EU CHMP recommends refusal of application for Xilonix (human IgG1 monoclonal antibody) in colorectal cancer- XBiotech

The EU Committee for Medicinal Products for Human Use (CHMP) adopted a negative opinion, recommending the refusal of the marketing authorisation for Xilonix (human IgG1 monoclonal antibody), from XBiotech, intended for treating debilitating symptoms of advanced colorectal cancer. The company presented results of a main study in 333 patients looking at the effects of this medicine on lean body mass (body weight excluding fat) and quality of life. The medicine was compared with placebo (a dummy treatment).

The CHMP had a number of concerns. First, the committee noted that the study did not show clear improvements in either lean body mass or quality of life. Secondly, there was an increased risk of infection in patients taking the medicine, which was not considered acceptable in vulnerable patients who will be receiving palliative care. Lastly, there were inadequate controls of the manufacturing process to ensure the medicine would have the same quality as the product used in clinical trials. Therefore, the CHMP was of the opinion that the benefits of this medicine did not outweigh its risks and recommended that it be refused marketing authorisation.