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
PRINCETON, N.J.--(BUSINESS WIRE)--Bristol-Myers Squibb Company (NYSE:BMY) announced today that the Committee for Medicinal Products for Human Use (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 (EU).
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 tumor types.
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 tumor types.