Opdivo + Yervoy combo approved in EU for advanced melanoma

12 May 2016

The first and only immuno-oncology combination therapy for the treatment of advanced melanoma has been approved by the European Commission.

US drugmaker Bristol-Myers Squibb’s (NYSE: BMY) Opdivo (nivolumab) and Yervoy (ipilimumab) combination can now be marketed in all 28 member states of the EU.

The approval was based on the Phase III, double-blind, randomized CheckMate -067 study, which demonstrated superior progression-free survival (PFS) and objective response rates (ORR) in patients with unresectable or metastatic melanoma, regardless of BRAF mutational status, versus Yervoy alone.

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