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 September 22, 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 September 22, 2014).

Share This



More Health & Medicine News

Monday, September 22, 2014

Featured Research

from universities, journals, and other organizations


Featured Videos

from AP, Reuters, AFP, and other news services

Sierra Leone in Lockdown to Control Ebola

Sierra Leone in Lockdown to Control Ebola

AP (Sep. 21, 2014) Sierra Leone residents remained in lockdown on Saturday as part of a massive effort to confine millions of people to their homes in a bid to stem the biggest Ebola outbreak in history. (Sept. 20) Video provided by AP
Powered by NewsLook.com
Sierra Leone's Nationwide Ebola Curfew Underway

Sierra Leone's Nationwide Ebola Curfew Underway

Newsy (Sep. 20, 2014) Sierra Leone is locked down as aid workers and volunteers look for new cases of Ebola. Video provided by Newsy
Powered by NewsLook.com
Changes Found In Brain After One Dose Of Antidepressants

Changes Found In Brain After One Dose Of Antidepressants

Newsy (Sep. 19, 2014) A study suggest antidepressants can kick in much sooner than previously thought. Video provided by Newsy
Powered by NewsLook.com
Could Grief Affect The Immune Systems Of Senior Citizens?

Could Grief Affect The Immune Systems Of Senior Citizens?

Newsy (Sep. 19, 2014) The study found elderly people are much more likely to become susceptible to infection than younger adults going though a similar situation. Video provided by Newsy
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