Skip to content

Why Is November 29, 2012 Important For Exelixis’ Orphan Drug Cabozantinib For Medullary Thyroid Cancer ?

November 25, 2012

       Exelixis was scheduled to present orphan drug Cabozantinib before a FDA Oncologic Drug Advisory Committee Meeting on November 8 – 9, 2012. But on August 29, 2012, the FDA notifies Exelixis that Cabozantinib is removed from the AdComm Agenda. The FDA gives the drug a Priority Review on July 30, 2012. The FDA PDUFA date is scheduled for Thursday, November 29, 2012.    

        One just has to look at the data for Cabozantinib to feel positive about its chances for FDA approval on November 29, 2012 : 

–  Extends median Progression-Free Survival (PFS) to 11.2 months, compared to 4 months for placebo 

–  Overall response rate is 28%, compared with 0% for placebo 

–  Mild adverse side effects. 

References

DailyFinance.com November 25, 2012 article titled, “2 Important Decisions to Watch For This Week in the Biotech Sector”  

DailyFinance.com August 31, 2012 article titled, “Reading Between the FDA Lines”  

GlobalRegulatoryScience.com November 21, 2012 article titled, “Exelixis Stock Treads Water Ahead of FDA Decision”  

SeekingAlpha.com November 21, 2012 article titled, “Wednesday’s Bio-Pharma Catalyst Trades and Watch List”  

Copyright © 2012-2013, Orphan Druganaut Blog.  All rights reserved.

Advertisements
Leave a Comment

Leave a Reply

Fill in your details below or click an icon to log in:

WordPress.com Logo

You are commenting using your WordPress.com account. Log Out / Change )

Twitter picture

You are commenting using your Twitter account. Log Out / Change )

Facebook photo

You are commenting using your Facebook account. Log Out / Change )

Google+ photo

You are commenting using your Google+ account. Log Out / Change )

Connecting to %s

%d bloggers like this: