Posted by Michael Wonder on 22 Apr 2017
Bristol-Myers Squibb receives positive CHMP opinion recommending approval of Opdivo (nivolumab) for the treatment of patients with previously treated locally advanced or metastatic urothelial carcinoma, a type of bladder cancer
21 April 2017 - First positive CHMP opinion for an immuno-oncology agent for patients with locally advanced or metastatic urothelial cancer.
Bristol-Myers Squibb Company announced today that the CHMP of the European Medicines Agency has recommended the approval of Opdivo (nivolumab) for the treatment of locally advanced unresectable or metastatic urothelial carcinoma (mUC) in adults after failure of prior platinum-containing therapy. The CHMP recommendation will now be reviewed by the European Commission (EC), which has the authority to approve medicines for the European Union.
Opdivo is the first and only PD-1 immune checkpoint inhibitor for the treatment of patients with previously treated mUC to receive a positive CHMP opinion. Opdivo is already approved by the EC for six indications in four distinct tumour types.
