FAQs

What is EGFR (epidermal growth factor receptor)?
    
Human tumors frequently express high levels of receptors in the EGFR family. The binding of natural ligands (e.g. the  epidermal growth factor (EGF) or the transforming growth factor-α (TGF-α)) to EGFR produces a biological signal to the cell that initiates several functions that promote tumor growth and survival. Expression of EGFR has been associated with more aggressive disease. Therefore, therapies directed at preventing the function of these receptors could be useful cancer treatments.     


     

What is cetuximab (C225)?
    

Cetuximab (also known as C225) is an investigational monoclonal antibody designed to exclusively target and block the epidermal growth factor receptor (EGFR), which is expressed on the surface of certain cancer cells. Cetuximab is being developed in the United States by ImClone Systems and Bristol-Myers Squibb. Merck KGaA licensed the right to market cetuximab outside of the U.S. and Canada and the co-exclusive right to market cetuximab in Japan from ImClone Systems Incorporated of New York in 1998. Cetuximab has been approved in USA and Switzerland.
    


   

Why do drugs typically have multiple names (cetuximab, C225)?
    

As drugs go through the development process, they are assigned an identification name for initial study, usually an alpha-numeric combination (C225). As they move through the development cycle, they are then assigned a generic/ INN name (cetuximab) based on the drug's biological make-up. As a drug nears approval and market, what is known as a "brand name" is developed and trademarked for use in the broad population.
     


    

How is cetuximab given to patients?
    

Cetuximab is administered via an intravenous infusion.
     


     

Will there be a compassionate use program?
    

Merck KGaA is focussed on the regulatory submission of cetuximab so that patients most likely to benefit will have access to cetuximab as soon as possible. It is our position that we will not offer cetuximab outside our monitored studies. There are ongoing trials in colorectal cancer in which patients may participate, if they meet the protocol eligibility criteria.
     


    

Where can I find more information on cetuximab?
     

A considerable amount of data on cetuximab has already appeared in medical literature, much of it under the generic name cetuximab.  Some of the earlier work referred to cetuximab by its code number C225.
  





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