Featured Research

from universities, journals, and other organizations

FDA Approves New Drug For The Most Common Type Of Lung Cancer

Date:
November 25, 2004
Source:
U.S. Food And Drug Administration
Summary:
The Food and Drug Administration (FDA) announced the approval of Tarceva (erlotinib) tablets as a single agent treatment for patients with locally advanced or metastatic non-small cell lung cancer (NSCLC), the most common form of lung cancer in the U.S. Tarceva is being approved as a treatment for patients whose cancer has continued to progress despite other treatments, including at least one prior chemotherapy regimen.

November 19, 2004 -- The U.S. Food and Drug Administration (FDA) announced the approval of Tarceva (erlotinib) tablets as a single agent treatment for patients with locally advanced or metastatic non-small cell lung cancer (NSCLC), the most common form of lung cancer in the U.S. Tarceva is being approved as a treatment for patients whose cancer has continued to progress despite other treatments, including at least one prior chemotherapy regimen.

Tarceva is a drug that inhibits an enzyme, tyrosine kinase, associated with a Human Epidermal Growth Factor Receptor. The drug has shown improved survival in patients with locally advanced or metastatic NSCLC. Tarceva received "Fast Track" status from FDA during its development.

"FDA believes it is crucial for cancer patients to have many safe and effective treatment options available to them in their battle against this disease" said Dr. Lester M. Crawford, Acting FDA Commissioner. "With the approval of Tarceva thousands of patients with lung cancer will not only have access to another treatment option, but one that extends life."

Safety and efficacy were demonstrated in one randomized trial in 731 patients comparing Tarceva to placebo. The primary endpoint in this trial was survival. The median overall survival was 6.7 months in the Tarceva group compared with 4.7 months in the placebo group.

The mechanism of action by which Tarceva exerts its clinical benefit is not fully understood. However, Tarceva was developed to block growth stimulatory signals in cancer cells. These signals are mediated in part by enzymes called tyrosine kin sases. Tarceva blocks the tyrosine kinase associated with Epidermal Growth Factor Receptor (EGFR).

In about one third of the patients tumor cells were examined to see whether they had high or low levels of EGFR. Among the approximately 55% who had high EGFR the effect on survival was much greater than it was in people whose EGFR levels were low. The relationship will be explored further in the future.

Common side effects reported with Tarceva in clinical trials were diarrhea, rash, nausea, and vomiting. Tarceva may cause fetal harm when administered to pregnant women.

FDA reviewed the application for Tarceva utilizing the "rolling review" procedures that are available to new drug applications designated as "Fast Track." In rolling review, FDA starts reviewing specific components of a drug approval application even before all the application components have been submitted to the agency. For Tarceva, the first piece of the application was submitted in January 2004, and the last portion in July 2004.

Cancer of the lung and bronchus is the second most common cancer among both men and women and is the leading cause of cancer death in both sexes in the Unites States. NSCLC is the most common type of lung cancer, accounting for almost 80% of lung cancers.

The drug will be manufactured by OSI Pharmaceuticals Inc., and distributed by Genentech Inc., of South San Francisco, Calif.


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 Approves New Drug For The Most Common Type Of Lung Cancer." ScienceDaily. ScienceDaily, 25 November 2004. <www.sciencedaily.com/releases/2004/11/041124160558.htm>.
U.S. Food And Drug Administration. (2004, November 25). FDA Approves New Drug For The Most Common Type Of Lung Cancer. ScienceDaily. Retrieved August 29, 2014 from www.sciencedaily.com/releases/2004/11/041124160558.htm
U.S. Food And Drug Administration. "FDA Approves New Drug For The Most Common Type Of Lung Cancer." ScienceDaily. www.sciencedaily.com/releases/2004/11/041124160558.htm (accessed August 29, 2014).

Share This




More Health & Medicine News

Friday, August 29, 2014

Featured Research

from universities, journals, and other organizations


Featured Videos

from AP, Reuters, AFP, and other news services

3 Things To Know About The Ebola Outbreak's Progression

3 Things To Know About The Ebola Outbreak's Progression

Newsy (Aug. 29, 2014) Here are three things you need to know about the deadly Ebola outbreak's progression this week. Video provided by Newsy
Powered by NewsLook.com
Killer Amoeba Found in Louisiana Water System

Killer Amoeba Found in Louisiana Water System

AP (Aug. 28, 2014) State health officials say testing has confirmed the presence of a killer amoeba in a water system serving three St. John the Baptist Parish towns. (Aug. 28) Video provided by AP
Powered by NewsLook.com
Who Could Be Burnt by WHO's E-Cigs Move?

Who Could Be Burnt by WHO's E-Cigs Move?

Reuters - Business Video Online (Aug. 28, 2014) The World Health Organisation has called for the regulation of electronic cigarettes as both tobacco and medical products. Ciara Lee looks at the impact of the move on the tobacco industry. Video provided by Reuters
Powered by NewsLook.com
CDC Director On Ebola Outbreak: 'It's Worse Than I Feared'

CDC Director On Ebola Outbreak: 'It's Worse Than I Feared'

Newsy (Aug. 28, 2014) CDC director Tom Frieden says the Ebola outbreak is even worse than he feared. But he also said there's still hope to contain it. 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