Clinical data supporting approval was predominantly generated by an open label, multinational randomized trial involving 463
patients. One group was administered the product while the other group received supportive care alone. Administration of Vectibix
resulted in prolonged progression-free survival, from an average of 60 days to 96 days. The most common and sometimes severe
negative side effects included dermatologic toxicities and adverse (sometimes severe infusion related) reactions also occurred
in a minority of recipients. The product is manufactured and marketed by Amgen (Thousand Oaks, CA).
Gary Walsh, PhD, is an associate professor in the Industrial Biochemistry Program at the University of Limerick, Limerick City, Ireland,
+353.61.202664, Gary.walsh@ul.ie
REFERENCES
1. US Food and Drug Administration. Approvals of FDA-regulated products. Available from
http://www.fda.gov/opacom/7approvl.html.
2. European Medicines Agency. EMEA annual report 2006. Available from http://
http://www.emea.europa.eu/index/indexh1.htm.
3. European Medicines Agency. EPARs for authorised medicinal products for human use. Available from http://
http://www.emea.europa.eu/htms/human/epar/eparintro.htm.
4. Walsh G. Biopharmaceuticals: approvals and approval trends in 2004. BioPharm Int. 2005;18(8):58–65.
5. Walsh, G. Biopharmaceuticals: approval trends in 2005. BioPharm Int. 2006;19(8):58–68.
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