European Regulatory Review for Merck's PD-1 Inhibitor for Advanced Melanoma

It could be the first anti-PD-1 therapy in Europe, if approved.

European Commission

Merck, known as MSD outside the United States and Canada, today announced the European Medicines Agency (EMA) has accepted for review a Marketing Authorization Application (MAA) for pembrolizumab (MK-3475), the company’s investigational anti-PD-1 antibody, for the treatment of advanced melanoma. If approved by the (EC), pembrolizumab has the potential to be the first anti-PD-1 therapy in Europe. Additional regulatory filings in other countries outside of Europe are planned by the end of 2014.

“With the five-year survival rate for patients with advanced melanoma at less than 20 percent, there remains a need to offer patients additional options,” said Dr. Roy Baynes, senior vice president, clinical development, Merck Research Laboratories. “We are pleased to have regulatory applications under review in the United States and Europe as we work toward bringing pembrolizumab to patients around the world.”

Source: MarketWatch