Find Information About:

Drugs & Supplements

Get information and reviews on prescription drugs, over-the-counter medications, vitamins, and supplements. Search by name or medical condition.

Pill Identifier

Pill Identifier

Having trouble identifying your pills?

Enter the shape, color, or imprint of your prescription or OTC drug. Our pill identification tool will display pictures that you can compare to your pill.

Get Started
My Medicine

My Medicine

Save your medicine, check interactions, sign up for FDA alerts, create family profiles and more.

Get Started

WebMD Health Experts and Community

Talk to health experts and other people like you in WebMD's Communities. It's a safe forum where you can create or participate in support groups and discussions about health topics that interest you.

  • Second Opinion

    Second Opinion

    Read expert perspectives on popular health topics.

  • Community


    Connect with people like you, and get expert guidance on living a healthy life.

Got a health question? Get answers provided by leading organizations, doctors, and experts.

Get Answers

Sign up to receive WebMD's award-winning content delivered to your inbox.

Sign Up

Lung Cancer Health Center

Font Size

Lung Cancer Drug Iressa Fails Test.

Recently Approved Drug Fails to Save Lives in Clinical Trial

WebMD Health News

Dec. 21, 2004 - A lung cancer drug recently approved under the FDA's accelerated approval process has failed to provide any benefits for those taking it in a major clinical trial.

The results of the trial, released last week, show that the lung cancer patients who took the drug Iressa did not live any longer than those who took a placebo.

FDA officials say lung cancer patients currently taking Iressa should consult with their doctors as soon as possible but should not change their treatment without first talking to their doctor.

Other chemotherapy drugs for lung cancer include Taxotere and Tarceva, which have been shown to extend the life of people with non-small-cell lung cancer whose cancer has progressed while being treated with other drugs.

Iressa was approved in May 2003 to treat people with non-small-cell lung cancer who had failed two or more courses of chemotherapy. Non-small-cell lung cancer is the most common form of lung cancer and accounts for about 80% of all cases.

The FDA's accelerated approval process allows the agency to approve a drug for marketing if it's deemed reasonably likely to benefit people taking the drug.

FDA officials say Iressa was approved because data from initial clinical trials showed that it caused tumors to shrink in 10% of lung cancer patients, which was thought to predict a survival benefit.

Another provision of the accelerated approval program is that the drug's manufacturer must further study the drug to verify the expected benefit.

In this case, a clinical trial started after the approval of Iressa looked at 1,700 lung cancer patients. The study showed that the drug did not prolong survival. Iressa's maker, AstraZeneca, is a WebMD sponsor.

Under the program, the FDA may remove from the market a drug that fails to show a benefit. Officials say a decision will be made regarding Iressa after they have evaluated the recent study results.

Today on WebMD

Broken cigarette
Do you know the myths from the facts?
man with a doctor
Our health check will steer you in the right direction.
sauteed cherry tomatoes
Fight cancer one plate at a time.
Lung cancer xray
See it in pictures, plus read the facts.
15 Cancer Symptoms Men Ignore
Lung Cancer Risks Myths and Facts
cancer fighting foods
Improving Lung Cancer Survival Targeted Therapy
Lung Cancer Surprising Differences Between Sexes
Pets Improve Your Health
Vitamin D
Lung Cancer Surgery Options