European Commission Approves MSD's Anti-PD-1 Therapy, KEYTRUDA® (pembrolizumab), for Both First-line and Previously-treated Patients with Advanced Melanoma

MSD, known as Merck in the United States and Canada, today announced that the European Commission has approved KEYTRUDA® (pembrolizumab), the company's anti-PD-1 therapy, for the treatment of advanced (unresectable or metastatic) melanoma in adults. The European Commission approval of pembrolizumab is based on data from three clinical studies conducted in more than 1,500 first-line and previously-treated patients with advanced melanoma. Pembrolizumab received European Commission regulatory approval based on Phase 3 data which showed it is the first and only anti-PD-1 therapy to provide a statistically superior survival benefit as a monotherapy compared to ipilimumab, the current standard of care for advanced melanoma. Today's approval allows marketing of pembrolizumab in all 28 EU member states at the approved dose of 2 mg/kg every three weeks. "Today's European approval supports our goal of accelerating immuno-oncology research for the benefit of patients around the world," said Dr. Roger M. Perlmutter, president, Merck Research Laboratories. "We believe that the broad data set supporting this approval helps illustrate the significant potential of pembrolizumab to treat advanced melanoma, a devastating disease." "MSD has long-believed that innovation and access must go hand-in-hand, which is why we work to bring forward new innovations, and ensure access to those innovations," said Deepak Khanna, senior vice president and regional president, Europe, MSD Oncology. "MSD is committed to working collaboratively with governments and other stakeholders to ensure that pembrolizumab will be made available to advanced melanoma patients in Europe as rapidly as possible."