European Medicines Agency adopts a final negative opinion for an extension of indications for bevacizumab

On 22 May 2014, the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) adopted a negative opinion, recommending the refusal of a change to the marketing authorisation for the medicinal product bevacizumab (Avastin). The change concerned an extension of indication to add treatment of glioblastoma. The applicant requested a re-examination of the opinion. After considering the grounds for this request, the CHMP re-examined the initial opinion, and confirmed the refusal of the marketing authorisation on 22 September 2014. Read more here.