• E-mail
• Print
• Comment
• Font Size
• Digg
• del.icio.us
• Discuss article

FDA Panel to Review Cancer Drug

Posted on: Thursday, 3 March 2005, 06:00 CST

A Food and Drug Administration advisory panel on Friday will review recent research showing that the lung cancer drug Iressa, which received fast-track approval two years ago, fails to improve survival.

Even though tests showed that it helps only about 10% of patients, Iressa was approved in 2003 on the condition that its maker conduct additional studies to confirm the drug's benefits. The FDA created the fast-track program to speed promising drugs to patients who have life-threatening illnesses.

The FDA noted that certain patients, including women and non-smokers, fare much better than others, although researchers didn't know why. In April, researchers discovered patients who had tumors that responded to Iressa tend to share a common genetic profile, says Bruce Johnson of Dana-Farber Cancer Institute in Boston. The discovery has led scientists to talk of a new era of customized cancer care, in which doctors can prescribe drugs based on a patient's DNA.

In December, however, Iressa's manufacturer, AstraZeneca, announced that a study of nearly 1,700 patients showed those who took Iressa lived no longer than those who took placebos. Although AstraZeneca still sells the drug, it no longer promotes it.

Although the FDA has the authority to pull Iressa from the market, AstraZeneca doesn't expect that the Oncology Drugs Advisory Committee will recommend any regulatory action this week, says company spokeswoman Mary Lynn Carver. The company expects the FDA to delay a decision until additional analyses are released later this year.

Some patients with advanced cancer who often live only a few months have lived for years on Iressa, Carver says. Many new patients, however, are being treated instead with a similar drug, called Tarceva, which was given fast-track approval in November after tests showed that it prolongs life for those in advanced stages of disease.

The FDA has been under fire for approving drugs that were later found to pose health risks. But the American Cancer Society's Len Lichtenfeld says the FDA was right to approve Iressa.

Studies that measure overall survival rates, he says, can obscure the fact that some patients have dramatic recoveries.

''What do you say to patients who are likely to have an excellent response to a drug?'' he asks. ''Do we say, to someone in a desperate situation, that you can't have this drug?''

Source: USA TODAY

More News in this Category