Navigation Links
Taiho Pharmaceutical stellt Zulassungsantrag zur Herstellung und Vermarktung des neuartigen Antitumormittels TAS-102
Date:2/26/2013

TOKIO, 27. Februar 2013 /PRNewswire/ -- Taiho Pharmaceutical Co., Ltd. gab am 27. Februar bekannt, dass das Unternehmen am 26. Februar einen Zulassungsantrag zur Herstellung und Vermarktung des neuartigen, oral verabreichten Nukleosid-Antitumormittels TAS-102 (eine Kombination aus Trifluorthymidin (FTD) und Tipiracil-Hydrochlorid (TPI)) beim japanischen Ministerium für Gesundheit, Arbeit und Wohlfahrt gestellt habe. Taiho Pharmaceutical bemüht sich um die Zulassung von TAS-102 für die Indikation des inoperablen, rezidivierenden kolorektalen Karzinoms.

Der Zulassungsantrag beruht auf den Ergebnissen einer klinischen Phase-II-Studie (Studie 10040030), die an 20 Einrichtungen in ganz Japan durchgeführt wurde. Dabei handelte es sich um eine randomisierte Doppelblind-Vergleichsstudie von TAS-102 und einem Placebo an 172 Patienten mit inoperablen, rezidivierenden kolorektalen Karzinomen im fortgeschrittenen Stadium, die für herkömmliche Chemotherapie unempfänglich sind und mindestens zweimal oder häufiger mit Fluoropyrimidin, Irinotecan und Oxaliplatin behandelt wurden. Die Ergebnisse zeigten, dass die mit TAS-102 behandelte Gruppe eine verbesserte Gesamtüberlebensrate (mittleres Gesamtüberleben: 9,0 Monate vs. 6,6 Monate) und ein deutlich reduziertes Sterberisiko (HR: 0,56, p=0,0011) aufwies. Die am häufigsten berichtete Arzneimittelnebenwirkung mit einem CTCAE-Wert von 3 oder höher war Neutropenie. Durchfall, Müdigkeit, Übelkeit und sonstige Nebenwirkungen der Klasse 3 lagen nicht über 10 %. In einer ähnlichen Patientengruppe führt Taiho Pharmaceutical derzeit eine globale klinische Phase-III-Studie von TAS-102 bei kolorektalen Karzinomen (RECOURSE) durch. Das oberste Ziel besteht in der globalen Registrierung und Vermarktung des Wirkstoffs.

Taiho Pharmaceutical ist der Ansicht, dass TAS-102 einen signifikanten
'/>"/>

SOURCE Taiho Pharmaceutical Co., Ltd.
Copyright©2012 PR Newswire.
All rights reserved

Page: 1 2 3 4 5

Related medicine technology :

1. Taiho Pharmaceutical Submits Application for Approval to Manufacture and Market Novel Antitumor Agent TAS-102
2. Taiho Pharmaceutical présente une demande dhomologation pour la fabrication et la commercialisation du nouvel agent antitumoral TAS-102
3. Taiho Pharmaceutical Announces Start of Global Phase III Clinical Trial in Metastatic Colorectal Cancer with Novel Antitumor Agent TAS-102
4. Jazz Pharmaceuticals Reports Full Year And Fourth Quarter 2012 Financial Results
5. Cadence Pharmaceuticals CEO Ted Schroeder To Present At The Cowen & Company 33rd Annual Health Care Conference In Boston On March 5, 2013
6. Global Pharmaceutical Industry Trends: Procurement Budgets Stay the Same, Marketing Budgets to Experience Slight Decrease
7. Savient Pharmaceuticals to Hold Fourth Quarter and Year-End 2012 Financial Results Conference Call on Tuesday, March 19, 2013
8. Savara Pharmaceuticals Announces Formation of Clinical Advisory Board
9. Isis Pharmaceuticals Initiates Phase 2 Study Of ISIS-CRP Rx In Patients With Atrial Fibrillation
10. UBM Launches PharmaEvolution.com, an Online Peer-to-Peer Network for Pharmaceutical Industry Professionals
11. Alexza Pharmaceuticals Corporate Presentation to Be Webcast at Three Upcoming Investor Conferences
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:1/14/2014)... The Brandeis Medical Center, led by Dr. Emmanuel Brandeis , ... laser tattoo removal experience with the advanced Astanza Duality laser and ... quality cosmetic services with cutting edge medical technology and offering expert ... has seen a dramatic increase in the presence of ...
(Date:1/14/2014)... LEESBURG, Va. , Jan. 14, 2014 Animal Emergency Critical ... in Leesburg, Virginia is the first in ... hyperbaric oxygen chamber. Dr. Susan M. Barnes ... years. Dr. Barnes and husband, Dr. Cole Taylor , are ...
(Date:1/14/2014)... Inc. , a privately held company pioneering the development ... related neurodegenerative disorders, announced today the relocation of its ... as of January 15, 2014 and expanded lease agreement ... Oligomerix, which is focused on the development ...
Breaking Medicine Technology:Beverly Hills Physician Features Tattoo Removal with the Astanza Duality Laser, Offers $99 Special 2Hyperbaric Veterinary Medicine (hvm) Announces Animal Emergency Critical Care Installs A Small Animal Hyperbaric Chamber 2Oligomerix Relocates Corporate Headquarters and Secures Additional Laboratory Space from New York Medical College 2
... Corporation today announced the release of,new data concerning ... was conducted by the Department of Physiology at,University ... agreement with Millipore was announced in 2006. ,The ... research &,development scientist for Millipore’s Bioprocess Division, in,a ...
... June 20, 2007 /PRNewswire-FirstCall/ - SemBioSys,Genetics Inc. ... of,therapeutic proteins for metabolic and cardiovascular disease,today ... scientific poster and,abstract at the 67th Scientific ... Chicago. The Company's poster will disclose,recent accomplishments ...
Cached Medicine Technology:Millipore Corporation Announces New ReNcell Data from Collaboration,with ReNeuron 2Millipore Corporation Announces New ReNcell Data from Collaboration,with ReNeuron 3Millipore Corporation Announces New ReNcell Data from Collaboration,with ReNeuron 4SemBioSys to present new data at American Diabetes Association,annual meeting 2SemBioSys to present new data at American Diabetes Association,annual meeting 3
(Date:4/17/2014)... April 17, 2014-- Colic affects about one in five ... numerous pediatric visits during the first several months after ... symptoms was showing promise; however, the April 1, 2014 ... Sung, Valerie) reported on a study, "Probiotics and Infant ... L reuteri for infant colic did not ...
(Date:4/17/2014)... University School of Medicine (BUSM) have discovered that ... an experimental model. The findings, reported in the ... , may lead to more effective treatments for ... of the leading causes of illness and death ... impact by limiting the productivity of workers and ...
(Date:4/17/2014)... researchers at UC Davis has shown that the cyclin ... cell division, also boosts the mitochondrial activity to power ... has been shown to perform both jobs. This newfound ... control cellular energy production, potentially advancing cancer care and ... the journal Developmental Cell . , "These proteins ...
(Date:4/17/2014)... An international research team led by Cesar A. Arias, ... Center at Houston (UTHealth) has identified a new superbug ... The report appeared in the April 17 issue of ... The new superbug is part of a class of ... or MRSA, which is a major cause of hospital ...
(Date:4/17/2014)... days to find a colored ribbon representing a disease. A ... what color ribbon does one think of with lung cancer?, ... many suffering from the disease, black may be the only ... of lung cancer patients, primarily smokers between the ages of ... the stigma often felt by these patients, the emotional toll ...
Breaking Medicine News(10 mins):Health News:New study says probiotic use for infant colic is not effective in reducing symptoms 2Health News:BUSM researchers find anti-seizure drug may reduce alcohol consumption 2Health News:Dual role: Key cell division proteins also power up mitochondria 2Health News:New MRSA superbug emerges in Brazil 2Health News:Unraveling the 'black ribbon' around lung cancer 2
... , WASHINGTON, Dec. 8 The National Business Group on ... employers, announced today that Sally Welborn, Senior Vice President of ... Directors, effective immediately. , "We are thrilled to announce Sally,s ... Senior Vice President of Human Resources at Coca-Cola Enterprises ...
... , ... Technologies, Inc. , has been selected by the Blue Cross ... watchlist screening software for OFAC, OIG and EPLS and USA PATRIOT ... compliance software to BCBSA,s Chicago headquarters and its member Blue Cross ...
... , - May Set Stage ... Dec. 8 Neurology researchers have shown that feeding amino acids ... stage for the first effective treatment for cognitive impairments suffered by ... animal model that dietary intervention can restore a proper balance of ...
... panic disorder, study finds , TUESDAY, Dec. 8 (HealthDay ... in their blood might be at increased risk for ... , Researchers analyzed information on 1,987 adults, aged 20 ... Health and Nutrition Examination Survey between 1997 and 2004. ...
... defined as the pathological retrograde movement of gastric ... which may be important in reflux are observed ... disorder in these patients is ineffective esophageal motility ... been shown to be strongly associated with isolated ...
... to a lack of suitable studies, it is unclear ... autologous haematopoietic stem cell transplantation. With this type of ... are removed at a convenient time and generally re-implanted ... is neither indication nor proof of additional benefit compared ...
Cached Medicine News:Health News:National Business Group on Health Elects Sally Welborn, Walmart Executive, to Board of Directors 2Health News:The National Blue Cross and Blue Shield Association Selects ATTUS Technologies as Preferred Provider for OFAC, OIG, EPLS and USA PATRIOT Act Compliance 2Health News:The National Blue Cross and Blue Shield Association Selects ATTUS Technologies as Preferred Provider for OFAC, OIG, EPLS and USA PATRIOT Act Compliance 3Health News:With Amino Acid Diet, Mice Improve After Brain Injury 2Health News:With Amino Acid Diet, Mice Improve After Brain Injury 3Health News:Lead Exposure May Affect Mental Health 2Health News:Are manometric findings different between the patients with erosive and nonerosive disease? 2Health News:Autologous stem cell transplantation for soft tissue sarcoma: insufficient research into therapy 2Health News:Autologous stem cell transplantation for soft tissue sarcoma: insufficient research into therapy 3Health News:Autologous stem cell transplantation for soft tissue sarcoma: insufficient research into therapy 4
... 3 mirror lenses featuring ultra-clear Volk 3-Mirror ... 76°, 66° and 60°. The 3 ... well central and peripheral fundus viewing and ... angled to eliminate gaps in the visualized ...
... are a family of single-use direct view vitrectomy ... particular region of the retinal surface during eye ... 1 gram and is formed and polished to ... human cornea. Lenses come in boxes of 10 ...
... AFX Lens is a direct ... in an air-filled eye. In ... a primary air-fluid exchange vitrectomy ... sutureless design make it well ...
... Prism are designed for midperipherical ... for tractional retinal detachments (PDR, ... detachment. They can be used ... midperipheral laser applications. Direct image ...
Medicine Products: