCLC) patients who had failed prior chemotherapy treatments. The drug slowed or stopped tumor growth in only 10% of the patients in the clinical trial that was the basis for the approval. The response, however, in that group was dramatic. Subsequent research showed those patients had a certain genetic mutation which can now be tested before doctors prescribe the drug.

When Iressa continued to show the same 10% results in a follow-up study across all genetic types, FDA changed the label to restrict the use of Iressa to those who are currently taking the drug, about 4000 people, and to clinical trials.

"With a cancer as deadly as lung cancer, we cannot ignore the fact that Iressa is working in thousands of people and we should not prohibit new patients, especially those with the genetic mutation, from trying it," said Fenton.

"The real issue here is how to test drugs that are targeted to certain genetic mutations in the patient or the tumor," she said. "FDA and the drug companies must put the patients first and work together to develop a new and better way of testing these new therapies and of predicting who will benefit."