The EU CHMP will review its negative opinion of Human IgG1 monoclonal antibody specific for human interleukin-1 alpha XBiotech, intended to treat symptoms of advanced colorectal cancer.-XBiotech
On 18 May 2017, the Committee for Medicinal Products for Human Use (CHMP) adopted a negative opinion, recommending the refusal of the marketing authorisation for Human IgG1 monoclonal antibody specific for human interleukin-1 alpha XBiotech, intended for treating debilitating symptoms of advanced colorectal cancer. The company that applied for authorisation is XBiotech Germany GmbH. It may request a reexamination of the opinion within 15 days of receipt of notification of this negative opinion.
The company has applied for a marketing authorisation for this medicine and has requested a reexamination of the CHMP�s May 2017 opinion. Upon receipt of the grounds of the request, the CHMP will re-examine its opinion and issue a final recommendation.