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news.The European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) has granted accelerated review for marketing authorization of XBiotech's Xilonix true human monoclonal (IgG1k) antibody to treat advanced colorectal cancer.
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Accelerated review status enables CHMP to grant an opinion two months earlier than the standard 210-day period. In XBiotech’s case, a decision may happen as early as third quarter of this year.
Xilonix specifically targets and neutralizes interleukin-1 alpha (IL-1a), a molecule believed to promote the growth and spread of tumors, as well as mediate symptoms like metabolic dysregulation, fatigue and anxiety associated with advanced cancer.
XBiotech chairman, chief executive and founder John Simard said: "XBiotech is encouraged by CHMP’s action to grant accelerated review of Xilonix.
"There is an urgency to provide advanced colorectal cancer patients with access to new treatments that have been developed with their specific needs in mind."
The US Food and Drug Administration has already granted fast track designation to Xilonix for the treatment of advanced colorectal cancer.
The occurrence of colorectal cancer increases with economic development and aging, resulting in the increase of incidence globally.
In Europe, about 470,000 patients will be diagnosed with colorectal cancer in 2016, and half of the number are expected to progress and ultimately succumb to the disease.
Disease progression is related with significant morbidity, functional impairment and failure of several therapies with substantial toxicities.