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Did The FDA Approve Exelixis’ Orphan Drug Cometriq (Cabozantinib) for Medullary Thyroid Cancer ?

December 1, 2012

       On November 29, 2012, the FDA approves Exelixis’ orphan drug Cometriq (Cabozantinib) for the treatment of progressive, metastatic Medullary Thyroid Cancer (MTC). The approval is based on a Phase III clinical trial, EXAM, which met the primary efficacy endpoint of improving progression-free survival (PFS). 

         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.

 References 

Cabozantinib Clinical Trial Information

Cometriq Website  

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

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