EU CHMP recommends approval of Opdivo (nivolumab) in bladder cancer- BMS

The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency has recommended the approval of Opdivo (nivolumab), from BMS, 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).

The CHMP adopted its positive opinion based on results from the Phase II clinical trial CheckMate -275 in patients with locally advanced unresectable or mUC that progressed after a platinum-containing therapy and were treated with Opdivo. The primary endpoint of CheckMate -275 was objective response rate and additional efficacy measures included durability of response and overall survival. Data from CheckMate -275 were presented at the 2016 European Society for Medical Oncology Congress in October 2016 and published online in Lancet Oncology in January 2017.

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"Nivolumab in metastatic urothelial carcinoma after platinum therapy (CheckMate 275): a multicentre, single-arm, phase 2 trial£- Prof Padmanee Sharma, Prof Margitta Retz, MD, Arlene Siefker-Radtke, MD, Ari Baron, MD, et, al..Published: 25 January 2017 DOI: http://dx.doi.org/10.1016/S1470-2045(17)30065-7.