EMA accepts Merck's pembrolizumab MAA for review

US pharma giant Merck & Co (NYSE:MRK) says that the European Medicines Agency 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 European Commission, 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, the company said.

“With the five-year survival rate for patients with advanced melanoma at less than 20%, there remains a need to offer patients additional options,” said Roy Baynes, senior vice president, clinical development, at Merck Research Laboratories, adding: “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.”