The European Medicines Agency's Committee for Medicinal Products for Human Use issued a negative opinion of XBiotech's Lead mAb Xilonix, which treats advanced colorectal cancer, GEN reports.
GEN reports the recommendation against follows an EMA action in April after XBiotech informed the EMA of several outstanding issues, yet to be addressed.
Here's what you should know.
1. The committee said it would re-exam the drug and would promptly notify the EMA of its intent to do so if XBiotech resubmits the drug.
2. In a phase III study with EMA's Scientific Advisor Group, XBiotech said the drug improved response rate in 76 percent of patients.
3. In a separate phase III study determining overall survival rate, an independent data monitoring committee recommend the study continue unmodified.