Navigation Links
US FDA Advisory Committee Makes Recommendation on New Drug Application for Vandetanib in Advanced Medullary Thyroid Cancer
Date:12/2/2010

mittee, part of the FDA's evaluation of the New Drug Application submitted for vandetanib, is based on the results of ZETA, the Phase III, double-blind, placebo-controlled study. The ZETA study was designed to evaluate the safety and efficacy of vandetanib compared to placebo in patients with unresectable locally advanced or metastatic MTC. MTC accounts for four percent of all thyroid cancers, and the American Cancer Society estimates that more than 44,000 new cases of thyroid cancer will be diagnosed in the United States in 2010.

AstraZeneca filed the US regulatory submission for vandetanib in the second half of 2010. The FDA granted priority review status for the NDA and set a Prescription Drug User Fee Act (PDUFA) action date of January 7, 2011. AstraZeneca is consulting with regulatory authorities on a proposed trade name. Vandetanib is also currently under regulatory review by the European Medicines Agency (EMA).

The FDA frequently convenes advisory committee meetings to obtain independent expert guidance and recommendations on clinical matters. While the FDA is not required to follow this guidance, the agency takes the advice into consideration when rendering its final decisions on pending applications and other public health matters.

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. MTC accounts for four percent of all thyroid cancers. There are currently no approved treatment options for patients with advanced MTC.

The five-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 the ZETA study

ZETA was a Phase III, double-blind, placebo-controlled study that randomized 331 patients with unresectable locally advanced or metastatic MTC to oral, once-daily vandetanib 300mg or placebo. Results f
'/>"/>

SOURCE AstraZeneca
Copyright©2010 PR Newswire.
All rights reserved

Page: 1 2 3

Related medicine technology :

1. FDA Advisory Committees Recommend Continued U.S. Marketing Authorization for Trasylol(R)
2. Statement by KCP Chairman Dr. Edward Jones in Response to FDA Advisory Committee on Benefits and Risks of Erythropoietin-Stimulating Agents in Treatment of Kidney Patients
3. Targeted Genetics Reports on Recombinant DNA Advisory Committee (RAC) Review of its Phase 1/2 Trial of tgAAC94 for Rheumatoid Arthritis
4. Schiffrin Barroway Topaz & Kessler, LLP and Janet Jenner & Suggs, LLC Comment on Conagra Advisory Regarding Pot Pies Linked to Salmonella Outbreak
5. Solvay Pharmaceuticals, Inc. Responds to Advisory Committee Recommendation for Further Study of Tedisamil to Treat Atrial Fibrillation
6. FDA Advisory Committee Supports Efficacy and Safety of Zyprexa(R) Long-Acting Injection (LAI) for Schizophrenia Treatment
7. HUYA Bioscience Intl Announces World-Class Clinical Advisory Team for New Anti-Arrhythmic Compound Sourced From China
8. FDA Advisory Committee Unanimously Recommends U.S. Approval of Sugammadex, the First and Only Selective Relaxant Binding Agent
9. Ortho Biotech Statement on U.S. Food and Drug Administration Oncologic Drugs Advisory Committee Vote
10. UBC Forms European Advisory Board to Enhance Data Quality of CNS Trials
11. FDA Advisory Committee Unanimously Recommends Approval of Ustekinumab for Treatment of Moderate to Severe Plaque Psoriasis
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:9/23/2014)... Sept. 23, 2014 CASI Pharmaceuticals, Inc. (Nasdaq: ... the acquisition, development and commercialization of innovative therapeutics addressing ... market with a primary focus on China ... Shrotriya , MD, Chairman and Chief Executive Officer of ... appointment was made in connection with the recently announced ...
(Date:9/23/2014)...  Soligenix, Inc. (OTCQB: SNGX) (Soligenix or the ... address unmet medical needs in the areas of ... has appointed Rasappa Arumugham , PhD, as ... has over 25 years of diverse experience in ... of formulation research, analytical method development, quality control ...
(Date:9/23/2014)... Sept. 23, 2014  As physicians seek information ... communication channels to learn about new therapies or ... from a new report by global sales and ... that communicating via a customized mix of digital ... best opportunity to engage with physicians. And, productive ...
Breaking Medicine Technology:CASI Pharmaceuticals Announces Appointment Of Rajesh C. Shrotriya, MD To The Board Of Directors 2CASI Pharmaceuticals Announces Appointment Of Rajesh C. Shrotriya, MD To The Board Of Directors 3CASI Pharmaceuticals Announces Appointment Of Rajesh C. Shrotriya, MD To The Board Of Directors 4Soligenix Appoints Rasappa Arumugham, PhD, as Vice President of Biopharmaceutical Development 2Soligenix Appoints Rasappa Arumugham, PhD, as Vice President of Biopharmaceutical Development 3Soligenix Appoints Rasappa Arumugham, PhD, as Vice President of Biopharmaceutical Development 4As sales reps see doors close for in-person visits with physicians, digital doors open communication 2As sales reps see doors close for in-person visits with physicians, digital doors open communication 3As sales reps see doors close for in-person visits with physicians, digital doors open communication 4As sales reps see doors close for in-person visits with physicians, digital doors open communication 5
(Date:9/23/2014)... 2014 Avid collector Andrew Hawley, from Vintage ... Eagle Auditorium Seattle concert posters. The Doors were a smash ... that year. The Seattle Eagles Auditorium concert was held on ... return to Eagles Auditorium in November the same year. The ... and comes in three colors. The poster is a split ...
(Date:9/23/2014)... 2014 What: Rutgers Presbyterian Church, ... Side that embodies the inclusion and diversity of ... and the Ecological Crisis, a public lecture led ... Emerita of Old Testament at Louisville Presbyterian Seminary. ... that lends insight into current ecological problems, including ...
(Date:9/23/2014)... Oregon survey about an exercise DVD that adds short ... elementary school students found it had a high level ... clear advantages for overly sedentary educational programs. , Called ... the Healthy Youth Program of the Linus Pauling Institute ... Brain Breaks leads children in 5-7 minute segments of ...
(Date:9/23/2014)... (September 23, 2014) Both patients and healthcare ... computed tomography (CT) colonography greatly outweighs the potential ... precipitated by false-positive diagnoses, according to a new ... journal Radiology . , Diagnostic tests used ... organ. However, when screening for colorectal cancer with ...
(Date:9/23/2014)... September 23, 2014 The ... rhinitis (AR) is highly fragmented, with the ... formulations available, under different regulatory restrictions, with ... Europe has the most developed market, with ... allergen immunotherapy tablets (AITs) all being available. ...
Breaking Medicine News(10 mins):Health News:Inhabiting Eden: Christians, Scripture, and the Ecological Crisis – Public Lecture to Discuss Faith-Based Environmentalism 2Health News:'Brain Breaks' increase activity, educational performance in elementary schools 2Health News:'Brain Breaks' increase activity, educational performance in elementary schools 3Health News:Patients accept false-positives to achieve diagnostic sensitivity 2Health News:Patients accept false-positives to achieve diagnostic sensitivity 3Health News:Allergen extract Allergic Rhinitis Specific Immunotherapy Market to Grow $688.3m by 2018 Says a New Report Available at MarketOptimizer.org 2Health News:Allergen extract Allergic Rhinitis Specific Immunotherapy Market to Grow $688.3m by 2018 Says a New Report Available at MarketOptimizer.org 3Health News:Allergen extract Allergic Rhinitis Specific Immunotherapy Market to Grow $688.3m by 2018 Says a New Report Available at MarketOptimizer.org 4
... Increase for Small Business Owners at ... http://www.bluecrossca.com/click4biz , THOUSAND OAKS, Calif., ... fastest growing segments of California,s economy, however,many small business owners ... Blue Cross of California has just made it,easier for small ...
... vitamins and minerals does not seem to prevent the degenerative ... study published on bmj.com today. , Age related ... older people. It is caused by the progressive break down ... centre of the retina at the back of the eye. ...
... 8 Proposed,regulations that would govern who owns ... grants to for-profit organizations fail,to ensure affordable access ... for the research, the Foundation for Taxpayer and ... the people who have paid for the research ...
... Saturn, committed to health, fitness,and healthy living in communities ... health and fitness expo, held in conjunction with the ... Saturn Health and Fitness Expo, which runs Oct. 19-20 ... vendors,informational booths and groups that provide services to runners. ...
... 8 - The Washington,State Veterinary Medical Association awarded ... veterinarian with Olympia Pet,Emergency in Lacey. (Logo: ... his award in recognition of his dedication to,organized ... Washington,State University,s College of Veterinary Medicine, he has ...
... Help ... Owners Cope, SACRAMENTO, Calif., Oct. ... and language skills died last,month, his owner, scientist Irene Pepperberg, needed time ... it. Newspapers and web,sites printed his obituary and many people sent condolences. ...
Cached Medicine News:Health News:New Online Tool Makes Enrollment in Blue Cross of California Easier 2Health News:Antioxidants do not prevent degenerative eye disease 2Health News:Revised California Stem Cell Research Rules Fail to Ensure Affordable Access to Cures, Consumers Warn 2Health News:Saturn Shows Its Commitment to Health and Fitness by Becoming Expo Title Sponsor for The Detroit Free Press/Flagstar Marathon 2Health News:Lacey Veterinarian Awarded 2007 WSVMA Recent Graduate Award 2Health News:We Love Our Pets and Grieve When They Die 2Health News:We Love Our Pets and Grieve When They Die 3
... HIV-1 Antibody Test (Reveal Test) is MedMiras ... antibodies in human serum or plasma against ... in response to HIV infection. The Reveal ... membrane technology, and is comprised of a ...
... The OraQuick ADVANCE Rapid ... a single-use, qualitative immunoassay ... Human Immunodeficiency Virus Type ... 2 (HIV-2) in oral ...
... The advanced performance benefits ... been applied to the ... Implants) Upper Extremity Plates. ... combine to provide a ...
... of TiMAX material have been applied to a ... and an ultra-low profile combine to provide a ... extremity. , ,This complete set of periarticular plates ... , Fibula Composite Plate , Spider ...
Medicine Products: