EMA accepts pembrolizumab to the Merck MAA review for the treatment of advanced melanoma -
Merck (NYSE: MRK), 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), an experimental anti-PD-1 antibody of the company, for the treatment of advanced melanoma. If approved by the European Commission (EC), pembrolizumab has the potential to be the first anti-PD-1 therapy in Europe. Additional regulatory filings in other countries outside Europe are planned by the end of 2014.
"With the rate of five-year survival for patients with advanced melanoma less 20 percent, there is a need to offer patients additional options, "said Dr. Roy Baynes, vice president, clinical development, Merck Research Laboratories. "We are pleased to have regulatory applications to study in the US and Europe, we are working to pembrolizumab to patients around the world."
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