Spamdex - Spam Archive

Report spam

Send in your spam and get the offenders listed

Create a rule in outlook or simply forward the spam you receive to questions@spamdex.co.uk

Also in service.govdelivery.com

Drug Information Update - FDA approves targeted therapy for first-line treatment of patients with a type of metastatic lung cancer

FDA Division of Drug Information: Know the Moment It Happens

The Division of Drug Information (DDI) is CDER's focal point for public inquiries. We serve the public by providing information on human drug products and drug product regulation by FDA.


The U.S. Food and Drug Administration today approved Iressa (gefitinib) for the first-line treatment of patients with metastatic non-small cell lung cancer (NSCLC) whose tumors harbor specific types of epidermal growth factor receptor (EGFR) gene mutations, as detected by an FDA-approved test.

 

Lung cancer is the leading cause of cancer-related death among men and women in the U.S. and, though more common in men, the number of deaths from lung cancer in women is increasing. According to the National Cancer Institute, an estimated 221,200 Americans will be diagnosed with lung cancer, and 158,040 will die from the disease this year. NSCLC is the most common type of lung cancer. Mutations in the EGFR gene are present in about 10 percent of NSCLC tumors.

 

Iressa is a kinase inhibitor that blocks proteins that promote the development of cancerous cells with certain EGFR mutations. It is intended for the treatment of patients whose tumors express the most common types of EGFR mutations in NSCLC (exon 19 deletions or exon 21 L858R substitution gene mutations). The therascreen EGFR RGQ PCR Kit was approved as a companion diagnostic test to identify patients with tumors having the EGFR gene mutations in order to determine which patients would be appropriate for treatment with Iressa.

 

The FDA granted Iressa orphan product designation for the treatment of EGFR mutation-positive metastatic NSCLC. Orphan product designation is given to drugs intended to treat rare diseases, which provides financial incentives – like tax credits, user fee waivers, and eligibility for market exclusivity – to promote their development.

 

The efficacy and safety of Iressa for this use was demonstrated in a multi-center, single-arm clinical trial of 106 patients with previously untreated, EGFR mutation-positive metastatic NSCLC. The study’s primary endpoint was objective response rate, or the percentage of patients who experienced complete and partial shrinkage or disappearance of the tumors after treatment. Participants received Iressa 250 mg once daily. Results showed that tumors shrank in about 50 percent of patients after treatment and this effect lasted an average of six months. The response rates were similar in patients whether their tumors had EGFR exon 19 deletions or exon 21 L858R substitution mutations.

For more information, please visit: Iressa


This is an automated message delivery system.  Replying to this message will not reach DDI staff.  If you have comments or questions, please contact us at: 1-888-INFO FDA (1-888-463-6332) or (301) 796-3400 from 8:00 am - 4:30 pm ET Monday - Friday.  You can also email us at druginfo@fda.hhs.gov.


This email was sent to using GovDelivery, on behalf of: U.S. Food & Drug Administration (FDA) · 10903 New Hampshire Ave · Silver Spring, MD 20993 · 800-439-1420 Powered by GovDelivery

---------------------------

All titles, content, publisher names, trademarks, artwork, and associated imagery are trademarks and/or copyright material of their respective owners. All rights reserved. The Spam Archive website contains material for general information purposes only. It has been written for the purpose of providing information and historical reference containing in the main instances of business or commercial spam.

Many of the messages in Spamdex's archive contain forged headers in one form or another. The fact that an email claims to have come from one email address or another does not mean it actually originated at that address! Please use spamdex responsibly.


Yes YOU! Get INVOLVED - Send in your spam and report offenders

Create a rule in outlook or simply forward the junk email you receive to questions@spamdex.co.uk | See contributors

Google + Spam 2010- 2017 Spamdex - The Spam Archive for the internet. unsolicited electric messages (spam) archived for posterity. Link to us and help promote Spamdex as a means of forcing Spammers to re-think the amount of spam they send us.

The Spam Archive - Chronicling spam emails into readable web records index for all time

Please contact us with any comments or questions at questions@spamdex.co.uk. Spam Archive is a non-profit library of thousands of spam email messages sent to a single email address. A number of far-sighted people have been saving all their spam and have put it online. This is a valuable resource for anyone writing Bayesian filters. The Spam Archive is building a digital library of Internet spam. Your use of the Archive is subject to the Archive's Terms of Use. All emails viewed are copyright of the respected companies or corporations. Thanks to Benedict Sykes for assisting with tech problems and Google Indexing, ta Ben.

Our inspiration is the "Internet Archive" USA. "Libraries exist to preserve society's cultural artefacts and to provide access to them. If libraries are to continue to foster education and scholarship in this era of digital technology, it's essential for them to extend those functions into the digital world." This is our library of unsolicited emails from around the world. See https://archive.org. Spamdex is in no way associated though. Supporters and members of http://spam.abuse.net Helping rid the internet of spam, one email at a time. Working with Inernet Aware to improve user knowlegde on keeping safe online. Many thanks to all our supporters including Vanilla Circus for providing SEO advice and other content syndication help | Link to us | Terms | Privacy | Cookies | Complaints | Copyright | Spam emails / ICO | Spam images | Sitemap | All hosting and cloud migration by Cloudworks.

Important: Users take note, this is Spamdex - The Spam Archive for the internet. Some of the pages indexed could contain offensive language or contain fraudulent offers. If an offer looks too good to be true it probably is! Please tread, carefully, all of the links should be fine. Clicking I agree means you agree to our terms and conditions. We cannot be held responsible etc etc.

The Spam Archive - Chronicling spam emails into readable web records

The Glass House | London | SW19 8AE |
Spamdex is a digital archive of unsolicited electronic mail 4.9 out of 5 based on reviews
Spamdex - The Spam Archive Located in London, SW19 8AE. Phone: 08000 0514541.