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The FDA has granted accelerated approval to Vectibix (panitumumab) for the treatment of metastatic colorectal cancer in patients who have progressed on standard chemotherapy.
The approval was fast-tracked based on results of a randomized, controlled trial of some 450 patients with metastatic colorectal cancer after undergoing chemotherapy. Overall survival was similar in the Vectibix and control groups. However, the mean time to disease progression or death was 96 days for patients receiving Vectibix compared with 60 days for those receiving standard care. In addition, 8% of patients receiving study drug experienced tumor shrinkage.
Vectibix is a human monoclonal antibody that binds to the epidermal growth factor receptor. Vectibix's manufacturer, Amgen, says will cost about 20% less than the colorectal cancer drug Erbitux (cetuximab) -- a recombinant monoclonal antibody that also interferes with epidermal growth factor. Erbitux costs about $4000 every 2 weeks.
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Link: FDA press release (Free)
Link: Amgen press release (Free)
Link: New York Times story (One-time registration required)