Featured Research

from universities, journals, and other organizations

FDA Statement On Iressa

Date:
December 24, 2004
Source:
U.S. Food And Drug Administration
Summary:
The Food and Drug Administration (FDA) has learned from AstraZeneca that a large clinical trial comparing Iressa (gefitinib) with placebo in patients with non-small cell lung cancer who had failed other courses of cancer therapy showed no survival benefit from taking Iressa.

December 17, 2004 -- The FDA today released the following statement regarding the failure of a clinical trial of Iressa (gefitinib) to show an overall survival advantage in treating patients with lung cancer:

The Food and Drug Administration (FDA) learned yesterday from AstraZeneca that a large clinical trial comparing Iressa (gefitinib) with placebo in patients with non-small cell lung cancer who had failed other courses of cancer therapy showed no survival benefit from taking Iressa.

Patients currently taking Iressa should consult with their physicians as soon as possible; patients should not change their therapy without first consulting with their physicians.

Alternative therapies are available. FDA has approved Taxotere (docetaxel) and Tarceva (erlotinib), both of which have been shown in studies to improve survival in patients with non-small cell lung cancer whose cancer has progressed while on previous therapies.

FDA approved Iressa on May 2, 2003, under the Agency's accelerated approval (Subpart H) program, for the treatment of patients with non-small cell lung cancer who had failed two or more courses of chemotherapy. The accelerated approval provisions in FDA's regulations allow the agency to approve a drug for marketing based on an effect on a surrogate endpoint -- such as a sign of a disease or the results of a laboratory test -- that is considered reasonably likely to predict clinical benefit (improved symptoms or survival). Iressa was approved because the data from clinical trials showed that it caused significant shrinkage in tumors in about 10% of patients, and this was thought likely to increase patients' overall survival time.

One requirement for drugs approved under the agency's accelerated approval program is that the sponsor must study them further after approval to verify the expected clinical benefit. After the approval of Iressa in 2003, AstraZeneca conducted a study in approximately 1700 patients to determine whether the drug would in fact prolong survival in comparison to patients taking placebo. The results announced today indicate that the drug did not prolong survival. Under FDA's accelerated approval program, the Agency has the authority to remove a drug from the market if a postmarketing clinical study fails to verify clinical benefit. After FDA has evaluated the recent study results, FDA will determine whether Iressa should be withdrawn from the market or if other regulatory actions are appropriate.


Story Source:

The above story is based on materials provided by U.S. Food And Drug Administration. Note: Materials may be edited for content and length.


Cite This Page:

U.S. Food And Drug Administration. "FDA Statement On Iressa." ScienceDaily. ScienceDaily, 24 December 2004. <www.sciencedaily.com/releases/2004/12/041219133438.htm>.
U.S. Food And Drug Administration. (2004, December 24). FDA Statement On Iressa. ScienceDaily. Retrieved April 24, 2014 from www.sciencedaily.com/releases/2004/12/041219133438.htm
U.S. Food And Drug Administration. "FDA Statement On Iressa." ScienceDaily. www.sciencedaily.com/releases/2004/12/041219133438.htm (accessed April 24, 2014).

Share This



More Health & Medicine News

Thursday, April 24, 2014

Featured Research

from universities, journals, and other organizations


Featured Videos

from AP, Reuters, AFP, and other news services

Deadly Fungus Killing Bats, Spreading in US

Deadly Fungus Killing Bats, Spreading in US

AP (Apr. 24, 2014) A disease that has killed more than six million cave-dwelling bats in the United States is on the move and wildlife biologists are worried. White Nose Syndrome, discovered in New York in 2006, has now spread to 25 states. (April 24) Video provided by AP
Powered by NewsLook.com
Companies Ramp Up Wellness to Lower Health Costs

Companies Ramp Up Wellness to Lower Health Costs

AP (Apr. 24, 2014) That little voice telling you to exercise, get in shape and get healthy is probably coming from your boss. More companies are beefing up wellness programs to try and cut down their health care costs. (April 24) Video provided by AP
Powered by NewsLook.com
FDA Wants To Ban Sales Of E-Cigarettes To Minors

FDA Wants To Ban Sales Of E-Cigarettes To Minors

Newsy (Apr. 24, 2014) The Food and Drug Administration wants to crack down on the use of e-cigarettes, banning the sale of the product to minors. Video provided by Newsy
Powered by NewsLook.com
Michigan Man Sees Thanks to 'bionic Eye'

Michigan Man Sees Thanks to 'bionic Eye'

AP (Apr. 23, 2014) A legally blind Michigan man is 'seeing something new every day' thanks to a high-tech retinal implant procedure. He's one of the first in the country to receive a 'bionic eye' since the federal government approved the surgery. (April 23) Video provided by AP
Powered by NewsLook.com

Search ScienceDaily

Number of stories in archives: 140,361

Find with keyword(s):
Enter a keyword or phrase to search ScienceDaily for related topics and research stories.

Save/Print:
Share:

Breaking News:
from the past week

In Other News

... from NewsDaily.com

Science News

Health News

Environment News

Technology News



Save/Print:
Share:

Free Subscriptions


Get the latest science news with ScienceDaily's free email newsletters, updated daily and weekly. Or view hourly updated newsfeeds in your RSS reader:

Get Social & Mobile


Keep up to date with the latest news from ScienceDaily via social networks and mobile apps:

Have Feedback?


Tell us what you think of ScienceDaily -- we welcome both positive and negative comments. Have any problems using the site? Questions?
Mobile: iPhone Android Web
Follow: Facebook Twitter Google+
Subscribe: RSS Feeds Email Newsletters
Latest Headlines Health & Medicine Mind & Brain Space & Time Matter & Energy Computers & Math Plants & Animals Earth & Climate Fossils & Ruins