The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) adopted a negative opinion on XBiotech’s lead product, its human interleukin-1α monoclonal antibody (mAb), and recommended against approval of the mAb in Europe for treating the debilitating symptoms of advanced colorectal cancer (CRC).
The recommendation against approval comes as no surprise, as last month the EMA registered a negative trend vote after meeting with XBiotech to discuss its Day 180 List of Outstanding Issues related to the marketing authorization application for the antibody.
In its Form 8-K filing, XBiotech said it believes it has a “strong position for re-examination,” and would “promptly” notify the EMA that it wanted the Marketing Authorisation Application (MAA) re-examined. The firm has 60 days to submit its grounds for appeal.
XBiotech’s Xilonix™ has been developed as a first-in-class True Human™ IgG1k interleukin-1α mAb, which the firm says in a Phase III study in CRC patients demonstrated a 76% relative improvement in response rate, compared with placebo. The study was undertaken as a collaboration between XBiotech and the EMA’s Scientifc Advisory Group.
A Phase III global trial in advanced CRC patients is separately evaluating Xilonix treatment on overall survival. During February, an interim analysis by the study’s independent data monitoring committee led to its recommendation to continue the study without modification.