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news.The European Committee for Medicinal Products for Human Use has issued a positive opinion recommending a conditional marketing authorization for Amgen's Vectibix for patients with refractory metastatic colorectal cancer with non-mutated Kras genes.
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According to the company, the committee's positive opinion for Vectibix is based on a positive benefit and risk assessment in a patient population that currently has few treatment options available to them. As part of the review, clinical data supporting the utility of Kras mutation status as a biomarker for clinical outcome were provided.
Willard Dere, senior vice president and international chief medical officer said: “We are pleased that Vectibix has received a positive opinion for conditional approval so patients in the European Union have further treatment options for metastatic colorectal cancer.”