Bristol-Myers receives 'positive' CHMP opinion on Opdivo approval
Bristol-Myers Squibb announced that the Committee for Medicinal Products for Human Use of the European Medicines Agency has recommended the approval of Opdivo for the treatment of locally advanced unresectable or metastatic urothelial carcinoma in adults after failure of prior platinum-containing therapy. The CHMP recommendation will now be reviewed by the European Commission, 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 tumor types. "We view the CHMP recommendation of Opdivo for previously treated locally advanced or metastatic urothelial carcinoma as an important milestone for the patients. Bristol-Myers Squibb looks forward to collaborating with the European Commission as it considers this potential new indication for Opdivo," said Murdo Gordon, executive vice president and chief commercial officer, Bristol-Myers Squibb.