Navigation Links
US and EU Regulatory Submissions for Vandetanib in Advanced Medullary Thyroid Cancer Accepted for Review
Date:9/23/2010

LONDON, Sept. 23 /PRNewswire/ -- AstraZeneca today announced that the US Food and Drug Administration (FDA) and the European Medicines Agency (EMA) have accepted regulatory submissions for review of the investigational drug vandetanib in the treatment of patients with advanced medullary thyroid cancer (MTC). The FDA also granted priority review status for the new drug application and set a Prescription Drug User Fee Act (PDUFA) action date of 7 January 2011.

(Logo: http://photos.prnewswire.com/prnh/20091027/PH99766LOGO)

(Logo: http://www.newscom.com/cgi-bin/prnh/20091027/PH99766LOGO)

The submissions are supported by the results from the ZETA study evaluating the safety and efficacy of vandetanib compared to placebo in patients with advanced MTC. AstraZeneca is consulting with regulatory authorities on a proposed trade name.

ZETA was a Phase III, double-blind, placebo-controlled study that randomized 331 patients with advanced MTC to oral once-daily vandetanib 300mg or placebo. The study results were presented on 7 June 2010 at the American Society of Clinical Oncology annual meeting in Chicago.  Results from ZETA showed that treatment with vandetanib significantly extended progression-free survival, the primary endpoint of the study, in patients with advanced MTC.  In ZETA, vandetanib demonstrated a 54% reduction in the rate of progression compared to placebo (HR=0.46, p=0.0001). The objective response rate (ORR), a secondary endpoint, was 45% versus 13% across the two groups (p<0.0001).

The most common adverse events (incidence >25%) associated with vandetanib in the ZETA study included diarrhoea, rash, nausea, hypertension and headache. The incidence of protocol-defined QTc prolongation was 8%.  The safety profile of vandetanib in this study was similar to what has been previously observed in other studies in medullary thyroid and non-small cell lung cancer.

Vandetanib targets the vascular endothe
'/>"/>

SOURCE AstraZeneca
Copyright©2010 PR Newswire.
All rights reserved

Page: 1 2

Related medicine technology :

1. Advanced Health Media Further Expands Investment in Regulatory Compliance; Company Announces Ms. Susan Y. Leonard as Chief Compliance Officer
2. Spirus Medical Announces Japanese Regulatory Approval to Market ENDO-EASE® Product Line
3. Cardiogenesis Executive Chairman Paul J. McCormick Updates Commercial and Regulatory Progress in Interview With Wall Street Reporter, Available Online
4. YesDTC Holdings and BioElectronics Receive Japanese Regulatory Review Date
5. BioElectronics and YesDTC Holdings Receive Japanese Regulatory Review Date
6. Endo Pharmaceuticals Completes Next Step in Regulatory Process for FORTESTA™ for Men With Low Testosterone
7. California Cryobank Welcomes New Director of Quality/Regulatory Affairs
8. Systech International and Videojet Brazil Partner to Meet Brazils Emerging Pharmaceutical Regulatory Requirements
9. Prolifiq Offers Best Practices Solution for Selling Medical Devices in Tough Regulatory Environment
10. Ethicon Endo-Surgery SEDASYS(R) System Receives Regulatory Approval in Canada and CE Mark in European Union
11. Micromet Highlights Clinical Plans and Regulatory Strategy for Lead Product Candidate Blinatumomab at its Annual R&D Day
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:7/30/2015)... Texas , July 30, 2015 /PRNewswire/ ... company focused on gynecologic disease, announced today ... financial results after the market close on ... investor conference call and webcast at 4:30pm ... 13, 2015 at 4:30pm Eastern/1:30pm Pacific  ...
(Date:7/30/2015)... , July 30, 2015  NanoSmart Pharmaceuticals, Inc., ... platforms, has received Orphan Drug Designation from the ... drug product that uses NanoSmart,s proprietary drug delivery ... dactinomycin for the treatment of Ewing,s sarcoma, a ... granted NanoSmart,s Orphan Drug Designation on the basis ...
(Date:7/30/2015)... Flexpoint Ford, a private equity firm focused ... that it has entered into a partnership with ... form Kastle Therapeutics, LLC (Kastle).  The new company, headquartered ... acquiring, developing and commercializing pharmaceuticals targeted toward diseases with ... therapies already approved for marketing, as well as clinical ...
Breaking Medicine Technology:NanoSmart Receives Second FDA Orphan Drug Designation for Treatment of Pediatric Cancer 2Flexpoint Ford Announces Partnership with Alan MacKenzie and Bryan Stuart to Form Kastle Therapeutics 2Flexpoint Ford Announces Partnership with Alan MacKenzie and Bryan Stuart to Form Kastle Therapeutics 3
... the world,s only amputee professional kiteboarder and waverider, will be ... Thursday, Jan. 6 on the Discovery Channel,s HD Theater. All ... 17th. Using the Renegade prosthetic foot from Freedom ... the wind as it whistles through the most rugged terrain ...
... 2011 BioDrain Medical, Inc. (OTC Bulletin Board: BIOR ... surgical fluid disposal, announced today it is eligible for trading ... The company was admitted to the OTCBB early in 2010 ... market maker going out of business.  For the last several ...
Cached Medicine Technology:Discovery Channel to Feature World's Only Amputee Kiteboarder 2BioDrain Medical, Inc. Is Eligible for Trading on the OTCBB, Notice of Allowance on Canadian Patent Application 2
(Date:7/30/2015)... ... July 30, 2015 , ... World ... am Fine, an app invention that can help people during emergencies. , "The ... Cooper, CEO and Creative Director of World Patent Marketing. "Currently, there are about ...
(Date:7/30/2015)... (PRWEB) , ... July 30, 2015 , ... OSF ... to results from the 2015 Most Wired Survey conducted by Hospitals & Health Networks. ... health system owned and operated by The Sisters of the Third Order of ...
(Date:7/30/2015)... ... July 30, 2015 , ... ... entitled " Lovetraction Lines ." It's for women interested in improving their love ... desire. The course, which officially launched to the public early this morning, has ...
(Date:7/30/2015)... ... July 30, 2015 , ... ... worked to protect victims in San Diego, California’s Gaslamp Quarter Plaza for five ... Gaslamp Quarter Plaza actively monitor the area for any suspicious activity. These cameras ...
(Date:7/30/2015)... (PRWEB) , ... July 30, 2015 , ... Google recently ... an upcoming dedicated web site. As discussed in a June 8, 2015 article published ... collisions reported so far have been caused by its computer-driven cars, which such industry ...
Breaking Medicine News(10 mins):Health News:Emergency Alert Can Be A Rude Awakening Without World Patent Marketings New App Invention, I AM FINE 2Health News:Emergency Alert Can Be A Rude Awakening Without World Patent Marketings New App Invention, I AM FINE 3Health News:Emergency Alert Can Be A Rude Awakening Without World Patent Marketings New App Invention, I AM FINE 4Health News:Emergency Alert Can Be A Rude Awakening Without World Patent Marketings New App Invention, I AM FINE 5Health News:OSF HealthCare Named One of the Most Wired Systems 2Health News:OSF HealthCare Named One of the Most Wired Systems 3Health News:Lovetraction Lines - Review Examining Simone Myers' New Online Course Released 2Health News:Eyepartner Software Helps Victims in Gaslamp Quarter Plaza 2Health News:Eyepartner Software Helps Victims in Gaslamp Quarter Plaza 3Health News:New Google Policy on Reporting Driverless Auto Accidents Points Out Growing Complexity of Personal Injury Law in the 21st Century, Says Law Offices of Burg and Brock 2Health News:New Google Policy on Reporting Driverless Auto Accidents Points Out Growing Complexity of Personal Injury Law in the 21st Century, Says Law Offices of Burg and Brock 3
... who bring them pebbles to build egg nests. Hummingbirds ... guarded by larger males. , New research shows ... will still attempt to trade sexual currency for provisions, ... Michigan School of Public Health. , The exchange of ...
... Men with serious injuries, such as traumatic brain injury or ... If these men have strong traditional masculine ideas and abuse ... and come to terms with their emotions and situations. A ... find better ways to understand and treat men who fit ...
... clinical trials could start in several years, study says , , ... inhibits the formation of scar tissue at the site of ... regenerate has been developed by researchers at Northwestern University in ... ability to regrow after a spinal injury, but they,re blocked ...
... extend safety practices, CDC reports , , THURSDAY, April 10 ... of foodborne illnesses have remained constant in the United ... And that leveling off of the rate of food ... Control and Prevention,s goal of reducing the overall number ...
... cancer-killing activities in cultured cells. While they are ... trials, just how they execute their effects is ... papers, Vanderbilt-Ingram Cancer Center investigators provide a potential ... cells and offer clues about possible adverse effects ...
... PHILADELPHIA, April 10 SAGES 2008 ANNUAL ... a new study showing,laparoscopic surgery reduced the ... when compared to open surgery in a ... of the following three surgical,procedures: hysterectomy, cholecystectomy ...
Cached Medicine News:Health News:Just like penguins and other primates, people trade sex for resources 2Health News:Triple threat: Young macho men with serious injuries often abuse alcohol 2Health News:Gel Enables Severed Spinal Cord Fibers to Regrow 2Health News:Foodborne Illnesses Remain Constant in U.S. 2Health News:Foodborne Illnesses Remain Constant in U.S. 3Health News:The good and bad side of anti-cancer compounds 2Health News:The good and bad side of anti-cancer compounds 3Health News:Study Showed Minimally Invasive Surgery Reduced Risk of Hospital-Acquired Infections Compared to Open Surgery 2Health News:Study Showed Minimally Invasive Surgery Reduced Risk of Hospital-Acquired Infections Compared to Open Surgery 3
... Bard Collagen Implant, the world's leading bulking ... for the treatment of Stress Urinary Incontinence ... surrounding urethral tissue to aid coaptation in ... body's own structure, Contigen Bard Collagen Implant ...
... Titan™ Inflatable Penile Prosthesis (IPP) ... to be surgically implanted into ... of erectile dysfunction (also known ... the patient with voluntary control ...
... The AMS 650™ and 600M™ malleable ... many patientsespecially those with limited dexterity. These ... allows the patient to position them in ... make the penis rigid enough for sexual ...
... continues to be a proven, reliable penile ... to have mechanical reliability rates of over ... ioflex material contributes to excellent mechanical reliability ... Bioflex: ,Provides maximum, controlled girth expansion to ...
Medicine Products: