Send in your spam and get the offenders listed
Create a rule in outlook or simply forward the spam you receive to email@example.com
FDA Approves IRESSA® (gefitinib) for Treating Locally Advanced or Metastatic Non-Small Cell Lung Cancer Expressing Epidermal Growth Factor Receptor (EGFR) Exon 19 Deletion or Exon 21 (L858R) Substitution Mutations
On July 13, 2015, the United States Food and Drug Administration (FDA) approved IRESSA (gefitinib) tablets, an epidermal grow factor receptor (EGFR) tyrosine kinase inhibitor, for the first-line treatment of patients with metastatic non-small cell lung cancer (NSCLC) whose tumors have EGFR exon 19 deletions or exon 21 (L858R) substitution mutations as detected by an FDA-approved test. The recommended dose of IRESSA tablets is 250 mg orally once daily (QD) taken with or without food. The following are key clinical pharmacology related highlights from the regulatory review of this application:
General Pharmacokinetics and Pharmacodynamics of Gefitinib
Drug Interaction Potential
Use in Specific Populations
Safety and Efficacy
The efficacy and safety of IRESSA was demonstrated in a multicenter, single-arm, open-label clinical trial. The primary endpoint of objective response rate was 50% [95% confidence interval (CI): 40, 60]. The median duration of response was 6 months (95% CI: 5.6, 11.1 months). These results were supported by another randomized trial which reported that a retrospective analysis of the subgroup of 186 EGFR mutation-positive patients suggested an improvement in progression free survival with IRESSA (n=88) compared to carboplatin/paclitaxel (n=98).
The most common adverse events (AEs) were rash, diarrhea, dry skin, nausea, vomiting, cough, and asthenia. Interstitial lung disease, a known AE associated with gefitinib use that is more common in Asian patients, was reported in 1 (1%) Caucasian patient and in 16 (2.6%) Asian patients.
Full prescribing information is available at http://go.usa.gov/3fHuv.
The Office of Clinical Pharmacology (OCP) regulatory reviews for new drugs or biologics are often available for viewing shortly following approval at the Agency's Drugs@FDA website (http://go.usa.gov/3fHuM).
We always welcome your thoughts regarding the format, content, and utility of information you receive via this Burst email initiative. Comments may be sent via email to firstname.lastname@example.org.
This Burst was prepared by the Clinical Pharmacology Review Team including Robert Schuck, Clinical Pharmacologist, Genomics and Targeted Therapy Group, and Hong Zhao, Team Leader, Division of Clinical Pharmacology V, Office of Clinical Pharmacology, Office of Translational Sciences, CDER, FDA.
FDA/Center for Drug Evaluation and Research (CDER)
Office of Translational Sciences
Office of Clinical Pharmacology
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.
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.
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.