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Exelixis, Orphan Drug Cometriq (Cabozantinib), And The Drug Pipeline:’s Perspective

December 6, 2012

        On November 29, 2012, the FDA approves Exelixis’ orphan drug Cometriq (Cabozantinib) for the treatment of progressive, Metastatic Medullary Thyroid Cancer (MTC). This is Exelixis’ 1st approved drug. 

         What else does Exelixis have in their Drug Pipeline ?’s December 4, 2012 article titled, “Exelixis’s Promising Pipeline Of Drugs”  answers this question. 

         Here is the sequence of historical events for the FDA approval of Cometriq :  

1)  Receives FDA Orphan Drug Designation (ODD) on November 29, 2010   

2)  Submits Rolling New Drug Application (NDA) in May 2012   

3)  Receives FDA Priority Review on July 30, 2012 and assigning of November 29, 2012, for the PDUFA date   

4)  Removal from FDA Oncologic Drug Advisory Committee (ODAC) Meeting scheduled for November 8 – 9, 2012, on August 29, 2012   

5)  Approval on PDUFA date of November 29, 2012

       Exelixis on November 29, 2012 , announces that the European Medicines Agency (EMA) accepts for review the Marketing Authorization Application (MAA) for Cometriq for MTC.  

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

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