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Why Is Takeda Pharmaceuticals And Seattle Genetics’ Orphan Drug Adcetris (Brentuximab Vedotin) In The News Again ?

November 26, 2012

            In a November 26, 2012 Press Release, Seattle Genetics announces that Adcetris (Brentuximab Vedotin) receives FDA Orphan Drug Designation (ODD) for the treatment of Mycosis Fungoides (MF). ALCANZA is the Phase III clinical trial from Seattle Genetics and Takeda Pharmaceuticals, for patients with CD30-positive relapsed CTCL (including MF). 

            At the 54th American Society of Hematology (ASH) Annual Meeting, scheduled for December 8 – 11, 2012, in Atlanta, data is to be presented from 2 investigator-sponsored trials of Adcetris in CTCL. 

            Facts about Mycosis Fungoides : 

–   Most common subtype of Cutaneous T-Cell Lymphoma (CTCL) 

–   Also known as Sezary Syndrome; mycosis fungoides translates to “mushroom-like fungal disease” 

–   Approximately 40 – 100% of patients live with the disease for at least 10 years; difficult to remove the disease entirely & remission is less common than with other types of cancer 

–   Most treatment is considered “palliative”, and is designed to slow rather than eliminate the disease.       

           Adcetris has the following history in the United States:  

–   On October 23, 2008, receives FDA ODD for systemic anaplastic large cell lymphoma  (sALCL).  On August 19, 2011, receives FDA orphan approval & exclusivity start date for sALCL 

–   On January 30, 2007, receives FDA ODD for Hodgkin Lymphoma (HL).  On August 19, 2011, receives FDA orphan approval & exclusivity start date for HL.  

    Adcetris has the following history in Europe :   

–   On January 15, 2009, EMA’s CHMP gives orphan drug designation for treatment of HL & sALCL; On July 19, 2012, receives from EMA’s CHMP a positive opinion, recommending the granting of a conditional marketing authorization for HL and sALCL; On October 25, 2012, EC grants a marketing authorization valid throughout the EU   

–    On January 11, 2012, receives orphan designation from EMA for CTCL.    

References 

Cutaneous Lymphoma Foundation  

Mycosis Fungoides Foundation  

Orphan Druganaut November 23, 2012 Blog Post titled, “When Will Takeda Pharmaceuticals’ Orphan Drug Adcetris Be Launched In Europe ?”     

Seattle Genetics Clinical Trials  

Seattle Genetics Drug Pipeline  

SeekingAlpha.com November 26, 2012 article titled, “Show Me The Money: ADC Revenue Payloads Miss The Mark”  

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

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