The Committee for Medicinal Products for Human Use of the European Medicines Agency granted accelerated review for Xilonix by XBiotech, a biopharmaceutical company and developer based in Austin, Texas, according to Street Insider.
Here are four takeaways:
1. Xilonix is XBiotech's first-in-class monoclonal antibody treatment for advanced colorectal cancer.
2. A decision on Xilonix's approval could come as early as third quarter 2016.
3. XBiotech recently received approval of its marketing authorization application for Xilonix based on results of a phase III study, which showed a 76 percent relative improvement in response rate in patients treated with the antibody as compared to placebo.
4. In the United States, Xilonix has received Fast Track designation by the FDA for the treatment of advanced colorectal cancer.