Zalutumumab is a fully human EGFr monoclonal antibody that has demonstrated clinical benefit in refractory Head & Neck cancer and has the potential to be developed for and expand into large solid tumor markets.

EGFr is a proven oncology target, but there is room for a new product because of weaknesses in the currently available anti-EGFr products.

Zalutumumab:

• has shown a clinical benefit 
• has the most promising overall mechanisms of action in its class  
• in clinical studies has been dosed in a personalized way to maximize exposure for each patient, using the rash as a biomarker 
• is not expected to produce a hypersensitivity reaction against galactose-a-1,3-galactose, as seen with cetuximab 
• effectiveness is not changed by EGFr mutations 
• has strong patent protection until 2024

Regulatory Pathway:

• Genmab has received preliminary feedback from selected national European regulatory authorities and FDA
• Genmab believes a MAA for zalutumumab in second line head and neck cancer could be pursued based on available clinical data
• Additional clinical study data would be required prior to a US regulatory submission 

Zalutumumab is available for out-licensing.

Please see the following announcements regarding zalutumumab Phase III clinical results:
Headline Results announcement
June 2010 ASCO presentation of clinical study results