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Published on 3 July 2014

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Pembrolizumab under regulatory review

MSD has announced that 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 European Commission (EC), pembrolizumab has the potential to be the first licensed anti-PD-1 therapy in Europe. Additional regulatory filings in other countries outside of Europe are planned by the end of 2014.

MSD has announced that 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 European Commission (EC), pembrolizumab has the potential to be the first licensed 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 Roy Baynes, MD, 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.”



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