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 endothelial growth factor receptor (VEGFR), epidermal growth factor receptor (EGFR), and rearranged during transfection (RET) pathways -- all pathways involved in tumour growth.

NOTES TO EDITORS:

About MTC

The American Cancer Society estimates that more than 44,000 new cases of thyroid cancer will be diagnosed in the United States in 2010.  Across Europe the incidence is over 50,000 cases per year.

MTC accounts for 5% of all thyroid cancers.

The 5-year survival rates in patients with MTC that has spread to nearby organs (Stage III) and other parts of the body (Stage IV) are 81% and 28% respectively.

About AstraZeneca

AstraZeneca is a global, innovation-driven biopharmaceutical business with a primary focus on the discovery, development and commercialisation of prescription medicines.  As a leader in gastrointestinal, cardiovascular, neuroscience, respiratory and inflammation, oncology and infectious disease medicines, AstraZeneca generated global revenues of US $32.8 billion in 2009.  For more information please visit: www.astrazeneca.com


'/>"/>
SOURCE AstraZeneca
Copyright©2010 PR Newswire.
All rights reserved

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:9/25/2017)... , Sept. 25, 2017   Montrium ... Master File solutions, today—from the IQPC Trial Master ... , NL)—announced that EastHORN Clinical Services has ... clinical programs and TMF management. EastHORN, a leading ... eTMF platform to increase transparency to enable greater ...
(Date:9/22/2017)... ROCKVILLE, Md. , Sept. 22, 2017  As ... by Republican Senators Bill Cassidy (R-LA) and ... Kalorama Information notes that the medical device industry is ... the medical device tax, the 2.3% excise tax on ... Act.  But they also want covered patients, increased visits ...
(Date:9/19/2017)... ZirMed Inc ., a recognized leader in cloud-based revenue cycle ... ranked #1 by its users for the seventh consecutive year ... ZirMed was recognized as the top-ranked end-to-end revenue cycle management ... 200 beds and holds one of the longest #1 ranking ... ...
Breaking Medicine Technology:
(Date:10/13/2017)... Las Vegas, Nevada (PRWEB) , ... October 13, 2017 , ... ... of 7® Hemp CBD Oil utilizing Purzorb™ technology. Applying the Purzorb™process to full spectrum ... CBD dose required and providing a CBD form that can be easily incorporated into ...
(Date:10/13/2017)... (PRWEB) , ... October 13, 2017 , ... The Visiting ... Day Market. Featuring a collection of specialty vendors and unique items from across the ... and quality-focused health and wellness services offered by the VNA. The boutique will ...
(Date:10/13/2017)... VA (PRWEB) , ... October 13, 2017 , ... ... of DevOps and Agile Software Development, has been awarded a contract by the ... Blanket Purchase Agreement (BPA) aims to accelerate the enterprise use of Agile methodologies ...
(Date:10/12/2017)... ... , ... Planet Fitness, one of the largest and fastest growing franchisors and ... flagship location in Covington, LA at 401 N. U.S. Highway 190, in January of ... Depot in the Holiday Square shopping center. Its location allows it to serve both ...
(Date:10/12/2017)... ... October 12, 2017 , ... ... system that we intend to develop to enable prevention of a major side ... severe hearing loss, especially in pediatric patients. For cisplatin, hearing loss is FDA ...
Breaking Medicine News(10 mins):