CHMP recommends against XBiotech's colorectal cancer candidate

EMA’s CHMP recommended against approval of an MAA from XBiotech Inc. (NASDAQ:XBIT) for Xilonix (Hutruo, CV-18C3, T2-18C3, RA-18C3, MABp1, CA-18C3) to treat symptoms of advanced colorectal cancer, including cachexia. CHMP cited lack of efficacy in improving lean body mass or quality of life (QOL), increased risk of infection and inadequate manufacturing controls. XBiotech said it plans to inform EMA of its request for a re-examination.

Last month, XBiotech said EMA issued a negative “trend” vote for the company's MAA (see BioCentury, May 1)...