May 11, 2016
Bristol-Myers Squibb Company has announced that the European Commission (EC) has approved Opdivo in combination with Yervoy for treating advanced (unresectable or metastatic) melanoma in adults. This combination represents the first and only approved combination of two Immuno-Oncology agents in the European Union (EU). Due to this approval, it has become legitimate to market Opdivo + Yervoy Regimen in all 28 Member States of the EU.
Dr. James Larkin, from The Royal Marsden and lead author on CheckMate – 067, the trial that led to this approval, said: “Historically, advanced melanoma has been a very difficult-to-treat disease. Now, with this approval, patients in Europe will have a treatment option combining two Immuno-Oncology therapies, Opdivo and Yervoy, which in a Phase 3 randomized trial has shown its ability to deliver superior efficacy versusYervoy monotherapy in progression-free survival and response. This is truly good news for healthcare providers and the patients they treat, as it represents an important new treatment option with the potential for improved outcomes.”
“Today’s approval of the Opdivo + Yervoy Regimen for advanced melanoma patients supports our goal of developing innovative treatment approaches that have the potential to improve patient outcomes. The Opdivo + YervoyRegimen is the first and only approved Immuno-Oncology combination, and only Regimen to deliver superior efficacy compared to Yervoy, and we are thrilled to make this novel combination treatment available to patients with advanced melanoma in Europe,” said Emmanuel Blin, senior vice president, Head of Commercialization, Policy and Operations, Bristol-Myers Squibb.