BioSpace Collaborative

Academic/Biomedical Research
News & Jobs
Biotechnology and Pharmaceutical Channel Medical Device and Diagnostics Channel Clinical Research Channel BioSpace Collaborative    Job Seekers:  Register | Login          Employers:  Register | Login  

NEWSLETTERS
Free Newsletters
Archive
My Subscriptions

NEWS
News by Subject
News by Disease
News by Date
PLoS
Search News
Post Your News
JoVE

CAREER NETWORK
Job Seeker Login
Most Recent Jobs
Search Jobs
Post Resume
Career Fairs
Career Resources
For Employers

HOTBEDS
Regional News
US & Canada
  Biotech Bay
  Biotech Beach
  Genetown
  Pharm Country
  BioCapital
  BioMidwest
  Bio NC
  BioForest
  Southern Pharm
  BioCanada East
  C2C Services & Suppliers™
Europe
Asia

DIVERSITY

PROFILES
Company Profiles

INTELLIGENCE
Research Store

INDUSTRY EVENTS
Research Events
Post an Event
RESOURCES
Real Estate
Business Opportunities

 News | News By Subject | News by Disease News By Date | Search News
Get Our Industry eNewsletter FREE email:    
   

GlaxoSmithKline (GSK) Gets Speedy EU Review for Melanoma Drug


2/12/2013 7:47:29 AM

Recently, GlaxoSmithKline ( GSK ) announced that it has submitted a regulatory application for its oncology candidate, trametinib, as a monotherapy, for the BRAF V600 mutation-positive metastatic melanoma indication to the European Medicines Agency (EMA). The company is also looking to get trametinib in combination with another oncology candidate, dabrafenib, approved for use in adults with BRAF V600 mutation-positive metastatic melanoma. Glaxo's application seeking approval of trametinib as a monotherapy as well as combination therapy has been granted accelerated assessment by EMA's Committee for Medicinal Products for Human Use (CHMP). A final decision by the European Commission (EC) is expected by mid-Jul 2013. Glaxo submitted the marketing application primarily on the basis of encouraging data from a phase III study of trametinib as a single agent. The trial evaluated the use of trametinib versus dacarbazine or paclitaxel monotherapy in BRAF V600 mutation positive metastatic melanoma patients.



   
Melanoma

ADD TO DEL.ICIO.US    ADD TO DIGG    ADD TO FURL    ADD TO STUMBLEUPON    ADD TO TECHNORATI FAVORITES
 

//-->