AVEO Oncology Announces Updated Overall Survival Hazard Ratio | EXEL Message Board Posts

EXEL   /  Message Board  /  Read Message

 

 






Keyword
Subject
Between
and
Rec'd By
Authored By
Minimum Recs
  
Previous Message  Next Message   Post Message   Post a Reply return to message boardtop of board
Msg  22731 of 22760  at  9/11/2019 12:09:52 PM  by

erniewerner


 In response to msg 22730 by  wilderguide
view thread

Re: AVEO Oncology Announces Updated Overall Survival Hazard Ratio

"Wouldn't this set a dangerous precedent by lowering the bar for future approvals?"
 
I don't think so.  This will be a marginal approval, not so much because of a weak data set, as because the control arm drug is weak.  Remember though, drugs get approved based on superiority to placebo on a regular basis.  Cabo was approved in medullary thyroid cancer based on PFS with no OS advantage.  The first interim for that trial showed an OS HR = 1.0 and FDA scheduled an adcomm to discuss that result.  FDA had EXEL do another data lock and the HR dropped to somewhere around .90 in favor of Cabo and the adcomm was cxed.  At least Tivo had an active control, albeit a marginal one.
 
As long as there are no negative surprises hiding in the Tivo 3 data set, I think it will get approved and I think it should get approved.  Drugs get approved based on noninferiority on a regular basis.  More choices is a good thing and for patients who make it all the way to 4th or 5th line treatment, Tivo may be a good choice.   


     e-mail to a friend      printer-friendly     add to library      
| More
Recs: 2     Views: 233
Previous Message  Next Message   Post Message   Post a Reply return to message boardtop of board


About Us  •  Contact Us  •  Follow Us on Twitter  •  Members Directory  •  Help Center  •  Advertise
Not a member yet? What are you waiting for? Create Account
Want to contribute? Support InvestorVillage by donating
© 2003-2019 Investorvillage.com. All rights reserved. User Agreement
   
Financial Market Data provided by
.


Loading...